New York City, NY, United States
New York City, NY, United States

Pfizer, Inc. /ˈfaɪzər/ is an American multinational pharmaceutical corporation headquartered in New York City, and with its research headquarters in Groton, Connecticut, United States. It is one of the world's largest pharmaceutical companies by revenues.Pfizer develops and produces medicines and vaccines for a wide range of medical disciplines, including immunology, oncology, cardiology, diabetology/endocrinology, and neurology. Pfizer's products include the blockbuster drug Lipitor , used to lower LDL blood cholesterol; Lyrica ; Diflucan , an oral antifungal medication; Zithromax , an antibiotic; Viagra ; and Celebrex/Celebra , an anti-inflammatory drug.Pfizer was founded by cousins Charles Pfizer and Charles F. Erhart in New York City in 1849 as a manufacturer of fine chemicals. Pfizer's discovery of Terramycin in 1950 put it on a path towards becoming a research-based pharmaceutical company. Pfizer has made numerous acquisitions, including Warner–Lambert in 2000, Pharmacia in 2003 and Wyeth in 2009. The Wyeth acquisition was the largest of the three at US$68 billion. Pfizer is listed on the New York Stock Exchange, and its shares have been a component of the Dow Jones Industrial Average since April 2004.In September 2009, Pfizer pleaded guilty to the illegal marketing of the arthritis drug Bextra for uses unapproved by the U.S. Food and Drug Administration , and agreed to a $2.3 billion settlement, the largest health care fraud settlement at that time. Pfizer also paid the U.S. government $1.3 billion in criminal fines related to the "off-label" marketing of Bextra, the largest monetary penalty ever rendered for any crime. Called a repeat offender by prosecutors, this was Pfizer's fourth such settlement with the U.S. Department of Justice in the previous ten years. Wikipedia.


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The present disclosure generally relates to nanoparticles comprising an endo-lysosomal escape agent, a nucleic acid, and a polymer. Other aspects include methods of making and using such nanoparticles.


The present disclosure generally relates to nanoparticles comprising a substantially hydrophobic acid, a basic therapeutic agent having a protonatable nitrogen, and a polymer. Other aspects include methods of making and using such nanoparticles.


Patent
Pfizer | Date: 2016-11-03

A compound having the structure: or a pharmaceutically acceptable salt thereof, or a pharmaceutically acceptable solvate of said compound or pharmaceutically acceptable salt, wherein A and A are independently C or N, where C may be unsubstituted or substituted by halo or C_(1)-C_(6 )alkyl; R and R^(0 )are independently selected from the group consisting of H, C_(1)-C_(6 )alkyl, hydroxy(C_(1)-C_(6 )alkyl), phenyl(C_(1)-C_(6 )alkyl), and (CH_(2))_(n)W, where W is C_(3)-C_(8 )cycloalkyl, phenyl, naphthyl, 5- or 6-membered heteroaryl or heterocyclic containing 1-3 N, S and/or O atoms, SO_(2)R, NHSO_(2)R, NRSO_(2)R and SR, where R and R are independently C_(1)-C_(6 )alkyl or C_(3)-C_(8 )cycloalkyl, etc.; wherein each of said alkyl, cycloalkyl, heterocyclic, phenyl, naphthyl or heteroaryl may be unsubstituted or substituted by phenyl, heteroaryl, etc.; or, R and R^(0 )and the N atom to which they are bonded together form a monocyclic or bicyclic heterocyclic ring which may be unsubstituted or substituted by (a) halo, hydroxy, heteroaryl, C_(1)-C_(6 )alkyl, C_(1)-C_(6 )alkoxy, etc., or (b) (CH_(2))_(n)W, where W is C_(3)-C_(8 )cycloalkyl, phenyl, etc.; R^(1 )is H, halo or cyano; R^(2 )and R^(2 )are independently H, C_(1)-C_(6 )alkyl, cyano, C_(1)-C_(6 )alkoxy, C_(1)-C_(6 )alkylthio, or C_(3)-C_(8 )cycloalkyl where alkyl, alkoxy, or cycloalkyl is optionally substituted by one or more fluorine atoms; X is a bond, CO, CONH, SO_(2), SONH, or (CH_(2))_(m); R^(3 )is H, C_(1)-C_(4 )alkyl, phenyl, naphthyl, 5- or 6-membered heteroaryl or heterocyclic containing 1-3 N atoms, a 5-membered heteroaryl or heterocyclic, etc., or (c) 2 O or S atoms and 0-2 N atoms; wherein each of said phenyl, naphthyl, heteroaryl or heterocyclic is optionally substituted by alkyl, 1 substituent YR^(4 )and/or 1-4 substituents each independently selected from R^(5); with the proviso that when X is CO or SO_(2), R^(3 )is not H; Y is a bond, (CH_(2))_(m) or O; R^(4 )is (a) H, C_(1)-C_(6 )alkyl, C_(3)-C_(8 )cycloalkyl, halo, oxo, OR^(6), NR^(7)R^(8), SR^(6), SOR^(9), SO_(2)R^(9), COR^(6), OCOR^(6), COOR^(6), NR^(6)COR^(6), CONR^(7)R^(8), etc.; (b) phenyl or naphthyl, said phenyl and naphthyl being optionally substituted with 1-5 substituents selected from C_(1)-C_(6 )alkyl, C_(3)-C_(8 )cycloalkyl, halo, cyano, OR^(6), NR^(7)R^(8), etc.; or (c) a 3 to 8-membered saturated or partially unsaturated monocyclic heteroaryl, etc.; R^(6 )is H, C_(1)-C_(6 )alkyl or C_(3)-C_(8 )cycloalkyl, etc.; R^(7 )and R^(8 )are each independently H, C_(1)-C_(6 )alkyl or C_(3)-C_(8 )cycloalkyl or are taken together with the nitrogen atom to which they are attached to form a 4-, 5- or 6-membered saturated heterocyclic ring containing 1-2 nitrogen atoms or 1 nitrogen and 1 oxygen atom, said C_(1)-C_(6 )alkyl is optionally substituted by C_(3)-C_(8 )cycloalkyl, halo, etc., and said heterocyclic ring being optionally substituted by one or more C_(1)-C_(6 )alkyl or C_(3)-C_(8 )cycloalkyl groups; R^(9 )is C_(1)-C_(6 )alkyl or C_(3)-C_(8 )cycloalkyl; and, m and n are independently 0, 1, 2 or 3. The invention also relates to pharmaceutically acceptable salts of these compounds and to pharmaceutically acceptable solvates thereof; to compositions containing such compounds; and to the uses of such compounds in the treatment of various diseases, particularly asthma and COPD.


The present disclosure generally relates to therapeutic nanoparticles. Exemplary nanoparticles disclosed herein may include about 0.1 to about 50 weight percent of a corticosteroid; and about 50 to about 99 weight percent biocompatible polymer.


Patent
Pfizer and Stemcentrx Inc. | Date: 2016-06-08

The present invention provides for anti-EFNA4 antibody-drug conjugates and methods for preparing and using the same.


Patent
Pfizer and Kyowa Hakko Kirin Co. | Date: 2015-05-15

The present disclosure describes combination therapies comprising an antibody which specifically binds to human CCR4 and a selective 4-1BB agonist, and the use of the combination therapies for the treatment of cancer.


The present invention provides, in part, compounds of Formula (I): and pharmaceutically acceptable salts thereof; processes for the preparation of; intermediates used in the preparation of; and compositions containing such compounds or salts, and their uses for treating D1-mediated (or D1-associated) disorders including, e.g., schizophrenia (e.g., its cognitive and negative symptoms), schizotypal personality disorder, cognitive impairment (e.g., cognitive impairment associated with schizophrenia, AD, PD, or pharmacotherapy therapy), ADHD, Parkinsons disease, anxiety, and depression.


Patent
Pfizer | Date: 2016-05-16

Disclosed herein are humanized antibodies in which human germline residues are introduces to the complementarity determining regions (CDRs) of a non-human donor antibody. Also described herein are libraries of antibody variable domains (e.g., phage-display libraries) and methods for screening for humanized antibodies.


The invention relates to antibodies, and antigen-binding fragments thereof, that specifically bind TFPI and inhibit an activity thereof. Such antibodies and fragments are useful for treating bleeding disorders and shortening clotting time.


The present invention provides, in part, compounds of Formula I: and pharmaceutically acceptable salts thereof; processes for the preparation of; intermediates used in the preparation of; and compositions containing such compounds or salts, and their uses for treating MAGL-mediated diseases and disorders including, e.g., pain, an inflammatory disorder, traumatic brain injury, depression, anxiety, Alzheimers disease, a metabolic disorder, stroke, or cancer.


This invention relates to a novel crystalline form of 6-[(4R)-4-methyl-1,1-dioxido-1,2,6-thiadiazinan-2-yl]isoquinoline-1-carbonitrile which is useful as a selective androgen receptor modulator (SARM), and to compositions thereof and suitable processes for the preparation thereof.


The present invention provides novel imidazo[4,5-c]quinoline and imidazo[4,5-c][1,5]naphthyridine derivatives of Formula (I), and the pharmaceutically acceptable salts thereof wherein R^(1), R^(1a), R^(1b), R^(2), R^(4), R^(5), R^(6), X and Z are as defined in the specification. The invention is also directed to pharmaceutical compositions comprising the compounds of Formula (I) and to use of the compounds in the treatment of diseases associated with LRRK2, such as neurodegenerative diseases including Parkinsons disease or Alzheimers disease, cancer, Crohns disease or leprosy.


The present invention provides, in part, compounds of Formula (I): and pharmaceutically acceptable salts thereof; processes for the preparation of; intermediates used in the preparation of; and compositions containing such compounds or salts, and their uses for treating D1-mediated (or D1-associated) disorders including, e.g., schizophrenia (e.g., its cognitive and negative symptoms), schizotypal personality disorder, cognitive impairment (e.g., cognitive impairment associated with schizophrenia, AD, PD, or pharmacotherapy therapy), ADHD, Parkinsons disease, anxiety, and depression.


The present invention provides, in part, compounds of Formula (I) and pharmaceutically acceptable salts thereof; processes for the preparation of; intermediates used in the preparation of; and compositions containing such compounds or salts, and their uses for treating D1-mediated (or D1-associated) disorders including, e.g., schizophrenia (e.g., its cognitive and negative symptoms), schizotypal personality disorder, cognitive impairment (e.g., cognitive impairment associated with schizophrenia, AD, PD, or pharmacotherapy therapy), ADHD, Parkinsons disease, anxiety, and depression.


Patent
Pfizer and Amgen Inc. | Date: 2016-03-31

The present invention relates to antibodies including human antibodies and antigen-binding portions thereof that specifically bind to MAdCAM, preferably human MAdCAM and that function to inhibit MAdCAM. The invention also relates to human anti-MAdCAM antibodies and antigen-binding portions thereof. The invention also relates to antibodies that are chimeric, bispecific, derivatized, single chain antibodies or portions of fusion proteins. The invention also relates to isolated heavy and light chain immunoglobulins derived from human anti-MAdCAM antibodies and nucleic acid molecules encoding such immunoglobulins. The present invention also relates to methods of making human anti-MAdCAM antibodies, compositions comprising these antibodies and methods of using the antibodies and compositions for diagnosis and treatment. The invention also provides gene therapy methods using nucleic acid molecules encoding the heavy and/or light immunoglobulin molecules that comprise the human anti-MAdCAM antibodies. The invention also relates to transgenic animals or plants comprising nucleic acid molecules of the invention.


The present invention is directed to compounds, tautomers and pharmaceutically acceptable salts of the compounds which are disclosed, wherein the compounds have the structure of Formula I,


The present invention is directed to compounds, tautomers and pharmaceutically acceptable salts of the compounds which are disclosed, wherein the compounds have the structure of Formula I, wherein the variables R^(1), R^(2), R^(3), R^(4 )and X are as defined in the specification. Corresponding pharmaceutical compositions, methods of treatment, methods of synthesis, and intermediates are also disclosed.


The present invention is directed to compounds, tautomers and pharmaceutically acceptable salts of the compounds which are disclosed, wherein the compounds have the structure of Formula I, and the variables R^(1), R^(2 )and R^(3 )are as defined in the specification. Corresponding pharmaceutical compositions, methods of treatment, methods of synthesis, and intermediates are also disclosed.


Patent
Rinat Neuroscience and Pfizer | Date: 2015-04-21

The present invention provides transglutaminase-mediated antibody-drug conjugates with high anti-body-drug ratio (DAR) comprising 1) glutamine-containing tags, endogenous glutamines, and/or endogenous glutamines made reactive by antibody engineering or an engineered transglutaminase (e.g., with altered substrate specifity); and 2) amine donor agents comprising amine donor units, linkers, and agent moieties, wherein the DAR is at least about 5. The invention also provides methods of making and methods of using such higher drug loaded antibody-drug conjugates.


Patent
Pfizer | Date: 2015-04-17

The present invention relates to compounds of formula (I)


The present invention provides, in part, compounds of Formula I: and pharmaceutically acceptable salts thereof; processes for the preparation of; intermediates used in the preparation of; and compositions containing such compounds or salts, and their uses for treating D1-mediated (or D1-associated) disorders including, e.g., schizophrenia (e.g., its cognitive and negative symptoms), cognitive impairment (e.g., cognitive impairment associated with schizophrenia, AD, PD, or pharmacotherapy therapy), ADHD, impulsivity, compulsive gambling, overeating, autism spectrum disorder, MCl, age-related cognitive decline, dementia, RLS, Parkinsons disease, Huntingtons chorea, anxiety, depression, MDD, TRD, bipolar disorder, chronic apathy, anhedonia, chronic fatigue, post-traumatic stress disorder, seasonal affective disorder, social anxiety disorder, post-partum depression, serotonin syndrome, substance abuse and drug dependence, drug abuse relapse, Tourettes syndrome, tardive dyskinesia, drowsiness, excessive daytime sleepiness, cachexia, inattention, sexual dysfunction, migraine, SLE, hyperglycemia, atherosclerosis, dislipidemia, obesity, diabetes, sepsis, post-ischemic tubular necrosis, renal failure, hyponatremia, resistant edema, narcolepsy, hypertension, congestive heart failure, postoperative ocular hypotonia, sleep disorders, and pain.


Patent
Vanderbilt University and Pfizer | Date: 2015-02-20

Disclosed herein are improved optical detection methods comprising interferometric detection systems and methods of detecting a binding interaction between a sample comprising uncultured tissue homogenate and an analyte, together with various applications of the disclosed techniques. This abstract is intended as a scanning tool for purposes of searching in the particular art and is not intended to be limiting of the present invention.


The present invention relates to novel polymorphic forms of 8-fluoro-2-{4-[(methylamino)methyl]phenyf}-1,3,4,5-tetrahydro-6H-azepino(5,4,3-cd]indol-6-one;(I), and to processes for their preparation. Such polymorphic forms may be a component of a pharmaceutical composition and may be used to treat a mammalian disease condition mediated by poly(ADP-ribose) polymerase activity including the disease condition such as cancer.


A procedure to isolate large quantities of capsular polysaccharides (CPS) from culture supernatants as well as bacterial cells of gram-negative arid gram-positive bacteria using base extraction is described. The procedure is simple, rapid, reproducible and applicable to a variety of bacterial species. The method also yields novel CPS characterized by their lack of covalent attachment to extraneous peptidoglycan. Vaccines and methods of immunization against bacterial infection using the CPS obtained by the process of the invention are also disclosed.


Numerous recent reports document a lack of reproducibility of preclinical studies, raising concerns about potential lack of rigor. Examples of lack of rigor have been extensively documented and proposals for practices to improve rigor are appearing. Here, we discuss some of the details and implications of previously proposed best practices and consider some new ones, focusing on preclinical studies relevant to human © 2014 Elsevier Inc.


Patent
Stem CentRx and Pfizer | Date: 2014-10-28

The present invention provides for anti-EFNA4 antibody-drug conjugates and methods for preparing and using the same.


Patent
Pfizer and Agouron Pharmaceuticals Inc. | Date: 2014-06-06

Enantiomerically pure compound of formula 1 are provided, as well as methods for their synthesis and use. Preferred compounds are potent inhibitors of the c-Met protein kinase, and are useful in the treatment of abnormal cell growth disorders, such as cancers.


The CRYDIS exchange programme will establish and support international and inter-sectoral transfer of knowledge and expertise in pharmaceutical and instrument science between several EU research institutes and industrial companies. It will also enhance understanding of the value of inter-sectoral exchange mechanisms for taking research to market. CRYDIS undertakes innovative, collaborative research on the clinically-important topic of dissolution of drug substance particles in bio-relevant media and the undesired subsequent nucleation and re-precipitation of the drug prior to its absorption. Using innovative advances in UV imaging technology, CRYDIS investigates the utility of novel dissolution assays as key tools to obtain fundamental data on the mechanism and kinetics of undesired nucleation and re-precipitation during or following dissolution, a significant problem for the pharmaceutical industry which struggles to obtain sufficient exposure to poorly soluble drug substances to ensure an effective dose is absorbed by the patient. The key technologies in this proposal offer a step change in capability and functionality, offering the potential to undertake more detailed studies of the dissolution/re-precipitation processes relevant to pharmaceutical materials. Access to this key technology and the further development of its capability offers the potential for breakthroughs in development of process understanding and of robust and widely applicable protocols. Additional value is brought to CRYDIS through close working with synergistic European networks, leveraging a greater knowledge input and impact outreach. Running parallel with the science programme, an innovation management work-package analyses effectiveness of the exchange mechanism in building a shared culture, transferring knowledge and developing understanding of processes that drive a product to market. The outcomes of this will be used to advise and drive potential future exchange activities.


Grant
Agency: GTR | Branch: EPSRC | Program: | Phase: Research Grant | Award Amount: 5.84M | Year: 2011

In the 1980s it began to be possible to produce potentially unlimited quantities of human proteins by placing the gene defining them in a simple organism such as yeast. From this grew a new kind of medicine capable of treating conditions such as severe arthritis, haemophilia, growth deficiency, and some cancers that previously had no satisfactory treatments. As well as having great clinical value the resulting technology has become the basis of a new and fastest growing part of the pharmaceutical industry, described as biopharmaceuticals. Because the molecules involved are proteins, they are orders of magnitude larger and more complex than conventional drugs such as aspirin and their processing is much more demanding. They are also so complex that they cannot in general be characterised with precision except in relation to the methods by which they are made. That means the capacity to precisely define such processes is critical to clinical safety and commercial success. Full scale trials of the processes are so costly they can only be conducted once clinical promise is established but, given the number of factors governing processing of even first generation products, there have often been hold-ups so extensive as to delay availability to patients. UCL has pioneered micro scale methods that are sufficiently good at predicting efficient conditions for large scale performance that far fewer and better focussed large scale trials suffice. That resolves part of the problem but an even greater challenge is now emerging. The early biopharmaceuticals were in general the easiest ones to produce. The final scales were also relatively modest. Now, the next generation of biopharmaceuticals are more complex materials and with rising demand the scales are far larger so that processes push the boundaries of the possible. The combined complexity of the product and the process with so many variables to consider means that the managers need better systematic means of supporting their decisions. Already the cost of developing a single biopharmaceutical can exceed 0.7 billion and take 10 years. With more advanced biopharmaceuticals these figures tend to rise and yet the worlds governments are facing a healthcare cost crisis with more older people. They therefore exert pressure on companies to reduce prices. Because the public wishes to have medicines that do not pose risks, regulations become ever more stringent so they are a major factor in defining the bioprocess. This also adds to the need for managers to have sector-specific decisional-support aids well grounded in the detailed engineering of the processes. Finally, it is now possible to apply molecular engineering to proteins and vaccines to enhance their therapeutic properties but this can also cause serious bioprocessing problems. The research vision developed with detailed input from UK industry experts will apply these methods as the foundation for another step change whereby much faster and lower cost information can be gathered and integrated with advanced decisional techniques to give managers a better foundation on which to base their policies. The academic team from leading UK universities provides the necessary continuum of skills needed to assess the ease of manufacture of novel drugs, the costs of processing and of delivery to patients. We will work with companies to test the outcomes to ensure they are well proven prior to use on new biopharmaceuticals. This will cut costs so that all the patients who might benefit can receive them and at the earliest possible date achieved within the severely restricted budgets now available to the NHS.


Grant
Agency: Cordis | Branch: FP7 | Program: CP-IP-SICA | Phase: KBBE.2010.1.3-01 | Award Amount: 12.38M | Year: 2011

Livestock production efficiency is impaired by helminth infection which is ubiquitous in cattle, sheep and goats world-wide. It causes severely debilitating gastro-intestinal, respiratory and hepatic disorders, dependent on the infecting species. The treatment and prevention of helminth parasitism in livestock continues to rely almost exclusively on the use of anthelmintic drugs, an approach threatened by the global emergence of anthelmintic resistance. An alternative approach is vaccination. Members of the present consortium (from the EU and Switzerland, North and South America, North and South Africa, Australia, 2 SMEs and 1 major animal health company) have developed prototype vaccines with the predicted required efficacy to control major gastro-intestinal nematode infections of livestock, notably Ostertagia ostertagi in cattle and Haemonchus contortus in sheep, the liver fluke Fasciola hepatica in sheep and cattle with leading positions in subunit vaccine development against Cooperia onchophora, Dictyocaulus viviparus in cattle and the tapeworm Echinococcus granulosus in dogs. This proposal aims to deliver at least one prototype vaccine to the point of uptake by the commercial sector or through government/philanthropic agencies and this will be addressed by 1) Developing effective native or synthetic vaccines, the latter using novel, molecular expression systems. 2) Defining the protective immune responses induced by these vaccines to order to optimise the structure of the antigens and the method of their delivery. 3) Defining vaccine efficacy with trials in both housed and grazing livestock 4) Providing a platform for training and knowledge exchange which includes participation in training programmes, short exchanges of staff, workshops,and web site provision. 5) Interacting closely with computer modellers, the animal health industry, farmer organisations and other stakeholders to define required vaccine characteristics. 6) Knowledge exchange/dissemination to policy makers, scientists, government departments and the general public.


Grant
Agency: Cordis | Branch: FP7 | Program: CP-FP | Phase: HEALTH-2007-2.4.5-11 | Award Amount: 4.04M | Year: 2008

Incontinence affects almost 66 million people in the European Union. The Over Active Bladder (OAB) symptom complex is one of the major causes for incontinence, with a large number of affected persons and immense associated health care costs. The causes for the over active bladder contractions, underlying the urinary urgency of OAB are unknown, and current treatments are only partially effective. This collaborative and translational project, involving interaction between experimental and clinical urology scientists will focus on OAB and will characterize the different interacting cellular components and signaling systems in the wall of normal urinary bladders and OAB. The release of local mediators in the bladder wall, the properties of a newly described cell type (the interstitial cells, which may play a role in bladder over activity), the sensory signaling pathways (TRPV1-receptors), the receptor interaction and cellular communication are considered in order to create an integrated view on the mechanisms of bladder over activity. A strong emphasis is put on interaction between basic science and clinical applications, using a translational approach involving both specific animal models and human tissue from patients with defined urodynamic information. Several ethical and logistic issues with the use of human tissue are specifically addressed. An important further aspect of the experiments on human tissue is a direct analysis of the links between genetic and the urodynamic data of the patients, using unique biobanks. This will allow us further insight into the mechanisms of disease and possibly to identify new therapeutic targets. In close collaboration with a small company, we will develop an innovative potential physical therapy to affect bladder function. We will develop novel pharmacotherapeutic strategies and diagnostic tools, based on the characterization of cell properties, gene expression, receptors signaling systems of the bladder wall.


Grant
Agency: Cordis | Branch: FP7 | Program: CSA-CA | Phase: KBBE.2010.1.3-02 | Award Amount: 1.09M | Year: 2011

Animal diseases can cause serious social, economic and environmental damage and in some cases also threaten human health. An increasing number of the major disease problems or threats faced by the livestock industry and zoonoses are of a global nature. The overall aim of the global strategic alliances for the coordination of research on the major infectious diseases of animals is to improve coordination of research activities on the major infectious diseases of livestock and zoonoses so as to hasten the delivery of improved control methods. This will be achieved through the establishment of an international forum of R&D programme owners/managers and international organisations for the purpose of sharing information, improving collaboration on research activities and working towards common research agendas and coordinated research funding on the major animal diseases affecting livestock production and/or human health. It will build on the groundwork established by the SCAR collaborative working group on animal health and welfare research, the EMIDA ERA-NET project and specific INCO-NETs involving partner countries. The scope of the project will include co-ordination of research relevant to emerging and major infectious diseases of livestock, including fish and managed bees, and those infections of livestock that may carry the risk of disease threat to human health. Diseases of wildlife will also be considered where they are identified as reservoirs of infection with emerging and major infectious diseases of humans or production animals. These objectives will be delivered through the following five workpackages: WP1. Project coordination, management, communication and dissemination; WP2. Sharing information on existing research programmes; WP3. Analysis of and responding to global, regional and industry sector priorities; WP4. Networking of ongoing research activities on major issues and WP5. Developing a strategic trans-national animal health research agendas.


GENEVA, Nov. 28, 2016 (GLOBE NEWSWIRE) -- Addex Therapeutics (SIX: ADXN) announced today the appointment of Roger G. Mills, M.D., to the newly created position of Chief Medical Officer. Dr. Mills brings more than 25 years of biopharmaceutical industry experience at both global pharmaceutical companies and biotechnology companies, including Acadia Pharmaceuticals, Pfizer, Gilead Sciences, Abbott Laboratories and Wellcome, across a spectrum of disease areas.  His extensive track record includes managing drug development programs from Investigational New Drug Application preparation through to post-marketing and OTC products, including NUPLAZID(TM) for the treatment of Parkinson's disease psychosis, as well as regulatory affairs and business development activities.  Most recently, Dr. Mills was with Acadia Pharmaceuticals for nine years, serving as Executive Vice President, Development and Chief Medical Officer.  In this role, he oversaw the largest ever international phase III program in Parkinson's disease psychosis, and led the Company's New Drug Application submission to the US Food and Drug Administration (FDA) for NUPLAZID, which was subsequently approved and remains the first and only medication approved by the FDA in this indication. "We are delighted to welcome Roger to the Addex team, he brings a unique blend of drug development expertise, commercial experience and US public biotechnology company operations knowledge," said Tim Dyer, CEO of Addex. "Roger's experience in helping to successfully and significantly grow Acadia will be invaluable to Addex as we continue to execute on our strategy to develop dipraglurant for levodopa-induced dyskinesia associated with Parkinson's disease." "I am excited to join Addex at such a critical juncture in the Company's corporate development," said Roger Mills. "Addex's development pipeline holds significant promise, and I look forward to applying my broad experience in the pharmaceutical industry and dealing with regulatory agencies to successfully advance the Company's product candidates." Dr. Mills currently serves as a Visiting Professor at the Centre for Age Related Diseases, Institute of Psychiatry, Psychology and Neuroscience, King's College London.  He received his medical degree from Imperial College, Charing Cross Hospital Medical School, London, UK. About Addex Therapeutics Addex Therapeutics (www.addextherapeutics.com) is a biopharmaceutical company focused on the development of novel, orally available, small molecule allosteric modulators for neurological disorders. Allosteric modulators are an emerging class of small molecule drugs which have the potential to be more specific and confer significant therapeutic advantages over conventional "orthosteric" small molecule or biological drugs.  Addex's allosteric modulator drug discovery platform targets receptors and other proteins that are recognized as essential for therapeutic intervention - the Addex pipeline was generated from this pioneering allosteric modulator drug discovery platform. Addex's lead drug candidate, dipraglurant (mGluR5 negative allosteric modulator or NAM) has successfully completed a phase IIa POC in Parkinson's disease levodopa-induced dyskinesia (PD-LID), and is being prepared to enter registration trials for PD-LID with support from the Michael J. Fox Foundation for Parkinson's Research (MJFF). In parallel, dipraglurant's therapeutic use in dystonia is being investigated with support from the Dystonia Medical Research Foundation (DMRF). Addex's second clinical program, ADX71149 (mGluR2 positive allosteric modulator or PAM) is being developed in collaboration with Janssen Pharmaceuticals, Inc for epilepsy. In addition, ADX71441 (GABAB receptor PAM) has received regulatory approval to start phase I and is being investigated for its therapeutic use in Charcot-Marie-Tooth Type 1A disease (CMT1A), cocaine and alcohol use disorder and nicotine dependence. Discovery programs include mGluR4PAM for neurodegenerative diseases, mGluR7NAM for psychosomatic disorders and TrkBPAM for neurodegenerative disorders which are being advanced in collaboration with the Universities of Lausanne and Geneva under the Swiss CTI grant program; and mGluR3PAM which is being advanced in collaboration with Pierre Fabre Pharmaceuticals. Disclaimer / Forward-looking statements: This communication does not constitute an offer or invitation to subscribe for or purchase any securities of Addex Therapeutics Ltd. This publication may contain certain forward-looking statements concerning the Company and its business. Such statements involve certain risks, uncertainties and other factors which could cause the actual results, financial condition, performance or achievements of the Company to be materially different from those expressed or implied by such statements. Readers should therefore not place undue reliance on these statements, particularly not in connection with any contract or investment decision. The Company disclaims any obligation to update these forward-looking statements.


News Article | February 27, 2017
Site: globenewswire.com

HARTFORD, Conn., Feb. 27, 2017 (GLOBE NEWSWIRE) -- The Connecticut Technology Council (CTC) is pleased to announce the 50 women who have been selected as Women of Innovation finalists for the 2017 Women of Innovation awards program. The Women of Innovation® program seeks to celebrate and create a growing network of women in the “trenches” of STEM. Finalists are the scientists, researchers, academics, manufacturers, student leaders, drafters, entrepreneurs, and technicians who create tomorrow’s advancements through their efforts in Connecticut today. The 50 finalists will be recognized at the Women of Innovation® awards gala at the Aqua Turf Club in Plantsville on March 29 from 5 p.m. to 8:30 p.m. A winner in each of the eight award categories will be announced live during the program. The keynote speaker at this year’s ceremony is Adda Birnir, Founder and CEO of Skillcrush, a woman-centric online learning community that helps advance digital skills and creativity, and has been featured on the BBC, Mashable, Fast Company, and Business Insider. Tickets, registration, and details are available online at the CTC website, www.CT.org. The complete list of 2017 Women of Innovation® Finalists is posted below. “For the last twelve years, the Women of Innovation awards ceremony has honored outstanding women who have made significant professional, academic, and community achievements,” said Bruce Carlson, President and CEO of the Connecticut Technology Council. “The 2017 Women of Innovation awards dinner will continue our tradition of celebrating these women and their accomplishments, and marks our expanding program offerings to include and professional growth opportunities to all involved with Women of Innovation, a move aligned with the Connecticut Technology Council’s new strategic initiatives. These initiatives work to fill clear needs in the tech ecosystem here in the state.” The Women of Innovation® program is aligned with CTC’s Talent & Workforce strategic initiative, which is dedicated to bringing a robust tech talent pipeline to Connecticut. Diversity hiring is a significant facet of the Talent & Workforce initiative. Other initiatives include Growth & Innovation, dedicated to serving companies in the growth phase, and the IT & Infrastructure initiative, which focuses on supporting and advocating for the best in tech resources and infrastructure here in Connecticut. Women of Innovation® finalists are nominated by their peers, coworkers, and mentors, and are selected based on their professional experience, history of innovation, ability to think creatively and solve problems, and demonstration of leadership. Students are judged on inventiveness, accomplishment in science and technology, independent research, and academic achievement. This year’s 50 finalists includes researchers, educators, engineers, managers, students and entrepreneurs who work or study biotech, pharmaceuticals, software, computer hardware, advanced materials, medical devices, IT, or associated fields. High school, undergraduate and graduate students who have demonstrated extraordinary and unique achievements in their technology disciplines are also among the finalists. The winner in the Youth Innovation and Leadership category will receive a $4,000 scholarship from Medtronic, one of the program’s presenting sponsors. Women of Innovation® is presented in conjunction with the following companies: Day Pitney LLP, Medtronic Inc, and United Technologies Corporation. The program is supported by Pfizer Inc. and Pitney Bowes Inc., with contributions from Premier Limousine and Marcum LLP. For questions regarding the program or awards dinner please contact Paige Rasid at 860.289.0878 x335. Below is a list of the 2017 Women of Innovation® with their affiliated organizations and town of employment or hometown: Jennifer McFadden, Yale University, Madison Summer McGee, University of New Haven, West Haven Janice Naegele, Wesleyan University, Middletown Michelle Bellinger, Academy of Aerospace & Engineering, West Hartford Nivea Torres, Connecticut Technical High School System (CTHSS), Middletown Jun Chen, University of Connecticut, School of Engineering, Storrs Deborah Dorcemus, University of Connecticut, Danbury Erin Duffy, Yale University, West Haven Wafa Elmannai, University of Bridgeport, Bridgeport Manisha Mishra, University of Connecticut, Storrs Jessica Angier, Hybrid Intelligence, Inc., Shelton                                Jessica Bailey, Greenworks Lending, Darien Wendy Davis, GestVision, Inc., Guilford Marcia Fournier, Bioarray Genetics, Farmington Ellen Matloff, My Gene Counsel, LLC, North Haven Melissa Baran, Sikorsky Aircraft, A Lockheed Martin Company, Stratford Vicki Conant, Sikorsky Aircraft, A Lockheed Martin Company, Stratford Jennifer Graham, Sikorsky Aircraft, A Lockheed Martin Company, Stratford Karen Iannella, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield Jacqueline Jones, PhD., Medtronic, Branford Bhagyashree Khunte, Pfizer, Inc., Groton Jeanne Larsen, UTC Aerospace Systems, Windsor Locks Ping Liu, Sikorsky Aircraft, A Lockheed Martin Company, Stratford Devu Manikantan Shila, Ph.D, United Technologies Research Center, East Hartford Jennifer McLaurin, UTC Aerospace Systems, Windsor Locks Lindsay O'Donnell, Sikorsky Aircraft, A Lockheed Martin Company, Naugatuck Kremena Simitchieva, Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield Susan Baserga, Yale School of Medicine, New Haven Jinbo Bi, University of Connecticut, Storrs Alison Gotkin, United Technologies Research Center, East Hartford Nancy Petry, UConn Health, Farmington Danyel Racenet, Medtronic, North Haven Kelly Valentine, Medtronic, North Haven Christine Wetzel, 3M, Meriden Margaret Bailey, Sonalysts, Waterford Jeanine Gouin, Milone & MacBroom, Inc., Cheshire Chun Li, Diameter Health, Farmington Mary Ellen Mateleska, Mystic Aquarium, a division of Sea Research Foundation, Mystic Feliciatas Thurmayr, MD, PhD., Quality Health Ideas, Inc., Suffield Meghan West, CNC Software Inc /Mastercam, Tolland The Connecticut Technology Council is a statewide association of technology oriented companies and institutions, providing leadership in areas of policy advocacy, community building and assistance for growing companies. Speaking for over 2,000 companies that employ some 200,000 residents, the Connecticut Technology Council seeks to provide a strong and urgent voice in support of the creation of a culture of innovation. This includes working to position Connecticut as a leader in idea creation, workforce preparation, entrepreneurial aptitude, early stage risk capital availability and providing on-going support and mentoring to high potential firms. For more information, visit www.ct.org.


News Article | February 15, 2017
Site: www.eurekalert.org

A new investigational delivery method for localized vaginal estrogen therapy that utilizes an applicator free softgel to alleviate moderate-to-severe vaginal pain during intercourse (dyspareunia), a symptom of vulvar and vaginal atrophy (VVA), received high rates of patient satisfaction among post-menopausal women, according to post-trial survey results published in the journal Menopause. "These survey results show that something as simple as a change to a more elegant delivery system that is easier to use and not messy might empower more post-menopausal women to seek prescription treatment for VVA, and perhaps help them stay with the application guidelines for longer," said study first author Sheryl Kingsberg, PhD, Division Chief, OB/GYN Behavioral Medicine, UH Cleveland Medical Center; Professor of Obstetrics and Gynecology and Psychiatry, Case Western Reserve University School of Medicine; and first author of the survey analysis. "We still have to find better ways to educate the millions of women suffering with VVA about the symptoms, however, so that more of them know it is common, decide to discuss treatment with their healthcare professional, and seek symptom relief with appropriate treatment." The new results were part of a multi-center randomized, placebo-controlled phase 3 clinical trial for TX004HR, an investigational bio-identical 17β-estradiol applicator free vaginal softgel capsule. Previous publications have shown TX004HR to be safe and effective at alleviating symptoms of VVA. The survey, which included 731 respondents with a 96 percent response rate, sought to quantify participants' satisfaction with the application method and overall treatment delivery system. The majority of women taking either TX004HR or placebo (85.4 - 92.1 percent) found the product easy to use. VVA is a chronic condition associated with genitourinary syndrome of menopause (GSM). VVA affects 50 to 70 percent of post-menopausal women, and is characterized by pain with sexual activity, dryness, and discomfort. Current on-the-market treatments for VVA include both over-the-counter creams and moisturizers as well as several safe and effective prescription treatments in cream, tablet, ring or oral form. Previous survey research completed by Dr. Kingsberg and others has shown that while 32 million women may be experiencing symptomatic VVA and suffering from related impacts on sexual function, interpersonal relationships, self-esteem and overall quality of life, only 7 percent are currently using a prescription therapy to alleviate symptoms. Though they may suffer from physical and emotional pain as a result of VVA, women may not feel comfortable discussing these symptoms with a healthcare professional, may not recognize the symptoms as treatable, may not fully understand the treatment options available, or if they did receive treatment, found the current prescription treatment options inconvenient, messy, or uncomfortable to use. Financial disclosure: Dr. Kingsberg has served as a consultant for TherapeuticsMD, the manufacturer of TX004HR, as well as Acerus Pharmaceuticals, AMAG Pharmaceuticals, Bayer Healthcare, Emotional Brain, Materna, Novo Nordisk, Nuelle, Palatin Technologies, Pfizer, Sermonix Pharmaceuticals, Shionogi Inc. and Valeant Pharmaceuticals. Founded in 1866, University Hospitals serves the needs of over 1 million patients per year through an integrated network of 18 hospitals, more than 40 outpatient health centers and 200 physician offices in 15 counties throughout northern Ohio. The system's flagship academic medical center, University Hospitals Cleveland Medical Center, located on a 35-acre campus in Cleveland's University Circle, is affiliated with Case Western Reserve University School of Medicine. The main campus also includes University Hospitals Rainbow Babies & Children's Hospital, ranked among the top children's hospitals in the nation; University Hospitals MacDonald Women's Hospital, Ohio's only hospital for women; and University Hospitals Seidman Cancer Center, part of the NCI-designated Case Comprehensive Cancer Center. UH is home to some of the most prestigious clinical and research programs in the nation, including cancer, pediatrics, women's health, orthopedics, radiology, neuroscience, cardiology and cardiovascular surgery, digestive health, dermatology, transplantation and urology. UH Cleveland Medical Center is perennially among the highest performers in national ranking surveys, including "America's Best Hospitals" from U.S. News & World Report. UH is also home to Harrington Discovery Institute at University Hospitals - part of The Harrington Project for Discovery & Development. UH is the second largest employer in northern Ohio with 26,000 employees. For more information, go to UHhospitals.org.


- Designation is first step to inclusion in Early Access to Medicines Scheme ("EAMS"), providing patients with faster access to innovative medicines GAITHERSBURG, Maryland, Nov. 2, 2016 /PRNewswire/ -- Vtesse, Inc., a company committed to developing drugs that will benefit patients with extremely rare, life-threatening diseases, announced today that the MHRA, an executive agency of the Department of Health in the United Kingdom that is responsible for ensuring that medicines and medical devices are acceptably safe, has granted a Promising Innovative Medicine ("PIM") designation for VTS-270, Vtesse's investigational drug for children with Niemann-Pick Type C1 disease ("NPC"). "It is extremely gratifying to the NPC community, to the team at Vtesse, and to all of the individuals, organizations, and institutions who are tirelessly working on the development of VTS-270 that it has been recognized by the MHRA as a scientific innovation that may improve the lives of people living with NPC," said Ben Machielse, Drs., President and Chief Executive Officer of Vtesse, Inc. "It takes considerable collaboration and dedication to advance the clinical study and regulatory processes for drug development in the rare disease space. Above all, we thank all the parents who have supported the development of VTS-270." "This UK PIM designation, coupled with the U.S. FDA Breakthrough Therapy Designation granted earlier this year, demonstrates the strength of the preliminary clinical data of NPC treatment with VTS-270," added Kevin Johnson, PhD, MBA, Vice President, Regulatory Affairs at Vtesse. "Both designations afford us enhanced regulatory opportunities, which we will rely on as we complete our rigorous Phase 2b/3 clinical trial and seek regulatory approvals to bring this drug to market as quickly as possible." A PIM Designation is an early indication that a medicinal product is a promising candidate for the Early Access to Medicines Scheme ("EAMS"), in the treatment, diagnosis or prevention of life-threatening or seriously debilitating conditions with unmet need. The EAMS is a UK program run by the MHRA that aims to give patients with life-threatening conditions access to specified pre-license medicines when there is a clear medical need. "The PIM designation, which is based on Phase 1/2 clinical trial data from patients with NPC, is an important achievement for Vtesse, VTS-270 and the Niemann-Pick community," said Paul Gissen, PhD, MRCPCH, Great Ormond Street Hospital, who is an investigator in Vtesse's Phase 2b/3 clinical trial of VTS-270. "The MHRA's PIM designation is based on three criteria: a life-threatening or seriously debilitating condition with a high unmet medical need, a medicinal product that is likely to offer major advantages over current treatment used in the UK, and a reasonable expectation of a positive benefit-risk balance for patients. We look forward to continuing study with VTS-270, and – as a clinical investigator – I'm pleased that the MHRA has granted this designation." Results from the VTS-270 treated group in the intrapatient Phase 1/2 dose escalation study that, after 12 months and 18 months of monthly dosing, disease progression as measured by the NPC Neurological Severity Score (NSS) was reduced as compared to a matched natural history study control group. Changes in hearing, which were anticipated as an adverse event, and transient ataxia and transient fatigue were observed in the study. Vtesse's ongoing Phase 2b/3 clinical trial of VTS-270 is enrolling patients in the United Kingdom at Birmingham Children's Hospital and Great Ormond Street Hospital. The trial is also ongoing at sites in the United States, France, Germany, Spain, Turkey and Australia. For more information, including the current list of participating study sites, visit www.theNPCstudy.com. NPC is a progressive, irreversible, chronically debilitating – and ultimately lethal – genetic disease. It is caused by a defect in lipid transportation within the cell, which leads to excessive accumulation of lipids in the brain, liver and spleen. The NIH's National Center for Advancing Translational Sciences (NCATS) and Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) conducted the preclinical research and initiated the drug development phase for VTS-270 in close collaboration with parents and patient support groups. Vtesse is leading the late-stage drug development process. Vtesse, Inc. is a rare disease company dedicated to developing drugs for patients suffering from diseases that are underserved. Vtesse is working collaboratively with the NIH, other leading academic centers, parents, and patient advocacy groups, to advance a pivotal clinical study of VTS-270 (a well-characterized mixture of HPβCD with a specific compositional fingerprint that distinguishes it from other HPβCD mixtures) to treat NPC, and to conduct pre-clinical discovery and development of other novel drugs for NPC and other lysosomal storage diseases (LSDs). The company is led by a highly experienced management team that has been involved in the development of more than 20 approved drugs. An experienced consortium of investors, including Alexandria Venture Investments, Bay City Capital LLC, Lundbeckfond Ventures, New Enterprise Associates, and Pfizer Venture Investments, has committed initial funding adequate to bring VTS-270 through a pivotal clinical trial. Vtesse is based in Gaithersburg, Maryland and is the first spin-out company from Cydan Development, Inc. For more information, visit www.vtessepharma.com.


MIAMI, Feb. 28, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK), today announces that GeneDx, a subsidiary of OPKO Health, is proud to participate as a founding member in Illumina Inc.’s (NASDAQ:ILMN) iHope Network on International Rare Disease Day, which takes place today.  iHope Network is led by a group of clinical laboratory partners committed to providing clinical whole-genome sequencing (cWGS) to children with undiagnosed rare diseases. The iHope program aims to offer this advanced technology to help end diagnostic odysseys that these patients and their families endure. In addition to GeneDx, the iHope Network currently consists of the following institutions: Illumina, the Garvan Institute of Medical Research, and Hudson Alpha. As an iHope Network partner, GeneDx has committed to donating 10 whole-genome sequencing tests per year. The variants identified through testing will be shared via public variant databases including ClinVar. By sharing this variant information, GeneDx continues its long-standing commitment to sharing data for better patient care while also contributing to the rare disorder community through further collaboration and research. “We are thrilled to have GeneDx as a founding member of the iHope Network, which will transform the lives of pediatric patients with limited access to resources and who need a genetic diagnosis quickly. As a leader in the field, GeneDx’s clinical whole-genome testing will prove invaluable to these families,” said Ryan Taft, PhD, Senior Director of the Scientific Research Population and Medical Genomics Department, Illumina. GeneDx was founded in 2000 by two scientists from the National Institutes of Health (NIH) with a mission to provide diagnostic testing for patients with rare and ultra-rare disorders. Today, GeneDx has grown into a global industry leader in genomics, having provided testing to patients and their families in over 55 countries. Led by its world-renowned whole exome sequencing program, and an unparalleled comprehensive genetic testing menu, GeneDx has a continued expertise in rare disorders. Both GeneDx and the iHope program strive to provide answers to those affected by rare diseases and to increase awareness for these disorders. “We are delighted to become a participating partner of Illumina’s iHope Network,” said Jane Juusola, PhD, FACMG, Director of the Clinical Genomics Program, GeneDx. “As a laboratory founded to address the needs of patients diagnosed with rare genetic diseases, the very principle of the iHope program aligns with our founding mission. Through our donation of 10 whole-genome sequencing tests, we hope to bring closure to the diagnostic odysseys for children with undiagnosed rare diseases.” GeneDx is a world leader in genomics with an acknowledged expertise in rare and ultra-rare genetic disorders, as well as one of the broadest menus of sequencing services available among commercial laboratories. GeneDx provides testing to patients and their families in more than 55 countries.  GeneDx is a business unit of BioReference Laboratories, a wholly owned subsidiary of OPKO Health, Inc.  To learn more, please visit www.genedx.com. For GeneDx’s complete list of testing options, please visit www.genedx.com or email genedx@genedx.com.  Follow on Twitter @GeneDx and become a fan on Facebook @GeneDxLab to get real-time updates. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes BioReference Laboratories, the nation’s third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator for androgen deficiency indications. Our biologics business includes hGH-CTP, a once weekly human growth hormone injection (in Phase 3 and partnered with Pfizer), a long-acting oxyntomodulin for diabetes and obesity (in Phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), and such statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected benefits of the iHope program, that it will benefit patients with rare disease and better patient care, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, as well as the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


News Article | February 15, 2017
Site: www.prweb.com

Pierian Biosciences, the premier developer of life science technologies providing treatment directing data to aid physicians in selecting the most appropriate therapy for their patients with cancer, has named Mark S. Gelder, MD, as chief medical officer. “We rely on Mark to ensure the delivery of quality diagnostic assays: the immune-proximity assay, CEER®, recently renamed PathwayINTELTM, and our drug response profiling assay, MiCK®, recently renamed ChemoINTELTM,” says Robert Henry, president and chief executive officer of Pierian Biosciences. “We’ll also be looking for Mark to help us maintain our industry presence and guide the development of collaborative agreements with partners such as academic centers, pharmaceutical companies and oncologists.” In addition, Gelder provides medical, clinical and scientific oversight as well as helping to define the company’s strategic direction. Dr. Gelder brings more than 25 years of oncology clinical trial and drug development experience to Pieiran. He is board certified in Internal Medicine, Obstetrics and Gynecology and Gynecologic Oncology. As an experienced researcher and clinician, he has significant regulatory experience working closely with the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) and in various leadership roles at pharmaceutical companies including Pfizer, Wyeth, Bayer, GE Healthcare, Heron Therapeutics and Inovio Pharmaceuticals. A graduate of the University of Virginia School of Medicine, Gelder received his residency training in internal medicine at University of Virginia and an additional residency in obstetrics and gynecology at the University of Alabama at Birmingham. While at UAB, Gelder also completed a fellowship in gynecologic oncology. He is currently a fellow of the American College of Obstetrics and Gynecology. Pierian’s PathwayINTEL is a functional proteomic profiling assay which provides quantitative information on the expression and activation status of proteins of interest to identify the true oncogenic “driver” and allow selection of the most appropriate targeted and/or biologic therapy for cancer patients. ChemoINTEL, the company’s functional drug response profiling assay, provides actionable information to guide selection on the effectiveness of cytotoxic agents to enhance clinical treatment decision-making. About Pierian Biosciences Based in Franklin, Tenn., Pierian Biosciences is a privately held life sciences and clinical pathology laboratory company offering treatment-directing diagnostic data to support more effective and lower cost cancer treatment. The company’s technology includes the ChemoINTEL and the PathwayINTEL Assay platforms. The company has laboratories in Franklin, Tenn. and San Diego, CA. For more information visit http://pierianbio.com.


News Article | December 15, 2016
Site: www.rdmag.com

The Associated Press and the Center for Public Integrity investigated how pharmaceutical companies are using their political clout to push a new form of opioids as their answer to the epidemic of prescription painkiller abuse. The pills are marketed as abuse-deterrents because they usually are difficult to crush and dissolve, but they also are lucrative for the industry. — Lawmakers in 35 states introduced more than 100 bills over the last two years dealing with the harder-to-abuse opioids. Roughly half included nearly identical language requiring insurers to cover the new formulations, and several of the sponsors said they received the wording from pharmaceutical lobbyists. — At least 21 bills related to abuse-deterrent drugs have become state law in the last five years, including five that require insurers to pay for the more expensive drugs. — Manufacturers of abuse-deterrent opioids have spent more than $20 million on federal lobbying efforts that included legislation promoting those drugs between 2012 and 2015. — Drugmakers also have tried to influence state attorneys general. Two of the biggest, Purdue Pharma and Pfizer, gave a total of $950,000 to the Republican and Democratic attorneys general associations in 2015 and 2016, more than in the previous four years combined. — Abuse-deterrent painkillers represented less than 5 percent of all opioids prescribed last year but generated more than $2.4 billion in sales — roughly a quarter of the entire U.S. market for the drugs. — Converting the U.S. Department of Veterans Affairs medical system exclusively to the new formulations, according to one recent VA estimate, would increase its spending on prescription painkillers more than tenfold, to over $1.6 billion annually. — A federal bill passed this summer that includes a provision promoting abuse-deterrent opioids is expected to cost the federal government $75 million in lost Medicaid payments over 10 years. Makers of such harder-to-abuse drugs spent more than $1.7 million on lobbying efforts in 2016 that included that bill.


News Article | February 15, 2017
Site: www.prweb.com

Harold D. Span is pleased to announce the release of his new book, “Living in the Shadows of Love and Happiness.” Growing up during the time of segregation and limited opportunities for people of color, Span conquered conditioned fears, always thinking there was a meaning in my life that was more important than recognized. The book is “an amalgamation of life experiences, travels, scholarship, outreach, cultural awareness, and devotion,” says Span. "Living in the Shadows of Love and Happiness" provides the insight to guide those who need help with achieving love and happiness. The book is the result of personal experience. The end result is a feeling of wholeness, allowing the reader to finally enjoy love and happiness they deserve. “Read this book! Become self-empowered and remove all obstacles in the way of the true realization of your Black Potential!” –Ben Miles About Harold D. Span Harold D. Span is a husband, the father of a teenage son, and the founder and CEO of SASCO, Inc. and is judged by A.T. Kearney as one of three Best World-wide Promotional Products Suppliers. Since its inception in 1979, Span has been responsible for the overall development of SASCO, resulting in millions of dollars in annual revenue. Span received his Bachelors Of Science in Management from Tuskegee University and is a Pfizer Fellow of Dartmouth College’s Amos Tuck School of Business Administration. Span enjoys golf, international travel (Africa, Asia, Caribbean Islands), and voracious reading of newspapers, magazines, Anthropology, Psychology, biographies, and the Classics. His new book, “Living in the Shadows of Love and Happiness”, represents a compendium of those efforts.


SOUTH SAN FRANCISCO, Calif.--(BUSINESS WIRE)--Circle Pharma, Inc. today announced a Series A financing round in which it has issued over $4.5M of shares of Series A Preferred Stock. The financing was led by Mission Bay Capital, with Pfizer Inc. (NYSE:PFE), ShangPharma Investment Group, Ltd. and a syndicated group of individual investors joining the round. In connection with the financing, Walter H. Moos, Ph.D., representing ShangPharma, has joined the Circle Board of Directors. “We are delighted with the participation of such high caliber investors in our first equity round,” said David J. Earp, J.D., Ph.D., Circle’s president and CEO. “With our seed funding, we established Circle’s computational design platform, advanced our synthetic chemistry capabilities in collaboration with ChemPartner, and engaged in a target-based collaboration with Pfizer. The Series A funds will be used to support Circle’s therapeutic pipeline, which is focused on intracellular protein-protein interactions that are key drivers in oncogenic pathways. We are also now building a physical library of cell-permeable macrocycles to augment our computational design tools, and this library will later be available to our collaboration partners. We are particularly excited to welcome Walter Moos to our Board of Directors. Dr. Moos brings a wealth of life sciences R&D experience, having served most recently as the president of SRI Biosciences and previously in senior executive roles at MitoKor, Chiron and Warner-Lambert/Parke-Davis. His teams have advanced numerous pharmaceutical products from discovery to commercialization, and we are fortunate to have him join Circle.” “I am very much looking forward to taking an active role on Circle’s board,” said Walter Moos. “The combination of innovative technology and the great team at Circle could help unlock high value targets that have long been considered out of reach of drug developers.” Dr. Moos has served on about 20 business and scientific boards, including Amunix, Oncologic (Aduro), Onyx (Amgen), Rigel and the Biotechnology Industry Organization (BIO). Macrocyclic peptides have the potential to allow drug developers to address the large proportion of known therapeutic targets (estimated at up to 80%) that are considered undruggable with conventional small molecule or biologic modalities. In particular, there is great interest in developing macrocycles to modulate protein-protein interactions, which play a role in almost all disease conditions, including cancer, fibrosis, inflammation and infection. However, the development of macrocyclic therapeutics has been limited by the need for a greater understanding of how to develop macrocycles with appropriate pharmacokinetics, cell permeability and oral bioavailability. Circle’s ability to design potent macrocycles with intrinsic cell permeability could unlock access to challenging, high value therapeutic targets that have been out of reach to other approaches. Circle is developing a new paradigm for macrocycle drug discovery based on rational design and synthetic chemistry. Circle’s technology facilitates the design and synthesis of intrinsically cell-permeable macrocycles that can address both intra- and extra-cellular therapeutic targets, and can be delivered by oral administration. Circle’s macrocycle development platform is applicable across a wide range of serious diseases; the company is initially focusing its internal development efforts on intracellular protein-protein interactions that are key drivers in cancer. Circle’s founders are Prof. Matthew P. Jacobson (Chair of the Dept. of Pharmaceutical Chemistry at UC San Francisco and co-founder of Global Blood Therapeutics (NASDAQ: GBT) and Relay Therapeutics) and Prof. R. Scott Lokey (Dept. of Chemistry and Biochemistry, UC Santa Cruz and director of the UCSC Chemical Screening Center).


News Article | February 23, 2017
Site: globenewswire.com

ANN ARBOR, Mich., Feb. 23, 2017 (GLOBE NEWSWIRE) -- Zomedica Pharmaceuticals Corp. (TSX-V:ZOM), a veterinary pharmaceutical and health care solutions company, today announced that Robert W. DiMarzo has joined the company as Executive Vice President of Global Strategy. In this new company position, DiMarzo is responsible for expanding Zomedica’s business outside North America via business development opportunities and globalization strategies for existing pipeline products. “A proven entrepreneur in the animal health space, Robert’s extensive experience in the United States, Europe, Asia, and Latin America, for industry leaders such as Pfizer Animal Health, complements the qualifications of our talented executive team,” stated Gerald Solensky Jr., Chief Executive Officer at Zomedica. “Given his successful animal health background, Robert is here to help bring our unique pipeline of therapeutics and diagnostics to the global markets.” DiMarzo comes to Zomedica with more than 25 years of animal health leadership experience in manufacturing, distribution, marketing and sales, and strategic operations for pharmaceutical and diagnostic companies. Prior to joining Zomedica, DiMarzo served as Principal with DiMarzo Business Consulting where he advised business, financial, and government entities on globalization, business development, and growth strategies within the animal health and human biotechnology industries. Prior to that, DiMarzo was Vice President of Commercial Development and Product Category Management with the global animal health group at Henry Schein. Before that, he was Executive Chairman of the U.S. animal health distributor Ivesco Holdings LLC. Under his leadership, Ivesco transformed into a successful category leader that was acquired in November 2013 by MWI Veterinary Supply, Inc., now a wholly-owned subsidiary of AmerisourceBergen. DiMarzo also served as Executive Vice President of Sales and Marketing for the veterinary diagnostic startup Scandinavian Micro Biodevices, purchased by Zoetis in 2016. DiMarzo started his animal health career with Elanco, the animal health division of Eli Lilly, followed by 15 years with Pfizer Animal Health (now Zoetis) where he held several director-level and executive leadership positions in Brazil, Italy, and the U.S., leaving the company as President of U.S. Operations. During his tenure, DiMarzo elevated Pfizer’s U.S. Animal Health division to that of a recognized industry leader. A former U.S. Naval Officer and Peace Corps volunteer, DiMarzo has a Master of Business Administration from Harvard University and Bachelor of Science from Brown University. About Zomedica With U.S. operations based in Ann Arbor, Michigan, Zomedica is a veterinary pharmaceutical and health care solutions company creating products for companion animals (canine, feline and equine) by focusing on the unmet needs of clinical veterinarians. Zomedica is developing a diversified portfolio to include innovative drugs, drug-delivery technologies, diagnostics, and devices. With multiple clinical veterinarians in executive management, it is Zomedica’s mission to give veterinarians the opportunity to lower costs, increase productivity, and grow revenue while better serving the animals in their care. For more information, visit www.ZOMEDICA.com. Reader Advisory Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in the policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of the release. Except for statements of historical fact, this news release contains certain "forward-looking information" within the meaning of applicable securities law. Forward-looking information is frequently characterized by words such as "plan", "expect", "project", "intend", "believe", "anticipate", "estimate" and other similar words, or statements that certain events or conditions "may" or "will" occur. Although we believe that the expectations reflected in the forward-looking information are reasonable, there can be no assurance that such expectations will prove to be correct. We cannot guarantee future results, performance or achievements. Consequently, there is no representation that the actual results achieved will be the same, in whole or in part, as those set out in the forward-looking information. Forward-looking information is based on the opinions and estimates of management at the date the statements are made, and are subject to a variety of risks and uncertainties and other factors that could cause actual events or results to differ materially from those anticipated in the forward-looking information. Some of the risks and other factors that could cause the results to differ materially from those expressed in the forward-looking information include, but are not limited to: uncertainty as to whether our strategies and business plans will yield the expected benefits; availability and cost of capital; the ability to identify and develop and achieve commercial success for new products and technologies; the level of expenditures necessary to maintain and improve the quality of products and services; changes in technology and changes in laws and regulations; our ability to secure and maintain strategic relationships; risks pertaining to permits and licensing, intellectual property infringement risks, risks relating to future clinical trials, regulatory approvals, safety and efficacy of our products, the use of our product, intellectual property protection and the other risk factors disclosed under our profile on SEDAR at www.sedar.com. Readers are cautioned that this list of risk factors should not be construed as exhaustive. The forward-looking information contained in this news release is expressly qualified by this cautionary statement. We undertake no duty to update any of the forward-looking information to conform such information to actual results or to changes in our expectations except as otherwise required by applicable securities legislation. Readers are cautioned not to place undue reliance on forward-looking information.


News Article | February 15, 2017
Site: www.marketwired.com

MIAMI, FL--(Marketwired - Feb 14, 2017) - TCG Capital, an international finance and investment firm headquartered in Miami, announced today its acquisition of Mad Marketing Lab & Advertising, a full service point of sale (POS) company with offices in Miami, Mexico City, Madrid, and Taipei. As per the terms of the deal, TCG's leadership team will be named directors of the company. "Our team is in a permanent search for creative and value-driven companies that can provide diversification to our investment portfolio; as well as create synergies and vertical integration within our group," said Tony Jarrin, TCG Capital Managing Partner. "A company like Mad Marketing Lab & Advertising has a strong global footprint in the POS marketing space that along with talented professionals, provides expansion of our network of clients in our Credit Division, by adding strong counterparts and multinationals to our Asset Based Lending Portfolio." TCG's objectives in acquiring Mad Marketing Lab are to create portfolio diversification, synergies to other subsidiaries of the company and establish a stronger international presence in the market. "We are really excited about this deal. The POS industry is becoming more global and demanding every day and requires you give 150% and excellency is a must. By integrating MAD within TCG, we are creating strong synergy, reinforcing our team, gaining competitiveness, consolidating actual markets and expanding to new ones faster. We have also created an ambitious strategic plan that will be implemented in the next 3-5 years," said Fernando Baron, MAD Marketing Lab & Advertising Managing Partner of Asia and Europe. "This acquisition is mutually beneficial to our respective companies as we both bring finely-tuned expertise and abilities to the table to help us reach our goals and remain motivated to achieve," held Juan Carlos Zurita, TCG Capital Managing Partner. Mad Marketing Lab & Advertising specializes in product design and development, manufacturing and sourcing, project coordination, specialized campaign creation, strategic planning and branding for internationally recognized brands such as Heineken, Coca Cola, Pfizer, Nestle, Kraft Heinz and Pepsi. "We are thrilled about our partnership with TCG Capital. Our company is constantly evolving, as is the norm in modern marketing, and working with such an established financial entity like TCG allows us to explore unconventional avenues for our growth," said Jaime Fuster, MAD Marketing Lab & Advertising Managing Partner of the Americas. ABOUT TCG CAPITAL: TCG Capital, LLC is located at 201 Alhambra Circle, Suite 603, Coral Gables, FL 33134. For more information, visit http://www.tcgcapital.co. ABOUT MAD MARKETING LAB AND ADVERTISING: Mad Marketing Lab and Advertising is located at Moliere 50. Col Polanco Delegacion Miguel Hidalgo Cuidad de Mexico CP 11560. To learn more, visit http://www.madmkt.com/


" Questo è il primo studio clinico RCT sull'uso di un biosimilare in una malattia infiammatoria cronica intestinale. Pur disponendo già di moltissimi dati per CT-P13, sia del mondo reale che estrapolati, da qualche tempo i gastroenterologi avrebbero preferito essere rassicurati da uno studio clinico RCT, ed è quindi incoraggiante osservare i risultati positivi dello studio clinico RCT di Celltrion", è stato il commento di Jørgen Jahnsen, docente di gastroenterologia presso l'Università di Oslo, in Norvegia, ed esperto di primo piano. I risparmi reali sui costi associati all'uso di CT-P13 per tutte le indicazioni sono stati oggetto di studio in cinque paesi europei, a partire dall'inizio del 2015 fino al primo semestre del 2016. Secondo i dati presentati a ECCO, i risparmi complessivi sui costi rilevati per Germania, Italia, Spagna e Regno Unito sono stati pari a 32,4 milioni di euro, con risultati che suggeriscono la possibilità per altri 5.428 pazienti all'anno di accedere a questa importante terapia biologica. Non sono state rilevate riduzioni dei costi in Francia, in quanto il costo del biosimilare infliximab e dell'infliximab di riferimento era pari; ciononostante, il ricorso a CT-P13 è gradualmente aumentato nel paese.4 Le IBD rappresentano un aggravio importante per il sistema sanitario e per la società, con costi diretti calcolati in 4,6-5,6 miliardi di euro all'anno.6 Celltrion Healthcare effettua a livello mondiale attività di marketing, vendita e distribuzione dei biofarmaci sviluppati da Celltrion, Inc. tramite un'estesa rete internazionale che comprende più di 120 paesi diversi. I prodotti di Celltrion Healthcare sono realizzati a partire da colture cellulari di mammiferi in avanzate strutture studiate e realizzate per la conformità agli standard cGMP della FDA statunitense e agli standard GMP della UE. Per ulteriori informazioni visitare il sito: http://www.celltrionhealthcare.com/ Si tratta di uno studio clinico di fase III randomizzato, in doppio cieco e a gruppi paralleli mirato a esaminare l'efficacia e la sicurezza tra CT-P13 e l'infliximab di riferimento sui pazienti MC. Su 220 pazienti randomizzati in 58 centri di studio in 16 paesi, 214 pazienti hanno completato lo studio clinico fino alla settimana 6 per l'analisi primaria, e 180 pazienti hanno completato lo studio clinico fino alla settimana 30. Lo studio clinico è stato co-finanziato da Celltrion e Pfizer. CT-P13, sviluppato e prodotto da Celltrion, Inc., è stato il primo anticorpo monoclonale biosimilare approvato dall'Agenzia europea per i medicinali (EMA). È indicato per il trattamento di otto malattie autoimmuni, inclusa l'artrite reumatoide e le malattie infiammatorie intestinali. Ha ricevuto l'approvazione dell'EMA con il nome commerciale Remsima® nel mese di settembre del 2013 ed è stato lanciato in Europa agli inizi del 2015. La FDA statunitense ha approvato CT-P13 di Celltron nel mese di aprile 2016 con il nome commerciale Inflectra™. CT-P13 di Celltron è approvato in oltre 79 paesi (dati aggiornati al mese di gennaio 2017) inclusi Stati Uniti, Canada, Giappone e tutta l'Europa. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congresso della European Crohn’s and Colitis Organisation (ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congresso della European Crohn’s and Colitis Organisation (ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congresso della European Crohn’s and Colitis Organisation (ECCO) 2017. P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congresso della European Crohn’s and Colitis Organisation (ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Consultabile al link www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Ultimo accesso: gennaio 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.


ROCKVILLE, Md.--(BUSINESS WIRE)--GlycoMimetics, Inc. (NASDAQ:GLYC) today announced that pre-clinical research demonstrating the potential of two of its drug candidates, GMI-1271 and GMI-1359, against multiple myeloma will be shared via an oral presentation at the American Association for Cancer Research (AACR) Annual Meeting 2017 in Washington, DC. The company and its collaborators at Washington University in St. Louis will highlight data on GMI-1271, an antagonist of E-selectin, and GMI-1359, a dual antagonist of E-selectin and CXCR4, showing anti-cancer activity in preclinical models of multiple myeloma. “Our results show a strong effect on cancer cells in combination with chemotherapy and importantly, are supportive of our ongoing Phase 1 clinical studies in multiple myeloma of GMI-1271 as well as our study of GMI-1359 in multiple cancers,” said John Magnani, Ph.D., GlycoMimetics Senior Vice President and Chief Scientific Officer. “These results complement data from other preclinical studies and continue to build the rationale for our on-going clinical programs with both compounds.” Abstract #5005—Muz, B.B., et al. “Inhibition of E-Selectin or E-selectin together with CXCR4 re-sensitizes multiple myeloma to treatment.” Tuesday, April 4, 3:00-5:00 p.m. ET. The AACR Annual Meeting 2017 takes place from April 1 to 5, at the Walter E. Washington Convention Center. Meeting abstracts are available at AACR’s website. GMI-1271 is currently being evaluated in an ongoing Phase 1/2 clinical trial as a potential treatment for acute myeloid leukemia (AML) and in a Phase 1 clinical trial in multiple myeloma. GMI-1359 is now in a Phase 1 clinical trial. GlycoMimetics is a clinical-stage biotechnology company focused on cancer and sickle cell disease. GlycoMimetics' most advanced drug candidate, rivipansel, a pan-selectin antagonist, is being developed for the treatment of vaso-occlusive crisis in sickle cell disease and is being evaluated in a Phase 3 clinical trial being conducted by its strategic collaborator, Pfizer. GlycoMimetics' wholly-owned drug candidate, GMI-1271, an E-selectin antagonist, is being evaluated in an ongoing Phase 1/2 clinical trial as a potential treatment for AML and in a Phase 1 clinical trial in multiple myeloma. GlycoMimetics has also recently initiated a clinical trial with a third drug candidate, GMI-1359, a combined CXCR4 and E-selectin antagonist. GlycoMimetics is located in Rockville, MD in the BioHealth Capital Region. Learn more at www.glycomimetics.com. This press release contains forward-looking statements regarding GlycoMimetics’ planned activities with respect to the clinical development of its drug candidates, GMI-1271 and GMI-1359. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including the availability and timing of data from ongoing clinical trials, the uncertainties inherent in the initiation of future clinical trials, whether interim results from a clinical trial will be predictive of the final results of the trial or results of early clinical trials will be indicative of the results of future trials, expectations for regulatory approvals, availability of funding sufficient for GlycoMimetics’ foreseeable and unforeseeable operating expenses and capital expenditure requirements, other matters that could affect the availability or commercial potential of GlycoMimetics’ drug candidates and other factors discussed in the “Risk Factors” section of GlycoMimetics’ Annual Report on Form 10-K that was filed with the U.S. Securities and Exchange Commission on February 29, 2016, and other filings GlycoMimetics makes with the Securities and Exchange Commission from time to time. In addition, the forward-looking statements included in this press release represent GlycoMimetics’ views as of the date hereof. GlycoMimetics anticipates that subsequent events and developments may cause its views to change. However, while GlycoMimetics may elect to update these forward-looking statements at some point in the future, GlycoMimetics specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing GlycoMimetics’ views as of any date subsequent to the date hereof.


CAMBRIDGE, Mass.--(BUSINESS WIRE)--Cydan Development, Inc., an orphan drug accelerator dedicated to creating therapies that improve the lives of people living with rare genetic diseases, today announced its support for Rare Disease Day by making a gift to newly formed Children’s National Rare Disease Institute (CNRDI). This gift will go toward the CNRDI’s Innovation Fund, which supports new projects including diagnostics, devices, research, therapeutics, and process engineering, which will help advance the care and experience for children with rare diseases. “We are grateful for Cydan’s support of the Children’s National Rare Disease Institute,” said Marshall Summar, MD, chief of Genetics and Metabolism at Children’s National and chairman of the board at the National Organization for Rare Disorders (NORD). “With philanthropic investments from companies like Cydan, we will redefine the standard of care for children with genetic disorders, especially those largely unknown to the general medical community.” Chris Adams, Ph.D., co-founder and chief executive officer at Cydan, said, “We are proud to support Children’s National and this first-of-its-kind center in the U.S. focused exclusively on advancing the care and treatment of children and adults with rare genetic diseases. Rare diseases affect approximately 30 million Americans, and it’s heartening to see more resources dedicated to the identification, treatment and cure of these disorders.” As one of the first philanthropic contributions to the CNRDI Innovation Fund, Cydan’s gift will help to serve as a catalyst for rare disease care initiatives and help create an ever-expanding clinical knowledge base that advances the testing and development of rare disease therapies. Rare Disease Day® is an annual awareness day celebrated worldwide. This day is dedicated to elevating public understanding of rare diseases and calling attention to the special challenges faced by patients and their families. Rare Disease Day takes place every year on the last day of February to underscore the scientific, medical and social issues that affect this population. It was established in Europe in 2008 by EURORDIS, the organization representing rare disease patients in Europe, and is now observed in more than 80 nations. Rare Disease Day is sponsored by the National Organization for Rare Disorders® (NORD®), a leading independent, nonprofit organization committed to the identification, treatment, and cure of rare diseases. Cydan is an orphan drug accelerator dedicated to delivering therapies that will significantly improve the lives of people living with rare genetic diseases. Cydan evaluates experimental new therapies and advances those with the highest potential to be disease modifying treatments. Cydan’s goal is to launch new companies focused on developing promising therapies for rare genetic diseases with high unmet medical need. Vtesse, Cydan’s first new company, was launched in January 2015 and is developing a novel therapy for Niemann-Pick Disease Type C (NPC). Imara was launched in 2016 and is developing a novel treatment for Sickle Cell disease. Cydan was founded in 2013 by a management team with extensive drug discovery, clinical development and business development experience and financed by leading life sciences investors NEA, Pfizer Venture Investments, Lundbeckfond Ventures, Bay City Capital and Alexandria Venture Investments. The accelerator is based in Tech Square in Cambridge, Mass. For more information, visit http://www.cydanco.com or contact Cydan at info@cydanco.com. Children’s National Health System, based in Washington, DC, has been serving the nation’s children since 1870. Children’s National is ranked in the top 20 in every specialty evaluated by U.S. News & World Report; one of only four children’s hospitals in the nation to earn this distinction. Designated a Leapfrog Group Top Hospital and a two-time recipient of Magnet® status, this pediatric academic health system offers expert care through a convenient, community-based primary care network and specialty outpatient centers. Home to the Children’s Research Institute and the Sheikh Zayed Institute for Pediatric Surgical Innovation, Children’s National is one of the nation’s top NIH-funded pediatric institutions. Children’s National is recognized for its expertise and innovation in pediatric care and as a strong voice for children through advocacy at the local, regional and national levels. For more information, visit ChildrensNational.org.


News Article | October 26, 2016
Site: www.nature.com

Lapatinib, PLX-4032, trametenib, tarceva, ABT-199 and ABT-263 were purchased from Selleck-chem; QVD-OPh from Sigma; MG132 from Calbiochem; idarubicin and araC from Pharmacia and Upjohn. A-1210477 was made according to published methods26. Synthesis and characterization of S63845 is provided in the Supplementary Methods. Owing to light sensitivity, S63845 was stored in the dark. Following the previously published structure of MCL1 (PDB ID4WGI)43, a construct was designed with residues 173–321 of human MCL1 as a C-terminal fusion with maltose binding protein (MBP). In addition to the surface entropy-reducing (SER) mutations in MCL1 (K194A, K197A and R201A (ref. 43)), we also introduced E198A, E199A and K265A mutations into MBP (ref. 44). The plasmid encoding the MBP–MCL1 fusion protein was transformed into BL21(DE3)pLysS bacteria. A single colony was used to inoculate 5 ml terrific broth (Fisher BioReagents, (BP2468-2)) containing kanamycin and chloramphenicol at 100 μg ml−1 and 34 μg ml−1, respectively. After 3 h growth at 37 °C, the 5 ml culture was used to inoculate 2 l terrific broth containing the same antibiotics. At an OD of 0.7, the temperature was reduced to 18 °C before induction of MBP–MCL1 protein expression by addition of IPTG to a final concentration of 1 mM. Cells were harvested by centrifugation. Harvested cells were resuspended in 3 volumes of 20 mM Tris–HCl pH 7.4, 200 mM NaCl, 2 mM EDTA, 1 mM DTT and lysed by passing three times through an emulsiflex-C5 (Avestin). The lysate was clarified by centrifugation at 40,000 g, at 4 °C, for 60 min and applied to a 5-ml MBPTrap column (GE Healthcare). The MBP–MCL1 fusion protein was eluted in 20 mM Tris-HCl pH 7.4, 200 mM NaCl, 2 mM EDTA, 1 mM DTT, 10 mM maltose and further purified by size exclusion chromatography in 20 mM HEPES, 100 mM NaCl and 1 mM DTT. Protein eluted as a monomer was concentrated and used in crystallization studies. Apo crystals were grown at a concentration of 34 mg ml−1 (20 mM HEPES pH 7.5, 150 mM NaCl and 2 mM DTT) by the sitting drop vapour diffusion. 2 μl of the protein solution was mixed with 2 μl of the crystallization reservoir (25% PEG 3350, 0.2 M magnesium formate, 1 mM maltose) in a sitting drop plate. The plate was incubated at 284 K and suitable rod-like crystals appeared overnight. Individual crystals were harvested from the crystallization drops and transferred to a drop containing 4.5 μl of the crystallization reservoir solution plus 0.5 μl of S63845 (20 mM in DMSO). The mixture was incubated for 72 h at 284 K. Crystals were flash frozen in liquid nitrogen after cryoprotection using crystallization reservoir plus 20% ethylene glycol. Diffraction data were collected at the Soleil Synchrotron (France) on a beamline Proxima1 and were processed and scaled using XDS (ref. 45). The structure was solved by molecular replacement using MOLREP (ref. 46), using another crystal structure of an MBP–MCL1 fusion protein43. The data were subsequently refined using REFMAC5 (ref. 47). Interactive graphical model building was carried out with COOT. The ligand was clearly defined by the initial electron density maps. The progress of the refinement was assessed using R and the conventional R factor. Once refinement was completed, the structures were validated using various programs from the CCP4i package, CCP4. Statistic parameters are detailed in Extended Table 1. Fluorescence polarization assays were carried out in black-walled, flat-bottomed, low-binding, 384-well plates (Corning) in buffer A (10 mM HEPES, 150 mM NaCl, 0.05% Tween 20 pH 7.4 and 5% DMSO) in the presence of 10 nM fluorescein-PUMA (3-(((3′,6′-dihydroxy-3-oxo-3H-spiro(2-benzofuran-1,9′-xanthene)-5-yl)carbamothioyl)amino)-N-(6-oxohexyl)propanamide-AREIGAQLRRMADDLNAQY, from the polypeptide group, France). Final concentrations of MCL1, BCL-2 and BCL-X proteins were 10, 10 and 20 nM, respectively. The assay plates were incubated for 2 h at room temperature and the fluorescence polarization was measured on a Synergy 2 reader (exitation, 528 nm; emission, 640 nm; cut-off, 510 nm). The binding of increasing doses of the compound was expressed as a percentage reduction in mP compared to the window established between the ‘DMSO only’ and ‘total inhibition’ control (30 μM PUMA). The inhibitory concentrations of the drugs that gave a 50% reduction in mP (IC ) were determined, from 11-point dose response curves, in XL-Fit using a 4-parameter logistic model (Sigmoidal dose–response model). The K was subsequently calculated as described in ref. 48. All SPR measurements were performed on a BIAcore T200 instrument (BIAcore GE Healthcare). Direct binding experiments were performed at 20 °C on Series S NTA chips. 10 mM HEPES pH 7.4, 175 mM NaCl, 25 μM EDTA, 1 mM TCEP, 0.01% P20 and 1% DMSO was used as a running buffer (buffer B). The ligand surface was generated using double His-tagged proteins essentially as described in refs 49, 50. Serial dilutions of the compound in buffer B were injected over the protein surface. All sample measurements were performed at a flow rate of 30 μlper min (injection time 120 s, dissociation time 360 s). The sensor surface was regenerated by consecutive injections of 0.35 M EDTA pH 8.0 with 0.1 mg/ml−1 trypsin, 0.5 M imidazole and 45% DMSO (60 s, 15 μl per min). Data processing was performed using BIAevaluation 2.1 (BIAcore GE Healthcare Bio-Sciences Corp) software. Sensorgrams were double referenced before global fitting of the concentration series to a 1:1 binding model. Affinity determination by competition in solution experiments were performed at 30 °C in 10 mM HEPES pH 7.4, 150 mM NaCl, 3 mM EDTA, 1 mM TCEP, 2% glycerol, 0.05% P20 and 1% DMSO (buffer C). An MCL1-specific compound was immobilized on Series S CM5 chips by amine coupling as advised in the BIAcore GE Healthcare protocol. Serial dilutions of compounds in buffer B supplemented with fixed concentrations of protein were injected over the generated surface at a flow rate of 15 μl per min for 90 s. Calibration curves were generated using the same procedure by injecting different concentrations of protein over the same sensor chip. Affinity evaluations were performed using the affinity in solution model of BIA evaluation 2.1 (BIAcore GE Healthcare Bio-Sciences Corp) software. Mice were kept in either the Servier Research Institute or the Walter and Eliza Hall Institute (WEHI) specified pathogen-free animal areas for mouse experimental purpose (for Servier, facility license number B78-100-2). The care and use of animals was in accordance with European and national regulations for the protection of vertebrate animals used for experimental and other scientific purposes (directives 86/609 and 2003/65) and the requirements of the Servier Research Institute and WEHI Animal Ethics Committees. Sample sizes were chosen to reach statistical significance, and tumour measurements and all data analysis were performed in a blinded fashion. The Eμ-Myc transgenic mice are kept on a C57BL/6–Ly5.2+ background and have been described previously51. 8–10 week old female SCID mice (for transplantation with human AMO1 and H929 tumour cells) or Swiss Nude mice (Crl:NU(Ico)-Foxn1nu) (for transplantation with human MV4-11 tumour cells) were inoculated with 0.1 ml containing 5 × 106 of the indicated tumour cells subcutaneously into the right flank. The H929 and MV4-11 cells were resuspended in 100% matrigel (BD Biosciences) and the AMO1 cells in a 50:50 mixture of growth medium and matrigel. The width and length of the tumours were measured 2–3 times a week using an electronic caliper. Tumour volume was calculated using the formula: (length × width2)/2. When the tumour volume reached approximately 200 mm3, mice were randomized into different groups; that is, treatment with drug (different concentrations) or vehicle (n = 8 for each group). S63845 was formulated extemporaneously in 25 mM HCl, 20% 2-hydroxy propyl β-cyclo dextrin 20% (Fisher Scientifics) and administrated at the doses and schedules described in the figure legends. Tumour growth inhibition (TGI ) was calculated at the greatest response using the following equation: where day x is the day maximum where the number of animals per group in the control group is sufficient to calculate the TGI (%). For the statistical analysis of differences in tumour volume between treatment groups, a two-way ANOVA with repeated measures on day factor was performed on log-transformed data followed by Dunnett adjustment in order to compare each dose of drug to the control group. A complete tumour regression response was considered for the population with tumours 25 mm3 for at least three consecutive measurements. For ethical reasons, mice carrying tumours exceeding 2,000 mm3 were euthanized. Data are represented as mean of tumour volume ± s.e.m. over time (days) until at least one mouse per cohort had to be killed. Single-cell suspensions of 106 Eμ-Myc lymphoma cell lines (AH15A, AF47A, BRE966, 2253, MRE 721, 560), resuspended in phosphate-buffered saline (PBS), were injected into the tail vein of 8–9 week old female C57BL/6–Ly5.1+ mice. Mice were treated with either vehicle (25 mM HCl, 20% 2-hydroxy propyl β-cyclo dextrin) or 25 mg kg−1 S63845 (reconstituted in vehicle) on days 5–9 after transplant, administered by tail vein injection or, in some incidences when the tails became damaged, by retro-orbital injection. To generate the survival curves of the mice bearing the Eμ-Myc lymphoma cells, mice were killed when deemed unwell by experienced animal technicians. For the toxicity experiments, female C57BL/6–Ly5.1+ mice bearing Eμ-Myc lymphomas or non-tumour bearing C57BL/6–Ly5.1+ mice were killed 4 days after the 5-day drug treatment regimen had been completed (this equated to 13 days after transplantation of the tumour cells in the mice bearing the Eμ-Myc lymphoma cells). For the three mice injected with the AH15A Eμ-Myc lymphoma cells, those treated with vehicle were analysed after only 4 days of treatment because they were deemed too unhealty from the lymphoma to complete their prescribed regimen. For the maximal tolerated dose experiments, 7–8 week old C57BL/6 mice (3 male and 3 female mice in each arm) were treated with a dose of vehicle or S63845 (25 mg per kg, 40 mg per kg, 50 mg per kg or 60 mg per kg body weight) for 5 consecutive days by i.v. tail vein injection or by retro-orbital injection if the tails became damaged. The mice were analysed as they were killed, or for the mice surviving the entire course of treatment, 3 days after the 5-day treatment had been completed. For the initial toxicity studies, sections of spleen, lymph nodes, thymus, ovaries, uterus, kidneys, liver, pancreas, intestines, colon, heart, lung, sternum, backbone and muscle were fixed in 10% formalin and stained with haematoxylin and eosin. The weights of the spleen, thymus, (axillary, brachial and inguinal) lymph nodes, liver and kidneys were recorded. Cells were flushed from the bone marrow (two femurs and one tibia) and single cell suspensions of the spleen, thymus and lymph nodes were generated. The red blood cells were lysed by treatment with 0.168 M ammonium chloride and the white blood cell count was determined using a CASY cell counter (Scharfe System GmbH). All bone marrow or peripheral blood samples from patients with AML were collected after informed consent in accordance with guidelines approved by the Alfred and Royal Melbourne Hospital human research ethics committees. Mononuclear cells were isolated by Ficoll-Paque (GE Healthcare) density-gradient centrifugation, followed by red cell depletion in ammonium chloride (NH Cl) lysis buffer at 37 °C for 10 min. Cells were then resuspended in PBS containing 2% fetal bovine serum (FBS, Sigma). Mononuclear cells were suspended in RPMI-1640 (Gibco) medium containing penicillin and streptomycin (Gibco) and 15% heat-inactivated FBS (Sigma). Normal CD34+ progenitor cells from healthy donors were collected from granulocyte colony stimulating factor (G-CSF)-mobilized blood harvests and purified after Ficoll separation by CD34 positive selection using Miltenyi Biotec micobeads (Miltenyi Biotec. Cat. No. 130-046-703). The research with primary human cells was approved by the Human Research Ethics Committee (HREC) of Alfred Health. AML cells from patients and cells from normal donors were obtained following informed consent processes approved by the HRECs of Alfred Health and Melbourne Health. Colony-forming assays were performed on freshly purified and frozen mononuclear fractions from AML patients or normal cells from G-CSF mobilized normal, healthy donors. Primary cells were cultured in duplicate in 35-mm dishes (Griener-bio) at 104 to 105 cells. Cells were plated in 0.6% agar (Difco): AIMDM 2× (IMDM powder, Invitrogen), supplemented with NaHCO , dextran, penicillin and streptomycin, β-mercaptoethanol and asparagine, FBS (Sigma) at a 2:1:1 ratio of agar:AIMDM:FBS. For optimal growth conditions, all plates contained granulocyte/macrophage colony stimulating factor (100 ng per plate, genzyme), IL-3 (100 ng per plate, R&D Systems), stem cell factor (100 ng per plate, R&D Systems) and erythropoietin (4U per plate, Roche). Cells were cultured for 2–3 weeks in the presence or absence of drugs at 37 °C at 5% CO in a high humidity incubator. After incubation, plates were fixed with 2.5% glutaraldehyde in saline and scored using GelCount (Oxford Optronix). NCI-H929, RS4;11, MV4-11, HCT-116, BT-474, SK-Mel-2, PC-9 and H146 cells were cultured in RPMI 1640 medium, A2058 cells were cultured in DMEM medium and SK-MEL-28 cells were cultured in EMEM medium. All media were supplemented with 10% heat-inactivated FBS, 2 mM l-glutamine, 100 U ml−1 penicillin, 100 μg ml−1 streptomycin, and 10 mM HEPES pH = 7.4, at 37 °C, in 5% CO . For RS4;11 cells the medium was additionally supplemented with 4.5 g l−1 glucose. AMO1 cells were cultured in RPMI 1640 medium supplemented with 20% heat-inactivated FBS, 2 mM l-glutamine, 100 U ml−1 penicillin, 100 μg ml−1 streptomycin, and 10mM HEPES pH = 7.4. HeLa cells were cultured in DMEM medium (containing 10% heat-inactivated FBS, 10 mM HEPES, 100 U ml−1 penicillin, 100 μg ml−1 streptomycin). Cells were grown at 37 °C in a humidified atmosphere with 5% CO . All of the cell lines were purchased from the ATCC or DSMZ. Human Burkitt lymphoma (BL)-derived cell lines (Rael-BL, Kem-BL, BL2, BL30, BL31, BL41, and Ramos-BL, a gift from A.B. Rickinson and M. Rowe, University of Birmingham, UK) were cultured in RPMI 1640 medium supplemented with 10% heat-inactivated FBS, 1 mM glutamine, 1 mM sodium pyruvate, 50 μM α-thiogycerol (Sigma), and 20 nM bathocuproine disulfonic acid (Sigma) in a humidified incubator at 37 °C, 5% CO . The mouse Eμ-Myc lymphoma cell lines (AH15A, AF47A, 2253, BRE966, MRE 721 and 560) were cultured in high-glucose DMEM supplemented with 10% heat-inactivated FBS, 50 μM β-mercaptoethanol (Sigma), 100 μM asparagine (Sigma), 100 U ml−1 penicillin and 100 mg ml−1 streptomycin in a humidified incubator at 37 °C, 10% CO . The myeloma-derived cell lines were purchased from the ATCC, DSMZ or JCRB or provided by the laboratory of A. Spencer (XG1, KMS-26, ANBL6, WL-2 and OCI-MY1) and cultured as recommended by the suppliers at 37 °C in the presence of 5% CO . Bax−/−,Bak−/− H929, KMS-12-PE and AMO1 cells were generated using CRISPR/Cas9 genome editing as described below. HEK293T cells were cultured in DMEM supplemented with 10% heat-inactivated FBS at 37 °C in the presence of 10% CO . Media and supplements were purchased from Life Technologies unless specified otherwise. To test the sensitivity of 152 cell lines derived from several types of solid tumours or haematological malignancies (AML, lymphoma, bladder, central nervous system, colorectal, gastric, head and neck, liver, lung, breast, melanoma, ovarian, pancreas, prostate, renal, sarcoma and uterine) to S63845, cells were grown at 37 °C in a humidified atmosphere with 5% CO in RPMI 1640 medium (25 mM HEPES, with l-glutamine, Biochrom) supplemented with 10% (v/v) FBS (Sigma) and 0.1 mg ml−1 gentamicin (Life Technologies). Different culture media were used for VCap (DMEM, 10% FCS, 1% gentamycin), CALU1 (McCoy, 10% FCS 1% gentamycin) and U87MG (EMEM, 10% FCS 1% gentamycin). These cell lines were provided by the Children’s Hospital Cologne, the University Hospital Freiburg or the NCI or were purchased from ATCC, DSMZ, JCRB, ECACC or KCBL. Two cell lines used in this study were present in the list of commonly misidentified cell lines maintained by the International Cell Line Authentication Committee (ICLAC): NCI-H929 and U-937. For our study, H929 cells were obtained from authentic stocks (ATCC CRL-9068 and DSMZ ACC-163) and U937 cells were authenticated by STR analysis. All cell lines used in this study were verified to be mycoplasma negative before undertaking any experiments with them. Cell viability was measured using MTT (3-(4,5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide) colourimetric assay. Cells were seeded in 96-well microplates at a density to maintain control (untreated) cells in an exponential phase of growth during the entire experiment. Cells were incubated with compounds for 48 h followed by incubation with 1 mg ml−1 MTT for 4 h at 37 °C. Lysis buffer (20% SDS) was added and absorbance was measured at 540 nm 18 h later. All experiments were repeated at least three times. The percentage of viable cells was calculated and averaged for each well: per cent growth = (OD treated cells/OD control cells) × 100, and the IC , the concentration where the optical density was reduced by 50%, was calculated by a linear regression performed on the linear zone of the dose–response curve. Cells were harvested from exponential phase cultures, counted and plated in 96-well flat-bottom microtitre plates at a cell density depending on the cell line’s growth rate (4,000 to 30,000 cells for solid-tumour-derived cell lines, 10,000 to 60,000 for haematological cancer-derived cell lines). After a 24-h recovery period to allow the cells to resume exponential growth, 10 μl of culture medium (four control wells per plate) or of culture medium with the test compound were added by a liquid-handling robotic system and treated or untreated cells were cultured for a further 3 days. Compounds were applied in half-log increments at 10 concentrations in duplicate. After treatment of cells, 20 μl per well CellTiter-Blue reagent (Promega) was added. After incubation for up to 4 h, fluorescence was measured by using the Enspire Multimode Reader (Perkin Elmer, excitation λ = 531 nm, emission λ = 615 nm). IC values were calculated by 4-parameter, nonlinear curve fit using Oncotest Warehouse Software. To test the activity of S63845 in combination with the kinase inhibitors trametenib, tarceva, PLX-4032 and lapatinib, SK-MEL-28, BT-474, A2058, SK-Mel-2 and PC-9 cells were seeded into 96-well plates. After 24 h, cells were treated with the indicated compounds for 72 h and assayed for viability using the CellTiter-Glo reagent (Promega). Luminescence was measured at 0, 24, 48 and 72 h on independent plates seeded and treated at the same time. Results were normalized to the samples without treatment at time 0 h. To test the sensitivity of the multiple myeloma cell lines to S63845 cells were seeded into 96-well plates at 5,000 cells per well and treated at 5-point 1:8 serial dilutions of compounds starting from 10 μM. Cell viability was assessed at 48 h using the CellTiter-Glo Assay (Promega) following the manufacturer’s instructions and the plates were read using an Envision luminescence plate reader (Perkin Elmer). Results were normalized to the viability of cells that had been treated with 0.1% DMSO (vehicle) in medium for 48 h. The IC values were calculated using nonlinear regression algorithms in Prism software (GraphPad). To test the dependence of H929 cells on BCL-2, BCL-X , BCL-W, MCL1 or A1/BFL1 for their sustained survival, pools of cells stably expressing Cas9 (mCherry+) and inducibly expressing the relevant single guide RNA (sgRNA) (GFP+) were purified by flow cytometry (BD Biosciences) and seeded into 96-well plates (5,000 cells per well) in triplicates and their viability was determined by using the CellTiter-Glo assay 72 h after the addition of doxocycline (1 μg ml−1) to induce expression of the sgRNA targeting the corresponding genes. The data were normalized to the viability of cells infected with the empty vector. In some experiments, the viability (determined by propidium iodide exclusion) of the cells with or without co-treatment with the pan-caspase inhibitor QVD-OPh (25 μM; MP Biomedicals) for 12 h was also determined. Freshly purified mononuclear cells from AML patient samples were adjusted to a concentration of 2.5 × 105 per ml1 and 100 μl of cell suspensions were aliquoted per well into 96-well plates (Sigma). Cells were then treated with S63845, cytarabine (Pfizer), ABT-199 (Active Biochem) or idarubicin (Sigma) over a 6 log concentration range from 1 nM to 10 μM for 48 h and incubated at 37 °C, 5% CO . Cells were then stained with the Sytox blue nucleic acid stain (Invitrogen) and fluorescence measured by flow cytometric analysis using a LSR-II Fortessa machine (Becton Dickinson). FACSDiva software was used for data collection, and FlowJo software for data analysis. Blast cells were gated using forward and side light scatter properties. Viable cells excluding Sytox blue were determined at six concentrations for each drug and the 50% lethal concentration (LC , in μM) was calculated using nonlinear regression algorithms in Prism software (GraphPad). NCI-H929 cells were treated with the indicated compounds for 4 h, centrifuged and washed with binding buffer (10 mM HEPES, 140 mM NaCl, 2.5 mM CaCl ). Cells were incubated with 200 μl of binding buffer containing Annexin V–Alexa fluor 488 (Invitrogen) and propidium iodide (Sigma) for 15 min at 20 °C in the dark. 400 μl of binding buffer was added and samples were kept at 4 °C before flow cytometry analysis. For each sample, 104 cells were analysed by flow cytometry in an Epics XL/MCL flow cytometer (Beckman Coulter). Fluorescence was collected at 520 nm (Alexa fluor 488) and 630 nm ( propidium iodide). Human Burkitt lymphoma-derived cell lines and mouse Eμ-Myc lymphoma cell lines were plated at a density of 4 × 104 cells per well in flat-bottomed 96-well plates. These cells were treated with increasing doses of S63845 (typically 0.008, 0.025, 0.04, 0.2, 1, 5 μM) for 24 h. Cells were stained with Annexin V-FITC and propidium iodide, analysed on a FACS Calibur and live cells (Annexin V negative/propidium iodide negative) were recorded. Data are presented as per cent cell death induction relative to cells cultured in medium alone. Twenty-four hours after seeding, cells were treated with the indicated compounds for 6 h and harvested in lysis buffer (10 mM HEPES pH 7.4, 142.5 mM KCl, 5 mM MgCl , 1 mM EDTA, 1% NP40, protease and phosphatase inhibitors cocktails (Calbiochem)). Cleared lysates (5 μg protein) were prepared for immunodetection of cleaved PARP (a marker of apoptosis) by using the MSD apoptosis panel whole cell lysate kit (MSD) in 96-well plates according to manufacturer’s instructions, and were analysed on the Sector Image 2400. NCI-H929 cells were treated with S63845 for 4 h, washed with PBS and harvested in lysis buffer delivered with the cytochrome c release apoptosis assay kit (Qiagen). Cells were then homogenized using an ice-cold tissue grinder (40 passes). Homogenates were centrifuged at 700 g for 10 min at 4 °C. The supernatants were transferred into fresh tubes and centrifuged at 10 000 g for 30 min at 4 °C. The supernatants were collected as cytosolic fractions. Cytochrome c release was determined by western blotting using the cytochrome c antibody provided in the kit. Lysates were also analysed by immunoblotting using an anti-LDH antibody (Rockland 200-1173; used as protein loading control). Total protein extracts of myeloma cells were generated in lysis buffer (20 mM Tris-HCl pH 7.4, 135 mM NaCl, 1.5 mM MgCl , 1 mM EDTA, 10% glycerol) containing 1% Triton X-100 and complete protease inhibitors (Roche). Protein extracts of the other cell lines were generated in lysis buffer containing 10 mM HEPES pH 7.4, 142.5 mM KCl, 5 mM MgCl , 1 mM EDTA, 1% NP40, protease and phosphatase inhibitors cocktails (Calbiochem). Lysates were stored at −80 °C. Protein content was quantified using the Bradford assay (Bio-Rad). Lysates were diluted with LDS sample buffer (Invitrogen) at a 3:1 ratio and denatured at 95 °C for 7–10 min. 20–40 μg of protein extracts were separated by SDS–PAGE (NuPAGE 10% Bis Tris gels) and proteins transferred onto nitrocellulose membranes. The membranes were blocked in 5% skimmed milk in PBS and 0.1% Tween20 (blocking buffer) before incubation with antibodies. Rat monoclonal antibodies to BAX (21C10; WEHI) or BAK (7D10; WEHI) and mouse monoclonal antibody against HSP70 (N6; used as a loading control) were used. All antibodies were diluted in blocking buffer. Commercially available antibodies were also used: rabbit polyclonal antibodies against MCL1 (Santa Cruz, S-19, sc-819), PARP (Cell Signaling, 9542), BIM (Cell Signaling, C34C5 2933), Phospho-ERK (Cell Signaling, 9101), total ERK (Cell Signaling, 9102), BAK (BD 556396), BAX (Santa Cruz, sc-493) BCL-X (Transduction Laboratory, 610212) and mouse monoclonal antibodies against actin (Millipore, MAB1501R; used as a loading control), NOXA (Calbiochem, OP180), Flag-M2 (Sigma) and p53 (Santa Cruz, sc-126). HeLa cells were transiently transfected, using the Effecten reagent (Qiagen), with expression vectors encoding 3× Flag-tagged MCL1, BCL-X or BCL-2 (p3×Flag–CMV10, Sigma). After 24 h, cells were treated for 4 h with S63845 and then harvested in lysis buffer (10 mM HEPES pH 7.5, 150 mM KCl, 5 mM MgCl , 1 mM EDTA, 0.4% Triton X100, protease and phosphatase inhibitors cocktails (Calbiochem)). The cleared lysates were subjected to immunoprecipitation with anti-Flag M2 agarose beads (Sigma). The immunoprecipitates and inputs were analysed by immunoblotting using the antibodies listed above. Total RNA was extracted using RNeasy mini kit with DNase I treatment (Qiagen) and reverse transcripted using a high-capacity cDNA reverse transcription kit with RNAse inhibitor (Life Technologies). Conventional real-time PCR was performed on an ABI 7900HT system in 50 μl reaction volumes containing 2× TaqMan universal PCR master mix, 2.5 μl of 20× target/control assay mix and 5 μl of respective cDNA in an optical 96-well plate. NTCs (no template controls) using RNase-free water were included in the plate. Cycling conditions were 95 °C (10 min), followed by 40 PCR cycles at 95 °C (15 s) and 60 °C (1 min). TaqMan Gene Expression Assays (Life Technologies) for MCL1 evaluated the anti-apoptotic long (L) isoform NM_021960 (reference assay Hs01050896_m1). Two out of five reference genes including GAPDH, PPIA, 18S, UBC and SDHA, were selected on geNorm software as the optimal number of reference target genes (geNorm pairwise variation cut off V < 0.15). As such, the optimal normalization factor was calculated as the geometric mean (GM) of reference targets SDHA and PPIA (ref genes) and calculation of −ΔC was achieved as follows: Data are presented as fold change of relative quantification calculated as 2–ΔΔCt, with . Pair-wise comparisons were evaluated with a t-test. Aliquots of cells were stained in 24G2 (anti-FcγR, (Fcγ gamma receptor)) antibody containing hybridoma supernatant, containing fluorescently (FITC, R-PE or APC) labelled monoclonal antibodies against cell surface markers, and analysed on an LSR11C (Becton Dickinson) excluding propidium iodide + (dead) cells. The following antibodies were used: anti-CD25 (clone PC61), anti-CD4 (clones GK1.5 (Biolegend) and H129), anti-CD8 (clones 53-6.7 (Biolegend) and YTS 169), CD44 (clone IM7), anti-B220 (220 kDa form of CD45 expressed on B cells, clones RA3-6B2 (Biolegend)), anti-GR1 (granulocyte antigen 1, clone RB6-8C5), anti-MAC1 macrophage antigen 1, clone M1/70), anti-SCA1 (stem cell antigen 1, clone E13-161.7), anti-c-KIT (clone 2B8 (Biolegend)), anti-TCR (T cell receptor, Biolegend), anti-TER119 (clone TER-119), anti-IgM (clone 5.1), anti-IgD (clone 11-26C), anti-Ly5.1 (clone A20.1) and anti-Ly5.2 (clone S.450-15.2). Data were processed using FlowJo Version 9.9 (TreeStar). Blood cell counts and cell subset composition were determined using an ADVIA 2120 haematology analyser (Siemens). The vectors for the constitutive expression of Cas9 and the inducible expression of the sgRNAs have been previously described30. To target the BCL-2 family members, sgRNAs were designed ( http://crispr.mit.edu) and cloned into pFH1tUTG (ref. 30) with the exception of sgRNAs for MCL1, which have been previously described30. The sequences of the sgRNAs used in this study as well as the primers for amplifying the targeted regions for DNA sequence analysis are detailed in Supplementary Tables 1 and 2, respectively. The vectors to express the BIM variants have been previously described12, 13. To produce lentiviruses, the constructs of interest were co-transfected into HEK293T cells with the packaging viruses pMDLg/pRRE, pRSV RRE and pCMV VSV-G (all from Addgene) using the Effectene transfection reagent (Qiagen). The lentiviruses were harvested, filtered and used to infect target cells as previously described13, 30. Multiple-myeloma-derived cell lines were serially infected with lentiviruses that stably co-express Cas9 and the fluorescent marker, mCherry, and inducibly express the indicated sgRNAs plus stably express GFP. Double positive cells (mCherry+ GFP+) were purified using a BD FACSAria Fusion Sorter (BD Biosciences). Expression of the sgRNA was induced by the addition of doxycycline (1 μg ml−1; Sigma). The experiments targeting BCL-2, BCL-X , BCL-W, MCL1 and BFL1 were undertaken with pools of infected cells. To generate the BAX−/−,BAK−/− H929 clone, a BAX-deficient H929 clone was infected with a lentivirus expressing a sgRNA to target BAK, re-cloned and verified by DNA sequencing and western blotting (Fig. 2c). Sequences of sgRNAs and primers for targeted PCR used in this study are shown in Supplementary Tables 1 and 2. DNA sequence verification was carried out as previously described30. Briefly, genomic DNA was isolated using the DNeasy kit (Qiagen) and mutation of targeted DNA confirmed by the Illumina MiSeq30. The unique PCR primers with overhang sequences for each sgRNA are listed in Supplementary Table 2. Graphpad Prism software was used for generating Kaplan–Meier animal survival plots of vehicle and S63845 treated mice and performing statistical analysis (using a log-rank test (Mantel–Cox)). Graphpad Prism was also used to perform multiple unpaired two-tailed t-tests of vehicle-treated and S63845-treated mice to look for significant changes in the data generated from the ADVIA analysis of the blood and from the FACS analysis of the number of different cells present in the spleen, thymus, lymph nodes and bone marrow. Graphpad Prism was used to generate IC curves for cell lines treated with S63845 in vitro. GraphPad Software was used for statistical analysis. All data are expressed as mean ± s.d. P < 0.05 was considered to be significant. The PDB deposition code for the X-ray structure of the MBP-MCL1 complex with S63845 is 5LOF.


News Article | November 16, 2016
Site: www.prnewswire.co.uk

According to the report "Companion Animal Health Care Market", published by Market Data Forecast, the global market is projected to reach USD 17.20 Billion by 2021, at a CAGR of 6.20 % from 2016 to 2021. Free sample for the report is available at "http://www.marketdataforecast.com/market-reports/global-companion-animal-health-care-market-1249/request-sample" Companion animals are the animals which serve man by giving companionship and guarding their houses or offices. Various types of diseases in animals and their transfer to humans via their product consumption and companionship are escalating the market globally. Growing incidence of zoonotic and food borne diseases will be a potential concern to the health of pet animals. Increasing pet/companion ownership, growing health care concerns of pets, rising demand for improved nutrition, are the major factor driving the growth of the market. The factors that are hindering the growth of the market are restrictions by regulatory bodies have a negative impact on the sales of antibiotics, soaring costs and increasing regulations on animal testing have hindered a number of healthcare companies from manufacturing newly advanced drugs. Enquire more about the report at "http://www.marketdataforecast.com/market-reports/global-companion-animal-health-care-market-1249/inquire" The companion animal healthcare market is segmented as follows: Some of the major companies dominating the global market Pfizer Animal Health Ltd, Merck & Co Inc., Sanofi Aventis Animal Health, Zoetis Inc., Boehringer Ingelheim GmbH, Elanco Products Company, Bayer AG, Novartis animal Health Inc., Virbac SA, Ceva Sante Animale, Vetoquinol SA. Buy the full report now at "https://www.marketdataforecast.com/cart/buy-now/global-companion-animal-health-care-market-1249" The Companion Animal Healthcare market study offers the following deliverables: Checkout other related studies in the Animal Health Segment: Market Data Forecast is a firm working in the area of market research and business intelligence. With rich experience in research across various business domains, we cater to the needs of both individual and corporate clients. Our analyst team comprises expert professionals in market research, who with their collective knowledge and skillset dedicatedly serve clients from various industries and regions.


News Article | November 22, 2016
Site: www.newsmaker.com.au

Hemostats are agents used to compress or treat bleeding vessels in order to arrest hemorrhage. These products may reduce operating room time and decrease the number of blood transfusions required in surgical procedures. Hemostatic agents are available in various forms including pads, sponges, liquids, and powders. The ideal agent should be: Able to stop hemorrhage from large arteries and veins within two minutes of application Capable of effective application through pools of blood, packaged as a ready to use agent Simple to use even by non-medically trained responders Lightweight and durable Capable of extended storage under a wide range of temperatures Inexpensive Free from bacterial or viral risk This report focuses on the Hemostats in Global market, especially in North America, Europe and Asia-Pacific, Latin America, Middle and Africa. This report categorizes the market based on manufacturers, regions, type and application. Ethicon, Inc., Pfizer, Inc., Baxter International Inc., C. R. Bard, The Medicines Company, Anika Therapeutics, Inc., Advanced Medical Solutions, Integra LifeSciences Corporation, B Braun Melsungen AG, Gelita Medical GmbH, Equimedical, Vascular Solutions, Inc., Marine Polymer Technologies, Inc., Z-Medica, LLC, CryoLife, Inc., BioCer Entwicklungs-GmbH. To Know More, Ask Our Expert @ http://www.intenseresearch.com/market-analysis/global-hemostats-market-by-manufacturers-regions-type-and.html#inquiry-for-buying


News Article | December 22, 2016
Site: www.businesswire.com

SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces it has entered into global license and supply agreements with Novartis for the development and commercialization of a Captisol-enabled oral liquid formulation of trametinib, a kinase inhibitor currently indicated as a single agent or in combination with dabrafenib, for the treatment of patients with unresectable or metastatic melanoma with BRAF V600 mutation. Under the terms of the license, Ligand will be eligible to receive a license fee, royalties on future net sales, and revenue from Captisol material sales. Novartis will be responsible for all costs related to the program. “This represents an expansion of our relationship with Novartis as they develop an oral liquid formulation potential treatment option,” commented John Higgins, Chief Executive Officer of Ligand. “This transaction continues to show the ability of Captisol to address unmet solubility and other formulation issues facing the industry.” Captisol is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. Captisol was invented and initially developed by scientists in the laboratories of Dr. Valentino Stella at the University of Kansas’ Higuchi Biosciences Center for specific use in drug development and formulation. This unique technology has enabled several FDA-approved products, including Amgen’s Kyprolis®, Baxter International’s Nexterone® and Spectrum’s EVOMELA®. There are more than 40 Captisol-enabled products currently in various stages of development. Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly. This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding clinical development of Captisol-enabled trametinib, the possibility of regulatory approval for a pediatric indication, commercial success, efficacy, potency, competitiveness and the strength of Ligand's product portfolio. Actual events or results may differ from our expectations. For example, there can be no assurance that Captisol-enabled trametinib will progress through clinical development or receive required regulatory approvals within the expected timelines or at all, that further clinical trials will confirm any safety or other characteristics or profile, that there will be a market of any size for Captisol-enabled trametinib or that Captisol-enabled trametinib will be beneficial to patients or successfully marketed. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.


LOS ANGELES--(BUSINESS WIRE)--Glancy Prongay & Murray LLP (“GPM”) announces an investigation on behalf of Momenta Pharmaceuticals, Inc. (“Momenta” or the “Company”) (NASDAQ: MNTA) investors concerning the Company and its officers’ possible violations of federal securities laws. On February 17, 2017, Momenta revealed that a contracted Pfizer facility was in receipt of a warning letter from the U.S. Food and Drug Administration ("FDA"). Three days later, analysts from Leerink Capital Partners LLC stated that the FDA letter is alarming due to the fact that manufacturing warning letters can take years to resolve, and that a lengthy delay could hurt Momenta's market opportunity for its Glatopa 40mg product candidate. On this news, Momenta's share price has fallen as much as $4.30, or 22.63%, during intraday trading on February 21, 2017. If you purchased Momenta securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Lesley Portnoy, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles, California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to shareholders@glancylaw.com, or visit our website at www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.


BENSALEM, Pa.--(BUSINESS WIRE)--Law Offices of Howard G. Smith announces an investigation on behalf of Momenta Pharmaceuticals, Inc. (“Momenta” or the “Company”) (NASDAQ: MNTA) investors concerning the Company and its officers’ possible violations of federal securities laws. On February 17, 2017, Momenta revealed that a contracted Pfizer facility was in receipt of a warning letter from the U.S. Food and Drug Administration ("FDA"). Three days later, analysts from Leerink Capital Partners LLC stated that the FDA letter is alarming due to the fact that manufacturing warning letters can take years to resolve, and that a lengthy delay could hurt Momenta's market opportunity for its Glatopa 40mg product candidate. On this news, Momenta's share price has fallen as much as $4.30, or 22.63%, during intraday trading on February 21, 2017. If you purchased Momenta securities, have information or would like to learn more about these claims, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Howard G. Smith, Esquire, of Law Offices of Howard G. Smith, 3070 Bristol Pike, Suite 112, Bensalem, Pennsylvania 19020 by telephone at (215) 638-4847, toll-free at (888) 638-4847, or by email to howardsmith@howardsmithlaw.com, or visit our website at www.howardsmithlaw.com. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.


News Article | October 29, 2016
Site: www.prweb.com

Patrick A. Ward joins Advantu, a next generation software quality firm focusing on system performance, outsource preparation, and mission critical application verification/validation, as CTO. Richard J. Gorvetzian joins Advantu as Vice President of Engineering, a key role for rapid corporate growth. Advantu, a next generation software quality firm focusing on system performance measurement, outsource preparation and execution, and mission critical application development, today announced two new key hires: Patrick A. Ward, Chief Technology Officer and Richard J. Gorvetzian, Vice President of Engineering Ward comes to Advantu from CareFusion (now Becton Dickinson and Company) where he served as Director, Software Engineering, Infusion. Ward’s initial responsibilities include leading the development and growth of advanced software quality solutions for new and existing accounts. “Patrick brings a strong and diverse business background in software engineering and services consulting to spearhead the strategic growth of our company,” said Cindy Casselman, chief executive officer of Advantu. “He shares our commitment to providing the highest level of user experience for our clients, in order to provide solutions to their mission critical challenges with software development.” Prior to joining Advantu, Ward held Vice President, Director and Management positions with companies such as CareFusion/BD, Hospira/Pfizer, Alignent/Sopheon, Cardiff Software/Verity/HP and Andersen Consulting, LLP/Accenture, and he brings his extensive experience to bear – solving client issues with performance, outsource program implementation and mission critical applications in regulated environments. He holds patents in medication configuration information synchronization, and a medical device update systems, and he holds a bachelors degree in Computer Science from the University of Southern California. “Advantu is a unique firm specializing in helping companies achieve their optimal capacity and efficiency working in complex and constrained environments. I’m excited to bring our innovative approach to common legacy software development and quality testing challenges and delight our clients with repeatable success.” Advantu today announced that Richard J. Gorvetzian has joined the company as Vice President of Engineering. Gorvetzian comes to Advantu from CareFusion (now Becton Dickinson and Company) where he served as Director, Software Quality Engineering. Gorvetzian’s initial responsibilities include leading the development and growth of advanced quality assurance, testing and process improvement for new and existing clients. “Richard brings a strong background in software quality and process improvement; he understands the iterative process, and knows what it takes to put verification and validation teams on the path to success, in order to dramatically reduce risk and improve customer satisfaction with our clients’ products,” said Kris Kelly, president of Advantu. Prior to joining Advantu, Gorvetzian held Director and Management positions with companies such as CareFusion/BD, Hologic/Gen-Probe, Hospira/Pfizer, Stellcom, Intuit, Bridge Medical, Microsoft and Xerox Corporation. He holds the following degrees: Psychology from the University of California, Los Angeles Master of Science, Management from Antioch University Seattle About Advantu Advantu provides consulting services to help companies improve their customer’s experience by Identifying risk early in the process, which leads to shorter build cycles, reduced development costs and measurably improved system reliability. Advantu offers system performance measurement and testing, engineering talent sourcing/training, outsource (design and implementation) programs, and mission critical application testing solutions. Advantu is a woman-owned small business. Learn more at http://www.advantu.com


News Article | February 15, 2017
Site: www.prweb.com

Brands and advertisers spent an average of $5 million to capture viewers’ attention for 30 seconds during yesterday’s Super Bowl. That’s an investment of $166,667 per second. And the research, based on polling just concluded by Dialsmith and maslansky + partners (m + p) suggests that not only does each second of airtime come with a six-figure price tag, each second also can prove to be the difference between a winning ad and a losing ad. The polling, powered by Dialsmith’s Slidermetrix, went beyond the typical “thumbs up – thumbs down” or single score ratings done by most methods of scoring the Super Bowl ads. With Slidermetrix, viewers continuously rate the ads second-by-second as they watch, revealing what viewers were thinking in-the-moment and allowing for a deeper look into the magic moments that elicit an emotional response which ultimately can make an ad memorable or not. Key takeaways from this year’s polling are: Automakers are doing it right. Our top four scoring ads were all auto ads with Hyundai’s “A Better Super Bowl,” Mercedes Benz’s “Easy Driver,” Buick’s “Cam Newton and Miranda Kerr” and Kia’s “Hero’s Journey” spots receiving our highest marks. Just the ads please, hold the politics. Ads with politically charged themes made news but didn’t engage our viewers. In particular, 84 Lumber’s “The Journey Begins” ad fell flat as one of our lowest rated spots amongst older viewers, though the ad scored much higher with Millennials. The Bieber bomb. Several stars shined bright but not The Bieber. Ads that deftly weaved humor with star power were hits with our viewers. Peter Fonda (Mercedes), Melissa McCarthy (Kia) and Justin Timberlake and Christopher Walken (Bai) all received high grades. Whether it was the joke that fell flat or Bieber’s appeal, the T-Mobile ad missed the mark. Risk was rewarded. Going live is risky, but it’s also authentic and our viewers liked it. Both Hyundai’s and Snicker’s ads, shot during the Big Game, scored well with our viewers. Super- and Not-So-Super Seconds tell their own story. Hyundai’s spot produced our highest scoring second across all Super Bowl ads and one of the highest peak moments ever since we began testing five years ago. The moment captured a live, virtual reunion of US Army Corporal Trista Strauch, stationed in Zagan, Poland, with her family who were in attendance at the Super Bowl. The moment had a genuine, emotional tug-at-the-heartstrings appeal that won over our viewers. In contrast, 84 Lumber’s spot produced our lowest scoring second across all ads. Scores trended downward from start to finish as the weighty story, depicting a Mexican mother and daughter unfolded, bottoming out as the ad concluded without a “feel good” ending or any conclusion to speak of. Viewers reacted negatively to the sharp tone and weren’t too keen on having to go online to view the rest of the story. “Kia was Super Bowl ad perfection and we gave it an A. It tied into the product and it was funny,” said m+p president and partner Lee Carter, “Viewers reflected that Super Bowl and politics don’t mix. Depending on your political perspective you could have seen ads like 84 Lumber and Anheuser-Busch as political – we gave them a D and B, respectively. Bottom line, the more political, the more polarizing - 84 Lumber was an overtly political ad and Anheuser-Busch’s ad could have been interpreted as the American Dream.” For highlights of final scores and results, please see accompanying infographic or you can download the full report at: http://www.dialsmith.com/SB-ads-2017-results. How it works Using Slidermetrix, viewers are asked to continuously rate the ad while viewing it, using an on-screen slider with a scale from 0 (“Hate It!”) to 100 (“Love It!”). After rating the ad, viewers can see how their feedback compares to other viewers. This continuous rating method is similar to the moment-to-moment dial testing that market research consultants do for their media clients who use the data for placement and programming decisions as well as for content direction, including decisions by advertisers on the content for ads that air during the Super Bowl. About Dialsmith Dialsmith is a Portland, Oregon-based technology company that develops products and services for research, audience engagement and live event polling. Pioneers in the development of audience response tools for capturing and displaying continuous and in-the-moment feedback, Dialsmith is the worldwide marketer, seller and service provider for Perception Analyzer, Perception Analyzer Online, Slidermetrix and ISX Scoring. Featured on CNN, Fox News, 60 Minutes, Food Network, X Games and more, Dialsmith’s Perception Analyzer tools are the gold standard for dial testing focus groups, public opinion studies, academic research, mock juries and more. About m+p Brands and companies are faced with communications challenges that are complex and controversial. And the marketplace is crowded. To address these challenges, maslansky+partners has worked for the past 20+ years to perfect and refine its strategic counsel through cognitive behavioral science research. The strategic agency works with companies to help them translate corporate speak into language that is clear, credible and compelling for consumers and stakeholders. m+p helps clients understand how their audiences process and interpret information and show them how the right words and phrases can drive engagement and action. m+p has worked with many Fortune 500 companies, most of the top retail banks in the US, along with companies like AARP, Starbucks, Merck, Toyota and Pfizer (to name a few) – and because they work within a mix of industries their clients benefit from the agency’s breadth of experience.


News Article | December 6, 2016
Site: www.prweb.com

Superior Controls, Inc., a leading control system integrator of custom industrial automation and IT solutions, today announced the company has successfully completed its 50th consecutive audit. For nearly two decades, Superior Controls has reliably delivered professionally executed automation and control systems integration services to leading companies in life sciences, food and beverage, energy and other varied industries. “Our life science customers are increasingly requesting audits to ensure their automation partner possesses the knowledge and procedures to properly design and implement automation systems for FDA-regulated industries,” said Rick Pierro, president and CEO of Superior Controls. “We welcome audits; they ultimately make us stronger. Our customers can be confident that Superior Controls has in-house expertise and quality systems in place to design and build robust automation systems.” Superior Controls’ 50th audit was with a large Boston-based, publicly traded biotech company. The audits are required for all FDA-regulated industries, including biotech, medical device and pharmaceutical, and can last from two hours to four days. By integrating advice from every new auditor, Superior Controls’ Quality Assurance System has grown to over 1000 pages of Good Automated Manufacturing Practice (GAMP) 5.0 compliant validation templates and procedures. Superior Controls employs a wide range of disciplines, typically for the positions of Controls Engineer, Project Manager, Validation Specialist, and Technical Writer. The company hires capable engineers who are experienced in Allen-Bradley, GE, Delta V and/or Siemens controllers; iFIX, FactoryTalk View , and/or Wonderware SCADA software; and who are skilled in Visual Basic programming, SQL Server or other databases, and broad IT experience. To learn more about career opportunities, please contact us via email at hr(at)superiorcontrols(dot)com. About Superior Controls, Inc. Since 1993, Superior Controls, Inc. has reliably delivered professionally executed automation and control systems integration services to leading companies in 30 separate states and 15 countries. In addition to being six-time certified by the Control System Integrators Association (CSIA), Superior Controls has passed a number of project management and validation audits performed by industry leaders such as Pfizer, Biogen, GE Healthcare, and more. As Superior Controls now undergoes expansion, it will exhibit the same commitment to innovation and quality that customers have come to expect over the last 23 years.


News Article | November 2, 2016
Site: www.prnewswire.co.uk

2016 hemophilia drugs market research says one trend gaining traction in this market is increase in technological innovations. Currently, most of the hemophilia therapeutics available in the market are short-acting i.e., used only for when the individual suffers from bleeding. Apart from this, it is also observed that many of these products exhibit immunogenic reactions, which result in a reduced therapeutic effect of these products. Complete report on hemophilia drugs market spread across 84 pages, analyzing 5 major companies and providing 61 data exhibits is now available at http://www.rnrmarketresearch.com/global-hemophilia-drugs-market-2016-2020-market-report.html. The analysts forecast global hemophilia drugs market to grow at a CAGR of 4.76% during the period 2016-2020. According to the hemophilia drugs market report, drugs with prolonged action will drive the market. Earlier, parenteral formulations for treating hemophilia B required frequent administration of replacement factors. Drugs with favorable pharmacokinetic profiles, including prolonged mechanism of action are fast gaining acceptance among physicians and individuals. These long-acting formulations reduce the need for repeated dosing of medications, reducing injection site pain. According to the industry research analysts, the recombinant therapies segment accounted for the most of the hemophilia drugs market revenue shares and will continue to lead the market over the coming years. The growth of this segment is attributed to the increasing demand for prophylaxis therapies in developed countries and shift in preference from plasma-derived therapies to recombinant products in the emerging economies. Moreover, the entry of long-acting recombinant products such as ALPROLIX by Biogen, Advate by Baxter, among others will contribute to this segment's growth over the coming years. Americas led the global hemophilia drugs market in 2015 and is expected to continue its dominance until the end of 2020. The Americas have the highest revenue share in the global hemophilia drugs market with the US contributing to the majority of this revenue. Several countries in the region have introduced health care reforms which are having a positive impact on the market growth. Moreover, healthcare reforms in the US have also helped reduce the cost of pharmaceutical drugs, increased access to healthcare, and improved the overall quality of healthcare. These healthcare reforms are likely to have a positive impact on healthcare insurance and also reduce hospital stay and overall medical expenses which will boost hemophilia drugs market growth in the region. The following companies are the key players in the global hemophilia drugs market: Baxalta, Bayer, CSL Behring, Novo Nordisk, and Pfizer. Other prominent vendors in the market are: Alnylam Pharmaceuticals, Amarna Therapeutics, Asklepios BioPharmaceutical, Biogen, BioMarin, Catalyst Biosciences, Chiesi Farmaceutici, Dimension Therapeutics, Emergent BioSolutions, F. Hoffmann-La Roche, Grifols, Kedrion Biopharma, Octapharma, rEVO Biologics, OPKO Biologics, Sangamo Biosciences, Spark Therapeutics, Swedish Orphan Biovitrum, and UniQure Biopharma. Order a copy of Global Hemophilia Drugs Market 2016-2020 report @ http://www.rnrmarketresearch.com/contacts/purchase?rname=733369. Global Hemophilia Drugs Market 2016-2020, has been prepared based on an in-depth market analysis with inputs from industry experts. To calculate the market size, the report considers the revenue generated from the sales of of drugs used for the treatment of hemophilia, including hemophilia A, hemophilia B, and inhibitors. Another related report is Global Alpha-1 Antitrypsin Drugs Market 2016-2020, a key driver is the improved diagnosis of AATD. AATD is difficult to diagnose in the majority of cases. The Alpha-1 Foundation reports that around 3% of all people who have diagnosed with COPD may have undetected AATD. The condition is misdiagnosed in most of the cases as asthma, smoking-related COPD, bronchitis, bronchiectasis, or other pulmonary conditions. These underlying conditions may confuse the clinical picture and thus lead to the difficulty in diagnosis. However, awareness programs conducted by various organizations worldwide will help in recognizing and differentiating the condition from other diseases. Browse complete report @ http://www.rnrmarketresearch.com/global-alpha-1-antitrypsin-drugs-market-2016-2020-market-report.html. Explore other new reports on Diseases & Treatment Market @ http://www.rnrmarketresearch.com/reports/life-sciences/pharmaceuticals/diseases-treatment. RnRMarketResearch.com is your single source for all market research needs. Our database includes 100,000+ market research reports from over 95 leading global publishers & in-depth market research studies of over 5000 micro markets. With comprehensive information about the publishers and the industries for which they publish market research reports, we help you in your purchase decision by mapping your information needs with our huge collection of reports. We provide 24/7 online and offline support to our customers.


News Article | November 13, 2016
Site: www.reuters.com

NEW ORLEANS (Reuters) - Pfizer Inc's Celebrex arthritis drug was shown to be at least as safe as the widely used prescription-strength versions of painkillers ibuprofen and naproxen, and does not appear to cause heart problems that spurred the withdrawal of rival Vioxx, according to a large 10-year study presented on Sunday.


Honorees to be recognized at the AGENDA17 Conference FRAMINGHAM, MA--(Marketwired - November 14, 2016) - Computerworld -- the leading IT media brand dedicated to being the voice of business technology -- reveals the 2017 Computerworld Premier 100 Technology Leaders (click to tweet). One hundred leaders from technology and business are being acknowledged by Computerworld for their exceptional technology leadership and innovative approaches to business challenges. The honorees will be recognized during an awards ceremony at the AGENDA Conference, co-produced by CIO, Computerworld and the CIO Executive Council. The AGENDA17 conference will be held March 20-22, 2017, at Sawgrass Marriott Golf Resort & Spa in Ponte Vedra Beach, Florida. AGENDA is the business leadership conference focused on driving your business forward in changing times. At the 2017 conference, 300+ senior IT and line of business professionals will explore digital business demands including artificial intelligence (AI), Internet of Things (IoT), virtual reality and leadership in the digital economy, as well as hear first-hand experiences from experts and peers, including Premier 100 honorees. "The Premier 100 awards program highlights the exceptional work of an elite group of IT executives who are leading their organizations through times of unprecedented change. They are using technology to drive high-stakes business projects and create dynamic growth in their organizations," said Scot Finnie, editor-in-chief of Computerworld. "These 100 men and women are not only strategic business thinkers, but also team leaders who recognize the importance of recruiting and retaining the brightest talent to enable digital transformation and harness the opportunities of cloud, big data, mobile and social. We're pleased to recognize their leadership and honor their achievements." This year's Premier 100 honorees are not only leading their organizations through digital transformation, they are also launching cutting-edge projects that are helping their businesses thrive. This innovative spirit is cultivated throughout their organizations, driving team engagement and new business opportunities. "Maintaining status quo is no longer a business option. Organizations that cause disruption will quickly advance in their industry, and technology is often the force of this disruption," said Adam Dennison, SVP / General Manager, IDG Events & Publisher, CIO. "We are excited to recognize and bring together such a dynamic group of technology leaders at AGENDA17. Their stories will no doubt spark ideas in future winners and help elevate the technology industry overall." 2017 Premier 100 Honorees: Dimitris Agrafiotis, Chief data officer and head of technology products, Covance Peter Ambs, CIO, City of Albuquerque Peter Anderson, CIO, Greater Cleveland Regional Transit Authority Matthew Arvay, CIO, City of Virginia Beach, Va. Sami Ben Jamaa, Senior executive officer and CIO, Coca-Cola East Japan Timothy Birdsall, Senior vice president of Information Services and chief medical information officer, Cancer Treatment Centers of America Douglas Blackwell, Senior vice president and CIO, Horizon Blue Cross Blue Shield of New Jersey Brett Bonner, Vice president, IT Research and Development, Kroger Daniel Bosman, Managing director and assistant vice president, TD Securities Gary Brantley, CIO, DeKalb County School District Michal Cenkl, Director of Innovation and Technology, Center for Information and Technology, Mitre Christopher Chang, Senior vice president and CIO, Darden Restaurants Samuel Chesterman, Worldwide CIO, IPG Mediabrands Abhishek Choudhary, Manager, Information Systems, Indian Oil William Confalonieri, Chief digital officer, CIO and vice president, Deakin University Paul Czarapata, Vice president and CIO, Kentucky Community & Technical College System Paul Daugherty, CTO, Accenture Lesley Dickie, Vice president, Global Business Services, IT, Raytheon Jim Dye, Director, Global IT Infrastructure, Pittsburgh Glass Works Saman Far, Senior vice president, technology, FINRA (Financial Industry Regulatory Authority) Kim Felix, Vice president, IT, UPS Airlines Jeff Fields, CIO, Servpro Harry Folloder, CIO, Advantage Waypoint Michael Garcia, Vice president, Development Services, Fannie Mae Rodell Garcia, Chief technology adviser, Manila Water Gint Grabauskas, CTO, VIxxo José Güereque, IT and innovation director, Arca Continental Saravanan Gurumurthy, CTO, ForwardLine Greg Hart, Vice president, Cloud Services, McKesson Joseph Haskell, CTO, Planned Systems International Chong Huan, CIO, The Inland Real Estate Group Konstandinos Kalpos, Senior advisor, Cybersecurity, U.S. Department of Homeland Security Mohit Kapoor, Chief information and technology officer, TransUnion Hakan Karamanli, Executive vice president and CIO, Tam Faktoring Jeffrey Keisling, Senior vice president and CIO, Business Technology, Pfizer Sajed Khan, Senior vice president and CIO, United Solutions Akash Khurana, Vice president and CIO, McDermott International Georgette Kiser, Managing director and CIO, The Carlyle Group Wolfgang Krips, Executive vice president, Global Operations, and general manager, Amadeus Data Processing George Labelle, CIO, Independent Purchasing Cooperative Jason Lei, General manager, Intelligence Product, MediaMath Paul Lough, Vice president, Technology Strategy and Planning, and CTO, Navy Federal Credit Union Ryan Loy, Vice president, IT, Adtran Nandu Mahadevan, Vice president, SaaS Operations, BMC Software Charles Mance, Director, Communications & Technology Support Services, The George Washington University Saran Mandair, Vice president, Production Operations & IT, Yapstone Dave McCandless, Vice president, IT, Navis Trevor McDougall, CIO, Open Colleges Scott McIsaac, CTO, Secure-24 Matthew Minetola, Executive vice president of technology, CIO, Travelport Sumit Nagpal, Co-founder, chief architect and UX officer, LumiraDx USA Robert Napoli, CIO, Planned Parenthood of the Great Northwest and the Hawaiian Islands Sarah Naqvi, Executive vice president, CIO, HMSHost Rafat Naqvi, Vice president, IT Services, Avanade Steven Narvaez, IT director and CIO, City of Deltona, Fla. Timothy Newman, Associate deputy assistance secretary, HR Automation, Systems and Analytics, Department of Veteran Affairs Niel Nickolaisen, Senior vice president and CTO, O.C. Tanner Jim Noel, Vice president, Software Services, Veterans United Home Loans Anthony Norris, Senior vice president, IT, FedEx Services Ken Piddington, CIO and executive advisor, MRE Consulting Phil Potloff, Chief digital officer, Edmunds Prabhakar Posam, Head of IT & Business Process, PAE Kaushik Ray, Vice president, Global Architecture and Customer Engineering, Sungard Availability Services Jamshid Rezaei, CIO, Mitel Olaf Romer, Head of corporate IT and group CIO, Baloise Group Douglas Rousso, Senior vice president and CTO, CBS Theresa Rowe, CIO, Oakland University Sanjay Saraf, Senior vice president and CTO, Western Union Digital, Western Union Robin Sarkar, CIO, Lakeland Health Sorabh Saxena, Senior vice president, Software Development & Engineering, AT&T Julie Schlabach, Senior director, Emerging Technology Services, Cerner Glenn Schneider, Executive vice president and CIO, Discover Financial Services Lori Scott, CIO, NatureServe Carlos Selonke, CIO, Santander Bank John Showalter, Chief health information officer, University of Mississippi Medical Center Shane Snider, Executive vice president, IT and Customer Care, SkillPath Seminars Scott Spradley, Senior vice president and CIO, Hewlett Packard Enterprise Sanjay Srinivasan, Vice president and chief technology architect, Business Engineering, Vonage Suresh Srinivasan, CTO, NYU Langone Medical Center Tom Stafford, Vice president and CIO, Halifax Health Raied Stanley, Vice president, Business Systems, Metropolitan Utilities District Alan Stukalsky, Managing director and CIO, North America, Randstad North America Ramakrishnan Sudarshanam, Divisional vice president, IT, United Breweries Mike Sutten, Senior vice president and CTO, Kaiser Permanente Thomson Thomas, Senior vice president, Business Systems and Technology, HDFC Standard Life Insurance Sean Valcamp, Chief information security officer, Avnet Robin Veit, Director, Client Engineering and Operations, Starz Radhika Venkatraman, Senior vice president and CIO, Network and Technology, Verizon Craig Walker, Vice president and Global CIO Shell Downstream, Shell International Petroleum Melissa Ward, Vice president, IT, Eurpac Service Creighton Warren, CIO, USG Florian Wegener, Vice president and head of global ecommerce, Qiagen Tommy Whitten, District technology coordinator, Madison County Schools Judd Williams, CIO, National Collegiate Athletic Association Richard Wilson, Chief, Solution Delivery, Defense Health Agency Lisa Woodley, Vice president, Digital Experience, NTT Data Naoto Yamamoto, Chief, Business Solutions, United Nations Development Programme Michael Young, Chief product security officer, Esri Michael Yzerman, Vice president and Deputy CIO, Community Health Systems Sigal Zarmi, CIO, Network and U.S., PwC AGENDA17 Sponsorship Opportunities We invite leading technology solution providers to join us at AGENDA17 through our various sponsorship opportunities, including the awards celebration. Please contact Adam Dennison, SVP / General Manager, IDG Events & Publisher, CIO at adennison@idgenterprise.com to learn more. Follow Computerworld on Twitter: @Computerworld and #Premier100 Follow IDG Enterprise on Twitter: @IDGEnterprise Join Computerworld on LinkedIn Like Computerworld on Facebook About the Premier 100 Technology Leadership Awards The Premier 100 program was created in 2000 to spotlight individuals who have had a positive impact on their organizations through technology. These are individuals who manage internal IT organizations, mentor and motivate their IT teams and business colleagues, create a positive work environment, envision innovative solutions to business challenges and effectively manage and execute IT strategies. Each year nominees are invited to complete a survey that addresses a number of topics, including their background and experience and their attitude toward risk and innovation. Using Computerworld's IT Leader Index, which is a measurement of how closely an individual matches our definition of the IT Leader, we analyze the data. Each year, 100 honorees are selected to receive this life-time recognition award. Information on previous honorees can be viewed at: http://www.computerworld.com/s/article/9065479/Premier_100_IT_Leaders About AGENDA17 March 20-22, 2017 :: Ponte Vedra Beach, Florida :: AGENDAConference.com AGENDA is the business leadership conference focused on transforming business for the digital world. Transformation changes how companies look at technology, fostering conversations and partnerships among multiple business stakeholders. AGENDA17 brings together more than 300 senior IT and line of business leaders from a range of industries to develop action plans for the digital transformation at their organizations. This event creates a unique atmosphere for technology solution providers to integrate themselves into discussions during the strategic planning stage. About Computerworld Computerworld from IDG is the leading technology media brand helping senior IT, business decision-makers and key influencers navigate change with effective business strategy. As the voice of business technology, Computerworld enables the IT value chain with unique editorial coverage from setting strategies to deriving value. Computerworld's award-winning website (www.computerworld.com), focused conference series, strategic marketing solutions and research forms the hub of the world's largest (40+ edition) global IT media network and provides opportunities for IT vendors to engage this audience. Computerworld leads the industry with an online audience of over 7.2 million monthly page views (Omniture, January 2016 - March 2016 average) and was recognized in BtoB's 2013 Media Power 50 list; recognition Computerworld has received for more than 5 consecutive years. Computerworld is published by IDG Enterprise, a subsidiary of IDG. Company information is available at www.idgenterprise.com. About IDG IDG connects the world of tech buyers with insights, intent and engagement. IDG is the world's largest media, data and marketing services company that activates and engages the most influential technology buyers. Our premium brands, including CIO®, Computerworld®, PCWorld® and Macworld®, engage the most powerful audience of technology buyers providing essential guidance on the evolving technology landscape. Our global data intelligence platform activates purchasing intent, powering our clients' success. IDG Marketing Services creates custom content with marketing impact across video, mobile, social and digital. We execute complex campaigns that fulfill marketers' global ambitions seamlessly with consistency that delivers results and wins awards. IDG is the #1 tech media company in the world, per comScore.*


News Article | December 5, 2016
Site: www.eurekalert.org

NEW YORK NY (December 2, 2016)--The inability to hear subtle changes in pitch, a common and debilitating problem for people with schizophrenia, is due to dysfunctional N-methyl-D-aspartate (NMDA) brain receptors, according to a study by Columbia University Medical Center (CUMC) researchers. The study also shows that this hearing issue can be improved by combining auditory training exercises with a drug that targets NMDA receptors. The findings were published online today in the journal Brain. "Slight variations in our tone of voice are an important way of communicating emotions, such as happiness or sadness," said lead author Joshua T. Kantrowitz, MD, assistant professor of clinical psychiatry at CUMC. "This inability to detect subtle changes in pitch can also make it difficult to "sound out" words while reading, with over 70 percent of patients meeting criteria for dyslexia and further exacerbating communication problems in social and work situations. But while psychiatrists have recommended medications for symptom control, these treatments have not addressed the underlying auditory deficits." Dr. Kantrowitz and his colleagues compared auditory plasticity (the ability to learn from hearing tasks) in 40 stabilized schizophrenia patients and 42 healthy controls. Each subject listened to a series of tone pairs and was asked to indicate which tone was higher. Based on a subject's performance, the difficulty of the task was changed for the next pair of tones. When subjects correctly identified the higher tone, the pitch difference in subsequent tone pairs decreased; when subjects failed to identify the higher tone, the tones were moved further apart. "People with normal auditory plasticity usually get better at discriminating between the two tones as the test progresses, reflecting the ability to learn," said Dr. Kantrowitz. "And that was the case with the healthy controls in our study." At the start, there was a 50 percent difference in the pitch of the tones (e.g., 1,000 Hz and 1,500 Hz). On average, the healthy controls were able to discern between tones with a difference in pitch of as little as 3 percent. In contrast, the patients did not improve as much, detecting an average 16 percent difference in pitch. EEG recordings, made while the subjects performed auditory brain exercises, revealed that the schizophrenia patients had lower brainwave activity than the controls. Lower brainwave activity is associated with impaired auditory sensory cortex functioning and a reduced response to the training exercises. Dr. Kantrowitz and his colleagues suspected that schizophrenia patients' inability to improve their pitch discrimination is caused by dysfunction in their NMDA receptors, which are critical for learning and memory. If true, improving NMDA activity would improve their ability to discriminate between pitches. To test this hypothesis, some schizophrenia patients in the study were given D-serine, an amino acid that activates NMDA receptors, once a week for up to three weeks, while others were given a placebo. The patients significantly improved their pitch detection with auditory training, but only when D-serine was taken for two consecutive weeks. No improvement was seen in patients who took D-serine only once or in those who took a placebo. "It remains to be seen whether D-serine or another NMDA-activating drug is best suited for this purpose," said Dr. Kantrowitz. "What's important is that we now know that people with schizophrenia can improve their pitch detection with a combination of auditory training exercises and repeated doses of a learning-enhancing drug that effects the NMDA receptor." The study's senior investigator was Daniel C. Javitt, MD, professor of psychiatry at CUMC and director of schizophrenia research at the Nathan Kline Institute for Psychiatric Research, a facility of the New York State Office of Mental Health. The paper is titled, "Neurophysiological Mechanisms of cortical plasticity impairments in schizophrenia and modulation by the NMDA receptor agonist D-serine." The other contributors are: Michael L. Epstein, Odeta Beggel, Stephanie Rohrig, Jonathan M. Lehrfeld, Nadine Revheim, Nayla P. Lehrfeld, Jacob Reep, Emily Parker, Gail Silipo, and Merav Ahissar. The study was supported by grants from the National Institutes of Health (UL1 RR024156, P50 MH086385, and R01 MH049334), and the Dr. Joseph E. and Lillian Pisetsky Young Investigator Award for Clinical Research in Serious Mental Illness. Dr. Kantrowitz received consulting payments in the last two years from Vindico medical Education, Annenberg Center for Health Sciences at Eisenhower Health Advances, LLC, Strategic Edge Communications, Transperfect, Slingshot Insights, Kinetrix Croup, Havas Life and Cowen and Company. He has conducted clinical research supported by the National Institute of Mental Health, the Stanley Foundation, Roche-Genentech, Alkermes, Merck, Lundbeck, Forum, Sunovion, Novartis, Pfizer, and Lilly. He owns a small number of shares of common stock in GlaxoSmithLine. Dr. Javitt received consulting payments in the last two years from Sunovion, Forum, and Takeda. He has received research support from Roche. He holds intellectual property rights fro use of NMDA modulators in treatment of neuropsychiatric disorders. He holds equity in Glytech, AASI, and NeuroRx, and serves on the advisory boards of Promentis and NeuroRx. The others authors declare no conflicts of interest. Columbia University Medical Center provides international leadership in basic, preclinical, and clinical research; medical and health sciences education; and patient care. The medical center trains future leaders and includes the dedicated work of many physicians, scientists, public health professionals, dentists, and nurses at the College of Physicians and Surgeons, the Mailman School of Public Health, the College of Dental Medicine, the School of Nursing, the biomedical departments of the Graduate School of Arts and Sciences, and allied research centers and institutions. Columbia University Medical Center is home to the largest medical research enterprise in New York City and State and one of the largest faculty medical practices in the Northeast. The campus that Columbia University Medical Center shares with its hospital partner, NewYork-Presbyterian, is now called the Columbia University Irving Medical Center. For more information, visit cumc.columbia.edu or columbiadoctors.org.


CARMIEL, Israel, Feb. 14, 2017 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that its board of directors approved the record date for the Company’s 2017 Annual Meeting of Stockholders (the “Annual Meeting”) to be held on or about April 10, 2017.  Holders of the Company’s common stock at the close of business on March 15, 2017, the record date, will be entitled to receive notice of, and to vote at, the Annual Meeting. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®.  Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner.  Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries.  Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.  Protalix’s development pipeline includes the following product candidates: pegunigalsidase alfa, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; alidornase alfa for the treatment of Cystic Fibrosis; and others. To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made.  These statements are based on our current beliefs and expectations as to such future outcomes, and are valid only as of the date hereof.  We disclaim any obligation to update this information, except as may be required by law.


News Article | November 10, 2016
Site: www.prweb.com

This year marks 25 years in business for Benchworks, a rapidly growing privately held business dedicated to serving the life science industry. Benchworks’ operating units include a multi-location advertising agency with expertise in DTC/HCP campaign development; a wholesale DEA inspected pharmaceutical drug distribution business licensed to handle drug schedules II-V, including cold chain assets with facilities in Maryland, Kentucky and Florida; and lastly, a consulting business that works with life science and medical device companies on commercialization planning. The Benchworks family of companies has a particularly strong level of expertise in product launch management and product lifecycle optimization. Benchworks began serving a national audience in 2001, eventually earning long-term strategic assignments with pharmaceutical clients such as Pfizer, Shire, Otsuka and Teva. Currently Benchworks does business with over 25 life science and medical device companies in North America. “I am pleased to say that after decades of hard work, we have evolved Benchworks into a full-service strategic agency capable of handling AOR assignments,” said CEO Thad L. Bench Sr. “The acquisition of Safe Chain Solutions, our pharmaceutical drug distribution business, allows us to provide our life science clients with a robust platform to help them achieve their commercial goals.” A New Era For the past 25 years, Benchworks has remained family owned. Thad L. Bench Sr. leads the company as CEO, and his philosophies guide the company’s activities. “Being family owned means Benchworks can focus on nurturing a client’s brand, rather than quarterly numbers for stockholders,” said Thad Sr. Thad L. Bench II, a graduate of St. Mary’s College, recently joined Benchworks to support business development initiatives and marketing activities. This move further demonstrates the company’s commitment to a long-term strategy for growth and operational excellence. Looking forward, Thad Sr. says his goal is “to manage our growth in a way that is sustainable and guided by a sustained focus on quality and continued professional development of our people.” In addition, the company’s philosophy of graciousness and respect—toward clients, colleagues and agency partners—will never change, he added. “We are entering a period of robust, double-digit growth as Benchworks begins to gain its rightful market share. The commercial pressure on our clients makes Benchworks a very attractive option because we are a high-quality independent agency that represents an excellent value,” Thad Sr. said. “In my view, we are still very early in our commercial cycle,” he added. “While we are 25 years old as an organization, Benchworks feels to me like a young company full of promise, optimism and potential for exponential growth.” About Benchworks Benchworks, a comprehensive marketing services agency headquartered in Chestertown, Maryland, was founded in 1991. The company specializes in the design, production and launch of complete marketing and branding services. Clients include a wide variety of companies in the pharmaceutical, beverage, manufacturing and education industries in North America and Europe. Benchworks’ subsidiary, Safe Chain Solutions, specializes in the distribution of ethical drugs and 3PL services. For additional information, please view our video, visit http://www.Benchworks.com or call 800-536-4670.


Vooraanstaand expert Jørgen Jahnsen, hoogleraar Gastro-enterologie aan de Universiteit van Oslo, Noorwegen, gaf commentaar op de studie: “ Dit is de eerste RCT om het gebruik van een biosimilar bij inflammatoire darmaandoeningen te onderzoeken. Hoewel we al een schat aan geëxtrapoleerde en parktijkgegevens voor CT-P13 hebben, wilden gastro-enterologen al enige tijd de zekerheid van een RCT, en het is bemoedigend om dergelijke positieve data te zien van het RCT-onderzoek van Celltrion.” De werkelijke kostenbesparingen in verband met het gebruik van CT-P13 voor alle indicaties werden onderzocht in vijf Europese landen vanaf begin 2015 tot de eerste helft van 2016. Volgens de op ECCO gepresenteerde data bedroegen de totale kostenbesparingen waargenomen voor Duitsland, Italië, Spanje en het Verenigd Koninkrijk € 32,4 miljoen, en de bevindingen suggereren dat hierdoor nog eens 5428 patiënten per jaar toegang kunnen krijgen tot deze belangrijke biologische therapie. Er waren geen kostenbesparingen in Frankrijk, omdat de prijs van de biosimilar en het referentieproduct infliximab gelijk waren. Desondanks is het gebruik van CT-P13 in dit land echter geleidelijk toegenomen.4 Man Hoon Kim, President en CEO van Celltrion Healthcare, verklaarde: “ Bij Celltrion zijn we toegewijd aan het aanpakken van de behoeften van de klinische gemeenschap door middel van robuuste wetenschappelijke exploratie. Een pivotaal RCT-onderzoek naar de ziekte van Crohn is hiervan een belangrijk voorbeeld. De resultaten van dit cruciale onderzoek zijn in overeenstemming met onze andere RCT's en vele IBD-praktijkstudies die zijn uitgevoerd. Meer in het algemeen is het bevredigend om de veranderingen te zien die CT-P13 maakt in de voor financiële problemen staande gezondsheidszorgsystemen in Europa.” Inflammatoire darmziekten (IBD) zoals de ziekte van Crohn (CD) en colitis ulcerosa (UC) zijn chronische invaliderende gastrointestinale aandoeningen die van invloed zijn op het gehele leven van een patiënt.5 Ongeveer 2,5 - 3 miljoen mensen in Europa worden er door getroffen;6 CD treft ongeveer drie personen per 1.000 en UC ongeveer 5 personen per 1000.5 Celltrion Healthcare voert wereldwijde marketing, verkoop en distributie van biologische geneesmiddelen ontwikkeld door Celltrion, Inc. uit via een uitgebreid wereldwijd netwerk dat meer dan 120 verschillende landen bestrijkt. De producten van Celltrion Healthcare worden gemaakt in state-of-the-art faciliteiten voor zoogdiercelcultuur, ontworpen en gebouwd om te voldoen aan de Amerikaanse cGMP-normen van de FDA en de GMP-normen van de EU. Voor meer informatie kunt u terecht op: http://www.celltrionhealthcare.com/ De studie is een gerandomiseerde, dubbelblinde, parallelgroep, Fase Ⅲ studie om de werkzaamheid en veiligheid te onderzoeken van CT-P13 en referentie infliximab bij CD-patiënten. Van 220 patiënten gerandomiseerd in 58 studiecentra in 16 landen, maakten 214 patiënten vol tot week 6 voor de primaire analyse en 180 patiënten tot week 30. De studie werd in gelijke mate gefinancierd door Celltrion en Pfizer. CP-P13 is ontwikkeld en geproduceerd door Celltrion, Inc. en was 's werelds eerste monoklonaal antilichaam-biosimilar dat werd goedgekeurd door het Europees Geneesmiddelenbureau (EMA). Het is geïndiceerd voor de behandeling van acht auto-immuunziekten zoals reumatoïde artritis en inflammatoire darmziekte. Het werd in september 2013 door de EMA goedgekeurd onder de handelsnaam Remsima® goedgekeurd en begin 2015 gelanceerd in Europa. De Amerikaanse FDA keurde Celltrion's CT-P13 goed in april 2016 onder de handelsnaam Inflectra™. Celltrion's CT-P13 is goedgekeurd in meer dan 79 (vanaf januari 2017) landen, waaronder de VS, Canada, Japan en heel Europa. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congres van de Europese organisatie voor Crohn en Colitis ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Beschikbaar op www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [laatst bekeken januari 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013) 7, 322-337. Deze bekendmaking is officieel geldend in de originele brontaal. Vertalingen zijn slechts als leeshulp bedoeld en moeten worden vergeleken met de tekst in de brontaal, welke als enige rechtsgeldig is.


Dr Camp, who is a Senior Lecturer in the Department of Chemical Sciences at the University's School of Applied Sciences, has been exploring sugar-powered catalysis for the last six years. He heads a group of scientists at Huddersfield and also the University of Nottingham - where he was previously based - who are carrying out the research. Their findings are being relayed in presentations and articles, with the latest appearing in the new edition of RSC Advances, published by the Royal Society of Chemistry. The article concludes with the claim that "our study provides the groundwork for a simple technology that opens up exciting opportunities" by harnessing the reducing potential of renewable sugars. The concept of sugar-powered catalysis has also attracted interest at the House of Commons, when University of Huddersfield chemistry student David Austin - who has been working with Dr Camp - took part in an event showcasing the UK's best undergraduate research. Dr Camp said that although biological processes were the basis for his work, the research is pure chemistry. "We are inspired by nature, but we don't use enzymes or biological processes." Sugars have been used for catalysis in the past, said Dr Camp, but techniques such as advanced spectroscopy have enabled him and his co-researchers to make key breakthroughs such as the requirement to minimize oxygen from the system in order to allow for a sugar-powered process. The researchers have investigated a variety of reducing sugars - including sucrose and fructose - but glucose has become their principal focus. Dr Camp and his team are also examining the use of environmentally-benign solvent that contains no oil-derived substances. To this end, a collaboration has been formed with the multi-national company Circa, which is a pioneer in the processing of cellulose into a novel green solvent. Dr Camp and his team have also attracted financial backing from a wide range of UK-based companies, including AstraZeneca, Pfizer, GlaxoSmithKline, Vertex and Johnson Matthey. Sugar-powered catalysis has many potential applications, said Dr Camp, who is currently exploring its use its use the development of novel dyes for solar-cell in collaboration with Dr Elizabeth Gibson of the University of Newcastle. But he anticipates that agro-chemistry and pharmaceuticals will be the principal industries to use the new technology that he is developing, appreciating the cost and environmental benefits of using sugars. At the University of Huddersfield, Dr Camp has PhD researcher Thomas Bousfield working with him on sugar-powered catalysis. Undergraduate David Austin, who completes his four-year MChem degree this year, has also participated in the research, working on using sugars as the catalyst for producing drug-like molecules. Huddersfield-born David - who studied at Rastrick High School and Huddersfield New College before embarking on his degree - created a poster describing the sugar-powered catalysis concept and entered it into a contest organised by the British Conference of Undergraduate Research. It was selected for display at the prestigious Posters in Parliament event, described as "a remarkable collection of the best undergraduate research from across the country". Among visitors to the event was Colne Valley MP Jason McCartney, who tweeted the encounter. David spent the year-long work-placement component of his degree course at the Halifax plant of chemical industry multi-national Solvay. Keen to continue working on industrially-relevant chemistry, he saw Dr Camp's project as an ideal opportunity and he is convinced of its potential. More information: Jason E. Camp et al. Recyclable glucose-derived palladium(0) nanoparticles as in situ-formed catalysts for cross-coupling reactions in aqueous media, RSC Adv. (2016). DOI: 10.1039/C5RA25712C


News Article | December 16, 2016
Site: www.theguardian.com

Drugs companies are facing renewed questions about the prices they charge the NHS for life-saving medicines after a firm was accused of marking up a tablet by more than 12,000%. A week after US giant Pfizer was slapped with a record fine of £84.2m for alleged unfair price hikes, the Competition and Markets Authority accused another multinational, Actavis, of ramping up prices for life-saving hydrocortisone tablets from 70p a pack as of April 2008 to £88 by March 2016. The treatment is prescribed to people whose adrenal glands do not produce enough steroid hormones, such as those suffering from Addison’s disease. Almost 1m prescriptions were distributed over the last year. The regulator’s senior responsible officer, Andrew Groves, said the price increase was unfair because it is the only available drug on the market. “This is a lifesaving drug relied on by thousands of patients, which the NHS has no choice but to continue purchasing,” he said. “We allege that the company has taken advantage of this situation and the removal of the drug from price regulation, leaving the NHS – and ultimately the taxpayer – footing the bill for the substantial price rises,.” Both cases, as well as a previous investigation involving GSK, are currently being challenged by the drugs firms, but a spokesperson for the CMA said three further investigations are under way into the pharmaceutical sector, one of which is looking at another case of unfair pricing. But, he said, without conducting a sector-wide investigation of the pricing of generic drugs it was difficult to assess the extent of the problem. “There is legislation [being planned] to keep a closer eye on generics and that was partly [as a] result of some of the concerns that have come up from things we have been investigating,” he added. Drug companies face price controls for as long as their products are protected by patents. As soon as patents expire, drugs go “off-brand” meaning any rivals can develop generic copies. Normally this reduces costs as other players enter the market. But in these two cases, the lack of substitute products proved costly for the NHS, according to the regulator. The Pfizer case resulted in the NHS paying about £50m a year extra for its epilepsy medicine over the past four years, according to the CMA, while the Actavis increase cost about £70m extra annually. With other cases pending, it is possible that the cash-strapped NHS has been overcharged several hundreds of millions of pounds altogether over the past few years. Hydrocortisone tablets went off-brand of 2008. But according to the CMA, Actavis remained the only supplier until last year. Observers say there could be a number of reasons why. “It is typically a mix of scientific and regulatory and commercial factors that will impact on a decision whether to develop a generic or not,” said Warwick Smith, director general of the British Generic Manufacturers Association (BGMA). He added that if a drug is complicated to make, or there are only a small number of patients taking the medication, companies may chose not to produce the drug. If upheld, the Pfizer and Actavis cases would clearly show that the market for medicines falls down where the NHS has no alternatives for life-saving treatments. A spokesperson for the Association of the British Pharmaceutical Industry, the trade body for major pharmaceutical companies condemned such practices saying: “The ABPI has repeatedly said that it does not in any way support or condone the practice of ‘price hikes’ to generic medicines. This position has not changed.” Actavis was bought by the Israeli pharmaceutical company Teva earlier this year but it is now in the process of selling off the operation to Intas Pharmaceuticals to comply with EU rules. Tevas said it intended to defend the allegations although it said the pricing of the hydrocortisone product had never been under its control.


News Article | February 24, 2017
Site: news.yahoo.com

Some analysts cite Hillary Clinton's continued criticism of drug prices as a cause for a slump in biotech during the U.S. presidential campaign, but with the election behind us, many biotech enterprises saw at least a 9% increase due to Donald Trump's victory. Two companies in the biotech space entering the first quarter of 2017 may be in a position for their products, as well as stock prices, to move to greater heights, BioVie Inc. (BIVI) and Organovo Holdings Inc. (ONVO). Organovo is a microcap biotech that produces a 3D-printed model using human liver cells that can be used in early phase pharmaceutical trials. Currently, the industry is using a 2D model in which liver enzymes only last two days. Organovo's model is more robust and enzymes last 42 days. The company has 104.4 million shares and trades at $2.91, and the market cap is $303.84 million. The company noted in an Investor Presentation that Pfizer (PFE) spent $750 million in legal costs and another $150 million to remove a drug that did not show toxicity in 2D models but was in humans. If Organovo's product catches on, the stock will take off. In a recent press release, the company's chief scientist pointed out that 3D bioprinted proximal tubule tissue model exhibits key characteristics of renal physiology that can be used in vitro, meaning in animal research. This research was quoted in a recent academic article released by the Institute for Laboratory Animal Research (ILAR) Journal. The issue is that in pharmaceutical testing, the liver often rejects the drug. This is called drug-induced liver injury (DILI). Much of this research is conducted on animals in the early phases. According to a study, DILI was the second-most poorly predicted toxicity. This creates a big problem because of all the billions of dollars spent in drug research. Much of this money could be saved by uncovering liver problems early in the process. What works in animal research may not translate to the humans. This problem has existed for many decades. The 3D printer produces a model using human liver cells. According to the paper from ILAR Journal, "3D spheroid culture system represents a promising and phenotypically relevant hepatic system for routine toxicity testing." Furthermore, "bioprinting allows for the fabrication of 3D liver tissue that recapitulates native hepatic tissue architecture, cellular compartmentalization and intercellular interactions. Most importantly, the 3D tissue constructs generated using these approaches exhibit a broad range of highly differentiated in vivo-like liver features and functions while being maintained in vitro." The paper seems optimistic on 3D printed liver cells "as it addresses many of the shortcomings associated with traditional in vitro culture models and animal models." "Overall, the 3D bioprinting culture technology has attracted the attention of the pharmaceutical industry, especially for drug discovery and safety assessment." The paper was written by experts from the Food and Drug Administration, Merck (MRK), and other health care companies. Organovo recently had an article published by Frontiers in Physiology. According to the article, "Current preclinical methods using 2D cell cultures and animal models are unable to fully recapitulate clinical drug responses due to limited in vitro functional lifespan, or species-specific differences. Using Organovo's proprietary 3D bioprinting platform, we have developed a fully cellular human in vitro model of the proximal tubule interstitial interface comprising renal fibroblasts, endothelial cells and primary human renal proximal tubule epithelial cells to enable more accurate prediction of tissue-level clinical outcomes." The company's stock took a hit the other day. Fiscal 2017 revenue guidance was adjusted from $4.5 million to $6.2 million to $3.7 million to $4.5 million. The stock was at $3.83 early this month and is now at $2.91. It happens. It's a microcap biotech. As of the last quarter, the balance sheet showed $70 million in cash and no debt. Management gives a burn rate of $31 million to $34 million. It looks like Organovo has plenty of breathing room to conduct R&D. Sales jumped 160% in 2016 to $1.5 million. L'Oreal (OR.PA) is a major customer. The management team and board of directors have ties with Amgen (AMGN) and biotech venture capital. It seems they have no issues raising money. The company has been around for 10 years and is headquartered in San Diego. BioVie is on a mission to provide the technology to ward off liver disease. The company's BIV-201 is designed to tackle ascites formation by blocking neurohormonal signals to the body, meaning it targets ascites formation at its mechanistic source. The company's first clinical trial will address refractory ascites with the ultimate goal of getting the first approved drug for ascites on the market. Currently, the two-year survival in patients with diuretic-resistant ascites is approximately 25%. The company is also looking to use its patented technology to help patients with other forms of liver disease such as esophageal variceal bleeding (EVB) and hepatorenal syndrome type 1 and type 2. An extremely serious health issue, liver cirrhosis is advanced liver diseases often brought on by cirrhosis, hepatitis, alcoholism or nonalcoholic steatohepatitis (NASH). Estimates range from 20 million to 30 million Americans who have NASH and approximately 1.5 million will go on to develop liver cirrhosis. Ascites is a direct complication of advanced cirrhosis and affects approximately 100,000 individuals in the U.S. each year. The word on the street is that Trump's revamping of health care should positively impact trend-setters like BioVie allowing shorter to market times and greater support toward research efforts. The company is trading at 30 cents offering mega opportunities for ground-floor investors. BioVie is led by an impressive team with former experience at Merck, Amgen and Boston Heart Diagnostics. What I like about Organovo is that it has been around for 10 years and has real sales. It's transitioning from theoretical to tangible dollars. Pharmaceutical companies are cautious as they should be. No one wants to go way out on a limb for new technology until it is 100%. If the company surprises on the upside in revenues this year, the stock will skyrocket. If not, it will lag. Another positive is that there is somewhat of a following on the internet. Several sites follow Organovo. Disclosure: We do not own any of the stocks mentioned. This article first appeared on GuruFocus. Warning! GuruFocus has detected 2 Warning Signs with ONVO. Click here to check it out. The intrinsic value of ONVO


News Article | December 3, 2016
Site: www.eurekalert.org

Researchers are reporting the highest and most sustained levels to date of the essential blood-clotting factor IX in patients with the inherited bleeding disorder hemophilia B. After receiving a single dose of an experimental gene therapy in a clinical trial, patients with hemophilia produced near-normal levels of clotting factor IX, allowing them to stop clotting factor infusions and to pursue normal activities of daily life without disabling bleeding episodes. Lindsey A. George, MD, a hematologist at Children's Hospital of Philadelphia (CHOP) is the lead investigator of the phase 1/2 clinical trial sponsored by Spark Therapeutics, Inc. and Pfizer, Inc. The American Society of Hematology (ASH) today highlighted updated findings from that trial in a press conference during its annual meeting in San Diego. George will present those study results tomorrow at an ASH plenary scientific session. Katherine High, MD, a senior author of the study and Spark Therapeutics's president and chief scientific officer, described the updated interim trial data at today's press conference. The clinical trial of nine adult hemophilia B patients, aged 18 to 52 years, used a single dose of a gene therapy product engineered to enter patients' liver cells and direct the production of the blood clotting factor that they lack. George notes, "Our goal in this trial was to evaluate the safety of the gene therapy product and secondarily, to determine if we could achieve levels of factor IX that could decrease bleeding events in patients." She added, "These patients have a severe or moderate level of hemophilia, with baseline clotting factor level less than or equal to 2 percent of levels in healthy people. In current treatment, patients with hemophilia give themselves intravenous doses of factor IX up to a couple times a week. While generally effective, factor levels fluctuate, and patients may suffer painful, disabling joint bleeds when their clotting factor levels drop. Such a regimen requires significant planning of daily activities." In the current trial, said George, the patients maintained factor levels of approximately 30 percent, enough to lift them out of the severe category. "At these new levels, hemophilia patients do not typically need to self-treat with factor to avoid bleeding events," she said, adding, "This represents a potential dramatic improvement in their quality of life and a shift in the way we think about treating hemophilia." A factor level of 30 percent is near-normal, she added, and patients would be expected to experience bleeding only in the event of major trauma or surgery. One subject self-infused two days after receiving the gene therapy vector. Beyond this, no patients had any bleeding events or required factor for any reason. With significant reduction in bleeding events and factor use, six of the first seven patients reported increased physical activity and all reported improved quality of life. Two additional patients received the gene therapy product too recently to determine quality-of-life measures. Previous hemophilia gene therapy trials have been frustrated by an immune response to the gene therapy product that limited the success of the therapy. In the current trial, two patients experienced an immune response to the gene therapy that did not result in safety concerns, and were treated with steroids. The patients are still undergoing treatment but have maintained factor IX activity without bleeding. George reported that she is cautiously optimistic, acknowledging that this trial is a small study, with a short follow-up period as yet. However, as the researchers continue to monitor patients in the current trial, next steps will be to discuss with the U.S. Food and Drug Administration the outlines of a larger, phase 3 clinical trial. No gene therapies for any genetic diseases have yet been approved for clinical use in the U.S. Formerly a research leader at CHOP, High pursued groundbreaking preclinical investigations in hemophilia B gene therapy and provided scientific expertise to previous gene therapy trials in hemophilia and other genetic disorders at CHOP before moving to Spark Therapeutics, which was spun off from CHOP in 2013. CHOP maintains a financial interest in the company. About Children's Hospital of Philadelphia: Children's Hospital of Philadelphia was founded in 1855 as the nation's first pediatric hospital. Through its long-standing commitment to providing exceptional patient care, training new generations of pediatric healthcare professionals, and pioneering major research initiatives, Children's Hospital has fostered many discoveries that have benefited children worldwide. Its pediatric research program is among the largest in the country. In addition, its unique family-centered care and public service programs have brought the 535-bed hospital recognition as a leading advocate for children and adolescents. For more information, visit http://www.


News Article | February 16, 2017
Site: www.eurekalert.org

Scientists at Winship Cancer Institute of Emory University have mapped a vast spider web of interactions between proteins in lung cancer cells, as part of an effort to reach what was considered "undruggable." This approach revealed new ways to target cells carrying mutations in cancer-causing genes. As an example, researchers showed sensitivity to an FDA-approved drug, palbociclib, for a gene that is commonly mutated in lung cancer cells, which is now being tested in a clinical study. The results are published online in Nature Communications. Many genes that drive the growth of cancer cells don't have any drugs available against them. For "tumor suppressor" genes, researchers are often not sure how to go after them. When the tumor suppressors are gone, cells often become more deranged, but there's no bullseye left to target. Exploiting the cancer cells' derangement remains a daunting challenge, says senior author Haian Fu, PhD. "Our approach is to place tumor suppressors in the context of a network of cancer-associated proteins and link tumor suppressors to drugs through a known drug target protein," Fu says. "In this way, changes in a tumor suppressor may be linked with the response of the target to the connected drug." The study is part of a push by the National Cancer Institute's Cancer Target Discovery and Development (CTD2) network to translate genomics data into therapeutic strategies, he says. Emory is a member of the NCI CTD2 network. Fu holds the Winship Partner in Research endowed chair and is leader of Winship's Discovery and Developmental Therapeutics Program, director of the Emory Chemical Biology Discovery Center and professor of pharmacology and hematology and medical oncology. Co-corresponding author Fadlo Khuri, MD, maintains his professor appointment at Winship Cancer Institute and is now president of the American University of Beirut in Lebanon. Cancer researchers have been searching for ways to target mutations in the gene STK11/LKB1, found in 15 to 25 percent of non-small cell lung cancers. The tumor suppressor STK11/LKB11 encodes an enzyme that is thought to regulate cell migration and metabolism. One of the Winship team's newly identified interactions -- a "thread" in the spider web -- suggested that palbociclib, recently approved against metastatic breast cancer, may work against cells carrying mutations in LKB1, through LKB1's connection to CDK4, the target of palbociclib. That prediction was supported by genomic data analysis and cell culture experiments: lung cancer cells with LKB1 defects showed a tendency of increased sensitivity to palbociclib. Now a study led by Taofeek Owonikoko, MD, at Winship is using LKB1 status as a biomarker for interpreting the effect of palbociclib. If cells are complex machines, then a number of ways exist for figuring out how the machines' parts, dominated by proteins, fit together. Some of them involve multiple washing steps to remove nonspecific partners after breaking cells apart, but FRET (Förster resonance energy transfer) does not. If two fluorescent molecules with colors that are near on the spectrum are close enough (less than 10 nanometers), that proximity can be detected by FRET. Fu and his colleagues established a large-scale platform for tagging proteins with two different fluorescent molecules, introducing them into cancer cells, and then detecting interactions between the proteins. They call this network of cancer-associated proteins "OncoPPI." Starting with a set of 83 lung cancer-related proteins, the team detected more than 260 interactions that were not known previously. They tested the interactions several times, in different orientations, and in other lung cancer cell lines with selected interactions to establish reliability. More than 80 percent of the interactions the researchers detected could be confirmed by another method (GST pulldown). As an additional example to illustrate the utility of a protein interaction web, the team focused on the prominent oncoprotein Myc, which was also considered "undruggable." But the researchers could connect Myc indirectly through NSD3 to another protein called Brd4, against which inhibitors have been developed. Brd4 inhibitors are being currently tested in clinical trials. This finding revealed a new pathway Brd4-NSD3-Myc as potential targets for therapeutic intervention, Fu says. The OncoPPI research was supported by the National Cancer Institute Cancer Target Discovery and Development (CTD2) network (U01CA168449), lung cancer program project (P01CA116676) and Winship Cancer Institute (P30CA138292) and the Georgia Research Alliance, and the Emory University Research Committee. The clinical study of palbociclib is sponsored by Pfizer. Co-first authors are research associate Zenggang Li, PhD, now at Michigan State University, instructor Andrei Ivanov, PhD and Xiangya Hospital medical student Rina Su, now at Chao-yang Hospital, Capital Medical University in Beijing, China. Emory/Winship co-authors include Qi Qi, PhD, Philip Webber, PhD, Yuhong Du, PhD, Wei Zhou, PhD, Adam Marcus, PhD, Carlos Moreno, PhD, Lee Cooper, PhD and Margaret Johns, PhD, graduate students Valentina Gonzalez-Pecchi and Lauren Rusnak, and visiting medical student Songlin Liu. Collaborators from UT Southwestern contributed to the paper.


News Article | November 23, 2016
Site: www.newsmaker.com.au

MarketStudyReport.com adds “Precision Medicine Market Size By Technology (Big Data Analytics, Gene Sequencing, Drug Discovery, Bioinformatics, Companion Diagnostics), By Application (Oncology, CNS, Immunology, Respiratory), Industry Analysis Report, Regional Outlook (U.S., Canada, Germany, UK, France, Scandinavia, Italy, Japan, China, India, Singapore, Mexico, Brazil, South Africa, UAE, Qatar, Saudi Arabia), Application Potential, Price Trends, Competitive Market Share & Forecast, 2016-2023” new report to its research database. The report spread across 94 pages with table and figures in it. Global Precision Medicine Market size was more than $39.1 billion for 2015 and is predicted to register 10.51% of CAGR during forecast timeframe. It is innovative procedure for treating and preventing chronic ailments depending upon changes in individual genes and other lifestyle features. New approach helps doctors properly assess ailment risk and predict optimal treatment. Growing occurrence of cancer and increase in cancer prone geriatric population all across the globe is predicted to boost industry expansion. Threats related with sharing of patients genetic information can hinder industry growth. Insurance firms can use patient data and raise their premium for people who are at a risk of acquiring inherited diseases. Further, decline in rate of FDA (U.S. Food and Drug Administration) drug approval has minimized the rate of production of new medicines in spite of heavy investments. This aspect can hinder global precision medicine market expansion. Technology Trends The industry is segmented into different technologies like gene sequencing, companion diagnostics, big data analytics, bioinformatics and drug discovery. Gene sequencing segment size was more than $8.1 billion for 2015. Current FDA guidelines on next -generation sequencing dependent tests takes into consideration individual differences in genes of various persons, environments and life patterns while creating new type of healthcare. Companion diagnostics segment has acquired importance owing to rising concerns about rates of drug failures. Further, the segment is expanding at rapid pace owing to rise in financial support and approvals by government. Heavy throughput omics techniques applied in biological and basic research are predicted to propel bioinformatics segment growth. Out of all omics techniques next-generation technique is predicted to create key impact on the segment growth. Drug discovery technique contributed more than $9 billion for 2015 and is predicted to register CAGR of 8.31% during forecast timeframe. Further, biomarker directed treatments with medicine targeting epidermal growth factor receptor (EGFR),c-ros oncogene 1 receptor tyrosine kinase (ROS1) and anaplastic lymphoma kinase (ALK) have speeded up the production of new medicines. Precision Medicine Market Application Trends Global industry is segmented into various applications like respiratory application, oncology application, Immunology application and central nervous system (CNS) application. Oncology application contributed more than 30.1% of precision medicine market share for 2015 and is predicted to record CAGR of 10.91% during forecast timeframe. CNS application contributed more than $9.1 billion for 2015. Neuroscience therapeutics has been utilizing the approach for long duration. Regional Trends Global industry was segmented into key geographical regions like North America, MEA, Europe, APAC and Latin America. U.S. precision medicine market share was about 65.1% of revenue of North America. Factors like large allocation of budget by U.S. president to agencies like FDA( U.S. food and drug administration) , NIH (National Institute of Health) and NCI (National Cancer Institute) along with favorable government rules have contributed to the regional industry growth. Germany precision medicine market share was more than $2.5 billion for 2015 and is predicted to contribute significantly to the growth of European industry. Reason for industry growth in the region can be credited to the fact that many institutions have acquired biomarker analysis certification required for colorectal cancer detection tests. Further, medicine producing and diagnostic firms are making tremendous efforts for enhancing industry growth in Europe. Favorable compensation policies are predicted to promote industry growth in France. China contributed more than 25.1% to APAC precision medicine market share for 2015 and is predicted to remain key region in future. Favorable government initiatives and high contributions from academic labs has assisted in the regional industry growth. Competitive Trends Key industry players profiled in the report include Roche Holdings AG, Qiagen, Pfizer, Medtronic, Source Precision Medicine Incorporation, Silicon Biosystems, Tepnel Pharma Services, Covance, Biocrates Life Sciences AG, Novartis, Nanostring Technologies, Laboratory Corporation of America Holdings, Quest Diagnostics, Teva Pharmaceuticals, Intomics, Ferrer InCode, Eagle Genomics Limited and Quest Diagnostics. To receive personalized assistance, write to us @ [email protected] with the report title in the subject line along with your questions or call us at +1 866-764-2150


CARMIEL, Israel, Dec. 27, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) (the “Company”) announced today the confirmation of the recent letter of intent to purchase alfataliglicerase to treat Gaucher patients in Brazil by the Brazilian Ministry of Health (the “Brazilian Ministry”).  The Brazilian Ministry’s order consists of a number of shipments during 2017 for a total of approximately $24.3 million.  Shipments are to start in mid-2017 and continue through the end of the year, in increasing volumes.  The size of the final shipment of this order represents annual revenues of approximately $42 million.  “This order for alfataliglicerase will further bolster our liquidity, and we expect it to bring us close to the breakeven point for the fourth quarter of 2017.  We also anticipate having data from a number of our ongoing clinical programs during 2017,” said Mr. Moshe Manor, Protalix’s President and Chief Executive Officer.  “The upcoming year will be an exciting one for our company as our narrative is changing and we now have the ability to realize significant potential clinical and commercial value-creating opportunities.” Gaucher disease is a rare lysosomal storage disorder.  Alfataliglicerase is a plant cell-expressed form of the glucocerebrosidase enzyme that was approved by the Brazilian National Health Surveillance Agency in March 2013 for the long-term treatment of adults with Type I Gaucher disease and in November 2016 for the long-term treatment of children four years of age and above with Type I Gaucher disease. The Company owns all rights to alfataliglicerase in Brazil. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx(R).  Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner.  Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries.  Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.  Protalix’s development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; PRX-110 for the treatment of Cystic Fibrosis; and others. To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.  The terms “expect,” “anticipate, “believe,” “estimate,” “plan” and “intend” and other words or phrases of similar import are intended to identify forward-looking statements.  These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made.  These statements are based on our current beliefs and expectations as to such future outcomes.  Drug discovery and development involve a high degree of risk.  Factors that might cause material differences include, among others: risks related to the ultimate purchase by Fundação Oswaldo Cruz of alfataliglicerase pursuant to the stated purchase intentions of the Brazilian Ministry of Health of the stated amounts, if at all; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding the purchase of alfataliglicerase generally; risks related to our commercialization efforts for alfataliglicerase in Brazil; risks relating to the compliance by Fundação Oswaldo Cruz with its purchase obligations and related milestones under our supply and technology transfer agreement; risks related to the amount and sufficiency of our cash and cash equivalents; risks related to the amount of our future operating expenses; failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our outstanding notes or any other indebtedness; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission.  The statements in this press release are valid only as of the date hereof and we disclaim any obligation to update this information, except as may be required by law.


News Article | February 27, 2017
Site: globenewswire.com

MIAMI, Feb. 27, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK), a multinational biopharmaceutical and diagnostics company, will announce operating and financial results for the fourth quarter ended December 31, 2016 after the close of the U.S. financial markets on Wednesday, March 1, 2017. OPKO’s senior management will provide a business update and discuss its financial results in a conference call and live audio webcast beginning at 4:30 p.m. Eastern time on Wednesday, March 1, 2017. For those unable to participate in the live conference call or webcast, a replay will be available beginning March 1, 2017 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 80392791. The replay can be accessed for a period of time on OPKO’s website at http://investor.opko.com/events.cfm. About OPKO Health, Inc. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation’s third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator for androgen deficiency indications. Our biologics business includes hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), a long-acting oxyntomodulin for diabetes and obesity (in Phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com.


News Article | November 17, 2016
Site: www.newsmaker.com.au

The travel vaccines for the prevention of hepatitis A, hepatitis B, yellow fever, tetanus, poliomyelitis, meningococcal disease, typhoid fever are manufactured by leading market players namely Sanofi Pasteur, Merck, Novartis and GlaxoSmithKline. Health related complications are greater in developing countries and rural areas because of dissimilarities in sanitary conditions, available food and water bases. The immunization Practices Advisory Committee of the Center for Disease Control and Prevention (CDC) mentions that travelers should be up-to-date on routine immunizations, irrespective of travel plans. The target population for the travel vaccines market include outbound travelers. The travel vaccines for the prevention of hepatitis A, hepatitis B, yellow fever, tetanus, poliomyelitis, meningococcal disease, typhoid fever are manufactured by leading market players namely Sanofi Pasteur, Merck, Novartis and GlaxoSmithKline. Among these aforementioned companies, Sanofi Pasteur and GSK are the notable players in the travel vaccines market that accounts for approximately 85% of total market. Recently in March 2014, Sanofi Pasteur, the vaccines segment of Sanofi announced its long term strategic collaboration with SK Chemicals Company to develop pneumococcal conjugate vaccine (PCV). The driving factors for the growth of this market include increase in awareness about vaccine preventable diseases and rise in global travel traffic. Moreover, innovation of novel vaccine technologies and technological advancements towards molecular genetics is further boosting the growth of market in coming years. However, requirement of expertise for the production of vaccines and unfavorable healthcare funding towards vaccination could pose a challenge for the growth this market. Geographically, North America will be the leading market for global travel vaccines market, followed by Europe and Asia-Pacific. The major contributing factors for North America to lead the market include involvement of large number of companies in the production of vaccines and introduction of superior range of vaccines in the market. However, Asia-Pacific market is forecast to grow at a significant growth rate in coming years. Request TOC (desk of content material), Figures and Tables of the report: http://www.persistencemarketresearch.com/toc/5753 The leading players of this market include GlaxoSmithKline, Sanofi Pasteur, Merck, Novartis, and Pfizer. Other key participants of this market include ALK – Abelló A/S, Bavarian Nordic A/S, Crucell N.V., CSL Ltd. Medimmune Inc. and Vaxin Inc.


CARMIEL, Israel, Oct. 25, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that the first patient has been dosed in its global phase III clinical trial of PRX-102 for the treatment of Fabry disease.  There are currently six of the leading Fabry centers activated and participating in the trial, with up to an additional 21 centers, currently in different initiation processes, that are expected to be opened before year end. “The phase III Fabry trial is extremely important to the Company and remains a major focus for our team.  We are pleased to announce the first patient has been infused, a milestone we have been working towards,” said Mr. Moshe Manor, Protalix’s President and Chief Executive Officer.  “Interest from the physician and patient community in the trial is high, and a number of patients have already gone through the screening process.  The trial has certain stringent inclusion criteria in place to maximize the likelihood of demonstrating superiority.  Once all the anticipated trial sites are up and running, which we anticipate completing around year end, we will provide guidance regarding expected enrollment completion.” The phase III efficacy and safety clinical trial, which we refer to as the BALANCE Study, is a 24-month multi-center, randomized, double-blind, active control study of PRX-102 for the treatment of Fabry disease in Fabry patients with impaired renal function.  The trial is designed to enroll 78 patients previously treated with Fabrazyme® (agalsidase beta) with a stable dose for at least six months.  Enrolled patients will be randomized to continue treatment with 1 mg/kg of either Fabrazyme or PRX-102, at a 2:1 ratio of PRX-102 to Fabrazyme, respectively.  Patients are to be treated via intravenous (IV) infusions every two weeks. The sites are recruiting adult symptomatic Fabry patients with plasma and/or leucocyte alpha galactosidase activity (by activity assay) less than 30% mean normal levels.  All patients must have had treatment with a dose of 1 mg/kg agalsidase beta per infusion every two weeks for at least one year.  In addition, to be included in the trial, patients need to have certain eGFR values and a meaningful decline in annualize eGFR slope. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®.  Protalix's unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix's first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.  Protalix's development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-106, an orally-delivered anti-inflammatory treatment; PRX-110 for the treatment of Cystic Fibrosis; and others. To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.  The terms “anticipate,” “believe,” “estimate,” “expect,” “plan” and “intend” and other words or phrases of similar import are intended to identify forward-looking statements.  These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made.  These statements are based on our current beliefs and expectations as to such future outcomes.  Drug discovery and development involve a high degree of risk.  Factors that might cause material differences include, among others: failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission.  The statements in this release are valid only as of the date hereof and we disclaim any obligation to update this information.


News Article | November 15, 2016
Site: www.eurekalert.org

Drugs such as statins that have the potential to prevent strokes and other types of cardiovascular disease have not been prescribed to a large proportion of people at risk in the UK, according to a research article by Grace Turner of the University of Birmingham, Birmingham, UK and colleagues published in PLOS Medicine. Turner and colleagues studied data from THIN, a database that includes anonymized primary care health information for about 6% of the UK population. In an analysis of data from 29,043 people who had suffered a first-ever stroke or transient ischaemic attack during the period January 2009-December 2013, the authors compared the proportion of people prescribed one of three classes of drugs able to prevent strokes with the proportion of people who had a clinical need for one or more of the drugs. Among the patients, 17,680 were eligible to be prescribed at least one of the classes of drugs studied at the time of their stroke or transient ischaemic attack. The data indicate that 49% (7,836/16,028) of the patients were not prescribed a clinically-indicated lipid-lowering drug, such as a statin, 25% (1,740/7,008) were not prescribed anti-hypertensive drugs, and 52% (1,647/3,194) were not prescribed anticoagulant drugs. In this study, the reasons for drugs not being prescribed to individual patients--which could include those refusing medication -- were not available. However, the authors' findings suggest that improved prescribing could potentially avert up to 12,000 strokes per year in the UK. The study was funded by the National Institute for Health Research School for Primary Care Research (NIHR SPCR). TM was partly funded by the National Institute for Health Research (NIHR) through the Collaborations for Leadership in Applied Health Research and Care for West Midlands (CLAHRC-WM). The funders had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript. GMT reports grants from National Institute for Health Research (NIHR) School for Primary Care Research (SPCR), during the conduct of the study; TM reports funding from the NIHR through the Collaborations for Leadership in Applied Health Research and Care for West Midlands (CLAHRC-WM); MC reports funding from European Society of Cardiology & AFNET, and personal fees from Astellas Pharma, outside the submitted work. KC reports grants from Pfizer China, outside the submitted work. MGF and RR have nothing to disclose. Turner GM, Calvert M, Feltham MG, Ryan R, Fitzmaurice D, Cheng KK, et al. (2016) Under-prescribing of Prevention Drugs and Primary Prevention of Stroke and Transient Ischaemic Attack in UK General Practice: A Retrospective Analysis. PLoS Med 13(11): e1002169. doi:10.1371/journal.pmed.1002169 IN YOUR COVERAGE PLEASE USE THIS URL TO PROVIDE ACCESS TO THE FREELY AVAILABLE PAPER:


News Article | March 1, 2017
Site: globenewswire.com

MIAMI, March 01, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK), reports financial and operating results for the three months ended December 31, 2016. “OPKO reached a number of important milestones during 2016,” stated Phillip Frost, M.D., Chairman and Chief Executive Officer of OPKO.  “We launched RAYALDEE, the first new medicine we have developed and launched ourselves.  The commercial team is making great strides in the early days of the launch and has so far secured formulary access for 60% of all U.S. insured patients.” “Use of our innovative 4Kscore test for predicting the probability of aggressive prostate cancer increased to nearly 18,000 tests ordered in the fourth quarter.  We have now set the stage for continued, profitable growth at BioReference with a revenue cycle management program that is expected to improve financial results on an ongoing basis. “We have a number of important initiatives ahead of us in 2017 and early 2018.  We will complete the recently initiated clinical trial for our Claros POC diagnostic test for PSA and plan to file a PMA as quickly as possible upon completion.  Along with our partner, Vifor Fresenius, we plan to initiate a Phase 2 trial in dialysis patients with SHPT.  We also plan to initiate a Phase 2b trial for our SARM for the treatment of BPH, a condition that affects approximately 50 million men in the U.S., as well as a Phase 2 dose escalation study for TT401 to treat obesity and type II diabetes. “We are diligently working to complete analysis of the data from our Phase 3 clinical trial for hGH-CTP in adults and are aggressively advancing our pediatric Phase 3 clinical trial for hGH-CTP,” Dr. Frost concluded. OPKO’s senior management will provide a business update and discuss the results in greater detail  in a conference call and live audio webcast at 4:30 p.m. Eastern time today. The conference call dial in information is listed below. To access the webcast, please log on to the OPKO website at www.opko.com. For those unable to participate in the live conference call or webcast, a replay will be available beginning March 1, 2017 two hours after the close of the conference call. To access the replay, dial (855) 859-2056 or (404) 537-3406. The replay passcode is: 80392791. The replay can be accessed for a period of time on OPKO’s website at http://investor.opko.com/events.cfm. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator to treat men with BPH. Our biologics portfolio includes hGH-CTP, a once weekly human growth hormone injection (in phase 3 and partnered with Pfizer), and a long-acting Factor VIIa drug for hemophilia (in phase 2a). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as "expects," "plans," "projects," "will," "may," "anticipates," "believes," "should," "intends," "estimates," and other words of similar meaning, including statements regarding expected financial performance, whether we will experience continued, profitable growth at Bio-Reference, whether our revenue cycle management program will improve financial results, our product development efforts and the expected benefits of our products, including whether our ongoing and future clinical trials will be successfully completed on a timely basis or at all and whether the data from any of our trials will support approval, validation and/or reimbursement for our products, the expected timing for launch of our products in development, whether the data for the hGH-CTP study in adults will support approval of a BLA, the expected timing of commencing and concluding our clinical trials, enrollment in clinical trials, and disclosure of results for the trials, the timing of our regulatory submissions, our ability to market and sell any of our products in development, expectations about developing RAYALDEE for dialysis patients, our ability to obtain broad reimbursement coverage for the 4Kscore test, increased adoption rates for the 4Kscore, as well as other non-historical statements about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our Annual Reports on Form 10-K filed and to be filed with the Securities and Exchange Commission and in our other filings with the Securities and Exchange Commission, as well as integration challenges for Bio-Reference, EirGen, Transition, and other acquired businesses, the risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, that earlier clinical results of effectiveness and safety may not be reproducible or indicative of future results, that the 4Kscore, RAYALDEE, Varubi™, hGH-CTP, TT-401, TT-701, and/or any of our compounds or diagnostic products under development may fail, may not achieve the expected results or effectiveness and may not generate data that would support the approval or marketing of products for the indications being studied or for other indications, that currently available over-the-counter and prescription products, as well as products under development by others, may prove to be as or more effective than our products for the indications being studied. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made, and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


News Article | February 15, 2017
Site: www.marketwired.com

CARY, NC--(Marketwired - February 08, 2017) - The 2nd edition of Industry Standard Research's (ISR's) Biologic API Contract Manufacturer Quality Benchmarking report indicates that buyers of outsourced biologic API services are less loyal to the CMOs they use compared to one year ago. The report includes information on respondents' outsourcing philosophies and practices, CMO perceptions and interactions and CMO selection drivers before diving into a series of in-depth performance analyses specific to the large molecule offerings of 30 contract manufacturing organizations. 208 respondents provide rating assessments on 393 service encounters. "This year, the data showed a decrease in the industry average for CMO loyalty of almost one-third of a point on a ten-point scale among biologic API contract manufacturers," explained Kate Hammeke, Vice President, Market Research at Industry Standard Research. "ISR's loyalty metric is an index of overall satisfaction, likelihood to use again and willingness to recommend. Changes in these scores may be indicative of a broader decline in customer loyalty, which retail has been experiencing for a few years, or a more direct response to changes in satisfaction with service provider performance. For CMOs featured in the report, it makes sense to investigate whether the change in loyalty traces back to a specific loyalty component or whether it can be attributed to broader changes in customer behavior." The report provides a Consumer Reports-style analysis where each of the 30 CMOs included in the research is evaluated across 27 service quality attributes, making this report the most comprehensive assessment of quality in the contract manufacturing space. These performance metrics are categorized into four 'scorecards': Delivery Factors, Organization Factors, Capabilities and Staff Characteristics. From these performance evaluations, respondents indicated how well the manufacturers performed with respect to expectations specific to their experience working with the manufacturer(s). For buyers of outsourced services, the report includes highly valuable information to help guide CMO selection for large molecule projects from early clinical stages to commercialization. CMO performance attributes evaluated by respondents include Ability to manufacture biologic API, Reliable on-time delivery, Regulatory History, Quality performance metrics, Scale-up and tech transfer abilities, Scientific knowledge, Right-first-time measurements, and many others. Data include an in-depth analysis of 16 of the 30 featured contract manufacturers, including AbbVie Contract Manufacturing, Boehringer Ingelheim, Catalent, Celltrion, CMC Biologics, FujiFilm Diosynth Biotechnologies, GSK Contract Manufacturing, KBI Biopharma, Lonza, Novasep, Patheon, Pfizer CentreOne, Samsung BioLogics, Sanofi CEPiA, Therapure Biopharma and Wuxi AppTec. There are several stand-out CMOs this year. Two contract manufacturers -- Pfizer CentreOne and Sanofi CEPiA -- placed among the leaders across all of the four scorecards (Delivery, Organizational, Capabilities and Staff Characteristics). Among smaller CMOs, KBI Bio was a top performer in Delivery Factors and Staff Characteristics, while Therapure BioPharma scored well in Capabilities and Staff Characteristics. For more information on ISR's "Biologic API Contract Manufacturer Quality Benchmarking" report, please visit ISR's report page at http://www.isrreports.com/reports/biologic-api-contract-manufacturer-quality-benchmarking-2nd-edition/ Industry Standard Research is the premier, full service market research provider to the pharma and pharma services industries. With over a decade of experience, ISR delivers an unmatched level of domain expertise. For more information about ISR's off-the-shelf intelligence and custom research offerings, please visit the company's website at www.isrreports.com, email info@isrreports.com or follow ISR on Twitter @ISRreports.


News Article | March 1, 2017
Site: www.businesswire.com

THERADIAG (Paris:ALTER) (ISIN : FR0004197747, Mnémonique : ALTER), société spécialisée dans le diagnostic in vitro et le théranostic annonce aujourd’hui son chiffre d’affaires et ses résultats annuels consolidés pour l’exercice clos au 31 décembre 2016 et arrêtés par le Conseil d’administration du 28 février 2017. « Les partenariats signés en 2015 avec des acteurs internationaux majeurs de la pharma et du diagnostic ont entrainé, comme attendu, une forte croissance de notre activité dès l’exercice 2016 (+19%). Cette tendance sera renforcée en 2017 par la poursuite de notre développement aux Etats-Unis avec Miraca Life Sciences et notamment dans le cadre de l’accord Janssen. Le lancement en Europe des produits co-developpés avec notre partenaire chinois HOB Biotech contribuera également à cette évolution très positive. L’accélération significative de la croissance du chiffre d’affaires a permis la réduction de plus d’un tiers de notre perte opérationnelle au cours de l’exercice 2016 et nous permet d’envisager l’atteinte de l’équilibre financier à court terme », commente Michel Finance, Directeur Général de Theradiag. Le chiffre d’affaires annuel de la business unit théranostic atteint désormais 4 millions d’euros contre 2,3 millions d’euros sur l’exercice précédent, soit une croissance de 74% pour représenter 45% du chiffre d’affaires total. Il intègre les ventes résultant de ventes directes aux hôpitaux et aux laboratoires mais également, et pour une part significative en 2016, celles issues des différents partenariats avec Miraca Life Sciences, Janssen, UCB, et Hospira/Pfizer. Le développement des ventes avec Miraca Life Sciences sur le marché américain devrait être un facteur important de croissance pour les trimestres à venir et avoir un impact favorable sur l’année 2017. Au cours de l’exercice 2016, les coûts directs de recherche et développement se sont élevés, hors subvention, à 1,4 millions d’euros et ont été axés principalement sur la poursuite du développement des kits LISA TRACKER® et les projets menés sur la plateforme technologique microARN. Par ailleurs, en août 2016, Janssen Biotech Inc. a lancé le programme Janssen 2Inform destiné à offrir gratuitement des tests de monitoring pour aider les professionnels de santé à mieux utiliser le Remicade® dans le traitement des patients atteints de maladies inflammatoires chroniques de l’intestin (MICI). Grâce au partenariat signé entre Miraca Life Sciences et Theradiag, ce sont les tests de monitoring de Theradiag, que Miraca Life Sciences fournit sous le nom InformTxTM, qui sont proposés dans le programme Janssen 2Inform. Theradiag vend les matières nécessaires et perçoit des royalties sur les ventes réalisées par Miraca Life Sciences aux États-Unis. L’intérêt de la communauté scientifique pour le monitoring des biothérapies a été confirmé lors du 11ème congrès ECCO (European Crohn’s and Colitis Organisation) avec un nombre toujours plus important de données sur le monitoring des biothérapies présenté lors de ce congrès avec plus de 25 présentations orales et une quarantaine de posters. Ce chiffre a doublé en 2016, validant l’approche théranostique de Theradiag. Une quinzaine de présentations et posters étaient notamment basés sur les tests de monitoring Lisa Tracker® de Theradiag. Prestizia a été sélectionnée par le programme Eurostars-2, pour le soutien financier de son projet collaboratif PIONEER mené par sa plateforme de biologie moléculaire Prestizia et ses partenaires coréens du sud, l’Asan Medical Center et la société CbsBioscience. Le projet PIONEER est destiné à développer deux tests basés sur des biomarqueurs microARN circulants et des ARN messagers tissulaires dans le cancer du rectum. A propos de Theradiag Forte de son expertise dans la distribution, le développement et la fabrication de tests de diagnostic in vitro, Theradiag innove et développe des tests de théranostic (alliance du traitement et du diagnostic), qui mesurent l’efficacité des biothérapies dans le traitement des maladies auto-immunes, du cancer et du SIDA. Theradiag participe ainsi au développement de la « médecine personnalisée », favorisant l’individualisation des traitements, la mesure de leur efficacité et la prévention des résistances médicamenteuses. Theradiag commercialise la gamme Lisa Tracker, marquée CE, une solution complète de diagnostic multiparamétrique pour la prise en charge des patients atteints de maladies auto-immunes et traités par biothérapies. Via sa filiale Prestizia, Theradiag développe également de nouveaux marqueurs de diagnostic grâce à la plateforme microARN, pour la détection et le suivi du cancer du rectum et du VIH/SIDA. La société est basée à Marne-la-Vallée et Montpellier et compte plus de 75 collaborateurs.


News Article | February 17, 2017
Site: www.businesswire.com

BARCELONA--(BUSINESS WIRE)--Heute hat Celltrion Healthcare auf dem 12. Kongress der European Crohn’s and Colitis Organisation (ECCO) die primären Endpunkte seiner randomisierten kontrollierten Zulassungsstudie mit CT-P13 (Infliximab-Biosimilar) in Morbus Crohn vorgestellt. Die Daten weisen darauf hin, dass die Wirksamkeit und Unbedenklichkeit von CT-P13 in Patienten mit mittelschwerem bis schwerem Morbus Crohn vergleichbar ist mit Patienten, die mit dem Referenz-Infliximab behandelt wurden.1 Celltrion Healthcare hat darüber hinaus auch Daten aus zwei Beobachtungsstudien vorgestellt. Die erste Studie bewertete die Wirksamkeit und Sicherheit von CT-P13 in 74 pädiatrischen Patienten mit M. Crohn (MC) (bisher unbehandelte Patienten: 26, Wechselpatienten: 25) oder Colitis ulcerosa (CU) (bisher unbehandelte Patienten: 16, Wechselpatienten: 7). Die Daten belegen, dass CT-P13 sowohl in bisher unbehandelten pädiatrischen Patienten als auch in Wechselpatienten über 30 Wochen wirksam ist und gut vertragen wird.2 Echte Kosteneinsparungen beim Einsatz von CT-P13 für alle Indikationen wurden in fünf europäischen Ländern von Anfang 2015 bis in die erste Hälfte von 2016 untersucht. Nach den auf der ECCO vorgelegten Daten belaufen sich die in Deutschland, Italien, Spanien und dem Vereinigten Königreich festgestellten Einsparungen auf 32,4 Millionen Euro und die Ergebnisse lassen darauf schließen, dass dies weiteren 5.428 Patienten pro Jahr Zugang zu dieser wichtigen biologischen Therapie eröffnen könnte. In Frankreich wurden keine Kosteneinsparungen verzeichnet, da der Preis des Biosimilars und des Referenz-Infliximab gleich waren, und doch stieg auch in diesem Land die Verwendung von CT-P13 langsam an.4 Man Hoon Kim, President und CEO von Celltrion Healthcare, sagte: "Celltrion tritt durch belastbare wissenschaftliche Erforschung nachdrücklich für die Bedürfnisse von klinischen Anwendern ein. Eine randomisierte kontrollierte Zulassungsstudie für Morbus Crohn ist ein wichtiges Beispiel dafür, und die Ergebnisse dieser Studie stimmen mit anderen durchgeführten RCTs und vielen repräsentativen Studien zu entzündlichen Darmerkrankungen überein. Im weiteren Sinne ist es auch erfreulich zu sehen, was für Veränderungen CT-P13 in den finanziell überforderten Gesundheitssystemen in Europa hervorruft." Bei der Studie handelt es sich um eine randomisierte, doppeltblinde Phase-Ⅲ-Studie mit parallelen Gruppen zur Untersuchung der Wirksamkeit und Sicherheit von CT-P13 und Referenz-Infliximab in Patienten mit M. Crohn. Von 220 randomisierten Patienten in 58 Studienzentren in 16 Ländern haben 214 Patienten bis zu 6 Wochen für die Primäranalyse absolviert und 180 Patienten haben bis zu 30 Wochen abgeschlossen. Die Studie wurde zu gleichen Teilen von Celltrion und Pfizer finanziert. CT-P13 wurde von Celltrion Inc. entwickelt und hergestellt und war weltweit das erste monoklonale Antikörper-Biosimilar, das von der Europäischen Arzneimittel-Agentur (EMA) zugelassen wurde. Es ist zur Behandlung von acht Autoimmunerkrankungen, einschließlich rheumatoide Arthritis und entzündliche Darmerkrankungen, indiziert. Es wurde im September 2013 von der EMA unter dem Handelsnamen Remsima zugelassen® und Anfang des Jahres 2015 in Europa eingeführt. Die US-amerikanische Arzeimittelbehörde FDA hat CT-P13 von Celltrion im April 2016 unter dem Handelsnamen Inflectra™ zugelassen. CT-P13 von Celltrion ist in mehr als 79 (Stand Januar 2017) Ländern, einschließlich den USA, Kanada, Japan und zahlreichen europäischen Ländern, zugelassen. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Kongress der European Crohn’s and Colitis Organisation (ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Kongress der European Crohn’s and Colitis Organisation (ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Kongress der European Crohn’s and Colitis Organisation (ECCO) 2017.P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Kongress der European Crohn’s and Colitis Organisation (ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Verfügbar unter www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Letzte Aktualisierung: Januar 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.


- Cette désignation est une première étape dans l'inclusion au Programme d'accès anticipé aux médicaments (« EAMS »), permettant aux patients un accès plus rapide aux médicaments innovants GAITHERSBURG, Maryland, 2 novembre 2016 /PRNewswire/ -- Vtesse, Inc., société vouée à développer des médicaments dont bénéficieront des patients souffrant de maladies extrêmement rares, mettant la vie en danger, a annoncé aujourd'hui que la MHRA, agence exécutive du ministère de la Santé du Royaume-Uni et responsable de veiller à ce que les médicaments et les appareils médicaux soient raisonnablement sûrs, a accordé une désignation de médicament novateur prometteur (« PIM ») au VTS-270, médicament expérimental de Vtesse pour enfants atteints de la maladie de Niemann-Pick de type C1 (« NPC »). « Il est extrêmement gratifiant pour la communauté de la NPC, pour l'équipe chez Vtesse et pour toutes les personnes, organisations, et institutions qui sans relâche travaillent à la mise au point du VTS-270, que celui-ci ait été reconnu par la MHRA comme une innovation scientifique pouvant améliorer la vie des personnes vivant avec la NPC », a déclaré le docteur Ben Machielse, président et directeur général de Vtesse, Inc.« Il faut un dévouement et une collaboration considérables pour faire progresser l'étude clinique et les processus réglementaires aboutissant au développement de médicaments dans la sphère des maladies rares. Avant tout, nous remercions tous les parents qui ont apporté leur soutien au développement du VTS-270. » « Cette désignation PIM du Royaume-Uni, avec la désignation de traitement novateur accordée par le Secrétariat américain aux produits alimentaires et pharmaceutiques (FDA) plus tôt cette année, démontre la puissance des données cliniques préliminaires du traitement de la NPC par le VTS-270, » a ajouté le docteur Kevin Johnson, MBA (maîtrise en administration des affaires), vice-président des Affaires réglementaires chez Vtesse. « Les deux désignations nous ouvrent des possibilités réglementaires solides, sur lesquelles nous allons nous appuyer pour réaliser notre phase 2 b/3 rigoureuse d'essais cliniques, et nous chercherons les approbations réglementaires pour introduire ce médicament sur le marché aussi rapidement que possible. » Une désignation PIM est une indication précoce qu'un produit médicament est un candidat prometteur au Programme d'accès anticipé aux médicaments (« EAMS ») pour le traitement, le diagnostic ou la prévention de maladies mettant la vie en danger ou créant des conditions sérieusement débilitantes, avec des besoins non satisfaits. L'EAMS est un programme britannique dirigé par le MHRA et visant à ce que les patients atteints de conditions mettant leur vie en danger puissent avoir accès à des médicaments avec une préhomologation spécifique lorsqu'un besoin médical est manifeste. « La désignation PIM, basée sur la phase 1/2 des données d'essais cliniques sur des patients souffrant de NPC, est un accomplissement important pour Vtesse, pour le VTS-270 et pour la communauté de Niemann-Pick, » a commenté le docteur Paul Gissen, membre du Collège royal des pédiatres et des soins de l'enfant (MRCPCH) au Great Ormond Street Hospital, chercheur participant aux essais cliniques du VTS-270 de la phase 2 b/3 de Vtesse. « La désignation PIM du MHRA repose sur trois critères : une maladie mettant la vie en danger ou sévèrement débilitante avec un besoin médical important non satisfait, un produit médicamenteux susceptible d'apporter des avantages majeurs par rapport aux traitements actuellement utilisés au Royaume-Uni, et une attente raisonnable d'un équilibre positif avantages-risques pour les patients. Nous espérons fermement poursuivre l'étude avec le VTS-270 et, en tant que chercheur clinicien, je suis heureux que la MHRA ait décerné cette désignation. » Les résultats du VTS-270 sur le groupe traité dans la phase 1/2 d'étude intrapatiente de l'augmentation progressive de doses montrent qu'après 12 mois et 18 mois d'administration mensuelle, la progression de la maladie mesurée par la NPC neurologiques Severity Score (SNRS) a été réduite par rapport à un groupe témoin d'étude où la maladie suit son évolution naturelle. On a pu observer au cours de l'étude des changements dans l'ouïe, qui étaient prévus comme un événement indésirable, ainsi qu'une ataxie transitoire et une fatigue éphémère. La phase 2b/3 de l'essai clinique en cours de Vtesse sur le VTS-270 est en train de recruter des patients au Royaume-Uni au Children's Hospital de Birmingham et au Great Ormond Street Hospital. L'essai se poursuit également sur des sites aux États-Unis, en France, en Allemagne, en Espagne, en Turquie et en Australie. Pour davantage d'informations, dont la liste actuelle des sites participant à l'étude, visiter www.theNPCstudy.com. À propos de la maladie de NPC La maladie de Niemann-Pick de type C est une maladie génétique évolutive, irréversible, débilitante chronique et à terme mortelle. Elle est provoquée par un défaut du transport des lipides à l'intérieur de la cellule, ceci entraînant une accumulation excessive de lipides dans le cerveau, le foie et la rate. Le Centre national pour l'avancement des sciences translationnelles (NCATS) de l'Institut américain de la santé (NIH) et l'Institut national de santé de l'enfant et du développement humain (NICHD) de l'Eunice Kennedy Shriver ont réalisé la recherche préclinique et ont entrepris la phase de développement de médicament pour le VTS-270 en coopération étroite avec des parents et des groupes de défense de patients. Vtesse a pris la direction de la dernière étape du processus de développement du médicament. Vtesse, Inc. est une société spécialisée dans les maladies rares et axée sur le développement de médicaments destinés aux patients souffrant de maladies moins prises en compte. Vtesse travaille de façon collaborative avec le NIH, d'autres centres universitaires de pointe, des parents et des groupes de défense de patients afin de faire avancer une étude clinique clé du VTS-270 (composé spécifique bien caractérisé de HPβCD, ayant une composition spécifique dactyloscopique le distinguant des autres mélanges de HPβCD) pour le traitement de la NPC et afin de diriger la découverte et le développement précliniques d'autres médicaments nouveaux contre la NPC et divers troubles du stockage lysosomal (LSD). La société est dirigée par une équipe de gestion hautement expérimentée et qui a été associée au développement de plus de 20 médicaments approuvés. Le financement initial permettant d'amener le VTS-270 à un essai clinique clé est dû à l'engagement d'un consortium chevronné d'investisseurs comprenant Alexandria Venture Investments, Bay City Capital LLC, Lundbeckfond Ventures, New Enterprise Associates et Pfizer Venture Investments. Vtesse est basée à Gaithersburg dans le Maryland et il s'agit de la première société dérivée de Cydan Development, Inc. Pour davantage d'informations, visiter www.vtessepharma.com.


LOS ANGELES--(BUSINESS WIRE)--Goldberg Law PC announces that it is investigating Momenta Pharmaceuticals, Inc. (“Momenta” or the “Company”) (Nasdaq: MNTA) concerning possible violations of federal securities laws. If you purchased or otherwise acquired Momenta shares and would like more information regarding the investigation, we encourage you to click here, or contact Michael Goldberg or Brian Schall, of Goldberg Law PC, 1999 Avenue of the Stars Suite 1100, Los Angeles, CA 90067, at 800-977-7401, to discuss your rights without cost to you. You can also reach us through the firm’s website at http://www.Goldberglawpc.com, or by email at info@goldberglawpc.com. On February 17, 2017, Momenta revealed that a contracted Pfizer facility used to manufacture the Company's Glatopa product was sent a warning letter from the U.S. Food and Drug Administration ("FDA"). Momenta's Abbreviated New Drug Application for its Glatopa 40 mg product candidate is under regulatory review, and under FDA policy, final approval is dependent on the proper outcome of the compliance observations at the Pfizer manufacturing facility. On February 20, 2017, a Leerink Capital Partners LLC analyst stated that the FDA warning letter raises concerns for the Company, as manufacturing warning letters can take years to fix, and that a lengthy delay could lessen Momenta's market opportunity for Glatopa. When this information was revealed to investors, the value of Momenta fell, causing investors harm. If you have any questions concerning your legal rights, please immediately contact Goldberg Law PC at 800-977-7401, or visit our website at http://www.Goldberglawpc.com, or email us at info@goldberglawpc.com. Goldberg Law PC represents shareholders around the world and specializes in securities class actions and shareholder rights litigation. This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.


BOTHELL, Wash.--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq:SGEN), a global biotechnology company, today announced that it has received notice from the U.S. Food and Drug Administration (FDA) that a clinical hold or partial clinical hold has been placed on several early stage trials of vadastuximab talirine (SGN-CD33A) in acute myeloid leukemia (AML). The clinical holds were initiated to evaluate the potential risk of hepatotoxicity in patients who were treated with SGN-CD33A and received allogeneic stem cell transplant either before or after treatment. Six patients have been identified with hepatotoxicity, including several cases of veno-occlusive disease, with four fatal events. Overall, more than 300 patients have been treated with SGN-CD33A in clinical trials across multiple treatment settings. Seattle Genetics is working diligently with the FDA to determine whether there is any association between hepatotoxicity and treatment with SGN-CD33A, to promptly identify appropriate protocol amendments for patient safety and to enable continuation of these trials. The phase 1/2 trial of SGN-CD33A monotherapy in pre- and post-allogeneic transplant AML patients has been placed on full clinical hold. Two phase 1 trials have been placed on partial clinical hold (no new enrollment, existing patients may continue treatment with re-consent). These studies are SGN-CD33A monotherapy, including a subset of older AML patients in combination with hypomethylating agents, and SGN-CD33A combination treatment with 7+3 chemotherapy in newly diagnosed younger AML patients. No new studies will be initiated until the clinical holds are lifted. Seattle Genetics’ other ongoing trials of SGN-CD33A, including the phase 3 CASCADE trial in older AML patients and phase 1/2 trial in myelodysplastic syndrome, are proceeding with enrollment. Vadastuximab talirine (SGN-CD33A; 33A) is a novel investigational ADC targeted to CD33 utilizing Seattle Genetics’ proprietary ADC technology. CD33 is expressed on most AML and MDS blast cells. The CD33 engineered cysteine antibody is stably linked to a highly potent DNA binding agent called a pyrrolobenzodiazepine (PBD) dimer via site-specific conjugation technology (EC-mAb). PBD dimers are significantly more potent than systemic chemotherapeutic drugs and the EC-mAb technology allows uniform drug-loading onto an ADC. The ADC is designed to be stable in the bloodstream and to release its potent cell-killing PBD agent upon internalization into CD33-expressing cells. 33A was granted Orphan Drug Designation by both the U.S. Food and Drug Administration (FDA) and the European Commission for the treatment of AML. FDA orphan drug designation is intended to encourage companies to develop therapies for the treatment of diseases that affect fewer than 200,000 individuals in the United States. Seattle Genetics is an innovative biotechnology company that develops and commercializes novel antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. ADCETRIS® (brentuximab vedotin), the company’s lead product, in collaboration with Takeda Pharmaceutical Company Limited, is the first in a new class of ADCs commercially available globally in 65 countries for relapsed classical Hodgkin lymphoma (HL) and relapsed systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics is also advancing vadastuximab talirine (SGN-CD33A; 33A), an ADC in a phase 3 trial for acute myeloid leukemia. Headquartered in Bothell, Washington, Seattle Genetics has a robust pipeline of innovative therapies for blood-related cancers and solid tumors designed to address significant unmet medical needs and improve treatment outcomes for patients. The company has collaborations for its proprietary ADC technology with a number of companies including AbbVie, Astellas, Bayer, Celldex, Genentech, GlaxoSmithKline and Pfizer. More information can be found at www.seattlegenetics.com Certain of the statements made in this press release are forward looking, such as those, among others, relating to the potential that the full and partial clinical holds on the affected clinical trials for SGN-33A will be lifted so that these trials may continue and the possibility that SGN-CD33A may be approved for treatment of AML. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the inability to provide information and institute safety mitigation measures as required by the FDA to permit these trials to continue in which case these trials may be delayed or discontinued. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


IRVINE, Calif.--(BUSINESS WIRE)--Khang & Khang LLP (the “Firm”) announces that it is investigating claims against Momenta Pharmaceuticals, Inc. (“Momenta” or the “Company”) (Nasdaq: MNTA) concerning possible violations of federal securities laws. If you purchased shares of Momenta and want more information free of charge, please contact Joon M. Khang, Esquire, of Khang & Khang, 18101 Von Karman Avenue, 3rd Floor, Irvine, CA 92612, by telephone: (949) 419-3834, or by e-mail at joon@khanglaw.com. On February 17, 2017, Momenta revealed that a contracted Pfizer facility used to manufacture the Company's Glatopa product was sent a warning letter from the U.S. Food and Drug Administration ("FDA"). Momenta's Abbreviated New Drug Application for its Glatopa 40 mg product candidate is under regulatory review, and under FDA policy, final approval depends on the outcome of the compliance observations at the Pfizer manufacturing facility. On February 20, 2017, a Leerink Capital Partners LLC analyst stated that the FDA warning letter raises concerns for the Company, as manufacturing warning letters can take years to fix, and that a lengthy delay could weaken Momenta's market opportunity for Glatopa. When this information was revealed to investors, the value of Momenta fell, causing investors serious harm. If you have any questions concerning this notice or your rights, please contact Joon M. Khang, a prominent litigator for almost two decades, by telephone: (949) 419-3834, or by e-mail at joon@khanglaw.com. This press release may constitute Attorney Advertising in some jurisdictions.


News Article | November 15, 2016
Site: marketersmedia.com

— Cardiovascular disease (CVD) covers a range of difference diseases and conditions affecting the heart and/or blood vessels. The most crucial risk factors for CVD are hypertension and dyslipidemia of which accelerate the development of atherosclerotic plaques building up within blood vessels. As atheroma develops its causes stenosis of the blood vessels which can restrict blood flow to the body, brain or heart depending on its locale. It is also possible for the fibrous cap of the plaque to break off, triggering the coagulation cascade and causing a thrombus to form locally which can completely occlude blood flow. The treatments of CVD typically focus on prevention by controlling the risk factors of CVD. As such, the treatments usually fall within three categories: Anti-hypertensives aim to lower blood pressure; anti-dyslipidemia drugs aim to alter lipid levels to an acceptable range; and anti-thrombotic drugs aim to either prevent thrombus forming or work to mitigate the damage of a current thrombi, they do this by either interrupting the coagulation cascade or inhibiting platelet aggregation, both of which inhibit blood from clotting. There has been vast scientific innovation within the CVD therapeutics market over recent decades, particularly within the anti-dyslipidemia market with the advent of statins such as Lipitor, the best-selling drug of all time, which produce marked reductions in cholesterol levels. More recently, the commonly used direct factor Xa inhibitors which produce anti-coagulant effects, have been made available for oral administration and the advent of PCSK9 inhibitors provide a viable alternative dyslipidemia treatment for when statins are unsuitable or inefficient. There are currently 1368 pipeline drugs within the cardiovascular disease market, the largest therapy area being thrombosis, with 406 pipeline products indicated for treatment or prevention of thrombotic events. Among those pipeline drugs expected for imminent release to market there is a mixture of first-in-class products, typically anti-dyslipidemia drugs aiming to provide alternatives to statin therapy, and drugs belonging to currently popular classes such as the aforementioned PCSK9 inhibitors and direct factor Xa inhibitors. Scope - Analysis of innovation in the CVD market in the context of the overall pipeline and current market landscape. Also includes analysis of the deals landscape, including both licensing deals and co-development deals. Key indications covered in detail include hypertension, dyslipidemia and thrombotic events. - A brief introduction to CVD, including symptoms, pathophysiology, and an overview of pharmacotherapy for the key diseases. - Identification of key marketed products, with a focus on historical and forecast sales patterns and an overview of each drug’s mechanism of action. - Comprehensive review of the pipeline, analyzed on the basis of stage of development, molecule type and molecular target. - In-depth market forecasting from 2015 to 2022. The forecasts will provide an understanding of how epidemiology trends, new drug entries and drug patent expirations will influence market value. - Identification and assessment of key pipeline products, with a particular focus on those due to be brought to market in the near future, as well as a sales forecast for these products. - Identification of the leading companies in the market, in terms of market share and growth. Company analysis determines how dependent these companies are on CVD product revenue. In addition, analysis determines the primary factors that will drive market growth for the key companies. - Assessment of the licensing and co-development deal landscape for CVD therapies. This report will allow you to - - Understand the current clinical and commercial landscape through a comprehensive analysis of the innovation in the CVD market in the context of the overall pipeline and current market landscape. Also includes analysis of the deals landscape, including both licensing deals and co-development deals. Key indications covered in detail include hypertension, dyslipidemia and thrombotic events - Understand the current treatment landscape, with portfolios of key marketed products and a focus on historical and forecast sales patterns and an overview of the drug’s mechanism of action. - Analyze the CVD pipeline through a comprehensive review of the pipeline, segmented by stage of development, molecule type and molecular target. This review also provides a detailed look at CVD clinical trials as to provide an insight into the risk associated with attempting to bring CVD pipeline drugs. - Predict growth in market size, with in-depth market forecasting from 2015 to 2022. The forecast will provide an understanding of how epidemiology trends, new drug entries and new drug patents expirations will influence market value. - Identify the key pipeline products, with a particular focus on those due to be brought to market in the near future, as well as a sales forecast for these products. - Identify the leading companies in the market, in terms of market share and growth. Company analysis determines how dependent the key companies in the market are on revenue derived from CVD products. In addition, analysis determines the primary factors that will drive market growth for the key companies in the market. - Identify commercial opportunities in the CVD deals landscape by analyzing trends in licensing and co-development deals. Table of Contents 1 Table of Contents 5 1.1 List of Tables 7 1.2 List of Figures 8 2 Introduction 11 2.1 Therapy Area Introduction 11 2.2 Symptoms 11 2.3 Etiology, Pathophysiology, Comorbidities and Complications 12 2.3.1 Hypertension 12 2.3.2 Dyslipidemia 13 2.3.3 Thrombotic events 15 2.4 Diagnosis 17 2.4.1 Hypertension 17 2.4.2 Dyslipidemia 17 2.4.3 Thrombotic events 18 2.5 Prognosis 18 2.6 Epidemiology Patterns and Forecasts - Prevalence and Patient Segmentation 19 2.6.1 Hypertension 20 2.6.2 Dyslipidemia 21 2.6.3 Thrombotic events 21 2.7 Treatment 22 2.7.1 Thiazide Diuretics 23 2.7.2 Angiotensin Converting Enzyme Inhibitors 24 2.7.3 Angiotensin Receptor Blockers 25 2.7.4 Calcium Channel Blockers 25 2.7.5 Statins 25 2.7.6 Anticoagulants 26 2.7.7 Antiplatelet Drugs 27 2.7.8 Beta-adrenoceptor antagonists (Beta blockers) 27 2.7.9 Other Drugs 28 3 Key Marketed Products 29 3.1 Overview 29 3.2 Crestor (rosuvastatin) - AstraZeneca 29 3.3 Zetia (ezetimibe) - Merck & Co 30 3.4 Lipitor (atorvastatin) - Pfizer 32 3.5 Praluent (alirocumab) - Sanofi 34 3.6 Xarelto (rivaroxaban) - Bayer 35 3.7 Eliquis (apixaban) - Bristol-Myers Squibb and Pfizer 37 3.8 Plavix (clopidogrel) - Sanofi 38 3.9 Brilinta (ticagrelor) - AstraZeneca 40 3.10 Entresto (valsartan plus sacubitril) - Novartis 41 3.11 Benicar (olmesartan medoxomil) - Daiichi Sankyo 43 3.12 Conclusion 44 4 Pipeline Landscape Assessment 46 4.1 Overview 46 4.2 Pipeline Development Landscape 46 4.3 Molecular Targets in the Pipeline 49 4.4 Clinical Trials 53 4.4.1 Failure Rate by Stage of Development, Indication, Molecule Type and Molecular Target 53 4.4.2 Clinical Trial Duration by Stage of Development, Indication, Molecule Type and Molecular Target 57 4.4.3 Clinical Trial Size by Stage of Development, Indication, Molecule Type and Molecular Target 60 4.4.4 Aggregate Clinical Program Size by Stage of Development, Indication, Molecule Type and Molecular Target 63 4.5 Conclusion 66 5 Multi-Scenario Market Forecast to 2022 67 5.1 Overall Market Size 67 5.2 Generic Penetration 69 5.3 Revenue Forecast by Molecular Target 70 5.3.1 Coagulation Cascade 71 5.3.2 P2Y12 Receptors 71 5.3.3 Beta 1 Adrenergic Receptors 72 5.3.4 PCSK9 Inhibitors 73 5.3.5 HMG-CoA Reductase Inhibitors (statins) 74 5.3.6 Renin angiotensin system (RAS) 75 For more information, please visit http://www.wiseguyreports.com


News Article | February 21, 2017
Site: globenewswire.com

MIAMI, Feb. 21, 2017 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (NASDAQ:OPK) today announced that senior management will participate at the 2017 RBC Capital Markets’ Healthcare Conference taking place February 22-23, 2017 at the New York Palace Hotel and at the Cowen Group’s 37th Annual Health Care Conference taking place March 6-8, 2017 at The Boston Marriott Copley Place. The 2017 RBC Capital Markets’ Healthcare Conference presentation will be webcast live on the OPKO Investor Relations page of the corporate website at www.opko.com.  To access the live webcast please log onto the OPKO website approximately fifteen minutes before the presentation to register and download any necessary audio software.  The audio presentation will be available at this link for a limited time after the live presentation. About OPKO Health, Inc. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 400-person sales and marketing team to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency (launched in November 2016), VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation pending FDA approval), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator for androgen deficiency indications.  Our biologics business includes hGH-CTP, a once-weekly human growth hormone injection (in phase 3 and partnered with Pfizer), a long-acting Factor VIIa drug for hemophilia (in phase 2a) and a long-acting oxyntomodulin for diabetes and obesity (in phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at www.opko.com.


News Article | November 23, 2016
Site: globenewswire.com

MIAMI, Nov. 23, 2016 (GLOBE NEWSWIRE) -- OPKO Health, Inc. (Nasdaq:OPK), today announced that it will commence shipments of RAYALDEE™ (calcifediol) extended-release capsules to distributors in the United States on Tuesday, November 29, 2016.  The product will be available nationwide at retail pharmacies as early as Wednesday, November 30, 2016.  The U.S. launch of RAYALDEE follows the successful introduction of the product to thousands of nephrologists attending the American Society of Nephrology (ASN) Kidney Week Meeting last week in Chicago.  RAYALDEE was approved by the U.S. Food and Drug Administration (FDA) on June 17, 2016. “The RAYALDEE launch represents a major milestone for OPKO,” commented Phillip Frost, M.D., CEO and Chairman of OPKO.  “RAYALDEE is the first product developed by OPKO to be commercialized by our own marketing and sales teams, and represents an important contribution to the care of patients with chronic kidney disease.  Based on the highly positive reception of RAYALDEE by nephrologists attending the recent ASN meeting, we believe that RAYALDEE will become a mainstay in the armamentarium of treatment options available for kidney disease patients.” RAYALDEE (calcifediol) extended-release capsules are approved by the FDA for the treatment of secondary hyperparathyroidism (SHPT) in adult patients with stage 3 or 4 chronic kidney disease (CKD) and serum total 25-hydroxyvitamin D levels less than 30 ng/mL.  RAYALDEE is not indicated for the treatment of SHPT in patients with stage 5 CKD or end-stage renal disease on dialysis.  RAYALDEE has a patented formulation and is designed to raise serum total 25-hydroxyvitamin D (prohormone) concentrations to targeted levels (at least 30 ng/mL) and to reduce elevated intact parathyroid hormone (iPTH).  The full prescribing information for RAYALDEE is available at www.rayaldee.com. Potential side effects of RAYALDEE include hypercalcemia (elevated serum calcium), which can also lead to digitalis toxicity, and adynamic bone disease with subsequent increased risk of fractures if intact PTH levels are suppressed by RAYALDEE to abnormally low levels.  Severe hypercalcemia may require emergency attention; symptoms of hypercalcemia may include feeling tired, difficulty thinking clearly, loss of appetite, nausea, vomiting, constipation, increased thirst, increased urination, and weight loss.  Digitalis toxicity can be potentiated by hypercalcemia of any cause.  Excessive administration of RAYALDEE can cause hypercalciuria, hypercalcemia, hyperphosphatemia, or oversuppression of iPTH.  Common symptoms of vitamin D overdosage may include constipation, decreased appetite, dehydration, fatigue, irritability, muscle weakness, or vomiting.  Patients concomitantly taking cytochrome P450 inhibitors, thiazides, cholestyramine, phenobarbital or other anticonvulsants may require dose adjustments and more frequent monitoring. The most common adverse reactions in clinical trials (≥3% and more frequent than placebo) were anemia, nasopharyngitis, increased blood creatinine, dyspnea, cough, congestive heart failure and constipation. CKD is a condition characterized by a progressive decline in kidney function.  The kidney is normally responsible for excreting waste and excess water from the body, and for regulating various hormones.  CKD is classified in five stages — mild (stage 1) to severe (stage 5) disease — as measured by the kidney's glomerular filtration rate.  According to the National Kidney Foundation, CKD afflicts over 26 million people in the U.S., including more than 20 million patients with moderate (stages 3 or 4) and severe (stage 5) forms of CKD.  In stage 5 CKD, kidney function is minimal to absent and patients require regular dialysis or a kidney transplant for survival. RAYALDEE is only indicated for treating SHPT in patients with stage 3 or stage 4 CKD. SHPT is a condition commonly associated with CKD in which the parathyroid glands secrete excessive amounts of iPTH.  SHPT arises as a result of vitamin D insufficiency or impaired kidney function that prevents sufficient production of vitamin D hormone to properly regulate calcium and phosphorus metabolism, and PTH secretion.  Prolonged elevation of blood PTH causes excessive calcium and phosphorus to be released from bone, leading to elevated serum calcium and phosphorus, softening of the bones (osteomalacia) and calcification of vascular and renal tissues.  SHPT affects 40-60% of patients with moderate CKD and approximately 90% of patients with severe CKD. Vitamin D insufficiency is a condition in which the body has low vitamin D stores, characterized by inadequate blood levels of vitamin D prohormone, known as 25-hydroxyvitamin D.  An estimated 70-90% of CKD patients have vitamin D insufficiency, which can lead to SHPT and resultant debilitating bone diseases.  Vitamin D insufficiency has been associated with increased mortality in CKD. OPKO Health is a diversified healthcare company that seeks to establish industry-leading positions in large, rapidly growing markets. Our diagnostics business includes Bio-Reference Laboratories, the nation's third-largest clinical laboratory with a core genetic testing business and a 420-person sales force to drive growth and leverage new products, including the 4Kscore® prostate cancer test and the Claros® 1 in-office immunoassay platform. Our pharmaceutical business features RAYALDEE, an FDA-approved treatment for SHPT in stage 3-4 CKD patients with vitamin D insufficiency, VARUBI™ for chemotherapy-induced nausea and vomiting (oral formulation launched by partner TESARO and IV formulation PDUFA date: January 2017), TT401, a once or twice weekly oxyntomodulin for type 2 diabetes and obesity which is a clinically advanced drug candidate among the new class of GLP-1 glucagon receptor dual agonists, and TT701, an androgen receptor modulator for androgen deficiency indications.  Our biologics business includes hGH-CTP, a once-weekly human growth hormone injection (in phase 3 and partnered with Pfizer), a long-acting Factor VIIa drug for hemophilia (in phase 2a) and a long-acting oxyntomodulin for diabetes and obesity (in phase 1). We also have production and distribution assets worldwide, multiple strategic investments and an active business development strategy. More information is available at www.opko.com. This press release contains "forward-looking statements," as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), regarding product commercialization efforts and other non-historical facts about our expectations, beliefs or intentions regarding our business, technologies and products, financial condition, strategies or prospects, including statements regarding the anticipated launch and availability of RAYALDEE, that RAYALDEE will effectively control secondary hyperparathyroidism in patients with stage 3 or 4 chronic kidney disease, whether RAYALDEE will be safe and effective in controlling SHPT, and the market potential for RAYALDEE. Many factors could cause our actual activities or results to differ materially from the activities and results anticipated in forward-looking statements. These factors include those described in our filings with the Securities and Exchange Commission, particularly any factors that could affect the availability or commercial potential of RAYALDEE, as well as risks inherent in funding, developing and obtaining regulatory approvals of new, commercially-viable and competitive products and treatments, including the risks that others may develop products which are superior to RAYALDEE, and that RAYALDEE may not have advantages or prove to be superior over presently marketed products, including the currently used high monthly doses of prescription vitamin D2, activated vitamin D hormone and over-the-counter vitamin D supplements. In addition, forward-looking statements may also be adversely affected by general market factors, competitive product development, product availability, federal and state regulations and legislation, the regulatory process for new products and indications, manufacturing issues that may arise, patent positions and litigation, among other factors. The forward-looking statements contained in this press release speak only as of the date the statements were made and we do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.


Global Self-Injections Market Forecast to 2024 - New Report by Data Bridge Market Research Global Self-Injections Market, By Type (Devices (Needle-Free, Auto, Pen, Wearable Injectors), Formulations), Dosage Form, Therapeutic Application, Route of Administration, End-User, Distribution Channel, Geography (North America, Europe, APAC, MEA, South America) – Trends and Forecast to 2024 Dallas, TX, February 24, 2017 --( The self-injections market is segmented based on type, dosage form, therapeutic application, route of administration, end-user, distribution channel, and geography. On the basis of type, the global self-injections market is segmented into devices and formulations. The devices market is segmented into needle-free injectors, auto injectors, pen injectors, wearable injectors, and other devices. The needle-free injectors market is further segmented on the basis of product, technology, and usability. The product segment is categorized into fillable and prefilled. The auto-injectors market is segmented into product, technology, design, and usability. The product segment is categorized into fillable and prefilled. The pen-injectors market is segmented into product, design, and usability. The product segment is categorized into single-chambered and dual-chambered. The design segment is further categorized into standard and customized. Based on therapeutic application, the market is segmented intoautoimmunediseases, hormonal disorders, oncology, orphan diseases, pain management, respiratory therapy, and others. The market is also segmented based on dosage formintosingle dose and multi-dose. On the basis of route of administration, the market is segmented into skin, circulatory /musculoskeletal, organs, and central nervous system. On the basis of end-user, the market is segmented into patient, physicians, home care settings and, others. The market is also segmented on the basis of distribution channel into hospital pharmacies, private clinics, chemist, and online pharmacies. Request for sample pages: https://databridgemarketresearch.com/reports/global-self-injections-market-trends-forecast-2024/ Based on geography, the self-injections market is segmented into geographical regions such as North America, Europe, Asia-Pacific, South America, Middle East and Africa and, Rest of the World. The geographical regions are further segmented into 24 major countries such as U.S. Canada, Mexico, Germany, France, U.K., Belgium, Switzerland, Belgium, Turkey, Japan, China, Singapore, Brazil, India, Russia, South Africa and many others. Read more: https://databridgemarketresearch.com/global-self-injectionsmarket-poised-grow-22-6/ The key players operating in this market are Abbvie, Inc., Antares Pharma, 3M, Becton Dickinson & Company, Baxter International Inc., Penjet Corporation, PharmaJet, GerresheimerAG,Pfizer Inc.,Terumo Corporation, Mylan N.V.,SHL Group,Bespak, Janssen Biotech Inc., Insulet Corporation, Unilife Corporation, West Pharmaceutical Services, Inc., Ypsomed, Eli lilly and Company,Haselmeier AG, Alkermes,AptarPharma,Credence MedSystems, Inc., SchottAG,Ypsomed, Owen Mumford Ltd., Glide Technologies,among other companies. About Data Bridge Market Research: Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process. Contact Info: Ravi Dubey Office Number 317, Amanora Chambers, Magarpatta Road, Hadapsar Pune – 411028 Maharashtra, India Toll Free: +1-888-387-2818 Mail: sales@databridgemarketresearch.com LinkedIn:https://www.linkedin.com/company/data-bridge-marketresearch?trk=nav_account_sub_nav_company_admin Dallas, TX, February 24, 2017 --( PR.com )-- Global self-injections market is expected to reach USD 119.5 billion by 2024, from USD 23.4 billion in 2016 growing at the CAGR of 22.6% in the forecast period 2017 to 2024.The self-injections market is segmented based on type, dosage form, therapeutic application, route of administration, end-user, distribution channel, and geography.On the basis of type, the global self-injections market is segmented into devices and formulations. The devices market is segmented into needle-free injectors, auto injectors, pen injectors, wearable injectors, and other devices.The needle-free injectors market is further segmented on the basis of product, technology, and usability. The product segment is categorized into fillable and prefilled.The auto-injectors market is segmented into product, technology, design, and usability. The product segment is categorized into fillable and prefilled.The pen-injectors market is segmented into product, design, and usability. The product segment is categorized into single-chambered and dual-chambered. The design segment is further categorized into standard and customized.Based on therapeutic application, the market is segmented intoautoimmunediseases, hormonal disorders, oncology, orphan diseases, pain management, respiratory therapy, and others. The market is also segmented based on dosage formintosingle dose and multi-dose.On the basis of route of administration, the market is segmented into skin, circulatory /musculoskeletal, organs, and central nervous system.On the basis of end-user, the market is segmented into patient, physicians, home care settings and, others. The market is also segmented on the basis of distribution channel into hospital pharmacies, private clinics, chemist, and online pharmacies.Request for sample pages: https://databridgemarketresearch.com/reports/global-self-injections-market-trends-forecast-2024/Based on geography, the self-injections market is segmented into geographical regions such as North America, Europe, Asia-Pacific, South America, Middle East and Africa and, Rest of the World. The geographical regions are further segmented into 24 major countries such as U.S. Canada, Mexico, Germany, France, U.K., Belgium, Switzerland, Belgium, Turkey, Japan, China, Singapore, Brazil, India, Russia, South Africa and many others.Read more: https://databridgemarketresearch.com/global-self-injectionsmarket-poised-grow-22-6/The key players operating in this market are Abbvie, Inc., Antares Pharma, 3M, Becton Dickinson & Company, Baxter International Inc., Penjet Corporation, PharmaJet, GerresheimerAG,Pfizer Inc.,Terumo Corporation, Mylan N.V.,SHL Group,Bespak, Janssen Biotech Inc., Insulet Corporation, Unilife Corporation, West Pharmaceutical Services, Inc., Ypsomed, Eli lilly and Company,Haselmeier AG, Alkermes,AptarPharma,Credence MedSystems, Inc., SchottAG,Ypsomed, Owen Mumford Ltd., Glide Technologies,among other companies.About Data Bridge Market Research:Data Bridge set forth itself as an unconventional and neoteric Market research and consulting firm with unparalleled level of resilience and integrated approaches. We are determined to unearth the best market opportunities and foster efficient information for your business to thrive in the market. Data Bridge endeavors to provide appropriate solutions to the complex business challenges and initiates an effortless decision-making process.Contact Info:Ravi DubeyOffice Number 317, Amanora Chambers,Magarpatta Road, HadapsarPune – 411028Maharashtra, IndiaToll Free: +1-888-387-2818Mail: sales@databridgemarketresearch.comLinkedIn:https://www.linkedin.com/company/data-bridge-marketresearch?trk=nav_account_sub_nav_company_admin Click here to view the list of recent Press Releases from Data Bridge Market Research


Biopharmaceutical company Pfizer has announced a major expansion of its humanitarian assistance program, giving broader access to the Prevnar 13 vaccine it produces in humanitarian emergency situations. The company will offer a new multidose vial (MDV) at the lowest price worldwide. The price of the vaccine is now $3.10 per dose. Aside from lowering the market price of the vaccine, the company will also donate money from the first year of implementation of the program to support humanitarian groups and organizations. This program follows a previous initiative by the British drug manufacturer GlaxoSmithKline, which stated back in September that it would cut the price of its pneumococcal vaccine, called Synflorix, to $3.05 when it comes to humanitarian crises. Humanitarian organizations fighting to reach a category of very vulnerable people should be supported in their efforts, said Pfizer. The Nov. 11 announcement stated that civil society organizations (CSOs) will have special pricings of the vaccine, thus continuing the company's trademark involvement in these types of actions. Additionally, Pfizer will also donate a number of vaccines in order to help the emergency needs of these vulnerable populations, and starting 2017 refugees will also have the possibility to receive the latest Prevenar 13 vaccine, which will contain four doses within the same size that currently only incorporates one dosage. This new type of vaccine, incorporating the effects of four shots into just one, is especially created in order to help the developing world populations. The storage and transportation of the vaccines will also benefit from reduced pricing offers, for the same purpose as the previously announced measures. The vaccines have, additionally, been prequalified by the World Health Organization. The vaccine was approved in the European Union in 2009, when infants and children were given the possibility to be administered the shots in order to prevent the pneumococcal disease. The shots are currently and extensively used in more than 150 countries worldwide, including the United States, Japan, Australia or Canada, against pneumococcal viral problems. Among the safety precautions that the users should know, people with former severe allergic reactions should not be administered with the medicine, as well as children with unsteady immune systems. The clinical and safety information about the administration of the vaccine also state that some of the most common adverse reactions were pain at the injection site, headaches or fatigue, increased or decreased sleep and fever. © 2017 Tech Times, All rights reserved. Do not reproduce without permission.


— Global Cancer Immunotherapies Market to 2022 - Immune Checkpoint Inhibitors and Therapeutic Cancer Vaccines to Characterize Increasingly Competitive Market The cancer immunotherapies market is forecast to rise from a value of $16.9 billion in 2015 to $75.8 billion in 2022, at a compound annual growth rate of 23.9%. The cancer immunotherapies pipeline is vast, with a significant degree of diversity in terms of molecule types and targets. The company landscape is growing increasingly competitive. Complete report on Global Cancer Immunotherapies Market to 2022 - Immune Checkpoint Inhibitors and Therapeutic Cancer Vaccines to Characterize Increasingly Competitive Market spread across 63 pages available at: http://www.reportsnreports.com/contacts/discount.aspx?name=799564 Understand the current clinical and commercial landscape through a comprehensive study of disease epidemiology, pathogenesis, symptoms, diagnosis and prognosis for the key indications covered in the report, which includes breast cancer, melanoma, NSCLC and ovarian cancer. • Cancer Immunotherapies Key Marketed Products • Cancer Immunotherapies Pipeline Landscape Assessment • Cancer Immunotherapies Multi-scenario Market Forecast to 2022 • Cancer Immunotherapies Company Analysis and Positioning • Cancer Immunotherapies Strategic Consolidations • Cancer Immunotherapies Market, Global, Epidemiology of Key Oncology Indications, 2016 • Cancer Immunotherapies Market, Global, Regional Lymph Node and Metastasis Staging, • Cancer Immunotherapies Market, Global, Eastern Co-operative Oncology Group Criteria, 2016 • Cancer Immunotherapies Market, Global, Breast Cancer Histopathological and Molecular Classification, 2016 • Cancer Immunotherapies Market, US, Breast Cancer Stage at Diagnosis and Five-Year Relative Survival (%), 2016 • Cancer Immunotherapies Market, US, Ovarian Cancer Stage and Survival Rates (%), 2016 • Cancer Immunotherapies Market, US, Lung Cancer Stage at Diagnosis and Five-Year Relative Survival (%), 2016 • Cancer Immunotherapies Market, US, Ovarian Cancer Stage at Diagnosis and Five-year Relative Survival Get Discount on Report at: http://www.reportsnreports.com/contacts/discount.aspx?name=799564 Companies Discussed In Report: Celgene, Bristol-Myers Squibb, Roche , Merck & Co, AstraZeneca , Novartis , Amgen , Pfizer, Kite Pharma Scope: The cancer immunotherapies market already consists of some commercially successful products. • Which classes of drug dominate the market? • What additional benefits have newly approved therapies brought to the market? The cancer immunotherapies pipeline is vast, with a significant degree of diversity in terms of molecule types and targets. • Which molecular targets appear most frequently in the pipeline? • What are the commercial prospects for the most promising late-stage pipeline products? The cancer immunotherapies market is forecast to rise from a value of $16.9 billion in 2015 to $75.8 billion in 2022, at a compound annual growth rate of 23.9%. • Which products are forecast to drive this substantial degree of growth? • Will generic competition have a significant impact on the market over the forecast period? The company landscape is growing increasingly competitive. • What are the leading companies in terms of market share? • Which companies are forecast to experience the greatest growth in market share? • What are the drivers of growth for key companies in the market? • How dependent are the key companies on this disease cluster for revenue? • Which companies rely heavily on this disease cluster for revenue? Get This Report at: http://www.reportsnreports.com/purchase.aspx?name=799564 Reasons to Buy • Understand the current clinical and commercial landscape through a comprehensive study of disease epidemiology, pathogenesis, symptoms, diagnosis and prognosis for the key indications covered in the report, which includes breast cancer, melanoma, NSCLC and ovarian cancer. • Assess the current treatment landscape, with product profiles covering prominent marketed therapies, including revenue forecasts. • Analyze the cancer immunotherapies pipeline and stratify by stage of development, molecule type, and molecular target. The most promising late-stage therapies are profiled and assessed in terms of clinical performance and competitiveness, alongside a single-product forecast. • Predict growth in market size, with in-depth market forecasting from 2015 to 2022. The forecasts will provide an understanding of how epidemiology trends, new drug entries, and patent expirations will influence market value. • Identify the leading companies in the market, in terms of market share and growth. Company analysis determines how dependent the key companies in the market are on revenue derived from cancer immunotherapy products. In addition, analysis determines the primary factors that will drive market growth for the key companies in the market. • Identify commercial opportunities in the cancer immunotherapies deals landscape by analyzing trends in licensing and co-development deals About Us: Reportsnreports.com is an online database of market research reports offer in-depth analysis of over 5000 market segments. The library has syndicated reports by leading market research publishers across the globe and also offer customized market research reports for multiple industries. For more information, please visit http://www.reportsnreports.com/reports/799564-global-cancer-immunotherapies-market-to-2022-immune-checkpoint-inhibitors-and-therapeutic-cancer-vaccines-to-characterize-increasingly-competitive-market.html


— Global Cancer Immunotherapies Market to 2022 - Immune Checkpoint Inhibitors and Therapeutic Cancer Vaccines to Characterize Increasingly Competitive Market The cancer immunotherapies market is forecast to rise from a value of $16.9 billion in 2015 to $75.8 billion in 2022, at a compound annual growth rate of 23.9%. The cancer immunotherapies pipeline is vast, with a significant degree of diversity in terms of molecule types and targets. The company landscape is growing increasingly competitive. Complete report on Global Cancer Immunotherapies Market to 2022 - Immune Checkpoint Inhibitors and Therapeutic Cancer Vaccines to Characterize Increasingly Competitive Market spread across 63 pages available at: http://www.reportsnreports.com/contacts/discount.aspx?name=799564 Understand the current clinical and commercial landscape through a comprehensive study of disease epidemiology, pathogenesis, symptoms, diagnosis and prognosis for the key indications covered in the report, which includes breast cancer, melanoma, NSCLC and ovarian cancer. • Cancer Immunotherapies Key Marketed Products • Cancer Immunotherapies Pipeline Landscape Assessment • Cancer Immunotherapies Multi-scenario Market Forecast to 2022 • Cancer Immunotherapies Company Analysis and Positioning • Cancer Immunotherapies Strategic Consolidations • Cancer Immunotherapies Market, Global, Epidemiology of Key Oncology Indications, 2016 • Cancer Immunotherapies Market, Global, Regional Lymph Node and Metastasis Staging, • Cancer Immunotherapies Market, Global, Eastern Co-operative Oncology Group Criteria, 2016 • Cancer Immunotherapies Market, Global, Breast Cancer Histopathological and Molecular Classification, 2016 • Cancer Immunotherapies Market, US, Breast Cancer Stage at Diagnosis and Five-Year Relative Survival (%), 2016 • Cancer Immunotherapies Market, US, Ovarian Cancer Stage and Survival Rates (%), 2016 • Cancer Immunotherapies Market, US, Lung Cancer Stage at Diagnosis and Five-Year Relative Survival (%), 2016 • Cancer Immunotherapies Market, US, Ovarian Cancer Stage at Diagnosis and Five-year Relative Survival Get Discount on Report at: http://www.reportsnreports.com/contacts/discount.aspx?name=799564 Companies Discussed In Report: Celgene, Bristol-Myers Squibb, Roche , Merck & Co, AstraZeneca , Novartis , Amgen , Pfizer, Kite Pharma Scope: The cancer immunotherapies market already consists of some commercially successful products. • Which classes of drug dominate the market? • What additional benefits have newly approved therapies brought to the market? The cancer immunotherapies pipeline is vast, with a significant degree of diversity in terms of molecule types and targets. • Which molecular targets appear most frequently in the pipeline? • What are the commercial prospects for the most promising late-stage pipeline products? The cancer immunotherapies market is forecast to rise from a value of $16.9 billion in 2015 to $75.8 billion in 2022, at a compound annual growth rate of 23.9%. • Which products are forecast to drive this substantial degree of growth? • Will generic competition have a significant impact on the market over the forecast period? The company landscape is growing increasingly competitive. • What are the leading companies in terms of market share? • Which companies are forecast to experience the greatest growth in market share? • What are the drivers of growth for key companies in the market? • How dependent are the key companies on this disease cluster for revenue? • Which companies rely heavily on this disease cluster for revenue? Get This Report at: http://www.reportsnreports.com/purchase.aspx?name=799564 Reasons to Buy • Understand the current clinical and commercial landscape through a comprehensive study of disease epidemiology, pathogenesis, symptoms, diagnosis and prognosis for the key indications covered in the report, which includes breast cancer, melanoma, NSCLC and ovarian cancer. • Assess the current treatment landscape, with product profiles covering prominent marketed therapies, including revenue forecasts. • Analyze the cancer immunotherapies pipeline and stratify by stage of development, molecule type, and molecular target. The most promising late-stage therapies are profiled and assessed in terms of clinical performance and competitiveness, alongside a single-product forecast. • Predict growth in market size, with in-depth market forecasting from 2015 to 2022. The forecasts will provide an understanding of how epidemiology trends, new drug entries, and patent expirations will influence market value. • Identify the leading companies in the market, in terms of market share and growth. Company analysis determines how dependent the key companies in the market are on revenue derived from cancer immunotherapy products. In addition, analysis determines the primary factors that will drive market growth for the key companies in the market. • Identify commercial opportunities in the cancer immunotherapies deals landscape by analyzing trends in licensing and co-development deals About Us: Reportsnreports.com is an online database of market research reports offer in-depth analysis of over 5000 market segments. The library has syndicated reports by leading market research publishers across the globe and also offer customized market research reports for multiple industries. For more information, please visit http://www.reportsnreports.com/reports/799564-global-cancer-immunotherapies-market-to-2022-immune-checkpoint-inhibitors-and-therapeutic-cancer-vaccines-to-characterize-increasingly-competitive-market.html


NEW YORK--(BUSINESS WIRE)--Levi & Korsinsky announces it has commenced an investigation of Momenta Pharmaceuticals, Inc. (NASDAQ: MNTA). On February 17, 2017, Momenta announced that a contracted Pfizer facility used to manufacture the Company's Glatopa product had received a warning letter from the U.S. Food and Drug Administration. The Company’s Abbreviated New Drug Application (ANDA) for its Glatopa 40 mg product candidate is still under regulatory review, with final approval reliant upon the acceptable resolution of the compliance observations at the Pfizer manufacturing facility. In an earnings call on February 21, 2017, Momenta President and CEO Craig Wheeler stated that, as a result of the warning letter, “it is unlikely that Sandoz’s ANDA for Glatopa 40 mg will be approved in the first quarter of 2017.” To obtain additional information, go to: or contact Joseph E. Levi, Esq. either via email at jlevi@zlk.com or by telephone at (212) 363-7500, toll-free: (877) 363-5972. Levi & Korsinsky is a national firm with offices in New York, New Jersey, California, Connecticut, and Washington D.C. The firm’s attorneys have extensive expertise and experience representing investors in securities litigation involving financial fraud, and have recovered hundreds of millions of dollars for aggrieved shareholders. Attorney advertising. Prior results do not guarantee similar outcomes.


NEW YORK--(BUSINESS WIRE)--Levi & Korsinsky announces it has commenced an investigation of Argos Therapeutics, Inc. (NASDAQ:ARGS). On February 17, 2017, Momenta announced that a contracted Pfizer facility used to manufacture the Company's Glatopa product had received a warning letter from the U.S. Food and Drug Administration. The Company’s Abbreviated New Drug Application (ANDA) for its Glatopa 40 mg product candidate is still under regulatory review, with final approval reliant upon the acceptable resolution of the compliance observations at the Pfizer manufacturing facility. In an earnings call on February 21, 2017, Momenta President and CEO Craig Wheeler stated that, as a result of the warning letter, “it is unlikely that Sandoz’s ANDA for Glatopa 40 mg will be approved in the first quarter of 2017.” To obtain additional information, go to: or contact Joseph E. Levi, Esq. either via email at jlevi@zlk.com or by telephone at (212) 363-7500, toll-free: (877) 363-5972. Levi & Korsinsky is a national firm with offices in New York, New Jersey, California, Connecticut, and Washington D.C. The firm’s attorneys have extensive expertise and experience representing investors in securities litigation involving financial fraud, and have recovered hundreds of millions of dollars for aggrieved shareholders. Attorney advertising. Prior results do not guarantee similar outcomes.


PHILADELPHIA and NEW YORK, March 01, 2017 (GLOBE NEWSWIRE) -- Spark Therapeutics (NASDAQ:ONCE) and Pfizer Inc. (NYSE:PFE) announced today that SPK-9001, the lead investigational candidate in the companies' SPK-FIX program has been granted support through the European Medicines Agency (EMA) PRIority MEdicines (PRIME) program. According to the EMA, PRIME is intended to enhance support for new treatments in development “that may offer a major therapeutic advantage over existing treatments, or benefit patients without treatment options.” “We are pleased that investigational SPK-9001 has been granted access to the PRIME program, which potentially will help accelerate the delivery of this potential gene therapy to European patients living with hemophilia B,” said Jeffrey D. Marrazzo, chief executive officer of Spark Therapeutics. “We appreciate the EMA’s dedication to moving treatments forward for patients who are underserved with current options, and we look forward to our continued collaboration on SPK-9001.” SPK-9001 is an experimental treatment for hemophilia B that is currently being investigated in an ongoing Phase 1/2 trial as a potential single-dose therapy. The PRIME program provides enhanced interaction and early dialogue with developers of promising medicines, which is intended to optimize development plans and speed up evaluation so these medicines can reach patients earlier. SPK-9001 received orphan product designation from the U.S. Food and Drug Administration (FDA) in September 2015, and later received breakthrough therapy designation from the FDA in July 2016. About Hemophilia B Hemophilia, a rare genetic bleeding disorder that causes the blood to take a long time to clot as a result of a deficiency in one of several blood clotting factors, is almost exclusively in males. People with hemophilia are at risk for excessive and recurrent bleeding from modest injuries, which have the potential to be life threatening. People with severe hemophilia often bleed spontaneously into their muscles or joints. The incidence of hemophilia B is one in 25,000 male births. People with hemophilia B have a deficiency in clotting factor IX, a specific protein in the blood. Hemophilia B also is called congenital factor IX deficiency or Christmas disease. Current standard of care requires recurrent intravenous infusions of either plasma-derived or recombinant factor IX to control and prevent bleeding episodes. There exists a significant need for novel therapeutics to treat people living with hemophilia. About the SPK-FIX Program and SPK-9001 Spark Therapeutics' proprietary technology platform for selecting, designing, manufacturing and formulating gene therapies was applied to developing compounds in the SPK-FIX program. The SPK-FIX program leverages a long history of hemophilia gene therapy research and clinical development conducted by Spark Therapeutics and its founding scientific team over nearly three decades. SPK-9001 is a novel, investigational bio-engineered adeno-associated virus (AAV) capsid expressing a codon-optimized, high-activity human factor IX variant enabling endogenous production of factor IX. SPK-9001 is being developed under a collaboration with Pfizer. Spark Therapeutics and Pfizer entered into a collaboration in December 2014 for the SPK-FIX program, including SPK-9001, under which Spark Therapeutics is responsible for conducting all Phase 1/2 studies for any product candidates, while Pfizer will assume responsibility for pivotal studies, any regulatory activities and potential global commercialization of any products that may result from the collaboration. About Spark Therapeutics Spark Therapeutics, a fully integrated company, strives to challenge the inevitability of genetic disease by discovering, developing, and delivering gene therapies that address inherited retinal diseases (IRDs), neurodegenerative diseases, as well as diseases that can be addressed by targeting the liver. Our validated platform successfully has delivered proof-of-concept data with investigational gene therapies in the retina and liver. Our most advanced investigational candidate, voretigene neparvovec, in development for the treatment of biallelic RPE65-mediated IRD, has received orphan designations in the U.S. and European Union, and breakthrough therapy designation in the U.S. The pipeline also includes SPK-7001 in a Phase 1/2 trial for choroideremia, and two hemophilia development programs: SPK-9001 (which also has received both breakthrough therapy and orphan product designations) in a Phase 1/2 trial for hemophilia B being developed in collaboration with Pfizer, and SPK-8011, in a Phase 1/2 trial for hemophilia A to which Spark Therapeutics retains global commercialization rights. To learn more about us and our growing pipeline, visit www.sparktx.com. Spark Cautionary Note on Forward-looking Statements This release contains "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the company's SPK-FIX program. Any forward-looking statements are based on management's current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in, or implied by, such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk that: (i) our lead SPK-FIX product candidate, SPK-9001, may not produce sufficient data in our Phase 1/2 clinical trial to warrant further development; and (ii) our overall collaboration with Pfizer may not be successful. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the "Risk Factors" section, as well as discussions of potential risks, uncertainties and other important factors, in our Annual Report on Form 10-K, our Quarterly Reports on Form 10-Q and other filings we make with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and Spark undertakes no duty to update this information unless required by law. Pfizer and Rare Disease Rare disease includes some of the most serious of all illnesses and impacts millions of patients worldwide,[i] representing an opportunity to apply our knowledge and expertise to help make a significant impact on addressing unmet medical needs. The Pfizer focus on rare disease builds on more than two decades of experience, a dedicated research unit focusing on rare disease, and a global portfolio of multiple medicines within a number of disease areas of focus, including hematology, neuroscience, and inherited metabolic disorders.[ii] Pfizer Rare Disease combines pioneering science and deep understanding of how diseases work with insights from innovative strategic collaborations with academic researchers, patients, and other companies to deliver transformative treatments and solutions. We innovate every day leveraging our global footprint to accelerate the development and delivery of groundbreaking medicines and the hope of cures. Click here to learn more about our Rare Disease portfolio and how we empower patients, engage communities in our clinical development programs, and support programs that heighten disease awareness and meet the needs of patient families. Pfizer Inc: Working together for a healthier world® At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. Pfizer Disclosure Notice: The information contained in this release is as of Feb. 28, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about SPK-9001 and the SPK-FIX program, including their potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical study commencement and completion dates as well as the possibility of unfavorable study results, including unfavorable new clinical data and additional analyses of existing clinical data; risks associated with initial data, including the risk that the final results of the Phase 1/2 study for SPK-9001 and/or additional clinical trials may be different from (including less favorable than) the initial data results and may not support further clinical development; whether and when any applications may be filed with regulatory authorities for SPK-9001; whether and when regulatory authorities may approve any such applications, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of SPK-9001; and competitive developments. A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.


Global Vitamins Market Information-by product type (water-soluble and fat-soluble), by form (capsules, tablets, granule and liquid), by application (food and beverages, animal feed, personal care and health care), and by Region - Forecast to 2027 Pune, India - February 17, 2017 /MarketersMedia/ — Market Scenario Globally, the market for Vitamins has been increasing due to health care industry. As there is an increase in health awareness, consumers with loss of appetite and other diseases prefer taking vitamins to boost up their immune. Major Key Players • DSM • Amway • Vitamin Shoppe • Bayer AG • Pharmavite LLC • NBTY Inc • Reckitt Benckiser Group PLC • ADM • Pfizer • BASF SE Request for Sample Report @ https://www.marketresearchfuture.com/sample_request/1331 Segments The market for Global Vitamins Market is segmented on the basis of by product type, form and application; by product type the Global vitamins market is segmented as water-soluble and fat-soluble. Further water-soluble is sub-segmented as vitamin b and vitamin c and fat soluble is sub-segmented as vitamin A, vitamin D, vitamin E and vitamin K and On the basis of form the Global vitamins Market is segmented as capsules, tablets, granule and liquid. By application, the market finds its usage in food and beverages, animal feed, personal care and health care The report for Global Vitamins Market of Market Research Future comprises of extensive primary research along with the detailed analysis of qualitative as well as quantitative aspects by various industry experts, key opinion leaders to gain the deeper insight of the market and industry performance. Taste the market data and market information presented through more than 50 market data tables and figures spread in 150 numbers of pages of the project report. Avail the in-depth table of content TOC & market synopsis on “Global Vitamins Market Research Report - Forecast to 2027” Study Objectives of Global Vitamins Market • In-depth analysis for individual segments and sub-segments for Vitamins • To estimate market size by product type, form, application and region • To understand the market dynamics of the market and provide market snapshot • To provide region level market analysis and future outlook for North America, Europe, Asia, and Rest of the World (ROW) and their countries • Company profiling of major players in the market and competitive landscaping • Identifying the crucial stages for developments in the value chain of Vitamins • Supply chain analysis of the product indicating the stake of the various suppliers, both basic producers and formulators/distributors, till the end-user • Evaluation of historical market trends, patents and technologies, and current government regulatory requirements related to Vitamins market Access Report Details @ https://www.marketresearchfuture.com/reports/vitamins-market Global Vitamins Market: By Region America • North America • US • Canada • Mexico • Latin America Europe • Germany • France • Italy • UK • Poland • Russia Asia-Pacific • China • India • Japan Row Regional Analysis of Global Vitamins Market North-America and Europe dominates the Global Vitamins Market with the largest market share followed by Asia and RoW, accounting for $XX million and is expected to grow over $XX million by 2027, and are expected to grow at CAGR of XX% respectively from 2016 to 2027. The report gives the clear picture of current market scenario which includes historical and projected market size in terms of value and volume, technological advancement, macro economical and governing factors in the market. The report provides details information and strategies of the top key players in the industry. The report also gives a broad study of the different market segments and regions Browse Related Reports:- Global Frozen Fruits and Vegetables Market Information- by Type (fruits, vegetables) by form (whole, puree, topping bar, other processed forms), by packaging(10-15 kgs,15-30 kgs, and >30 kgs), by application (Fruit- Whole Fruits, Fruit juices & Smoothies, Breakfast Cereals, Salads & Desserts, Bakery Foods, Yoghurt and Others), (Vegetable-Whole Vegetables, Pizza Toppings, Salads, RTE (Ready to Eat Foods), Noodles & Pastas, Soups, and Others) and by Region - Forecast to 2027 Know More about Report @ https://www.marketresearchfuture.com/reports/frozen-fruits-vegetables-market About Market Research Future: At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services. MRFR team have supreme objective to provide the optimum quality market research and intelligence services to our clients. Our market research studies by products, services, technologies, applications, end users, and market players for global, regional, and country level market segments, enable our clients to see more, know more, and do more, which help to answer all their most important questions. Contact Info:Name: Akash AnandOrganization: Market Research FutureAddress: Hadapsar Pune, India - 411028Phone: +1 646 845 9312Source URL: http://marketersmedia.com/vitamins-market-size-growth-segmentation-regional-breakdowns-competitive-landscape-shares-trends-strategies-forecast-2027/170835For more information, please visit https://www.marketresearchfuture.com/reports/vitamins-marketSource: MarketersMediaRelease ID: 170835


Injectable drug delivery is defined as a method of administration of medicines directly into patient’s blood circulation system using a specialized delivery device. It is considered as the most common and effective route of administration of most therapeutic agents to achieve the desired quick response. • Pfizer, Inc. (U.S.), • Eli Lilly and Company (U.S.). • Incube Labs, LLC (US) • Endocyte (US) • Genentech, Inc. (US) • Pearl Therapeutics Inc. (US) • Presage Biosciences (US) • QLT Inc.,(Canada) • E3D Elcam Drug Delivery Devices (Israel) • Alkermes Inc. (Republic of Ireland) • Teva Pharmaceutical Industries Ltd. (Israel) Global Injectable drug Delivery Devices market has been segmented on the basis of injector types which consist of Disposable Auto injector, Reusable Auto injector, Wearable injectors, pumps and others. On the basis of end users, the market is classified into; hospitals/clinics, home care, research laboratories. On the basis of delivery which consists of oral, injectors, sprays, inhalers and others The report for Global Injectable Drug Delivery Devices market of Market Research Future comprises of extensive primary research along with the detailed analysis of qualitative as well as quantitative aspects by various industry experts, key opinion leaders to gain the deeper insight of the market and industry performance. Taste the market data and market information presented through more than 50 market data tables and figures spread in 120 numbers of pages of the project report. Avail the in-depth table of content TOC & market synopsis on “Global Injectable Drug Delivery Devices Market Research Report- Forecast To 2027” • To provide detailed analysis of the market structure along with forecast for the next 10 years of the various segments and sub-segments of the global injectable drug delivery devices market • To provide insights about factors affecting the market growth • To analyze the global injectable drug delivery devices market based on various factors- price analysis, supply chain analysis, porters five force analysis etc. • To provide historical and forecast revenue of the market segments and sub-segments with respect to four main geographies and their countries- Americas, Europe, Asia, and Middle East & Africa • To provide country level analysis of the market with respect to the current market size and future prospective • To provide country level analysis of the market for segments by injector type, by end users by delivery method and sub-segments. • To provide strategic profiling of key players in the market, comprehensively analyzing their core competencies, and drawing a competitive landscape for the market • To track and analyze competitive developments such as joint ventures, strategic alliances, mergers and acquisitions, new product developments, and research and developments in the global injectable drug delivery devices market. Americas • North America • US • Canada • Latin America Europe • Western Europe • Germany • France • Italy • Spain • UK • Rest of Western Europe • Eastern Europe Asia– Pacific • Asia • China • India • Japan • South Korea • Rest of Asia • Pacific The Middle East& Africa The report gives the clear picture of current market scenario which includes historical and projected market size in terms of value and volume, technological advancement, macro economical and governing factors in the market. The report provides details information and strategies of the top key players in the industry. The report also gives a broad study of the different markets segments and regions Global Infusion Systems market, by Product Type (Ambulatory Pumps, I.V. Disposables, Syringe Pump Systems, Volumetric Pump Sets and others), by applications (chemotherapy, cardiovascular diseases, Diabetes, Pediatrics and others) by end users (Hospitals, Clinics, Research Laboratories and others) - Forecast to 2027 At Market Research Future (MRFR), we enable our customers to unravel the complexity of various industries through our Cooked Research Report (CRR), Half-Cooked Research Reports (HCRR), Raw Research Reports (3R), Continuous-Feed Research (CFR), and Market Research & Consulting Services. MRFR team have supreme objective to provide the optimum quality market research and intelligence services to our clients. Our market research studies by products, services, technologies, applications, end users, and market players for global, regional, and country level market segments, enable our clients to see more, know more, and do more, which help to answer all their most important questions. For more information, please visit https://www.marketresearchfuture.com/reports/injectable-drug-delivery-devices-market


SOUTH SAN FRANCISCO, Calif., Nov. 03, 2016 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody™ therapeutics for the treatment of cancer, today reported third quarter 2016 financial results.  “This quarter was marked by a number of significant milestones in our Probody pipeline, most notably the filing of our Investigational New Drug (IND) application for CX-072, our PD-L1-targeting Probody therapeutic for the treatment of cancer patients,” said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. “We have also made strong technical progress in our alliance with Bristol Myers Squibb on anti-CTLA-4 Probody therapeutics and look forward to presentations of preclinical proof-of-concept data at the European Society for Medical Oncology Symposium on Immuno-Oncology and the Society for Immunotherapy in Cancer 31st Annual Meeting & Associated Programs.” As of September 30, 2016, CytomX had cash and cash equivalents and investments of $180.5 million. The Company continues to expect full year net cash utilization of $20.0 to $25.0 million in 2016. Based upon its current operating plan, the Company expects its existing capital resources will be sufficient to fund operations through 2018. Upcoming Presentations CytomX and partner Bristol-Myers Squibb will present updates on their respective Probody programs at the upcoming European Society for Medical Oncology (ESMO) Symposium on Immuno-Oncology, held November 4-5, 2016, in Lausanne, Switzerland, and the Society for Immunotherapy in Cancer (SITC) 31st Annual Meeting & Associated Programs, held November 9-13, 2016, in National Harbor, MD. Third Quarter Financial Results Cash, cash equivalents and investments totaled $180.5 million as of September 30, 2016, compared to $186.7 million as of December 31, 2015. The decrease reflects cash used in operations, partially offset by a $30.0 million upfront payment received from AbbVie in connection with the collaboration agreements entered in April 2016, and a $10.0 million milestone payment received from Bristol-Myers Squibb in connection with its third target selection in January 2016. Research and development expenses were $13.3 million for the third quarter of 2016, compared to $9.2 million for the third quarter of 2015. The increase was primarily attributable to $1.7 million in manufacturing costs for the CX-072 and CX-2009 programs, $1.2 million to advance CX-072 into Phase 1 clinical development,  $0.9 million in personnel-related expenses due to an increase in headcount and $0.7 million in non-cash stock-based compensation due to higher stock valuation. General and administrative expenses were $5.0 million for the third quarter of 2016, compared to $4.1 million for the third quarter of 2015. The increase was predominantly due to $0.6 million in non-cash stock based compensation due to higher stock valuation, $0.2 million in personnel-related expenses due to an increase in headcount and $0.2 million in additional consulting and professional service expenses associated with operating as a public company. About PROCLAIM CytomX is launching the PROCLAIM (Probody Clinical Assessment In Man), a first-of its-kind clinical trial program that enables clinical study sites and physicians to access CytomX’s wholly-owned Probody therapeutics under one international umbrella. The first module within the PROCLAIM program is an open-label, dose-finding Phase 1/2 study evaluating CX-072 as monotherapy and in combination with Yervoy® (ipilimumab) or Zelboraf® (vemurafenib) in anti-PD-(L)1 inhibitor naïve patients with certain cancers. CX-072 is a PD-L1-targeting Probody therapeutic for the treatment of cancer patients. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial: Clinical data is expected to begin to emerge in the second half of 2017, and throughout 2018. The IND application for CX-072 is currently under review with FDA. About CytomX Therapeutics CytomX is an oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody technology platform. The Company uses the platform to create proprietary cancer immunotherapies against clinically-validated targets, as well as to develop first-in-class investigational cancer therapeutics against novel targets. CytomX believes that its Probody platform has the potential to improve the combined efficacy and safety profile of monoclonal antibody modalities, including cancer immunotherapies, antibody drug conjugates and T-cell-recruiting bispecific antibodies. Probody therapeutics are designed to take advantage of unique conditions in the tumor microenvironment to enhance the tumor-targeting features of an antibody and reduce drug activity in healthy tissues.  The Company’s investigational Probody therapeutics address clinically-validated cancer targets in immuno-oncology, such as PD-L1, against which the clinical candidate CX-072 is directed, as well as novel targets, such as CD-166, that are difficult to drug without causing damage to healthy tissues. In addition to its proprietary programs, CytomX is collaborating with strategic partners including AbbVie, Bristol-Myers Squibb Company, Pfizer Inc., MD Anderson Cancer Center and ImmunoGen, Inc. For more information, visit www.cytomx.com. Forward-Looking Statements This press release includes forward-looking statements, including statements related to the development and advancement of the Company’s product candidates into, and the successful completion of, clinical trials, including with respect to the timing of a Phase 1 clinical trial for CX-072 and the timing of an IND submission and the Phase 1 clinical trial for CX-2009, the availability of data from such clinical trials, the timing and success of certain of the Company’s collaborations and the Company’s ability to identify potential collaborators. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond the Company’s control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements. The Company’s Probody platform is in preclinical development, and the process by which a preclinical technology could potentially lead to an approved product is long and subject to significant risks and uncertainties. Projected net cash utilization and capital resources are subject to substantial risk of variance based on a wide variety of factors that can be difficult to predict.  Applicable risks and uncertainties include those relating to our preclinical research and development, the accuracy of the Company’s estimates relating to its ability to initiate and/or complete clinical trials, the Company’s ability to demonstrate evidence of efficacy and safety of its product candidates during clinical trials, the unpredictability of the regulatory process, regulatory developments in the United States and foreign countries, the Company’s existing and potential future collaborations and other risks identified under the heading "Risk Factors" included in our filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to the Company and speak only as of the date on which they are made. The Company does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.


News Article | February 23, 2017
Site: www.businesswire.com

SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) today reported financial results for the three and 12 months ended December 31, 2016, and provided an operating forecast and program updates. Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time. “2016 was an exceptional year for Ligand. We reported substantial revenue growing more than 50% over last year and strong operating cash flow. Evomela, a new commercial product with a high royalty rate to Ligand, launched and joined Promacta® and Kyprolis® as major drivers of royalty revenue. We also had a very successful year operating our OmniAb business following the acquisition of OMT approximately one year ago. Additionally, many new deals entered our portfolio and numerous late-stage partnered assets generated meaningful positive news,” said John Higgins, Chief Executive Officer. “2017 is positioned to be another year of strong growth in revenue and cash flow. We anticipate beginning to receive royalties from new product launches, and look forward to major data readouts from many late-stage partnered programs, results from our Phase 2 GRA trial and partners entering the clinic with antibodies from our OmniAb platform.” Total revenues for the fourth quarter of 2016 were $38.2 million, compared with $21.2 million for the same period in 2015, an increase of 80%. Royalty revenues were $19.6 million, compared with $11.5 million for the same period in 2015 primarily due to higher royalties from Promacta and Kyprolis. Material sales were $9.1 million, compared with $7.2 million for the same period in 2015 due to timing of Captisol® purchases for use in clinical trials and commercial products. License and milestone revenues were $9.5 million, compared with $2.4 million for the same period in 2015 due to a higher number of contract payments and contributions from OmniAb-related deals. Cost of goods sold was $2.9 million for the fourth quarter of 2016, compared with $0.9 million for the same period in 2015 due to the timing and mix of Captisol sales. Amortization of intangibles was $2.7 million, compared with $0.6 million for the same period in 2015 due primarily to additional amortization of intangibles related to the acquisition of OMT. Research and development expense was $6.4 million, compared with $2.3 million for the same period of 2015 as a result of the addition of OMT-related expenses, timing of spending on internal development programs and non-cash stock-based compensation expense. General and administrative expense was $6.6 million, compared with $6.2 million for the same period in 2015 due to costs associated with OMT and non-cash stock-based compensation expense. GAAP net loss for the fourth quarter of 2016 was $3.1 million, or $0.15 per share, compared with GAAP net income for the fourth quarter of 2015 of $6.3 million, or $0.29 per diluted share. GAAP net income for the fourth quarter of 2016 was impacted by a $9.0 million non-cash charge related to Viking Therapeutics, primarily for a markdown of the book value of our holdings in Viking to current market values. Adjusted net income for the fourth quarter of 2016 was $16.1 million, or $0.74 per diluted share, compared with adjusted net income for the same period in 2015 of $12.2 million, or $0.59 per diluted share. Adjusted net income and EPS are now being reported on a fully-taxed basis, as disclosed in the Form 8-K filed with the Securities and Exchange Commission January 18, 2017. See “Adjusted Financial Measures” and the accompanying table below for the adjusted calculations and reconciliation to comparable GAAP financial measures. As of December 31, 2016, Ligand had cash, cash equivalents and short-term investments of $141.0 million. Cash generated from operations was $21.0 million and $63.0 million for the 2016 fourth quarter and full year, respectively. Total revenues in 2016 were $109.0 million, compared with $71.9 million for 2015, an increase of 52%. Royalty revenues were $59.4 million, compared with $38.2 million for 2015 primarily due to higher royalties from Promacta and Kyprolis. Material sales were $22.5 million, compared with $27.7 million for 2015 due to timing of Captisol purchases for use in clinical trials and commercial products. License and milestone revenues were $27.0 million, compared with $6.1 million for 2015 due to a higher number of contract payments and contributions from OmniAb-related deals. Cost of goods sold was $5.6 million in 2016, compared with $5.8 million for 2015 due to the timing and mix of Captisol sales. Amortization of intangibles was $10.6 million, compared with $2.4 million for 2015 due primarily to additional amortization of intangibles related to the acquisition of OMT. Research and development expense was $21.2 million, compared with $11.0 million for 2015 as a result of the addition of OMT-related expenses, timing of spending on internal development programs and non-cash stock-based compensation expense. General and administrative expense was $26.6 million, compared with $24.4 million for 2015 due to costs associated with OMT and non-cash stock-based compensation expense. GAAP net loss in 2016 was $1.6 million, or $0.08 per share, compared with GAAP net income in 2015 of $229.8 million, or $10.83 per diluted share. The difference is primarily attributable to a net income tax benefit in 2015 of $206.0 million, or $9.70 per diluted share, from the release of valuation allowance. 2016 GAAP net loss was also impacted by a $23.1 million non-cash charge associated with our investment in Viking, primarily consisting of a loss on dilution as a result of Viking financings and the mark-to-market charge taken in the fourth quarter of 2016. Adjusted net income for 2016 was $46.7 million, or $2.15 per diluted share, compared with adjusted net income in 2015 of $47.6 million, or $2.31 per diluted share. The Company expects 2017 revenues to consist of three components: royalties, material sales and contract (license and milestone) revenue. At this time, Ligand estimates 2017 core revenue to include royalties of approximately $87 million, material sales of approximately $23 million and contract payments of at least $20 million. During 2017, Ligand estimates it could potentially receive up to an additional $30 million of contract payments, however external events are out of Ligand’s control so the Company will provide more information about the timing and probability for any additional contract revenue expected to be booked in 2017 as the year progresses. Ligand estimates that cash expenses for 2017 will be in the range of $28 million to $30 million, consistent with the cash expenses incurred for 2016. Ligand notes that with core revenue of $130 million, adjusted earnings per diluted share would be approximately $2.70. This amount is expected to be higher in the event additional contract revenue is received in 2017. The core adjusted EPS figure reflects the Company’s new fully-taxed adjusted EPS methodology, including a 36% to 39% tax rate, but the Company continues to pay less than 1% cash taxes as it utilizes its over $500 million of remaining NOLs. In May 2014 the Financial Accounting Standards Board issued Accounting Standards Codification Topic 606 (ASC 606), Revenue From Contracts With Customers, which is intended to provide a single, comprehensive revenue recognition model for all contracts with customers and thereby improve comparability within industries, across industries, and across capital markets. Companies must implement this new standard no later than January 1, 2018 and they can elect to adopt the standard after January 1, 2017. At this time, Ligand does not expect to adopt ASC 606 as of January 1, 2017. The Company reports adjusted results for diluted net income per share and net income, in addition to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP. The Company’s financial measures under GAAP include stock-based compensation expense, amortization of debt-related costs, amortization related to acquisitions, changes in contingent liabilities, net losses of Viking Therapeutics, mark-to-market adjustment for amounts owed to licensors, fair value adjustments to Viking Therapeutics convertible note receivable and warrants, unissued shares relating to the Senior Convertible Note, unissued shares relating to the anti-dilutive effect of fourth quarter and fiscal year 2016 GAAP net loss and adjustments for discontinued operations, and others that are listed in the itemized reconciliations between GAAP and adjusted financial measures included in this press release. However, other than with respect to total revenue, the Company only provides guidance on an adjusted basis and does not provide reconciliations of such forward-looking adjusted measures to GAAP due to the inherent difficulty in forecasting and quantifying certain amounts that are necessary for such reconciliation, including adjustments that could be made for changes in contingent liabilities, net losses of Viking Therapeutics, mark-to-market adjustments for amounts owed to licensors and fair value adjustments to Viking Therapeutics convertible note receivable. Management has excluded the effects of these items in its adjusted measures to assist investors in analyzing and assessing the Company’s past and future core operating performance. Additionally, adjusted diluted earnings per share is a key component of the financial metrics utilized by the Company’s board of directors to measure, in part, management’s performance and determine significant elements of management’s compensation. Ligand management will host a conference call today beginning at 4:30 p.m. Eastern time (1:30 p.m. Pacific time) to discuss this announcement and answer questions. To participate via telephone, please dial (877) 407-4019 from the U.S. or (201) 689-8337 from outside the U.S., using the passcode “Ligand.” To participate via live or replay webcast, a link will be available at www.ligand.com. Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory affairs and commercialization) to ultimately generate our revenue. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono- and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly. This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. Words such as “plans,” “believes,” “expects,” “anticipates,” and “will,” and similar expressions, are intended to identify forward-looking statements. These forward-looking statements include, without limitation, statements regarding: Ligand’s future revenue growth, including the timing, mix and volume of Captisol orders, the timing of the initiation or completion of clinical trials by Ligand and its partners, the timing of new product launches by Ligand and its partners and the related royalties Ligand expects to receive from its partners, the timing of review of clinical data by the FDA, expected value creation for shareholders and guidance regarding the full-year 2017 financial results. Actual events or results may differ from Ligand's expectations. For example, Ligand may not receive expected revenue from material sales of Captisol, expected royalties on other partnered products and research or development milestone payments. Ligand and its partners may not be able to timely or successfully advance any product(s) in its internal or partnered pipeline. In addition, there can be no assurance that Ligand will achieve its guidance for 2017 or any portion thereof or beyond, that Ligand's 2017 revenues will be at the levels as currently anticipated, that Ligand will be able to create future revenues and cash flows by developing innovative therapeutics, that results of any clinical study will be timely, favorable or confirmed by later studies, that products under development by Ligand or its partners will receive regulatory approval, that there will be a market for the product(s) if successfully developed and approved, or that Ligand's partners will not terminate any of its agreements or development or commercialization of any of its products. Further, Ligand may not generate expected revenues under its existing license agreements and may experience significant costs as the result of potential delays under its supply agreements. Also, Ligand and its partners may experience delays in the commencement, enrollment, completion or analysis of clinical testing for its product candidates, or significant issues regarding the adequacy of its clinical trial designs or the execution of its clinical trials, which could result in increased costs and delays, or limit Ligand's ability to obtain regulatory approval. Further, unexpected adverse side effects or inadequate therapeutic efficacy of Ligand's product(s) could delay or prevent regulatory approval or commercialization. In addition, Ligand may not be able to successfully implement its strategic growth plan and continue the development of its proprietary programs. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other risk factors affecting Ligand can be found in prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this release. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The information in this press release regarding certain third-party products and programs, including Promacta, a Novartis product, and Kyprolis, an Amgen product, comes from information publicly released by the owners of such products and programs. Ligand is not responsible for, and has no role in, the development of such products or programs. Ligand owns or has rights to trademarks and copyrights that it uses in connection with the operation of its business including its corporate name, logos and websites. Other trademarks and copyrights appearing in this press release are the property of their respective owners. The trademarks Ligand owns include Ligand®, Captisol® and OmniAb®. Solely for convenience, some of the trademarks and copyrights referred to in this press release are listed without the ®, © and TM symbols, but Ligand will assert, to the fullest extent under applicable law, its rights to its trademarks and copyrights. (1) Non-cash debt related costs is calculated in accordance with the authoritative accounting guidance for convertible debt instruments that may be settled in cash. (2) Loss from Viking reflects the Company's share of Viking's net loss of $1.2 million and $5.1 million for the three and twelve months ended December 31, 2016 respectively, and the decrease in the book value of the Company's equity method investment in Viking of $0.3 million and $10.6 million for the three and twelve months ended December 31, 2016, respectively, as a result of the Company's decreased ownership percentage in Viking after Viking's financing and an in impairment charge of $7.4 million for the year ended December 31, 2016 as a result of an other than temporary decrease in the value of our investment in Viking. The $28.2 million gain on deconsolidation of Viking in 2015 is not reflected above as an adjustment to GAAP results as the $28.2 million gain comprises primarily $29.2 million in consideration we received from a licensing arrangement, which we consider to be recurring in nature and core to our operations. The $29.2 million payment consists of the license fee, in the form of Viking common stock, we received under the Master Licensing Agreement (“MLA”) entered into between the Company and Viking in May of 2014 whereby the Company granted Viking rights to five programs. Pursuant to the MLA, as partial consideration for the grant of the rights and licenses under the MLA, upon the consummation of an initial public offering (“IPO”), Viking was required to issue to the Company shares of Viking common stock. In May 2015, Viking completed its IPO, at which time the Company received approximately 3.7 million shares of Viking common stock. (3) Changes in fair value of contingent consideration related to CyDex and Metabasis transactions. (4) Changes in fair value of Viking Therapeutics, Inc. note receivable and warrants. (5) Amounts due to Bristol-Myers Squibb relating to the agreement with Retrophin. (6) Prior to the quarter ended December 31, 2016, adjustments to GAAP included a separate income tax expense adjustment from GAAP tax expense to the amount of cash taxes paid or payable for the respective period. As of December 31, 2016, the presentation includes the tax effect of the adjustments to GAAP as prescribed by the updated Compliance and Disclosure Interpretations issued by the SEC in May, 2016. In the three months ended December 31, 2016 and 2015, cash taxes paid were $2 thousand and $9 thousand, respectively. A reconciliation to the previously reported adjusted results is presented below. (7) Deferred tax asset valuation allowance for the three and twelve months ended December 31, 2016 relates to a valuation allowance placed on the deferred tax asset associated with Viking losses including the other than temporary impairment charge of $7.4 million. Deferred tax asset valuation allowance for the twelve months ended December 31, 2015 primarily relates to the release of previously reserved net operating losses and credits. Note: Adjusted net income per share basic and diluted as presented above were also revised as a result of the changes to the income tax effect of the adjustments to GAAP as noted above


News Article | November 24, 2016
Site: www.newsmaker.com.au

Future Market Insights (FMI) delivers key insights on the global citric acid market in its latest report titled, “Citric Acid Market: Global Industry Analysis and Opportunity Assessment, 2016–2026”. In terms of value, the global citric acid market is expected to witness a CAGR of 4.6% during the forecast period due to various factors on which FMI offers vital insights in detail. Consumers are preferring products comprising of plant based natural ingredients due to various health issues. This is fuelling demand for citric acid worldwide.  Moreover, increased usage of citric acid as a cleaning agent due to a ban on phosphate in various regions is further expected to drive the market demand in the near future. Citric acid is used as an ingredient in manufacture of convenience food and beverages as it provides acidity, acts as a preservative, provides antioxidants and enhances the flavour, which is further expected to drive the market demand in the near future. This report discusses trends driving growth of each segment and offers analysis and insights on the potential of the global citric acid market in specific regions including North America, Latin America, Western Europe, Eastern Europe, Asia Pacific Excluding Japan (APEJ), the Middle East & Africa and Japan. Markets in APEJ and Western Europe are expected to record high growth rates in terms of value between 2016 and 2026. Among all the regions, Western Europe is estimated to account for a comparatively higher value share in 2016. The market in Western Europe is expected to remain dominant over the forecast period. APEJ is another major market for citric acid. China is estimated to be the largest producer of citric acid followed by India in 2015 across the region. This report covers detailed profiles of key players in citric acid market, which includes key strategies, key developments, product offerings and others. Key companies profiled in this report are Archer Daniels Midland Company, Shandong Juxian Hongde Citric Acid Co. Ltd., Jungbunzlauer Suisse AG, Basel, Delek Group, Cargill, Incorporated, Weifang Ensign Industry Co., Ltd., Tate & Lyle plc. COFCO Biochemical (AnHui) Co. Ltd., RZBC GROUP and Pfizer Inc.\


Research and Markets has announced the addition of the "Global Antifungal Drugs Market Analysis & Trends - Industry Forecast to 2025" report to their offering. The Global Antifungal Drugs Market is poised to grow at a CAGR of around 1.8% over the next decade to reach approximately $12.8 billion by 2025. This industry report analyzes the market estimates and forecasts for all the given segments on global as well as regional levels presented in the research scope. The study provides historical market data for 2013, 2014 revenue estimations are presented for 2015 and forecasts from 2016 till 2025. The study focuses on market trends, leading players, supply chain trends, technological innovations, key developments, and future strategies. With comprehensive market assessment across the major geographies such as North America, Europe, Asia Pacific, Middle East, Latin America and Rest of the world the report is a valuable asset for the existing players, new entrants and the future investors. Some of the prominent trends that the market is witnessing include raising awareness amid public, developing public-private partnership in pharmaceutical industry, latest technological advancements in antifungal infection therapeutics and growth opportunities/investment opportunities. Based on Drug type the market is categorized into polyenes, echinocandins, azoles, allylamines and other drug types. Depending on the Therapeutic Indication the market is segmented by dermatophytosis, candidiasis, aspergillosis and other therapeutic indications. Depending on the Product form the market is segmented by tablets, shampoo, liquids or spray, injections, gels and cream. Based on Application the market is categorized into powders, pastes, ointments, drugs, other applications. Based on Distribution channel the market is categorized into retail pharmacies, hospital pharmacies, E-commerce, specialty clinics and other distribution channels. - The report provides a detailed analysis on current and future market trends to identify the investment opportunities - Market forecasts till 2025, using estimated market values as the base numbers - Key market trends across the business segments, Regions and Countries - Key developments and strategies observed in the market - Market Dynamics such as Drivers, Restraints, Opportunities and other trends - In-depth company profiles of key players and upcoming prominent players - Growth prospects among the emerging nations through 2025 - Market opportunities and recommendations for new investments 4 Antifungal Drugs Market, By Drug Type 4.1 Polyenes 4.1.1.1 Liposomal Amphotericin B Corifungin 4.1.1.2 Natamycin 4.1.1.3 Hamycin 4.1.1.4 Candicidin 4.1.1.5 Amphotericin B Deoxycholate 4.1.1.6 Nystatin 4.1.1.7 Other Polyenes 4.2 Echinocandins 4.2.1.1 Micafungin 4.2.1.2 Caspofungin 4.2.1.3 Pneumocandins 4.2.1.4 Anidulafungin 4.2.1.5 Other Echinocandins 4.3 Azoles 4.3.1.1 Voriconazole 4.3.1.2 Posaconazole 4.3.1.3 Thiazoles 4.3.1.4 Ketoconazole 4.3.1.5 Itraconazole 4.3.1.6 Imidazoles 4.3.1.7 Fluconazole 4.3.1.8 Other Azoles 4.4 Allylamines 4.4.1.1 Terbinafine 4.4.1.2 Lamisil 4.4.1.3 Other Allylamines 4.5 Other Drug types 4.5.1.1 Greisiofulvin 4.5.1.2 Ciclopirox 4.5.1.3 Benzoic Acid 8 Antifungal Drugs Market, By Distribution channel 8.1 Retail Pharmacies 8.2 Hospital Pharmacies 8.3 E-commerce 8.4 Specialty Clinics 8.5 Other Distribution channels 8.5.1 Other Distribution channels Market Forecast to 2025 (US$ MN) 11 Leading Companies 11.1 Scynexis Inc. 11.2 Sanofi-Aventis 11.3 Pfizer Inc. 11.4 Novartis AG 11.5 Merck & Co. Inc 11.6 Kramer Laboratories 11.7 Johnson & Johnson 11.8 ID Sigma-Aldrich Corporation 11.11 Glenmark Pharmaceuticals Ltd 11.10 Glaxosmithkline 11.11 Enzon Pharmaceuticals 11.12 Bayer Healthcare 11.13 Astellas Pharma Inc 11.14 Asperqillus 11.15 Alternaria 11.16 Abbott Laboratories For more information about this report visit http://www.researchandmarkets.com/research/lp59rk/global_antifungal


News Article | November 28, 2016
Site: www.newsmaker.com.au

In terms of revenue, the global lysosomal storage diseases therapeutics market is projected to register a healthy CAGR of 10.0% over the forecast period and is estimated to be valued at US$ 14.36 Bn by 2026. In the report, Persistence Market Research analyzes the key factors and trends impacting the growth and performance of the global lysosomal storage diseases therapeutics market over the forecast period. An increasing diagnosis rate due to increasing awareness and financial incentives for orphan drug development to recover R&D costs is the primary factor fueling the growth of the global lysosomal storage diseases therapeutics market. Also, an increasing focus of major biopharmaceutical companies on the research and development of drugs for the treatment of rare diseases is expected to boost the global lysosomal storage diseases therapeutics market during the forecast period. Moreover, the number of treatment options currently in the pipeline is further expected to bolster revenue growth of the global lysosomal storage diseases therapeutics market during the forecast period. However, heterogeneity of the disease leading to underdiagnoses of lysosomal storage diseases, lack of treatment options, and high cost of treatment are factors likely to hamper the growth of the global lysosomal storage diseases therapeutics market over the forecast period. Advent of therapies targeting neuropathic manifestations by crossing blood brain barrier (BBB) and therapies that overcome immune response and have better tissue selectivity will define the future landscape of the global lysosomal storage diseases therapeutics market. Global lysosomal storage diseases therapeutics market has been segmented on the basis of Indication (Gaucher's Diseases, Fabry Diseases, Pompe’s Syndrome, Mucopolysaccharidosis, Others); Type of Therapy (Enzyme Replacement Therapy, Stem Cell Therapy, Substrate Reduction Therapy, Others); End User (Hospitals, Clinics); and Region (North America, Latin America, Europe, Asia Pacific (APAC), and Middle East & Africa (MEA)). The Gaucher's Diseases indication segment is estimated to account for 29.7% revenue share of the global lysosomal storage diseases therapeutics market by 2016 end. The Enzyme Replacement Therapy segment was valued at US$ 4,833.8 Mn in 2015 and is expected to exhibit the highest CAGR of 10.0% over the forecast period to reach US$ 13.58 Bn by 2026 end. The Hospitals end user segment is expected to witness 2.8X increase in revenue over the forecast period and is expected to create absolute $ opportunity of US$ 346.2 Mn in 2017 over 2016. Among regions, Europe is expected to be the dominant regional market in the global lysosomal storage diseases therapeutics market during the forecast period. The Europe market accounted for the highest revenue share of 34.8% and was valued at US$ 1,773.2 Mn in 2015; and is expected to witness a CAGR of 10.2% during the forecast period. North America is expected to be the second most lucrative market in the global lysosomal storage diseases therapeutics market and is estimated to represent absolute $ opportunity of US$ 159.6 Mn in 2017 over 2016. Shire PLC, Pfizer, Inc., Sanofi, BioMarin Pharmaceutical Inc., Actelion Ltd., Raptor Pharmaceutical Corp., Protalix Biotherapeutics Inc., and Amicus Therapeutics, Inc. are some of the companies operating in the global lysosomal storage diseases therapeutics market. Top market players are investing in focused R&D initiatives to develop innovative products for the treatment of rare diseases and are looking to drive growth in established markets through strategic partnerships, collaborations, and acquisitions. The report discusses individual strategies of these companies in terms of increasing focus on rare diseases, initiatives to increase awareness, and enhancing distribution base. The report concludes with strategic recommendations for players already present in the market and new players planning to enter the global lysosomal storage diseases therapeutics market.


News Article | November 23, 2016
Site: www.newsmaker.com.au

This report studies Central Nervous System Agents in Global market, especially in North America, Europe, China, Japan, Southeast Asia and India, focuses on top manufacturers in global market, with Production, price, revenue and market share for each manufacturer, covering  Johnson & Johnson  Pfizer  Novartis  Roche  Sanofi  Merck  GSK  Bayer  Bristol-Myers Squibb  AbbVie  Eli Lilly  AstraZeneca  Takeda  Actavis  Astellas  Teva  Biogen  Shire  Market Segment by Regions, this report splits Global into several key Regions, with production, consumption, revenue, market share and growth rate of Central Nervous System Agents in these regions, from 2011 to 2021 (forecast), like  North America  Europe  China  Japan  Southeast Asia  India Split by product type, with production, revenue, price, market share and growth rate of each type, can be divided into  Type I  Type II  Type III  Split by application, this report focuses on consumption, market share and growth rate of Central Nervous System Agents in each application, can be divided into  Application 1  Application 2  Application 3 Global Central Nervous System Agents Market Research Report 2016  1 Central Nervous System Agents Market Overview  1.1 Product Overview and Scope of Central Nervous System Agents  1.2 Central Nervous System Agents Segment by Type  1.2.1 Global Production Market Share of Central Nervous System Agents by Type in 2015  1.2.2 Type I  1.2.3 Type II  1.2.4 Type III  1.3 Central Nervous System Agents Segment by Application  1.3.1 Central Nervous System Agents Consumption Market Share by Application in 2015  1.3.2 Application 1  1.3.3 Application 2  1.3.4 Application 3  1.4 Central Nervous System Agents Market by Region  1.4.1 North America Status and Prospect (2011-2021)  1.4.2 Europe Status and Prospect (2011-2021)  1.4.3 China Status and Prospect (2011-2021)  1.4.4 Japan Status and Prospect (2011-2021)  1.4.5 Southeast Asia Status and Prospect (2011-2021)  1.4.6 India Status and Prospect (2011-2021)  1.5 Global Market Size (Value) of Central Nervous System Agents (2011-2021) 2 Global Central Nervous System Agents Market Competition by Manufacturers  2.1 Global Central Nervous System Agents Production and Share by Manufacturers (2015 and 2016)  2.2 Global Central Nervous System Agents Revenue and Share by Manufacturers (2015 and 2016)  2.3 Global Central Nervous System Agents Average Price by Manufacturers (2015 and 2016)  2.4 Manufacturers Central Nervous System Agents Manufacturing Base Distribution, Sales Area and Product Type  2.5 Central Nervous System Agents Market Competitive Situation and Trends  2.5.1 Central Nervous System Agents Market Concentration Rate  2.5.2 Central Nervous System Agents Market Share of Top 3 and Top 5 Manufacturers  2.5.3 Mergers & Acquisitions, Expansion 3 Global Central Nervous System Agents Production, Revenue (Value) by Region (2011-2016)  3.1 Global Central Nervous System Agents Production and Market Share by Region (2011-2016)  3.2 Global Central Nervous System Agents Revenue (Value) and Market Share by Region (2011-2016)  3.3 Global Central Nervous System Agents Production, Revenue, Price and Gross Margin (2011-2016)  3.4 North America Central Nervous System Agents Production, Revenue, Price and Gross Margin (2011-2016)  3.5 Europe Central Nervous System Agents Production, Revenue, Price and Gross Margin (2011-2016)  3.6 China Central Nervous System Agents Production, Revenue, Price and Gross Margin (2011-2016)  3.7 Japan Central Nervous System Agents Production, Revenue, Price and Gross Margin (2011-2016)  3.8 Southeast Asia Central Nervous System Agents Production, Revenue, Price and Gross Margin (2011-2016)  3.9 India Central Nervous System Agents Production, Revenue, Price and Gross Margin (2011-2016) 4 Global Central Nervous System Agents Supply (Production), Consumption, Export, Import by Regions (2011-2016)  4.1 Global Central Nervous System Agents Consumption by Regions (2011-2016)  4.2 North America Central Nervous System Agents Production, Consumption, Export, Import by Regions (2011-2016)  4.3 Europe Central Nervous System Agents Production, Consumption, Export, Import by Regions (2011-2016)  4.4 China Central Nervous System Agents Production, Consumption, Export, Import by Regions (2011-2016)  4.5 Japan Central Nervous System Agents Production, Consumption, Export, Import by Regions (2011-2016)  4.6 Southeast Asia Central Nervous System Agents Production, Consumption, Export, Import by Regions (2011-2016)  4.7 India Central Nervous System Agents Production, Consumption, Export, Import by Regions (2011-2016) 5 Global Central Nervous System Agents Production, Revenue (Value), Price Trend by Type  5.1 Global Central Nervous System Agents Production and Market Share by Type (2011-2016)  5.2 Global Central Nervous System Agents Revenue and Market Share by Type (2011-2016)  5.3 Global Central Nervous System Agents Price by Type (2011-2016)  5.4 Global Central Nervous System Agents Production Growth by Type (2011-2016) For more information or any query mail at [email protected] Wise Guy Reports is part of the Wise Guy Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe. Wise Guy Reports features an exhaustive list of market research reports from hundreds of publishers worldwide. We boast a database spanning virtually every market category and an even more comprehensive collection of market research reports under these categories and sub-categories.


Notes:  Production, means the output of Medical Nutrition  Revenue, means the sales value of Medical Nutrition This report studies Medical Nutrition in Global market, especially in North America, Europe, China, Japan, Southeast Asia and India, focuses on top manufacturers in global market, with Production, price, revenue and market share for each manufacturer, covering  Abbott Nutrition  Danone  Nestle  Ajinomoto  Alaris Medical Systems Inc  Arla Foods a.m.b.a.  B. Braun  Bard Access Systems Inc  Baxter  Boston Scientific Corporation  Corpak Medsystems  Covidien PLC  Fresenius Kabi AG  Hormel Health Labs Inc  Hospira, Inc.  ICU Medical Inc  Kimberly-Clark Health Care  Koninklijke Frieslandcampina NV Mead Johnson Nutrition  Medical Nutrition USA, Inc.  Neomed Inc  Nutricia Advanced Medical Nutrition  Pfizer Nutrition  Victus LLC  Vitaflo® International Ltd  Market Segment by Regions, this report splits Global into several key Regions, with production, consumption, revenue, market share and growth rate of Medical Nutrition in these regions, from 2011 to 2021 (forecast), like  North America  Europe  China  Japan  Southeast Asia  India  Split by product type, with production, revenue, price, market share and growth rate of each type, can be divided into  Type I  Type II  Type III  Split by application, this report focuses on consumption, market share and growth rate of Medical Nutrition in each application, can be divided into  Application 1  Application 2  Application 3 Global Medical Nutrition Market Research Report 2016  1 Medical Nutrition Market Overview  1.1 Product Overview and Scope of Medical Nutrition  1.2 Medical Nutrition Segment by Type  1.2.1 Global Production Market Share of Medical Nutrition by Type in 2015  1.2.2 Type I  1.2.3 Type II  1.2.4 Type III  1.3 Medical Nutrition Segment by Application  1.3.1 Medical Nutrition Consumption Market Share by Application in 2015  1.3.2 Application 1  1.3.3 Application 2  1.3.4 Application 3  1.4 Medical Nutrition Market by Region  1.4.1 North America Status and Prospect (2011-2021)  1.4.2 Europe Status and Prospect (2011-2021)  1.4.3 China Status and Prospect (2011-2021)  1.4.4 Japan Status and Prospect (2011-2021)  1.4.5 Southeast Asia Status and Prospect (2011-2021)  1.4.6 India Status and Prospect (2011-2021)  1.5 Global Market Size (Value) of Medical Nutrition (2011-2021) Wise Guy Reports is part of the Wise Guy Consultants Pvt. Ltd. and offers premium progressive statistical surveying, market research reports, analysis & forecast data for industries and governments around the globe. Wise Guy Reports understand how essential statistical surveying information is for your organization or association. Therefore, we have associated with the top publishers and research firms all specialized in specific domains, ensuring you will receive the most reliable and up to date research data available.


Research and Markets has announced the addition of the "Infusion Pumps - Global Strategic Business Report" report to their offering. The report provides separate comprehensive analytics for the US, Canada, Japan, Europe, Asia-Pacific, Latin America, and Rest of World. Annual estimates and forecasts are provided for the period 2015 through 2022. Also, a six-year historic analysis is provided for these markets. Market data and analytics are derived from primary and secondary research. This report analyzes the worldwide markets for Infusion Pumps in US$ by the following Product Segments: The report profiles 52 companies including many key and niche players such as: - Infusion Pumps: An Alternate Drug Delivery Option - Current and Future Analysis - Developed Economies Dominate Infusion Pumps Market - Asia-Pacific: The Fastest Growing Market for Infusion Pumps - Analysis by Product Segments - Ambulatory Infusion Pumps - Enteral Feeding Pumps - Insulin Infusion Pumps - Large Volume Infusion Pumps - PCA Infusion Pumps - Syringe Infusion Pumps - Infusion Errors & Technology Defenses Developed Over the Years - Rise in Incidence of Chronic Diseases Fuels Infusion Pumps Demand - The Diabetes Epidemic - Untapped Potential for Insulin Pumps - Global Diabetes Expenditure: Opportunity Indicator for Insulin Pumps Market - Cancer Pain Offers Potential Opportunities for Pain Management Pumps - Infusion Pumps - A Highly Consolidated Market - Insulin Pumps Market - Competition Intensifies - Comparison of Select Durable Insulin Pumps by Manufacturer - Medtronic Banks on New Solutions and Distribution Expansion to Retain Dominance - J&J's OneTouch Via - A Discrete Solution for On-Demand Insulin - Ypsomed Eyes Brighter Prospects with YpsoPump - Medtrum - A New Entrant with a Strong Product; Threatening to Take the Market by Storm - Competitive Landscape in the Insulin Patch Pump Market - OmniPod Benefits from Lack of Close Competition in its League - Insulet Focuses on Advances in Technology and Services to Gain Market Share - Cellnovo's Patch Pump Combines Functionality and Cost- Effectiveness - V-Go - An Affordable Patch Pump for Type II Diabetics - Expiry of Warranty Provides New Opportunities to Insulin Pump Makers - Customer Satisfaction: Crucial to Stay Competitive - Enteral Feeding Devices: An Intensely Competitive Market - Multinationals Target Emerging Markets - The New Hotspots for Growth - Infusion Errors: A Key Driving Force for Newer Technologies - Manufacturers Focus on Interoperability with EMR Systems - Security of Wireless Medical Device - A Vital Factor - Shift from Hospital Environments to Alternative-Sites/ Home Settings Drives the market for Home Infusion Pumps - Product Complexity Thwarts ROI on Devices - Smart Pump Technology: A Major Growth Driver - Smart Pumps with Innovative Features - Improving Functionality for Enhanced Patient Compliance - Maintaining Smartness Quotient of Smart Infusion Pumps - Product Bundling: A Double Whammy Success - Analgesia Infusion Pumps Continue to Register Favorable Growth - Disposable Ambulatory Infusion Pumps Market Exhibits Notable Stride Forward - Enteral Feeding Pumps Market Overview - Replacements Offer Potential Growth Opportunities - Preference for Enteral Nutrition over Parenteral Nutrition Bodes Well - Advantages and Disadvantages of Enteral Nutrition over Parenteral Nutrition - Enteral Nutrition Therapy in Treating Adult Malnutrition Offers Growth Opportunities - Home Enteral Therapy to Boost Demand for Enteral Feeding Devices - Insulin Pumps - Designed for Optimum Disease Management - The Rise of Smart Pumps - Manufacturers Eye Type II Diabetes Market - Implantable Insulin Pumps - The Next Generation of Insulin Pumps - Patch Pumps Gain Manufacturer Attention - Insulin Pump Training - An Important Driver - Complicated Insulin Pump Software Makes Pump Use Difficult for the Aged - Competition from Other Insulin Delivery Technologies Continues - Maturity Hits Volumetric Infusion Pumps Market - Equipment Recalls Thwarts Growth Prospects - Stringent Safety Regulations Impede Time-to-Market - Look into Select Technology Advancements - Ivenix Develops Next-Generation Infusion Management Platform - Innovfusion Develops Advanced Infusion Pumps to Provide Relief from Labor Pain - Summit Medical's Low-Cost Portable Infusion Pumps Improve Patient Care - Product Malfunctioning Erodes Penetration of Implantable Infusion Pumps Rise in Healthcare Spending in Developing Nations Bode Well for the Market Aging Population: A Strong Growth Driver Global Aging Population Statistics Opportunity Indicators Rise in Incidence of Cancer and Central Nervous System Diseases Foster Growth World Cancer Statistics: Incidence and Mortality Data Diabetes Incidence and Prevalence Global Diabetic Statistics Opportunity Indicators Alarming Rise in Obesity A Business Case for Diabetes Care Rise in HIV Prevalence Provides Ample Growth Opportunities Global HIV Statistics Opportunity Indicators for Enteral Feeding Devices - FDA Announces Initiative to Address Safety Concerns Related to Infusion Pumps - FDA Announces a New Mandate for Manufacturing Companies - Regulations Promote Adoption of Premium-Priced Safety Devices - ISO 80369 Standards for Small-Bore Connector - ENFit - The New ISO Standard Enteral Feeding Connecting System - Infusion Pumps: A Definition - Types of Infusion Pumps - Ambulatory Infusion Pumps - Non-Electronic Ambulatory Infusion Pumps - Advantages & Disadvantages of Non-Electronic Pumps - Electronic Ambulatory Infusion Pumps - Nerve Block Infusion Pumps - Enteral Feeding Pumps - Insulin Infusion Pumps - Large Volume Infusion Pumps - Pump Architecture of Volumetric Pumps - Classification by End-Use Application - Volumetric Pumps used in Acute Care Settings - Volumetric Pumps used in Alternate Care Settings - Patient Controlled Analgesic (PCA) Pumps - Syringe Infusion Pumps - Low-End and High-End Syringe Pumps - Implantable Infusion Pumps - Programmable Implantable Infusion Pumps - Constant Flow Implantable Infusion Pumps - Approved Applications of Implantable Infusion Pumps - Common Safety Features Available In Most Infusion Pumps - Key Problems Reported with Infusion Pumps - User Interface Issues - Software Issues - Alarm Errors - Damaged Components - Battery Failures - Fire, Shocks, Sparks or Charring - Intelligraphics Enters into Collaboration with Ivenixto Develop Intelligent Infusion Pump Platform - Smiths Medical Introduces New Software Version for use with Medfusion® 4000 wireless syringe pumps - Caesarea Medical Announces Launch of its latest Dual Channel Infusion Pump - Medtronic Launches MiniMed® 630G System - Hospira Introduces LifeCare PCA 7.0 infusion pump with EMR Connectivity - Smiths Medical Launches New CADD®-Solis Pump - Animas Bags FDA Approval for Animas® Vibe® Insulin Pump and Continuous Glucose Monitoring System - Medtronic Rolls Out MiniMed 640G Insulin Pump - B. Braun Medical Secures FDA Approval for Infusomat® Space Pump - Zyno Medical Gains CE Mark Approval for Z-800 Infusion Pump System - Hospira Receives FDA Clearance for Plum 360 Infusion System - BioLeonhardt Develops Stem Cell Pump - Animas Rolls Out Animas® Vibe Insulin Pump with Latest Dexcom CGM Technology - Baxter Gets FDA Clearance for SIGMA Spectrum Infusion Pump with Master Drug Library - Animas Bags CE Mark Approval for Animas® Vibe Insulin Pump and Dexcom G4 PLATINUM CGM System - Animas Secures FDA Approval for Animas® Vibe Insulin Pump and Continuous Glucose Monitoring System Omnicell and Hospira Collaborate for System Interoperability BD Enters into Collaboration with JDRF to Develop Extended Wear Innovations for Insulin Infusion Delivery Teleflex Signs Group Purchasing Agreement with Premier Inc. for Implantable Infusion Ports ICU Medical to Acquire Pfizer's Infusion Therapy Business Zyno Medical Receives FDA 510(k) Clearance for Nimbus II Ambulatory Infusion System InfuSystem to Acquire Infusion Pump Assets from InfusAID, LLC Medtronic to Manufacture and Deploy Advanced Diabetes Therapies in Chengdu, China Pfizer Considers Sale of the Infusion Pump Business Pfizer Acquires Hospira InfuSystem Completes Acquisition of Ciscura Becton Dickinson Takes Over CareFusion Hospira Inks Agreement with Cerner for Developing Infusion Pump Information Platform Animas Partners with Tidepool Medtronic Partners with BD to Develop New Insulin Pump with BD FlowSmart Technology Fresenius Kabi Inks Agreement with Amerinet Hospira Faces Class I Recall of GemStar Infusion System - Animas Corporation (USA) - Baxter International Inc. (USA) - B. Braun Melsungen AG (Germany) - Becton, Dickinson and Company (USA) - F. Hoffmann-La Roche Ltd. (Switzerland) - Fresenius SE & Co. KGaA (Germany) - Halyard Health, Inc. (USA) - Hospira, Inc. (USA) - ICU Medical, Inc. (USA) - Insulet Corporation (USA) - Medtronic, PLC (Ireland) - Moog, Inc. (USA) - Smiths Medical (USA) - Sooil Development Co. Ltd. (Korea) - Tandem Diabetes Care, Inc. (USA) - Teleflex Incorporated (USA) - Terumo Corporation (Japan) - The United States - Japan - Europe - France - Germany - The United Kingdom - Rest of Europe - Asia-Pacific (Excluding Japan) - Middle East - Latin America For more information about this report visit http://www.researchandmarkets.com/research/cq3cv2/infusion_pumps


Receive press releases from iHealthcareAnalyst, Inc.: By Email Global Highly Potent Active Pharmaceutical Ingredients Market by APIs, Drugs, Manufacturing, Therapeutics and Forecast to 2020, New Research by iHealthcareAnalyst, Inc. Maryland Heights, MO, March 02, 2017 --( Browse Highly Potent Active Pharmaceutical Ingredients Market by API (Biological, Chemical), Drugs (Branded, Generic, OTC), Manufacturing (In-House, Outsourcing or Contact-Based), Therapeutic Area (Diabetes, Cardiovascular, CNS, Oncology, Musculoskeletal Drugs) 2016-2020 report at https://www.ihealthcareanalyst.com/report/high-potency-active-pharmaceutical-ingredient-market/ Highly potent active pharmaceutical ingredients (HPAPIs) represent a significant change in the way pharmaceutical innovators are using small molecules to deliver new patient therapies. The shift toward highly potent APIs has not only led to a pipeline of more effective medicines that require lower doses and lead to fewer side effects, but also to new manufacturing challenges. During the last decade, the demand for HPAPIs has grown rapidly, mainly as a result of advances in clinical pharmacology and oncology research. HPAPIs drug manufacturing, storage and packaging is subject to Current Good Manufacturing Process (cGMP) regulations enforced by the U.S. FDA, EMEA and other international regulatory agencies. Contract manufacturing of HPAPI has been preferred over captive production due to high degree of competition and reduced profitability, geographical advantage and cost-effectiveness. The global highly potent active pharmaceutical ingredients (HPAPIs) market report estimates the market size (Revenue USD million - 2013 to 2020) for key market segments based on the API (biological, chemical), drug (branded, generic, OTC), manufacturing (in-house, outsourcing or contact-based), therapeutic area (diabetes, cardiovascular, CNS, oncology, musculoskeletal drugs, etc.), and forecasts growth trends (CAGR% - 2016 to 2020). The global highly potent active pharmaceutical ingredients market research report is further segmented by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global highly potent active pharmaceutical ingredients market report also provides the detailed market landscape, market drivers, restraints, opportunities), market attractiveness analysis and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent developments. Major players operating in the global highly potent active pharmaceutical ingredients (HPAPIs) market and included in this report are Alkermes plc, Cambrex Corporation, Dr. Reddy's Laboratories, Lonza Group, Novasep, Sandoz International GmbH, Pfizer, Inc., Sigma-Aldrich Co. LLC, and WuXi AppTec. To request Table of Contents and Sample Pages of this report visit: https://www.ihealthcareanalyst.com/report/high-potency-active-pharmaceutical-ingredient-market/ About Us iHealthcareAnalyst, Inc. is a global healthcare market research and consulting company providing market analysis, and competitive intelligence services to global clients. The company publishes syndicate, custom and consulting grade healthcare reports covering animal healthcare, biotechnology, clinical diagnostics, healthcare informatics, healthcare services, medical devices, medical equipment, and pharmaceuticals. In addition to multi-client studies, we offer creative consulting services and conduct proprietary single-client assignments targeted at client’s specific business objectives, information needs, time frame and budget. Please contact us to receive a proposal for a proprietary single-client study. Contact Us iHealthcareAnalyst, Inc. 2109, Mckelvey Hill Drive, Maryland Heights, MO 63043 United States Email: sales@ihealthcareanalyst.com Website: https://www.ihealthcareanalyst.com Maryland Heights, MO, March 02, 2017 --( PR.com )-- The global potent active pharmaceutical ingredients (HPAPIs) market to reach nearly USD 18.5 Billion in 2020, at a CAGR of 6.2% from 2016 to 2020, majorly due to patent expiry of blockbuster drugs and growing trend in pharmaceutical outsourcing.Browse Highly Potent Active Pharmaceutical Ingredients Market by API (Biological, Chemical), Drugs (Branded, Generic, OTC), Manufacturing (In-House, Outsourcing or Contact-Based), Therapeutic Area (Diabetes, Cardiovascular, CNS, Oncology, Musculoskeletal Drugs) 2016-2020 report at https://www.ihealthcareanalyst.com/report/high-potency-active-pharmaceutical-ingredient-market/Highly potent active pharmaceutical ingredients (HPAPIs) represent a significant change in the way pharmaceutical innovators are using small molecules to deliver new patient therapies. The shift toward highly potent APIs has not only led to a pipeline of more effective medicines that require lower doses and lead to fewer side effects, but also to new manufacturing challenges. During the last decade, the demand for HPAPIs has grown rapidly, mainly as a result of advances in clinical pharmacology and oncology research. HPAPIs drug manufacturing, storage and packaging is subject to Current Good Manufacturing Process (cGMP) regulations enforced by the U.S. FDA, EMEA and other international regulatory agencies. Contract manufacturing of HPAPI has been preferred over captive production due to high degree of competition and reduced profitability, geographical advantage and cost-effectiveness.The global highly potent active pharmaceutical ingredients (HPAPIs) market report estimates the market size (Revenue USD million - 2013 to 2020) for key market segments based on the API (biological, chemical), drug (branded, generic, OTC), manufacturing (in-house, outsourcing or contact-based), therapeutic area (diabetes, cardiovascular, CNS, oncology, musculoskeletal drugs, etc.), and forecasts growth trends (CAGR% - 2016 to 2020). The global highly potent active pharmaceutical ingredients market research report is further segmented by geography into North America (U.S., Canada), Latin America (Brazil, Mexico, Rest of LA), Europe (U.K., Germany, France, Italy, Spain, Rest of EU), Asia Pacific (Japan, China, India, Rest of APAC), and Rest of the World. The global highly potent active pharmaceutical ingredients market report also provides the detailed market landscape, market drivers, restraints, opportunities), market attractiveness analysis and profiles of major competitors in the global market including company overview, financial snapshot, key products, technologies and services offered, and recent developments.Major players operating in the global highly potent active pharmaceutical ingredients (HPAPIs) market and included in this report are Alkermes plc, Cambrex Corporation, Dr. Reddy's Laboratories, Lonza Group, Novasep, Sandoz International GmbH, Pfizer, Inc., Sigma-Aldrich Co. LLC, and WuXi AppTec.To request Table of Contents and Sample Pages of this report visit: https://www.ihealthcareanalyst.com/report/high-potency-active-pharmaceutical-ingredient-market/About UsiHealthcareAnalyst, Inc. is a global healthcare market research and consulting company providing market analysis, and competitive intelligence services to global clients. The company publishes syndicate, custom and consulting grade healthcare reports covering animal healthcare, biotechnology, clinical diagnostics, healthcare informatics, healthcare services, medical devices, medical equipment, and pharmaceuticals.In addition to multi-client studies, we offer creative consulting services and conduct proprietary single-client assignments targeted at client’s specific business objectives, information needs, time frame and budget. Please contact us to receive a proposal for a proprietary single-client study.Contact UsiHealthcareAnalyst, Inc.2109, Mckelvey Hill Drive,Maryland Heights, MO 63043United StatesEmail: sales@ihealthcareanalyst.comWebsite: https://www.ihealthcareanalyst.com Click here to view the list of recent Press Releases from iHealthcareAnalyst, Inc.


Sarasota, FL, Nov. 14, 2016 (GLOBE NEWSWIRE) -- Zion Research has published a new report titled “Osteoporosis Drugs Market (Bisphosphonates, Calcitonin, Rank Ligand Inhibitors, Parathyroid Hormone Therapy (PTH) and Selective Estrogen Receptor Modulators (SERMs)) for Male and Female Population: Global Industry Perspective, Comprehensive Analysis, Size, Share, Growth, Segment, Trends and Forecast, 2015 – 2021”. According to the report, the global osteoporosis drugs market was valued at approximately USD 11.20 billion in 2015 and is expected to reach approximately USD 14.30 billion by 2021, growing at a CAGR of around 4.0% between 2016 and 2021. Osteoporosis is a bone disease in which a fragile bone with an increased susceptibility to fracture. Bones that commonly fracture include the backbones, the bones of the forearm, and the hip. As a result, bones become weak and may break from a fall or, in serious cases, from sneezing or minor bumps.  Until a broken bone occurs there are typically no symptoms. Osteoporosis drugs are a kind of medicine for osteoporosis, such as Fosamax, Actonel, Boniva, Zoledronic Acid (Reclast or Zometa) and others. Browse through 27 Market Tables and 21 Figures spread over 110 Pages and in-depth TOC on “Global Osteoporosis Drugs Market: By Drug Class, Gender , Size, Share, Development, Trends, Segment, and Forecast 2015-2021”. The global osteoporosis drugs market is witnessing noteworthy growth on account of growing geriatric population coupled with changing lifestyles impinging bone health. Furthermore, increasing the prevalence of osteoporosis in postmenopausal women and increasing investment in drug discovery and development is also driving the growth of the market. Prevalence of osteoporosis is more common with age. Around 15% of white people in their 50s and 70% of those over 80 are affected by osteoporosis diseases. It is more common in women than men.  However, there are different side effects and complications associated with osteoporosis drugs such as irritable bowel syndrome, heartburn, nausea, and ulcers in the stomach. Thus, side effects of osteoporosis drugs may curb the market growth in the coming years. Nevertheless, focus on R&D for advanced development of new drugs and classes is expected to help in accentuating the market growth within the forecast period. On the basis of drug class, the market can be segmented into bisphosphonates, calcitonin, rank ligand inhibitors, parathyroid hormone therapy (PTH) and selective estrogen receptor modulators (SERMs).  Bisphosphonates were the leading segment and it accounted for around 48% share of total revenue generated in 2015. Bisphosphonates are commonly prescribed the drug for treatment and prevention of osteoporosis disease. Thus, this segment is expected to show strong growth within the forecast period. Parathyroid hormone therapy (PTH) was another key segment and it is expected to witness significant growth in the near future. Development of new drug classes such as PTH and RANK ligand inhibitors are projected to propel the growth of osteoporosis drug market in the coming years. Pipeline products such as odanacatib (cathepsin K inhibitor) and romosozumab are awaiting the approval and are anticipated to drive the market growth in the years to come. Browse the full "Osteoporosis Drugs Market (Bisphosphonates, Calcitonin, Rank Ligand Inhibitors, Parathyroid Hormone Therapy (PTH) and Selective Estrogen Receptor Modulators (SERMs)) for Male and Female Population: Global Industry Perspective, Comprehensive Analysis, Size, Share, Growth, Segment, Trends and Forecast, 2015 – 2021" report at https://www.zionmarketresearch.com/report/osteoporosis-drugs-market The osteoporosis drugs market is segmented on the basis of gender such as male and female. The female segment dominated the market and is expected to exhibit significant growth in the near future. There are wide discrepancies between the incidence rate in women and men. Moreover, about 90% of the hip fractures occur in people over 50 years old. In terms of revenue, North America constituted the largest share of the global osteoporosis drug market in 2015 and is expected to continue its dominance across the globe. The osteoporosis drug market is driven by increasing geriatric population, growing obesity, and rising prevalence of lifestyle associated diseases in the region. According to the National Osteoporosis Foundation about 54 million people in the U.S. aged above 50 years were affected by osteoporosis and low bone mass in 2013. In the U.S. more than 220,000 hip fractures are associated with osteoporosis. Inquire more about this report @ https://www.zionmarketresearch.com/inquiry/osteoporosis-drugs-market In 2015, North America was followed by Europe in terms of revenue. Europe was the second largest regional market and is projected to witness substantial growth in the years to come. This growth is mainly attributed to the growing aged population and increasing consumer awareness about osteoporosis care. Moreover, the adoption of new technologies is expected to witness significant growth in the years to come. According to International Osteoporosis Foundation, more than 25 million people suffered from osteoporosis in 2010 and the number is expected to reach around 33.0 million by 2030 in Europe. Asia Pacific is expected to be the fastest growing market in near future. The market is mainly driven by increasing population, rising incidence rate of osteoporosis, coupled with the rising health awareness among people especially in China, Japan, and India. According to a study on Epidemiology in Osteoporosis in Japan by the National Centre for Biotechnology Information, approximately 15 million people suffered from osteoporosis in Japan in 2011. The Middle East & Africa regional market is expected to witness significant growth within the forecast period. Increasing population coupled with growing incidences of osteoporosis disease is primarily driving the market in this region. Latin America is another important regional market and is expected to experience significant growth over the forecast period. The growth is mainly due to technological advancement. Life expectancy in Brazil is increasing and the government is becoming progressively more involved in osteoporosis diagnosis and treatment. Some of the key participants in osteoporosis drug market are Novartis International AG, Eli Lilly Amgen Inc., Forteo, Novo Nordisk A/S., F. Hoffmann La Roche Ltd., and Company, Merck & Co, Inc., Actavis plc, Pfizer, Inc., and Teva Pharmaceutical Industries Ltd.  Major players are implementing sustainability strategies including product expansions, new product development and merger & acquisitions to gain the advantage over the competitors. For instance, drug maker Actavis Inc. agreed to acquire Warner Chilcott PLC for about USD 5 billion in an all-stock deal aimed at enlarging Actavis's portfolio of specialty pharmaceutical brands—and shrinking its tax burden in 2013. Pipeline drugs of Merck and Pfizer are cathepsin and aprela are projected to provide growth platform these respective companies. Zion Market Research is an obligated company. We create futuristic, cutting edge, informative reports ranging from industry reports, the company reports to country reports. We provide our clients not only with market statistics unveiled by avowed private publishers and public organizations but also with vogue and newest industry reports along with pre-eminent and niche company profiles. Our database of market research reports comprises a wide variety of reports from cardinal industries. Our database is been updated constantly in order to fulfill our clients with prompt and direct online access to our database. Keeping in mind the client’s needs, we have included expert insights on global industries, products, and market trends in this database. Last but not the least, we make it our duty to ensure the success of clients connected to us—after all—if you do well, a little of the light shines on us.


News Article | November 21, 2016
Site: www.prweb.com

When engaging consumers via mobile, the most personal of devices, marketers are advancing their strategies, says a new report from the Mobile Marketing Association (MMA). The report reveals a significant increase in spend and use of more data-centric approaches that impact ad delivery and creative. While most marketers use location data for social and search, more than half of marketers polled are now leveraging location for targeting. The marketers who have increased their spend are becoming more sophisticated and value location for driving brand equity and customer experience versus just leads and sales. Marketers who gained confidence by leveraging location for increasing foot traffic now focus on applying the learnings for brand insights, measurement and attribution. On the flip side, small spenders, those that self-reported spending less than 8 percent of their digital marketing budget on mobile, are slower to adopt location tools and are less confident in their mobile efforts. Marketers cited data quality and transparency (40 percent), creating understandable differentiation among providers (39 percent) as top concerns. Data quality and reach are key factors when buying location targeting. “While targeting is still the key application for location, marketers are beginning to see the value in the data captured for insights, measurement and attribution. They all now see location data as valuable for driving both brand equity and customer experience, not just leads and sales,” explains Sheryl Daija, Chief Strategy Officer, Mobile Marketing Association. “However with an increase in adoption and value recognition, they expressed some concern around data quality and transparency and a lack of clear differentiation among providers. Both issues are important agenda items for the MMA and the Location committee to continue to address and we applaud the location providers for asking the tough questions. The report also alludes to some differences between the marketers and their agency counterparts: “This research clearly demonstrates that mobile marketing is rapidly moving up the location data adoption curve,” said Vikas Gupta, Vice President of Strategy at Factual. ‘Location has moved from a niche tactic to an underlying data layer that marketers are using with increasing sophistication for targeting, measurement, analytics, and insights.” The Location Data Study is the first MMA offering on the subject. The study is based on surveys and interviews with more than 400 brand leaders and senior agency executives. Supporting the research, Factual served as the primary report sponsor with participation from Digital Element, Dstillery, PlaceIQ, Plexure, Skyhook Wireless, Teralytics, Thinknear by Telenav, Ubimo, Verve Mobile, xAd. The MMA is the world’s leading global non-profit trade mobile marketing association comprised of more than 800 member companies, spanning nearly fifty countries around the world. Our members represent the entire mobile marketing ecosystem, including brand marketers, agencies, mobile technology platforms, media companies, operators and others. The MMA’s mission is to accelerate the transformation and innovation of marketing through mobile, driving business growth with closer and stronger consumer engagement. Anchoring the MMA’s mission are four core pillars: cultivate inspiration by driving innovation for the Chief Marketing Officer; build mobile marketing capabilities for marketers through fostering know-how and confidence; champion the effectiveness and impact of mobile through research providing tangible ROI measurement; and advocate for mobile marketers. Additionally, MMA industry-wide committees work collaboratively to develop and advocate global best practices and lead standards development. Members include: 1-800-Flowers.com, Allstate, American Express, Bank Of America, Campbell’s, Chase, Chobani, Choice Hotels, Citi, Colgate-Palmolive, DataXu, Dunkin’ Brands, E*TRADE, Electronic Arts, ESPN, Facebook, Ford, Foursquare, Google, Havas, Hilton, iHeartMedia, InMobi, Johnson & Johnson, Krux, Marriott, MasterCard, McDonald’s, Mondelez, Nestle, OpenMarket, Pandora, Pfizer, Pinterest, PlaceIQ, Procter & Gamble, R/GA, RadiumOne, Razorfish, Samsung, SAP, Sears, Spotify, Starcom, The Coca-Cola Company, The Rubicon Project, The Weather Company, T-Mobile, TUNE, Ubimo, Unilever, Verve, VEVO, Vibes, Visa, Walmart, Wendy’s, xAd , Zurich and many more. The MMA’s global headquarters are located in New York with regional operations in Asia Pacific (APAC), Europe/Middle East/Africa (EMEA) and Latin America (LATAM). For more information about the MMA please visit http://www.mmaglobal.com.


News Article | November 7, 2016
Site: www.newsmaker.com.au

Demand for infant formula is expected to reach US$ 24.5 billion in 2016, a growth of 9.3% from 2015. While the market in North America and Western Europe will grow at 5.9% and 7.1% respectively, growth will be strong in developing regions, with APEJ and MEA growing at 11.8% and 10.1% in 2016. Increasing participation of women in the workforce will continue to positively influence the market. Availability of baby formula with natural or organic ingredients are offering women the opportunity of returning to their jobs without compromising on their desires of providing healthy and nutritious foods to their babies. By product type, starting milk formula will remain the most attractive segment, growing by 9.7% in 2016 to reach US$ 11,632.2 Mn in revenues. While birth rates continue to decline globally, the number of births remains high in developing countries, which will continue to offer growth opportunities to manufacturers catering to this segment. Sales will remain strong through pharmacies, with this distribution segment accounting for 75.8% revenue share of the market in 2016, up from 75.7% in 2015. Pharmacy segment will grow by 9.4% in 2016, whereas supermarkets, the second largest distribution channel, will grow by 8.7%. Asia Pacific Excluding Japan (APEJ) will continue to be the largest market for infant formula in 2016, representing 46.0% revenue share of the market. China will continue to dominate the APEJ infant formula market, accounting for nearly 90% revenue share of the market in 2016. Developing countries in APEJ will be key to volume sales of infant formula, whereas US, Canada, and Western Europe will continue to contribute to value sales. Nestlé S.A., Groupe Danone, Abbott Nutrition, Mead Johnson Nutrition, The Kraft Heinz Company, Meiji Holdings Co. Ltd, Beingmate Baby & Child Food Co. Ltd., Synutra International, Inc., Pfizer Inc., FrieslandCampina are some of the market leaders identified across the value chain in the global infant formula market landscape. The global infant formula market is highly consolidated, with the top five players Nestle S.A., Groupe Danone, Abbott Nutrition, Mead Johnson Nutrition and The Kraft Heinz Company accounting for around 60% share of the global market. Leading companies are focusing on expanding their production capacity and launching new product offerings to consolidate their position. Long-term outlook: According to FMI’s analysis, the global infant formula market is expected to expand at a CAGR of 10.1% through 2026 and surpass US$ 64 billion in revenues.


The Mobile Marketing Association (MMA), the leading global trade association for the mobile industry, together with Kantar Millward Brown, today released its 2016 Global Mobile Trends Report, the second annual and largest review of mobile campaigns. Based on observations and analysis of the past year’s award-winning mobile campaigns, including MMA Smarties™ and Cannes Lions winners, the report suggests marketers re-balance their mobile campaigns, placing equal focus on strategy, media and creative. “A key insight from our analysis indicates that brands are evolving their strategy and media, but, in many cases, have an uneven focus on creative. Smarties submissions are judged on equal parts strategy, execution, creative and effectiveness, and we saw a clear shift between last year’s focus on creative and this year’s focus on strategy,” said Sheryl Daija, Chief Strategy Officer of the Mobile Marketing Association. “Brands have a wonderful opportunity to learn from campaigns that were courageous in pushing the creative and story-telling potential of mobile, while still executing on a strong strategy.” The Global Mobile Trends Report is a unique look at mobile marketing trends, as it evaluates both finalists and winners from the MMA’s Global Smarties Awards and the Cannes Mobile Lions – the two preeminent, mobile-first award competitions. It provides perspective on common elements shared by the most successful campaigns and sheds light on areas where marketers can innovate in the future. Strategies That Help Brands Win at Mobile Examples of strategies that permeated the winning campaigns included: The report also offers four emerging areas with potential: This year’s winners showcased the amazing use of technology to enhance mobile campaigns, but sometimes the focus on innovation was to the detriment of creative excellence,” says Joline McGoldrick, Vice President of Research, Kantar Millward Brown. The MMA will showcase both the Global Smarties and Cannes Lions Mobile shortlist as part of its Case Study Hub, which currently features nearly 800 mobile marketing campaigns from all over the world. The report is available for download and a webinar to discuss the highlighted campaigns and results is scheduled for December 14, 2016. To register for the webinar, visit http://www.mmaglobal.com. About the Mobile Marketing Association (MMA) The MMA is the world’s leading global non-profit trade mobile marketing association comprised of more than 800 member companies, spanning nearly fifty countries around the world. Our members represent the entire mobile marketing ecosystem, including brand marketers, agencies, mobile technology platforms, media companies, operators and others. The MMA’s mission is to accelerate the transformation and innovation of marketing through mobile, driving business growth with closer and stronger consumer engagement. Anchoring the MMA’s mission are four core pillars: cultivate inspiration by driving innovation for the Chief Marketing Officer; build mobile marketing capabilities for marketers through fostering know-how and confidence; champion the effectiveness and impact of mobile through research providing tangible ROI measurement; and advocate for mobile marketers. Additionally, MMA industry-wide committees work collaboratively to develop and advocate global best practices and lead standards development. Members include: 1-800-Flowers.com, Allstate, American Express, Bank Of America, Campbell’s, Chase, Chobani, Choice Hotels, Citi, Colgate-Palmolive, DataXu, Dunkin’ Brands, E*TRADE, Electronic Arts, ESPN, Facebook, Ford, Foursquare, Google, Havas, Hilton, iHeartMedia, InMobi, Johnson & Johnson, Krux, Marriott, MasterCard, McDonald’s, Mondelez, Nestle, OpenMarket, Pandora, Pfizer, Pinterest, PlaceIQ, Procter & Gamble, R/GA, RadiumOne, Razorfish, Samsung, SAP, Sears, Spotify, Starcom, The Coca-Cola Company, The Rubicon Project, The Weather Company, T-Mobile, TUNE, Ubimo, Unilever, Verve, VEVO, Vibes, Visa, Walmart, Wendy’s, xAd , Zurich and many more. The MMA’s global headquarters are located in New York with regional operations in Asia Pacific (APAC), Europe/Middle East/Africa (EMEA) and Latin America (LATAM). For more information about the MMA please visit http://www.mmaglobal.com.


NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that the U.S. Food and Drug Administration (FDA) has accepted for review a supplemental New Drug Application (sNDA) for its first-in-class CDK 4/6 inhibitor, IBRANCE® (palbociclib). The sNDA supports the conversion of the accelerated approval of IBRANCE in combination with letrozole to regular approval and includes data from the Phase 3 PALOMA-2 trial, which evaluated IBRANCE as initial therapy in combination with letrozole for postmenopausal women with estrogen receptor-positive, human epidermal growth factor receptor 2-negative (ER+, HER2-) metastatic breast cancer. This is the same patient population as the randomized Phase 2 PALOMA-1 trial upon which the accelerated approval of IBRANCE plus letrozole was granted in February 2015. The sNDA was granted Priority Review status, which accelerates FDA review time from 10 months to a goal of six months from the day of acceptance of filing.1 The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in April 2017. “Since its introduction in 2015, more than 45,000 patients have been prescribed IBRANCE by more than 9,000 providers in the U.S.,” said Liz Barrett, global president and general manager, Pfizer Oncology. “We are pleased that the PALOMA-2 trial has further demonstrated the significant clinical benefit of IBRANCE in the first-line setting, providing additional evidence for its continued use as a standard of care medicine.” PALOMA-2 is a randomized (2:1), multicenter, double-blind Phase 3 study that evaluated a total of 666 women from 186 global sites in 17 countries. The results of PALOMA-2 were presented at the 52nd American Society of Clinical Oncology (ASCO) Annual Meeting in June and recently published in the November 17, 2016 issue of The New England Journal of Medicine. The study demonstrated that IBRANCE in combination with letrozole improved progression-free survival compared to letrozole plus placebo as a first-line treatment for postmenopausal women with ER+, HER2- metastatic breast cancer. The adverse events observed with IBRANCE in combination with letrozole in PALOMA-2 were generally consistent with their respective known adverse event profiles. IBRANCE is the first and only FDA approved oral inhibitor of CDKs 4 and 6,2 which are key regulators of the cell cycle that trigger cellular progression.3,4 IBRANCE is approved in more than 50 countries. In the U.S., IBRANCE is indicated for the treatment of HR+, HER2- advanced or metastatic breast cancer in combination with letrozole as initial endocrine based therapy in postmenopausal women, or fulvestrant in women with disease progression following endocrine therapy.2 The indication in combination with letrozole is approved under accelerated approval based on PFS. Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial. The full prescribing information for IBRANCE can be found at www.pfizer.com. IMPORTANT IBRANCE® (palbociclib) SAFETY INFORMATION FROM THE U.S. PRESCRIBING INFORMATION Neutropenia was the most frequently reported adverse reaction in PALOMA-1 (75%) and PALOMA-3 (83%). In PALOMA-1, Grade 3 (57%) or 4 (5%) decreased neutrophil counts were reported in patients receiving IBRANCE plus letrozole. In PALOMA-3, Grade 3 (56%) or Grade 4 (11%) decreased neutrophil counts were reported in patients receiving IBRANCE plus fulvestrant. Febrile neutropenia has been reported in about 1% of patients exposed to IBRANCE. One death due to neutropenic sepsis was observed in PALOMA-3. Inform patients to promptly report any fever. Monitor complete blood count prior to starting IBRANCE, at the beginning of each cycle, on Day 14 of first 2 cycles, and as clinically indicated. Dose interruption, dose reduction, or delay in starting treatment cycles is recommended for patients who develop Grade 3 or 4 neutropenia. Pulmonary embolism (PE) has been reported at a higher rate in patients treated with IBRANCE plus letrozole in PALOMA-1 (5%) and in patients treated with IBRANCE plus fulvestrant in PALOMA-3 (1%) compared with no cases in patients treated either with letrozole alone or fulvestrant plus placebo. Monitor for signs and symptoms of PE and treat as medically appropriate. Based on the mechanism of action, IBRANCE can cause fetal harm. Advise females of reproductive potential to use effective contraception during IBRANCE treatment and for at least 3 weeks after the last dose. IBRANCE may impair fertility in males and has the potential to cause genotoxicity. Advise male patients with female partners of reproductive potential to use effective contraception during IBRANCE treatment and for 3 months after the last dose. Advise females to inform their healthcare provider of a known or suspected pregnancy. Advise women not to breastfeed during IBRANCE treatment and for 3 weeks after the last dose because of the potential for serious adverse reactions in nursing infants. The most common adverse reactions (≥10%) of any grade reported in PALOMA-1 of IBRANCE plus letrozole vs letrozole alone included neutropenia (75% vs 5%), leukopenia (43% vs 3%), fatigue (41% vs 23%), anemia (35% vs 7%), upper respiratory infection (31% vs 18%), nausea (25% vs 13%), stomatitis (25% vs 7%), alopecia (22% vs 3%), diarrhea (21% vs 10%), thrombocytopenia (17% vs 1%), decreased appetite (16% vs 7%), vomiting (15% vs 4%), asthenia (13% vs 4%), peripheral neuropathy (13% vs 5%), and epistaxis (11% vs 1%). Grade 3/4 adverse reactions (≥10%) in PALOMA-1 reported at a higher incidence in the IBRANCE plus letrozole group vs the letrozole alone group included neutropenia (54% vs 1%) and leukopenia (19% vs 0%). The most frequently reported serious adverse events in patients receiving IBRANCE plus letrozole were pulmonary embolism (4%) and diarrhea (2%). Lab abnormalities occurring in PALOMA-1 (all grades, IBRANCE plus letrozole vs letrozole alone) were decreased WBC (95% vs 26%), decreased neutrophils (94% vs 17%), decreased lymphocytes (81% vs 35%), decreased hemoglobin (83% vs 40%), and decreased platelets (61% vs 16%). The most common adverse reactions (≥10%) of any grade reported in PALOMA-3 of IBRANCE plus fulvestrant vs fulvestrant plus placebo included neutropenia (83% vs 4%), leukopenia (53% vs 5%), infections (47% vs 31%), fatigue (41% vs 29%), nausea (34% vs 28%), anemia (30% vs 13%), stomatitis (28% vs 13%), headache (26% vs 20%), diarrhea (24% vs 19%), thrombocytopenia (23% vs 0%), constipation (20% vs 16%), vomiting (19% vs 15%), alopecia (18% vs 6%), rash (17% vs 6%), decreased appetite (16% vs 8%), and pyrexia (13% vs 5%). Grade 3/4 adverse reactions (≥10%) in PALOMA-3 reported at a higher incidence in the IBRANCE plus fulvestrant group vs the fulvestrant plus placebo group included neutropenia (66% vs 1%) and leukopenia (31% vs 2%). The most frequently reported serious adverse reactions in patients receiving IBRANCE plus fulvestrant were infections (3%), pyrexia (1%), neutropenia (1%), and pulmonary embolism (1%). Lab abnormalities occurring in PALOMA-3 (all grades, IBRANCE plus fulvestrant vs fulvestrant plus placebo) were decreased WBC (99% vs 26%), decreased neutrophils (96% vs 14%), anemia (78% vs 40%), and decreased platelets (62% vs 10%). Avoid concurrent use of strong CYP3A inhibitors. If patients must be administered a strong CYP3A inhibitor, reduce the IBRANCE dose to 75 mg/day. If the strong inhibitor is discontinued, increase the IBRANCE dose (after 3-5 half-lives of the inhibitor) to the dose used prior to the initiation of the strong CYP3A inhibitor. Grapefruit or grapefruit juice may increase plasma concentrations of IBRANCE and should be avoided. Avoid concomitant use of strong CYP3A inducers. The dose of sensitive CYP3A substrates with a narrow therapeutic index may need to be reduced as IBRANCE may increase their exposure. IBRANCE has not been studied in patients with moderate to severe hepatic impairment or in patients with severe renal impairment (CrCl <30 mL/min). Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people’s lives. At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of health care products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer health care products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, we have worked to make a difference for all who rely on us. We routinely post information that may be important to investors on our website at www.pfizer.com. In addition, to learn more, please visit us on www.pfizer.com and follow us on Twitter at @Pfizer and @PfizerNews, LinkedIn, YouTube and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of December 21, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about IBRANCE (palbociclib), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial success of IBRANCE; the uncertainties inherent in research and development, including further investigation of the clinical benefit of IBRANCE, the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether regulatory authorities will be satisfied with the design of and results from our clinical studies; whether and when the sNDA will be approved and whether and when the accelerated approval for IBRANCE will be converted to regular approval in the U.S.; whether and when drug applications may be filed in any additional jurisdictions for IBRANCE for potential HR+/HER2- metastatic breast cancer indications or in any jurisdictions for any other potential indications for IBRANCE; whether and when any such other applications may be approved by regulatory authorities, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of IBRANCE; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results,” as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. 3 Weinberg RA. pRb and Control of the Cell Cycle Clock. In: Weinberg RA, ed. The Biology of Cancer. 2nd ed. New York, NY: Garland Science; 2014:275-329. 4 Sotillo E, Grana X. Escape from Cellular Quiescence. In: Enders GH, ed. Cell Cycle Deregulation in Cancer. New York, NY: Humana Press; 2010:3-22.


NEW YORK--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) today announced that a Biologics License Application (BLA) for inotuzumab ozogamicin has been accepted for filing and granted Priority Review by the U.S. Food and Drug Administration (FDA). Inotuzumab ozogamicin is being evaluated for the treatment of adult patients with relapsed or refractory B-cell precursor acute lymphoblastic leukemia (ALL). Inotuzumab ozogamicin received Breakthrough Therapy designation from the FDA in October 2015 for ALL. Priority Review status accelerates FDA review time from 10 months to a goal of six months from the day of acceptance of filing, and is given to drugs that may offer major advances in treatment or may provide a treatment for which no adequate therapy exists. The Prescription Drug User Fee Act (PDUFA) goal date for a decision by the FDA is in August 2017. “ALL that has recurred after, or is refractory to, first-line therapy is a rapidly progressing and deadly disease,” said Mace Rothenberg, MD, chief development officer, Oncology, Pfizer Global Product Development. “Based on the positive results of the INO-VATE 1022 Phase 3 trial, we believe inotuzumab ozogamicin, if approved, represents a new treatment option for adult patients with relapsed or refractory B-cell precursor ALL.” In addition, a Marketing Authorization Application (MAA) for inotuzumab ozogamicin in the same patient population is currently under review by the European Medicines Agency (EMA). The submissions are based on results from the Phase 3 INO-VATE 1022 trial, which enrolled 326 adult patients with relapsed or refractory B-cell ALL and compared inotuzumab ozogamicin to standard of care chemotherapy. The INO-VATE 1022 study had two independent primary endpoints, complete response with or without hematologic remission (CR/CRi) and overall survival (OS). Results from the trial were published in The New England Journal of Medicine in June 2016. Acute lymphoblastic leukemia (ALL) is an aggressive type of leukemia with a poor prognosis in adults.1 The current foundational treatment is intensive, long-term chemotherapy.2 In 2017, it is estimated that 5,970 cases of ALL will be diagnosed in the United States, with about 2 in 5 cases occurring in adults.3 Approximately 20 to 40 percent of newly diagnosed adults with ALL are cured with current treatment regimens.4 For patients with relapsed or refractory adult ALL, the five-year overall survival rate is less than 10 percent.5 Inotuzumab ozogamicin is an investigational antibody-drug conjugate (ADC) comprised of a monoclonal antibody (mAb) targeting CD22, a cell surface antigen expressed on approximately 90 percent of B-cell malignancies, linked to a cytotoxic agent.6 When inotuzumab ozogamicin binds to the CD22 antigen on B-cells, it is internalized into the cell, where the cytotoxic agent calicheamicin is released to destroy the cell.7 The most common adverse events (AEs) observed in clinical trials for inotuzumab ozogamicin were cytopenias, including febrile neutropenia. Common nonhematologic treatment-emergent AEs with inotuzumab ozogamicin included nausea, headache and pyrexia. Additionally, veno-occlusive liver disease (VOD) was observed more frequently in patients treated with inotuzumab ozogamicin, especially those who went on to receive hematopoietic stem cell transplantation. Inotuzumab ozogamicin originates from a collaboration between Pfizer and Celltech, now UCB. Pfizer has sole responsibility for all manufacturing and clinical development activities for this molecule. Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people’s lives. Pfizer Inc.: Working together for a healthier world® At Pfizer, we apply science and our global resources to bring therapies to people that extend and significantly improve their lives. We strive to set the standard for quality, safety and value in the discovery, development and manufacture of healthcare products. Our global portfolio includes medicines and vaccines as well as many of the world's best-known consumer healthcare products. Every day, Pfizer colleagues work across developed and emerging markets to advance wellness, prevention, treatments and cures that challenge the most feared diseases of our time. Consistent with our responsibility as one of the world's premier innovative biopharmaceutical companies, we collaborate with health care providers, governments and local communities to support and expand access to reliable, affordable health care around the world. For more than 150 years, Pfizer has worked to make a difference for all who rely on us. For more information, please visit us at www.pfizer.com. In addition, to learn more, follow us on Twitter at @Pfizer and @Pfizer_News, LinkedIn, YouTube, and like us on Facebook at Facebook.com/Pfizer. DISCLOSURE NOTICE: The information contained in this release is as of February 21, 2017. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about inotuzumab ozogamicin, an investigational oncology therapy, including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, the uncertainties inherent in research and development, including the ability to meet anticipated clinical trial commencement and completion dates and regulatory submission dates, as well as the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; whether and when applications for inotuzumab ozogamicin may be filed in any other jurisdictions; whether and when the BLA, MAA and any other such applications for inotuzumab ozogamicin may be approved by the FDA, the EMA or other regulatory authorities, respectively, which will depend on the assessment by such regulatory authorities of the benefit-risk profile suggested by the totality of the efficacy and safety information submitted; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of inotuzumab ozogamicin; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. 1 National Cancer Institute: Adult Acute Lymphoblastic Leukemia Treatment (PDQ®) – General Information About Adult Acute Lymphoblastic Leukemia (ALL). Available at: http://www.cancer.gov/cancertopics/pdq/treatment/adultALL/HealthProfessional/page1. Accessed March 21, 2016. 2 American Cancer Society: Typical treatment of acute lymphocytic leukemia. Available at: http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-treating-typical-treatment. Accessed March 21, 2016. 3 American Cancer Society: What are the key statistics about acute lymphocytic leukemia? Available at:http://www.cancer.org/cancer/leukemia-acutelymphocyticallinadults/detailedguide/leukemia-acute-lymphocytic-key-statistics . Accessed January 26, 2017. 4 Manal Basyouni A. et al. Prognostic significance of survivin and tumor necrosis factor-alpha in adult acute lymphoblastic leukemia. doi:10.1016/j.clinbiochem.2011.08.1147. 5 Fielding A. et al. Outcome of 609 adults after relapse of acute lymphoblastic leukemia (ALL); an MRC UKALL12/ECOG 2993 study. Blood. 2006; 944-950. 6 Leonard J et al. Epratuzumab, a Humanized Anti-CD22 Antibody, in Aggressive Non-Hodgkin’s Lymphoma: a Phase I/II Clinical Trial Results. Clinical Cancer Research. 2004; 10: 5327-5334. 7 DiJoseph JF. Antitumor Efficacy of a Combination of CMC-544 (Inotuzumab Ozogamicin), a CD22-Targeted Cytotoxic Immunoconjugate of Calicheamicin, and Rituximab against Non-Hodgkin’s B-Cell Lymphoma. Clin Cancer Res. 2006; 12: 242-250.


News Article | December 14, 2016
Site: www.marketwired.com

SYDNEY, AUSTRALIA--(Marketwired - December 14, 2016) - RocketSpace and DEXUS Property Group (DEXUS) today announced a partnership to launch a network of campuses in Australia designed specifically to service high-growth tech startups. Headquartered in San Francisco, RocketSpace provides tech startups with the unique community and services needed as they scale their business, including office-as-a-service, access to capital, hands-on workshops, peer group roundtables and networking events, among other services. Kevin George, DEXUS Executive General Manager, Office & Industrial said: "Australia is one of the world's fastest growing hubs for tech startups which are a key driver of innovation. We are excited to be partnering with RocketSpace to provide an unrivalled service to high-growth tech startups in Australia, creating a bridge between Silicon Valley and major hubs in Australia to help tech entrepreneurs grow." Duncan Logan, RocketSpace's founder and CEO said: "Australian startups have an incredible opportunity to scale and compete at a global level. Our goal is to accelerate their growth by bringing them into the RocketSpace ecosystem and creating a bridge between Australia and the world's top tech hubs. We've had the pleasure of hosting Austrade's Landing Pad in San Francisco and look forward to growing our relationships with Australian startups." Chris Hynes, DEXUS Head of Leasing said: "Our operating model makes this partnership more than a traditional landlord/tenant arrangement whereby DEXUS will work with RocketSpace to create hubs that take tech startup acceleration to a new level, providing members with collaborative workspaces and services as well as access to leading global corporations." At the intersection of startups and corporates, campus members will have access to RocketSpace's roster of more than 100 corporations who they've helped to plug into the startup ecosystem and drive disruption in their industry. RocketSpace will initially open campuses in three locations in Sydney, Melbourne and Brisbane in 2017. Like its other campuses, RocketSpace membership will be focused on funded tech startups with space for teams of 1 to 100 people. The campus will be equipped with a variety of workspace options as well as a multi-gigabit Internet connection, cafe, collaborative workspaces, and event space. Since launching in 2011, RocketSpace members have included more than 1,000 tech startups including 18 unicorns like Uber, Blippar, SuperCell and Spotify. Its Australian launch will expand RocketSpace's global presence to four top global tech hubs in 2017 which include Silicon Valley in the US, London, China and Australia. RocketSpace doesn't require equity from its startup members. Interested startups can learn more about becoming a RocketSpace member here: www.rocketspace.com/technology-campus-coworking-for-startups-australia. RocketSpace is a technology campus headquartered in the heart of San Francisco. Since 2011, the company has been helping tech entrepreneurs, startups and corporate innovation professionals bring the future to market. The company offers services to its members including programming, consulting, events, and office-as-a-service, which together create the perfect ecosystem and community for innovation to thrive. Select startup alumni include Uber, Spotify, Practice Fusion, and Leap Motion, and RocketSpace's roster of Corporate Innovation Services clients include JetBlue, Schneider Electric, Converse, Tata Communications, Royal Bank of Scotland, Pfizer Consumer Healthcare and ABinBev. For more information, visit www.rocketspace.com. DEXUS Property Group is one of Australia's leading real estate groups, investing directly in high quality Australian office and industrial properties. With $22.2 billion of assets under management, the Group also actively manages office, industrial and retail properties located in key Australian markets on behalf of third party capital partners. The Group manages an office portfolio of 1.8 million square metres located predominantly across Sydney, Melbourne, Brisbane and Perth and is the largest owner of office buildings in the Sydney CBD, Australia's largest office market. DEXUS is a Top 50 entity by market capitalisation listed on the Australian Securities Exchange under the stock market trading code 'DXS' and is supported by more than 31,000 investors from 21 countries. With 30 years of expertise in property investment, development and asset management, the Group has a proven track record in capital and risk management, providing service excellence to tenants and delivering superior risk-adjusted returns for its investors. www.dexus.com


SOUTH SAN FRANCISCO, Calif., Dec. 14, 2016 (GLOBE NEWSWIRE) -- CytomX Therapeutics, Inc. (Nasdaq:CTMX), a biopharmaceutical company developing investigational Probody™ therapeutics for the treatment of cancer, today announced that the U.S. Food and Drug Administration (FDA) has cleared the company’s Investigational New Drug (IND) application for its lead program, CX-072, a wholly-owned PD-L1-targeting Probody therapeutic for the treatment of cancer.  The company plans to immediately initiate the study and open clinical sites to support patient enrollment. “Initiating the first clinical program emerging from the Probody platform is a major milestone for CytomX,” said Sean McCarthy, D.Phil., president and chief executive officer of CytomX Therapeutics. “CX-072 has the potential to become a differentiated centerpiece of combination cancer therapy by targeting the tumor microenvironment, while sparing healthy tissues.  We are partnering with clinical trial sites to bring this innovative treatment option to patients as quickly as possible.” About PROCLAIM PROCLAIM (Probody Clinical Assessment In Man) is an international umbrella program designed to evaluate CytomX Probody therapeutics.  The first module to be initiated is the PROCLAIM-072 clinical study, an open-label, dose-finding phase 1/2 trial evaluating CX-072 as monotherapy and in combination with Yervoy® (ipilimumab) or Zelboraf®(vemurafenib) in patients with metastatic or locally advanced unresectable solid tumors or lymphomas. CytomX aims to achieve three goals as part of the PROCLAIM-072 clinical trial: Clinical data from PROCLAIM-072 is expected to begin to emerge in late 2017 and throughout 2018. About CytomX Therapeutics CytomX is a clinical stage, oncology-focused biopharmaceutical company pioneering a novel class of investigational antibody therapeutics based on its Probody technology platform. The company uses the platform to create proprietary cancer immunotherapies against clinically-validated targets, as well as to develop first-in-class investigational cancer therapeutics against novel targets. CytomX believes that its Probody platform has the potential to improve the combined efficacy and safety profile of monoclonal antibody modalities, including cancer immunotherapies, antibody drug conjugates and T-cell-recruiting bispecific antibodies. Probody therapeutics are designed to take advantage of unique conditions in the tumor microenvironment to enhance the tumor-targeting features of an antibody and reduce drug activity in healthy tissues.  The company’s investigational Probody therapeutics address clinically-validated cancer targets in immuno-oncology, such as PD-L1, against which the clinical candidate CX-072 is directed, as well as novel targets, such as CD-166, that are difficult to drug without causing damage to healthy tissues. In addition to its proprietary programs, CytomX is collaborating with strategic partners including AbbVie, Bristol-Myers Squibb Company, Pfizer Inc., MD Anderson Cancer Center, and ImmunoGen, Inc. For more information, visit www.cytomx.com. Forward-Looking Statements This press release includes forward-looking statements, including statements related to the development and advancement of the company’s product candidates into, and the successful completion of, clinical trials, including with respect to the timing of a Phase 1 clinical trial for CX-072 and the availability of data from such clinical trials. Such forward-looking statements involve known and unknown risks, uncertainties and other important factors that are difficult to predict, may be beyond our control, and may cause the actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied in such statements. Accordingly, you should not rely on any of these forward-looking statements. Our Probody platform is in preclinical development, and the process by which a preclinical technology could potentially lead to an approved product is long and subject to significant risks and uncertainties. Projected net cash utilization and capital resources are subject to substantial risk of variance based on a wide variety of factors that can be difficult to predict.  Applicable risks and uncertainties include those relating to our preclinical research and development and other risks identified under the heading "Risk Factors" included in our filings with the SEC. The forward-looking statements contained in this press release are based on information currently available to CytomX and speak only as of the date on which they are made. CytomX does not undertake and specifically disclaims any obligation to update any forward-looking statements, whether as a result of any new information, future events, changed circumstances or otherwise.


News Article | February 17, 2017
Site: www.businesswire.com

BARCELONA--(BUSINESS WIRE)--Today at the 12th Congress of the European Crohn’s and Colitis Organisation (ECCO), Celltrion Healthcare presented the primary outcome from its pivotal randomised controlled trial (RCT) of CT-P13 (biosimilar infliximab) in Crohn’s disease. The data indicate that the safety and efficacy of CT-P13 in patients with moderate-to-severe Crohn’s disease (CD) is comparable to those treated with reference infliximab.1 The Phase III RCT in 220 patients with CD examined whether CT-P13 is comparable to reference infliximab as determined by the Crohn’s Disease Activity Index (CDAI), a measurement used to quantify the symptoms of CD patients. According to the 6 week and 30 week data, similar clinical remission, CDAI-70 and CDAI-100 response rates were observed in both CT-P13 and reference infliximab treatment groups.1 Leading expert Jørgen Jahnsen, Professor of Gastroenterology at the University of Oslo, Norway commented on the study, “ This is the first RCT to examine the use of a biosimilar in inflammatory bowel disease. While we already have a wealth of extrapolated and real-world data for CT-P13, gastroenterologists have for some time wanted the reassurance of an RCT and it’s encouraging to see such positive data from Celltrion’s RCT trial.” Celltrion Healthcare also presented data from two observational studies. The first study evaluated the efficacy and safety of CT-P13 in 74 paediatric patients with CD (naïve patients: 26, switch patients: 25) or ulcerative colitis (UC) (naïve patients: 16, switch patients: 7). The data show that CT-P13 is effective in both treatment-naïve and switch paediatric patients over 30 weeks and is well-tolerated.2 The second study examined 204 CD patients (fistulising CD: 24, CD patients: 180) in South Korea from July 2012-2016. CT-P13 was found to be clinically consistent to reference infliximab and well tolerated up to six months in patients with moderate-to-severe CD and those with fistulising CD.3 Real-world cost savings associated with the use of CT-P13 across all indications were studied in five European countries from the beginning of 2015 to the first half of 2016. According to the data presented at ECCO, total cost savings observed for Germany, Italy, Spain and the UK amounted to €32.4 million and the findings suggest that this could allow an additional 5,428 patients a year access to this important biologic therapy. There were no cost savings in France, as the price of biosimilar and reference infliximab were the same, however despite this, use of CT-P13 has gradually increased in this country.4 Man Hoon Kim, President and CEO of Celltrion Healthcare, said, “ At Celltrion, we are committed to addressing the needs of the clinical community through robust scientific exploration. A pivotal RCT in Crohn’s disease is an important example of this, and the results from this pivotal trial are consistent with our other RCTs and many real-world IBD studies that have been conducted. More broadly, it’s rewarding to see the changes that CT-P13 is making in financially-constrained health systems in Europe.” Inflammatory bowel diseases (IBD), including Crohn’s disease (CD) and ulcerative colitis (UC), are chronic disabling gastrointestinal disorders that impact every aspect of a patient’s life.5 They affect an estimated 2.5-3 million people in Europe;6 CD affects about three people per 1,000 and UC about 5 people per 1,000.5 IBDs account for substantial costs to the healthcare system and society; the direct healthcare costs of IBDs are estimated to be €4.6-5.6 billion per year.6 Celltrion Healthcare conducts the worldwide marketing, sales and distribution of biological medicines developed by Celltrion, Inc. through an extensive global network that spans more than 120 different countries. Celltrion Healthcare’s products are manufactured at state-of-the-art mammalian cell culture facilities, designed and built to comply with the US Food and Drug Administration (FDA) cGMP guidelines and the EU GMP guidelines. For more information please visit: http://www.celltrionhealthcare.com/ The study is a randomised, double-blind, parallel- group, phase Ⅲ study to investigate efficacy and safety between CT-P13 and reference infliximab with CD patients. Out of 220 patients randomised in 58 study centres across 16 countries, 214 patients completed up to week 6 for the primary analysis, and 180 patients completed up to week 30. The study was funded equally by Celltrion and Pfizer. CT-P13 is developed and manufactured by Celltrion, Inc. and was the world’s first monoclonal antibody biosimilar approved by the European Medicines Agency (EMA). It is indicated for the treatment of eight autoimmune diseases including rheumatoid arthritis and inflammatory bowel disease. It was approved by the EMA under the trade name Remsima® in September 2013 and launched in Europe in early 2015. The US FDA approved Celltrion’s CT-P13 in April 2016 under the trade name Inflectra™. Celltrion’s CT-P13 is approved in more than 79 (as of January 2017) countries including the US, Canada, Japan and throughout Europe. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017.P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congress of the European Crohn’s and Colitis Organisation (ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Available at www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Last accessed January 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013)7,322-337.


News Article | February 15, 2017
Site: www.businesswire.com

NEW YORK--(BUSINESS WIRE)--In its latest Cardiology Report, BioPharm Insight (BPI) reported that Amgen’s Repatha Phase III FOURIER trial will be deemed successful by experts if it shows a 35% reduction in major cardiovascular events (MACE). The report from BPI, the most comprehensive life science news and analytical solution, highlights recent editorial coverage of cardiology therapies in development that have potentially market-moving clinical events expected in the next few months. It also provides analysis of sales forecasts and licensing deals. “Amgen’s announcement at the start of February that it met its primary and key secondary composite endpoints was a hugely anticipated event for a drug predicted to have peak sales in excess of $7 billion,” said Peter Murphy, BPI senior editorial analyst. Amgen management has reiterated the cardiovascular outcomes trial (CVOT) trial is powered to show a 15% risk reduction but did not provide further details on FOURIER outcomes, which the market widely expects could be a game-changer for the lipid-lowering treatment space. While equity analysts think a 20% reduction has been hit, experts BPI spoke to said that anything lower than a 35% MACE reduction may mean that the cost outweighs the treatment benefit. “Although Amgen’s news has significant implications for the entire PCSK9-inhibitor class, experts expect to see similar results between Repatha and its competitor Praluent,” said BPI reporter Alexandra Thompson. Amgen’s (NASDAQ:AMGN) Repatha and Praluent, from Sanofi (EPA:SAN) and Regeneron Pharmaceuticals (NASDAQ:REGN), were approved within one month of each other in 2015 and are currently the only two anti-PCSK9s on the market. BPI reports, though, that so far physicians and payers alike are not satisfied that PCSK9 inhibitors successfully lower LDL-c (bad cholesterol) levels. The market is looking for evidence that the reduction in LDL also drives a reduction in the likelihood of patients suffering potentially catastrophic cardiovascular events. Praluent’s Phase III CVOT is due in late 2017, and Alnylam Therapeutics (NASDAQ:ALNY)/The Medicines Company’s (NASDAQ:MDCO)/inclisiran is due to start its own Phase III trials soon. BPI’s Cardiology Report also highlights articles covering experts’ dubious expectations for Merck’s (NYSE:MRK) hypercholesterolemia drug anacetrapib’s Phase III CV trial following termination of three drugs of the same CETP inhibitor class. Pfizer’s (NYSE:PFE) torcetrapib, Roche’s (VTX:ROG) dalcetrapib and Eli Lilly’s (NYSE:LLY) evacetrapib all suffered high-profile clinical trial failures over the past decade. Additionally, the report offers insights on several ongoing therapies under development to prevent heart failure (HF), including Novartis’ (VTX:NOVN) Entresto (sacubitril/valsartan) and Mesoblast’s (ASX:MSB) MPC-150-IM. The perforation risk of MPC-150-IM’s transendocardial delivery could possibly limit its administration to specialized cardiology cell injection centers or warrant cardiologist training, but the significant positive outcomes of the earlier Phase II trial have analysts optimistic, forecasting peak sales of the HF therapy to be $5.2 billion if successful. Learn more about expected market catalyst events in Cardiology Indications with BioPharm Insight’s full report: BioPharm Insight is the most comprehensive life science market intelligence and analytics solution, featuring a team of investigative journalists writing exclusive news and thousands of healthcare data points, aggregated into one centralized source. In addition to the proprietary articles, BioPharm Insight is currently tracking 250,000 management and R&D contacts, 7,500 biopharma companies with full pipeline data, 120,000 investigational and approved drug profiles, 28,000 M&A and licensing deals, 10,000 extended sales forecasts and epidemiology profiles for hundreds of indications.


News Article | November 9, 2016
Site: globenewswire.com

Patient Enrollment Ongoing for Phase III Fabry Clinical Trial with approximately 10 Patients Currently in Evaluation and Screening Stages Enrollment for the Phase II Cystic Fibrosis Clinical Trial in Final Stages with Results Expected around Year-End CARMIEL, Israel, Nov. 09, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX) today announced financial results for the fiscal quarter ended September 30, 2016 and provided a business update. “We are very excited by the progress made with our product candidates,” said Moshe Manor, Protalix’s President and Chief Executive Officer.  “We are currently enrolling patients in seven sites globally for our phase III clinical trial of PRX-102 for the treatment of Fabry disease, and we are finalizing enrollment in our phase II clinical trial of AIR DNaseTM (PRX-110) for the treatment of Cystic Fibrosis (CF).” Financial Results for the Quarter Ended September 30, 2016 Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx(R).  Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner.  Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries.  Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.  Protalix’s development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; OPRX-106, an orally-delivered anti-inflammatory treatment; PRX-110 for the treatment of Cystic Fibrosis; and others. To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.  The terms “anticipate,” “believe,” “estimate,” “expect,” “plan” and “intend” and other words or phrases of similar import are intended to identify forward-looking statements. These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made. These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk.  Factors that might cause material differences include, among others: failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to the amount and sufficiency of our cash and cash equivalents; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding the purchase of alfataliglicerase, and our commercialization efforts for alfataliglicerase in Brazil generally; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our 2018 convertible notes or any other indebtedness; risks relating to the compliance by Fundação Oswaldo Cruz with its purchase obligations and related milestones under our supply and technology transfer agreement; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission.  The statements in this release are valid only as of the date hereof and we disclaim any obligation to update this information.


CARMIEL, Israel, Nov. 30, 2016 (GLOBE NEWSWIRE) -- Protalix BioTherapeutics, Inc. (NYSE MKT:PLX) (TASE:PLX), announced today that the first patient has been enrolled in its phase II clinical trial of OPRX-106 for the treatment of ulcerative colitis.  OPRX-106 is a plant cell-expressed recombinant human tumor necrosis factor receptor II fused to an IgG1 Fc domain (TNFRII-Fc). “With the enrollment of the first patient in our OPRX-106 phase II trial, clinical studies are now underway for our three lead assets,” said Mr. Moshe Manor, Protalix’s President and Chief Executive Officer.  “We look forward to announcing phase II data from our AIR DNaseTM clinical program around year-end, and data from our OPRX-106 phase II clinical trial in the second half of 2017.” The phase II clinical trial is a randomized, open label, 2-arm study of OPRX-106 in 20 patients with active mild to moderate ulcerative colitis.  Patients will be randomized to receive 2 mg or 8 mg of OPRX-106 administered orally, once daily, for 8 weeks.  The primary endpoint of the study is safety, including monitoring for adverse events following daily administration of the drug.  Key efficacy endpoints include relevant disease parameters of the drug, including Mayo score and rectal bleeding. If successful, OPRX-106 will be the first ever oral enzyme treatment as currently there are no other oral enzyme treatments available. The Company completed a phase I clinical trial of OPRX-106 in 15 healthy volunteers, and the drug was found to be safe and well tolerated.  The results of the phase I clinical trial were announced in August 2015.  Immunomodulatory effect was observed, including activation of T Regulatory cells showing biological activity in the gut.  In addition, early efficacy signals of OPRX-106 have been demonstrated in preclinical studies using inflammatory bowel disease immune-mediated mouse models.  The results of the preclinical studies show that OPRX-106 attributes to a positive change in symptoms and in serum levels of anti-inflammatory markers. Protalix is a biopharmaceutical company focused on the development and commercialization of recombinant therapeutic proteins expressed through its proprietary plant cell-based expression system, ProCellEx®.  Protalix’s unique expression system presents a proprietary method for developing recombinant proteins in a cost-effective, industrial-scale manner. Protalix’s first product manufactured by ProCellEx, taliglucerase alfa, was approved for marketing by the U.S. Food and Drug Administration (FDA) in May 2012 and, subsequently, by the regulatory authorities of other countries. Protalix has licensed to Pfizer Inc. the worldwide development and commercialization rights for taliglucerase alfa, excluding Brazil, where Protalix retains full rights.  Protalix’s development pipeline includes the following product candidates: PRX-102, a modified version of the recombinant human alpha-GAL-A protein for the treatment of Fabry disease; PRX-106, an orally-delivered anti-inflammatory treatment; PRX-110 for the treatment of Cystic Fibrosis; and others. To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995.  The terms “anticipate,” “believe,” “estimate,” “expect,” “plan” and “intend” and other words or phrases of similar import are intended to identify forward-looking statements.  These forward-looking statements are subject to known and unknown risks and uncertainties that may cause actual future experience and results to differ materially from the statements made.  These statements are based on our current beliefs and expectations as to such future outcomes. Drug discovery and development involve a high degree of risk.  Factors that might cause material differences include, among others: failure or delay in the commencement or completion of our preclinical and clinical trials which may be caused by several factors, including: slower than expected rates of patient recruitment; unforeseen safety issues; determination of dosing issues; lack of effectiveness during clinical trials; inability to monitor patients adequately during or after treatment; inability or unwillingness of medical investigators and institutional review boards to follow our clinical protocols; and lack of sufficient funding to finance clinical trials; the risk that the results of the clinical trials of our product candidates will not support our claims of safety or efficacy, that our product candidates will not have the desired effects or will be associated with undesirable side effects or other unexpected characteristics; risks related to the amount and sufficiency of our cash and cash equivalents; risks related to the successful conclusion of our negotiations with the Brazilian Ministry of Health regarding the purchase of alfataliglicerase, and our commercialization efforts for alfataliglicerase in Brazil generally; risks relating to our ability to make scheduled payments of the principal of, to pay interest on or to refinance our 2018 convertible notes or any other indebtedness; risks relating to the compliance by Fundação Oswaldo Cruz with its purchase obligations and related milestones under our supply and technology transfer agreement; our dependence on performance by third party providers of services and supplies, including without limitation, clinical trial services; delays in our preparation and filing of applications for regulatory approval; delays in the approval or potential rejection of any applications we file with the FDA or other health regulatory authorities, and other risks relating to the review process; the inherent risks and uncertainties in developing drug platforms and products of the type we are developing; the impact of development of competing therapies and/or technologies by other companies and institutions; potential product liability risks, and risks of securing adequate levels of product liability and other necessary insurance coverage; and other factors described in our filings with the U.S. Securities and Exchange Commission.  The statements in this release are valid only as of the date hereof and we disclaim any obligation to update this information.


NEW YORK & TOKYO--(BUSINESS WIRE)--Pfizer Inc. (NYSE:PFE) and Astellas Pharma Inc. (TSE:4503) today announced the Phase 4 PLATO study, evaluating the efficacy and safety of continued treatment with XTANDI® (enzalutamide), plus abiraterone acetate and prednisone as compared to treatment with abiraterone acetate and prednisone alone, did not meet its primary endpoint of improvement in progression-free survival (PFS) in patients with chemotherapy-naïve metastatic castration-resistant prostate cancer (CRPC) whose prostate-specific antigen (PSA) has previously progressed on XTANDI. “While the PLATO trial did not meet its primary endpoint, it is critical that we continue to focus on addressing the unmet needs of men with metastatic CRPC, who have a poor prognosis despite treatment advances,” said Mohammad Hirmand, M.D., interim chief medical officer at Medivation, Inc., which is now part of Pfizer. “We will continue to analyze these data to better understand the results with the goal of further helping these patients.” “XTANDI continues to remain an important treatment option for men with metastatic CRPC and their physicians. We are committed to continuing to explore the clinical potential of XTANDI across the disease continuum,” said Steven Benner, M.D., senior vice president, therapeutic area head for oncology development, Astellas. XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castrate-resistant prostate cancer (CRPC), based on clinical studies showing statistically significant overall survival benefit versus placebo. The Phase 4 PLATO trial (NCT01995513) is a global randomized, double-blind, placebo-controlled, two-period study designed to evaluate the efficacy and safety of continued treatment with XTANDI plus abiraterone acetate and prednisone at the time of confirmed PSA progression, as compared to treatment with abiraterone acetate and prednisone alone at the time of PSA progression. The study enrolled 509 patients with chemotherapy-naïve metastatic CRPC who received open label XTANDI during period 1 of the study, until PSA progression was confirmed. Eligible patients were then randomized to one of the two treatments and assessed for the primary endpoint of the study, PFS, defined by either: 1) radiographic progression or 2) unequivocal clinical progression or 3) death during the study. Period 1 patients were treated with XTANDI 160mg/day orally and period 2 patients were treated with blinded XTANDI 160 mg/day orally in combination with abiraterone at a dose of 1,000 mg/day administered orally and prednisone at a dose of 5 mg administered orally twice daily, versus placebo plus the same doses of abiraterone acetate and prednisone. For additional information regarding the PLATO trial, visit clinicaltrials.gov. Metastatic castration-resistant prostate cancer (CRPC) refers to prostate cancer that has spread to parts of the body other than the prostate, and continues to spread despite treatment.1 Up to 40 percent of men diagnosed with prostate cancer who undergo therapy develop metastatic, or advanced, prostate cancer.2 In the U.S., the five-year relative survival rate for prostate cancer patients with metastatic disease is 28 percent, compared with 100 percent for prostate cancer patients with non-metastatic disease.3 XTANDI (enzalutamide) is an androgen receptor inhibitor that blocks multiple steps in the androgen receptor signaling pathway within the tumor cell. In preclinical studies, enzalutamide has been shown to competitively inhibit androgen binding to androgen receptors, and inhibit androgen receptor nuclear translocation and interaction with DNA. The clinical significance of this mechanism of action (MOA) is unknown. XTANDI is approved by the U.S. Food and Drug Administration for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC). XTANDI is not indicated for women. XTANDI can cause fetal harm and potential loss of pregnancy. Seizure occurred in 0.5% of patients receiving XTANDI in clinical studies. In placebo-controlled studies, 8 of 1671 (0.5%) patients treated with XTANDI and 1 of 1243 (0.1%) patients treated with placebo experienced a seizure. In patients who previously received docetaxel, 7 of 800 (0.9%) patients treated with XTANDI experienced a seizure and no patients treated with placebo experienced a seizure. In a placebo-controlled study in chemotherapy-naïve patients, 1 of 871 (0.1%) treated with XTANDI and 1 of 844 (0.1%) patients treated with placebo experienced a seizure. In bicalutamide-controlled studies conducted in chemotherapy-naïve patients, 3 of 380 (0.8%) patients treated with XTANDI and 1 of 387 (0.3%) patients treated with bicalutamide experienced a seizure. Permanently discontinue XTANDI in patients who develop a seizure during treatment. Posterior Reversible Encephalopathy Syndrome (PRES) In post approval use, there have been reports of PRES in patients receiving XTANDI. PRES is a neurological disorder which can present with rapidly evolving symptoms including seizure, headache, lethargy, confusion, blindness, and other visual and neurological disturbances, with or without associated hypertension. A diagnosis of PRES requires confirmation by brain imaging, preferably MRI. Discontinue XTANDI in patients who develop PRES. The most common adverse reactions (≥ 10%) that occurred more commonly (≥ 2% over placebo) in the XTANDI patients from the two placebo-controlled clinical trials were asthenia/fatigue, back pain, decreased appetite, constipation, arthralgia, diarrhea, hot flush, upper respiratory tract infection, peripheral edema, dyspnea, musculoskeletal pain, weight decreased, headache, hypertension, and dizziness/vertigo. In the bicalutamide-controlled study of chemotherapy naïve patients, the most common adverse reactions (≥ 10%) reported in XTANDI patients were asthenia/fatigue, back pain, musculoskeletal pain, hot flush, hypertension, nausea, constipation, upper respiratory tract infection, diarrhea, and weight loss. In the study of patients taking XTANDI who previously received docetaxel, Grade 3 and higher adverse reactions were reported among 47% of XTANDI patients and 53% of placebo patients. Discontinuations due to adverse events were reported for 16% of XTANDI patients and 18% of placebo patients. In the placebo-controlled study of chemotherapy-naïve patients, Grade 3-4 adverse reactions were reported in 44% of XTANDI patients and 37% of placebo patients. Discontinuations due to adverse events were reported for 6% of both study groups. In the bicalutamide-controlled study of chemotherapy naïve patients, Grade 3-4 adverse reactions were reported in 38.8% of XTANDI patients and 37.6% of bicalutamide patients. Discontinuations due to adverse events were reported for 7.6% of XTANDI patients and 6.3% of bicalutamide patients. Lab Abnormalities: In the two placebo-controlled trials Grade 1-4 neutropenia occurred in 15% of XTANDI patients (1% Grade 3-4) and 6% of placebo patients (0.5% Grade 3-4). Grade 1-4 thrombocytopenia occurred in 6% of XTANDI patients (0.3% Grade 3-4) and 5% of placebo patients (0.5% Grade 3-4). Grade 1-4 elevations in ALT occurred in 10% of XTANDI patients (0.2% Grade 3-4) and 16% of placebo patients (0.2% Grade 3-4). Grade 1-4 elevations in bilirubin occurred in 3% of XTANDI patients (0.1% Grade 3-4) and 2% of placebo patients (no Grade 3-4). Infections: In a study of patients taking XTANDI who previously received docetaxel, 1% of XTANDI patients compared to 0.3% of placebo patients died from infections or sepsis. In the placebo-controlled study of chemotherapy-naïve patients, 1 patient in each treatment group (0.1%) had an infection resulting in death. Falls (including fall-related injuries) occurred in 9% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. Falls were not associated with loss of consciousness or seizure. Fall-related injuries were more severe in XTANDI patients, and included non-pathologic fractures, joint injuries, and hematomas. Hypertension occurred in 11% of XTANDI patients and 4% of placebo patients in the two placebo-controlled trials. No patients experienced hypertensive crisis. Medical history of hypertension was balanced between arms. Hypertension led to study discontinuation in < 1% of all patients in each arm. Effect of Other Drugs on XTANDI Avoid strong CYP2C8 inhibitors, as they can increase the plasma exposure to XTANDI. If co-administration is necessary, reduce the dose of XTANDI. Avoid strong CYP3A4 inducers as they can decrease the plasma exposure to XTANDI. If co-administration is necessary, increase the dose of XTANDI. Effect of XTANDI on Other Drugs Avoid CYP3A4, CYP2C9, and CYP2C19 substrates with a narrow therapeutic index, as XTANDI may decrease the plasma exposures of these drugs. If XTANDI is co-administered with warfarin (CYP2C9 substrate), conduct additional INR monitoring. You are encouraged to report negative side effects of prescription drugs to the FDA. Pfizer Oncology is committed to pursuing innovative treatments that have a meaningful impact on those living with cancer. As a leader in oncology speeding cures and accessible breakthrough medicines to patients, Pfizer Oncology is helping to redefine life with cancer. Our strong pipeline of biologics, small molecules and immunotherapies, one of the most robust in the industry, is studied with precise focus on identifying and translating the best scientific breakthroughs into clinical application for patients across a wide range of cancers. By working collaboratively with academic institutions, individual researchers, cooperative research groups, governments and licensing partners, Pfizer Oncology strives to cure or control cancer with its breakthrough medicines. Because Pfizer Oncology knows that success in oncology is not measured solely by the medicines you manufacture, but rather by the meaningful partnerships you make to have a more positive impact on people’s lives. Learn more about how Pfizer Oncology is applying innovative approaches to improve the outlook for people living with cancer at http://www.pfizer.com/research/therapeutic_areas/oncology. Astellas Pharma Inc., based in Tokyo, Japan, is a company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. We focus on Urology, Oncology, Immunology, Nephrology and Neuroscience as prioritized therapeutic areas while advancing new therapeutic areas and discovery research leveraging new technologies/modalities. We are also creating new value by combining internal capabilities and external expertise in the medical/healthcare business. Astellas is on the forefront of healthcare change to turn innovative science into value for patients. For more information, please visit our website at www.astellas.com/en. In October 2009, Medivation, Inc., which is now part of Pfizer (NYSE:PFE), and Astellas (TSE: 4503) entered into a global agreement to jointly develop and commercialize enzalutamide. The companies are collaborating on a comprehensive development program that includes studies to develop enzalutamide across the full spectrum of advanced prostate cancer as well as advanced breast cancer. The companies jointly commercialize XTANDI in the United States and Astellas has responsibility for manufacturing and all additional regulatory filings globally, as well as commercializing XTANDI outside the United States. The information contained in this release is as of December 14, 2016. Pfizer assumes no obligation to update forward-looking statements contained in this release as the result of new information or future events or developments. This release contains forward-looking information about XTANDI® (enzalutamide) that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial impact of the results of the PLATO study; the uncertainties inherent in research and development, including the possibility of unfavorable clinical trial results, including unfavorable new clinical data and additional analyses of existing clinical data; decisions by regulatory authorities regarding labeling, safety, and other matters that could affect the availability or commercial potential of XTANDI; risks related to the ability to sustain and increase the rate of growth in revenues for XTANDI despite increasing competitive, reimbursement and economic challenges; dependence on the efforts and funding by Astellas Pharma Inc. for the development, manufacturing and commercialization of XTANDI; and competitive developments. A further description of risks and uncertainties can be found in Pfizer’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015 and in its subsequent reports on Form 10-Q, including in the sections thereof captioned “Risk Factors” and “Forward-Looking Information and Factors That May Affect Future Results”, as well as in its subsequent reports on Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com. In this press release, statements made with respect to current plans, estimates, strategies and beliefs and other statements that are not historical facts are forward-looking statements about the future performance of Astellas. These statements are based on management’s current assumptions and beliefs in light of the information currently available to it and involve known and unknown risks and uncertainties. A number of factors could cause actual results to differ materially from those discussed in the forward-looking statements. Such factors include, but are not limited to: (i) changes in general economic conditions and in laws and regulations, relating to pharmaceutical markets, (ii) currency exchange rate fluctuations, (iii) delays in new product launches, (iv) the inability of Astellas to market existing and new products effectively, (v) the inability of Astellas to continue to effectively research and develop products accepted by customers in highly competitive markets, and (vi) infringements of Astellas’ intellectual property rights by third parties. Information about pharmaceutical products (including products currently in development), which is included in this press release is not intended to constitute an advertisement or medical advice. 2 "Current and emerging treatments in the management of castration-resistant prostate cancer." David Shapiro and Basir Tareen. Expert Rev Anticancer Ther. 2012;12(7):951-964.


MarketStudyReport.com adds “Global Lung Cancer Therapeutics Market 2016-2020” new report to its research database. The report spread across 101 pages with table and figures in it. The Report analysts forecast the global lung cancer therapeutics market to contribute around $11.19 billion during the period 2016-2020. About Lung Cancer Therapeutics Lung cancer is a common cause of mortality and morbidity in both developed and developing countries. Smoking is a major cause of lung cancer, though it also occurs in non-smokers. Lung cancer can be categorized into two major types, namely NSCLC and SCLC. NSCLC is the commonest type of lung cancer and constitutes almost 85%-90% of the total diagnosed cases. It grows and spreads quite slowly. Browse full table of contents and data tables at https://www.marketstudyreport.com/reports/global-lung-cancer-therapeutics-market-2016-2020/ The report covers the present scenario and the growth prospects of the global lung cancer therapeutics market for 2016-2020. To calculate the market size, the report considers the revenue generated from the sales of branded and generic drugs used to treat and prevent lung cancer therapeutics. The report also considers the revenues to be generated from the sales of drugs that are expected to be launched into the market along with the decline in revenues from the genericization of the marketed drugs during the forecast period. The market is divided into the following segments based on geography:  - Americas - APAC - EMEA The Report Global Lung Cancer Therapeutics Market 2016-2020, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market. Key vendors  - F. Hofmann-La Roche - Eli Lilly - AstraZeneca - Pfizer - Celgene Other prominent vendors  - Abbvie - Aetna - Agennix - Allergan - Amgen - ARIAD Pharmaceuticals - Astellas Pharma - Betta Pharmaceuticals - BeyondSpring Pharmaceuticals - BioNumerik Pharmaceuticals - Boehringer Ingelheim - Boston Biomedical - Bristol-Myers Squibb - Celldex - CTI BioPharma - Eisai - GlaxoSmithKline - GTx - Helsinn - Hutchison Medipharma - Ionis Pharmaceuticals - Kadmon Corporation - MabVax - Merck - Novartis - NovaRx Corporation - OncoGeneX - Ono Pharmaceutical - OSE Immunotherapeutics - OSI Pharmaceuticals - Peregrine - PharmaMar - Pierre Fabre - Qiagen - Recombio - Samsung Bioepis - Sanofi - SFJ Pharmaceuticals - Spectrum Pharmaceuticals - Sumitomo Dainippon Pharma - Synta - Takeda Pharmaceuticals - Teva Pharmaceutical - Xcovery Market driver  - Growing demand for targeted therapies - For a full, detailed list, view our report  Market challenge  - Growing popularity of alternative therapeutics  - For a full, detailed list, view our report  Market trend  - Emergence of nanomedicine platform for the treatment of lung cancer - For a full, detailed list, view our report  Key questions answered in this report  - What will the market size be in 2020 and what will the growth rate be? - What are the key market trends? - What is driving this market? - What are the challenges to market growth? - Who are the key vendors in this market space? - What are the market opportunities and threats faced by the key vendors? - What are the strengths and weaknesses of the key vendors? To receive personalized assistance, write to us @ [email protected] with the report title in the subject line along with your questions or call us at +1 866-764-2150


News Article | November 7, 2016
Site: www.newsmaker.com.au

MarketStudyReport.com adds “Global Female Contraceptive Market 2016-2020” new report to its research database. The report spread across 78 pages with table and figures in it. The Report analysts forecast the global female contraceptive market to grow at a CAGR of 3.48% during the period 2016-2020. About Female Contraceptives Adolescent fertility regulation and pregnancy prevention are important healthcare issues today. Although it is difficult to gauge the full extent of the unmet need for contraception, there is a great need for reproductive and sexual health education owing to the rise in STDs. Research suggests that behavior in adolescence results in a pattern for the rest of an individuals life. The absence of sexual and reproductive healthcare programs for adolescents can result in unwanted pregnancies and unsafe abortions. Browse full table of contents and data tables at https://www.marketstudyreport.com/reports/global-female-contraceptive-market-2016-2020/ The report covers the present scenario and the growth prospects of the global female contraceptives market for 2016-2020. To calculate the market size, the report considers the revenue generated from the overall retail sales of female contraceptive products globally. The market is divided into the following segments based on geography: Americas APAC EMEA The Report Global Female Contraceptives 2016-2020, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market. Key vendors Allergan Merck Millipore Pfizer Teva Pharmaceuticals Other prominent vendors Afaxys Agile Therapeutics Ansell Bayer Pharma Caya Ferring Pharmaceuticals Female Health Fuji Latex HLL Lifecare Janssen Pharmaceuticals Lipocine Lupin Pharmaceuticals Mayer Laboratories Okamoto Industries Reckitt Benckiser Syzygy Healthcare V-Care Pharma Market driver Growing importance of family planning For a full, detailed list, view our report Market challenge High cost and inaccessibility of health services For a full, detailed list, view our report Market trend Growing cases of sexually transmitted diseases (STDs) For a full, detailed list, view our report Key questions answered in this report What will the market size be in 2020 and what will the growth rate be? What are the key market trends? What is driving this market? What are the challenges to market growth? Who are the key vendors in this market space? What are the market opportunities and threats faced by the key vendors? What are the strengths and weaknesses of the key vendors? To receive personalized assistance, write to us @ [email protected] with the report title in the subject line along with your questions or call us at +1 866-764-2150


News Article | April 13, 2016
Site: www.nature.com

Embryos edited Researchers at Guangzhou Medical University in China have reported editing the genes of non-viable human embryos to try to make them resistant to HIV infection. The team collected a total of 213 fertilized human eggs, donated by 87 patients, that were unsuitable for implantation as part of in vitro fertility therapy because they contained an extra set of chromosomes. The researchers then used the CRISPR–Cas9 genome-editing technique to introduce into some of the embryos a mutation that cripples an immune-cell gene called CCR5. Some people naturally carry this mutation, which alters the CCR5 protein in a way that prevents the HIV virus from entering the cells it tries to infect. Genetic analysis showed that 4 of 26 human embryos targeted were modified with the CCR5 mutation. But in some embryos, not all sets of chromosomes harboured the mutation; some contained the unmodified gene, whereas others had acquired different mutations. In April 2015, a different China-based team announced that it had modified a gene linked to a blood disease in non-viable human embryos, igniting a worldwide storm of ethics concerns. See go.nature.com/igymgu for more. SpaceX rocket touches down at sea SpaceX took a major step towards re-usable rockets when it flawlessly landed the first stage of its Falcon 9 rocket on an unmanned ship in the Atlantic Ocean, after an 8 April launch from Cape Canaveral, Florida. It was the first successful landing of the rocket at sea, following four attempts that resulted in crashes. The company, based in Hawthorne, California, returned an intact Falcon rocket to land in December last year. The latest flight delivered cargo to the International Space Station (ISS), including an expandable astronaut habitat designed by Bigelow Aerospace of North Las Vegas, Nevada. The previous SpaceX mission to the ISS failed when a Falcon 9 rocket broke apart after launch in June 2015. Kepler scare NASA mission managers were shocked to discover on 7 April that the exoplanet-hunting Kepler space telescope had entered emergency mode. Mission control was able to return it to normal operations three days later, but the cause of the malfunction remained a mystery as Nature went to press. This was the first software glitch in Kepler’s seven years in space, although it previously suffered hardware breakdowns. The spacecraft has lost at least the first several days of a planet-hunting campaign that it was scheduled to begin on 7 April and conduct until 1 July. See go.nature.com/mu7woc for more. China satellite lab China has launched its largest-ever suite of microgravity and life-science experiments into orbit. The country’s Shijian-10 probe left the Jiuquan Satellite Launch Center in Gansu province, northern China, on 7 April. It is carrying 19 experiments that include tests to assess the effects of radiation on genes as well as the influence of microgravity on materials, fluid physics and combustion. The early development of mouse embryos in microgravity will also be examined. After its 15-day mission, the bullet-shaped craft will re-enter Earth’s atmosphere to be recovered from a landing site in Inner Mongolia. Self-driving lorries Six squads of automated lorries successfully arrived in Rotterdam in the Netherlands on 6 April after having driven themselves from Sweden, Belgium and Germany, with one fleet travelling more than 2,000 kilometres from Stockholm. The trial was part of the Dutch-government-led European Truck Platooning Challenge and included lorries from six different manufacturers. ‘Truck platooning’ involves two or more lorries connected by WiFi and driving in a convoy, with the first vehicle determining the speed and route. The technology aims to save fuel by enabling lorries to travel closer together, which reduces air drag. Bank climate plan The World Bank announced a Climate Change Action Plan on 7 April to help countries to meet their commitments under the United Nations climate agreement signed in Paris in December 2015, and to prepare for unavoidable impacts of climate change. Under the plan, the bank will mobilize US$25 billion in private financing for clean energy by 2020. Among other actions, it will quadruple funding for clean transportation programmes and help to bring early-warning systems for natural disasters to 100 million people. Reef catastrophe Huge swathes of coral in Australia’s Great Barrier Reef are undergoing severe bleaching (pictured), according to aerial surveys. Many corals in the northern part of the reef are likely to die, because raised sea temperatures have caused them to expel the symbiotic algae that give them their colour. Researchers at the ARC Centre of Excellence for Coral Reef Studies in Townsville, Queensland, who are assessing the damage, say that more than 1,200 kilometres of the roughly 2,300-kilometre-long reef have bleached, and that the situation is substantially worse than in the two previous bleaching episodes in 1998 and 2002. See go.nature.com/ys7bau for more. Cambodia tiger loss Tigers are no longer breeding in Cambodia and the population there should be considered “functionally extinct”, the conservation group WWF announced on 6 April in Phnom Penh. The last wild tiger there was seen on a camera trap in 2007 in the Mondulkiri Protected Forest. But the WWF noted that national estimates and data compiled by the International Union for Conservation of Nature suggest that global tiger populations have rebounded to 3,890, from about 3,200 in 2010. Cambodia plans to bring eight young tigers from India into its dry forests in the Eastern Plains by 2019, as part of the global Tx2 initiative aiming to double wild tiger populations by the year 2022. Pharma merger off A marriage between two large pharmaceutical companies has been called off. Pfizer of New York City and Allergan of Dublin announced on 6 April that they had terminated a proposed merger process, which would have enabled the resulting company to take advantage of lower taxes in Ireland. The news came two days after the US Department of the Treasury unveiled stricter rules on companies that seek to move abroad to avoid US taxes. Pfizer pledged to announce by the end of the year whether it will spin off some parts of the company. NASA science chief Former astronaut John Grunsfeld, who has overseen NASA’s science portfolio since 2012, announced his retirement from the space agency on 5 April. The physicist and space-telescope expert flew five times on the space shuttle — including three visits to the Hubble Space Telescope — and was the lead spacewalker on the final flight to maintain and upgrade the telescope in 2009. As associate administrator for NASA’s Science Mission Directorate, he was responsible for more than 100 missions, such as the New Horizons spacecraft that visited Pluto last year. Grunsfeld’s deputy, Geoff Yoder, will take charge until a successor is chosen. Contracts with the International Seabed Authority (ISA), which regulates sea-bed mining in international waters, have picked up in recent years. Although commercial mining operations have not yet started, governments and corporations have signed contracts with the ISA to allow them to explore areas of the world’s oceans for materials including manganese nodules, copper, zinc, cobalt and platinum. Researchers have warned about the environmental impacts, saying that stricter regulation is needed. 16–20 April The American Association for Cancer Research holds its annual meeting in New Orleans, Louisiana. go.nature.com/q1t4fp 17–22 April The American Meteorological Society’s 32nd meeting on hurricanes and tropical meteorology convenes in San Juan, Puerto Rico. go.nature.com/pvszif


BEVERLY HILLS, CA--(Marketwired - Nov 10, 2016) - Announced today, Literary and Broadcast Fall News: THE CREATIVE MANAGEMENT AGENCY: Creative Management Partners Announces Agent Alan Morell represented the negotiations and sale to Publishers, 19 client Authors works positioned for TV and Film: "How The ThinkPad Changed The World--And Is Shaping The Future" (Lenovo) By Arimasa Naitoh and William J. Holstein to Skyhorse Publishing; "The Sainted" (Trilogy) by Michael Medico to iBooks; "Common Sense for the Common Good" by Gary Johnson to Broadside; Audio Book of "Common Sense for the Common Good" by Gary Johnson to HarperCollins Publishers; "Immigration A-Z" by Lorraine D'Alessio Esq. to J. Boylston & Co.; "The Penis Book" by Aaron Spitz, MD to Rodale Press; "Osceola's Revenge: The Phenomena of Indian Casinos" by Gary Green to Brick Tower Press; "The Sicilian Diet" by Giovanni Campanile, MD to iBooks; "Drink Right" by Bob Arnot, MD to William Morrow; "Dream Chronicles" by David Rottenberg to iBooks; "Frankie Avalon Family Italian Cookbook" by Frankie Avalon to St. Martin's Press; "Chasing the Ghost: Life and Times of Charles 'The Ghost' Kennedy" by W. Zachary Malinowski to J. Boylston & Co.; "Just in Case: Lose Your Heart, Not Your Mind: The Smart Women's Guide to Marriage" by Aliette H. Carolan, Esq. to Brick Tower Press; "Facing East" by Jingdaun Yang MD with Norma Kamali to William Morrow; "Silver Dollar" by Alan Trustman to iBooks; "Finding the Supermodel in You" by Claudia Mason to Skyhorse; "U-Boats in Bahamas, Turks & Caicos" by Eric T. Wiberg to Brick Tower Press; "Seducing Celebrities One Meal At A Time" by Thaao Penghlis to iBooks; "Escape From Plauen" by Renate Stoever to iBooks and film screenplay in development. Mr. Alan Morell, Chairman and CEO, THE CREATIVE MANAGEMENT AGENCY: Creative Management Partners LLC, has 30 years of global experience in the successful development and management of talent, literary, TV and film packaging, commercial rights, corporate consulting, media positioning, sponsorship of live events and intellectual property (IP) rights. Mr. Morell is one of the few in the sports, entertainment and the arts industries, who has represented and managed clients that have won the prestigious awards: Grammy, Tony, Oscar, Emmy, ESPY, Victors and NY Times Best Selling Authors. Mr. Morell began his career with International Management Group (IMG), where he served in a variety of executive offices including Corporate Vice President (Executive of Talent, Commercial Rights, TV Packaging, Marquee Hospitality and Mergers & Acquisitions for Eastern and Western Hemispheres) serving corporate disciplines of global synergy within IMG diverse profit centers (International Management Inc.; International Merchandising Corp; Fashion Art Licensing; Trans World International). Mr. Morell currently serves as Chairman and CEO of THE CREATIVE MANAGEMENT AGENCY, Creative Management Partners LLC www.creativemanagementpartners.com, a full-service agency. In addition to associations with virtually every major television broadcast news and programming networks in Corporate, Scripted and Unscripted (e.g. Disney ABC, Viacom CBS, Comcast NBCUniversal, Time Warner, HBO, Showtime, News America FOX, ESPN, Bravo, NatGEO, A&E, E, Pivot, Meredith Video Studios, OWN, Lifetime, MSNBC, CNBC, Discovery Communications, Time Inc., Coca-Cola Entertainment, PepsiCo Entertainment, Google Inc.); Mr. Morell has significant relationships in publishing and legitimate stage, foreign and domestic investment groups. In publishing, Mr. Morell's client authors "works," many of which are NY Times Best Selling Authors, have been bided out e.g. Publishers and his client Books to Film and Television; HarperCollins; iBooks, Hachette, St. Martin's Press, Grand Central, Rodale, Hay House, Simon & Schuster, Random House, William Morrow, Palgrave Macmillan, Penguin, Brick Tower Press et al. Throughout his career, Mr. Morell created and/or managed more than 2,500 campaigns for talent and events globally within the disciplines of Sports (including the management of the "Legends and Masters of Tennis," which involved careers and campaigns of Rod Laver, Ken Rosewall, Bjorn Borg, John Newcombe, Illie Nastase, Bobby Riggs and Billie Jean King; "Masters of Hockey" with Phil Esposito and Bobby Orr; "Stars on Ice" with Scott Hamilton; "World Series of Golf" with Arnold Palmer; Entertainment (including management of the campaigns of Liberace, Henny Youngman, "Jilly Rizzo's Rat Pack Tour" featuring Frank Sinatra, & Dean Martin, Pro-Celebrity campaigns with Charlton Heston, Gene Wilder, Gene Hackman and the Arts including the management of campaigns for Bill Cosby, Bobby Short, opera "Aida," "Madame Butterfly" and the London Symphony Orchestra; Gaming campaigns for Riviera, Bellagio, The Mirage, Flamingo, Las Vegas Hilton, Trump Atlantic City, Monte-Carlo S.B.M. Hotels, Casinos. Mr. Morell served as the Executive Producer, hired by the Vatican DOB for the Visit of Pope John Paul II to New York. Mr. Morell was engaged by Jay Coleman, for Commercial Representation of "The Rolling Stones 50th Anniversary Tour." Served as Commercial Sponsorship Advisor to President Ronald Reagan and President Bill Clinton inaugurals. As Director and Chief Executive Officer of CatalystOne, Inc. (software company), was responsible for that company's sale of software to the United States Olympic Committee (USOC) for the USVA sector. Recently in 2016, Mr. Morell represented Gov. Gary E. Johnson, Libertarian Candidate for President of the United States for Gov. Johnson's book COMMON SENSE FOR THE COMMON GOOD by HarperCollins and the sales of his Audio Book to imprint Broadside. At THE CREATIVE MANAGEMENT AGENCY: Creative Management Partners, Mr. Morell's client list ranges from select individuals in Literary, Broadcast, Sports, Entertainment, the Arts, to Global Corporations. Mr. Morell is the leading Agent with Doctors in Literary and Broadcast, Fortune 500 Companies, e.g. Bob Arnot, MD: "Aztec Diet" Harper Collins NY Times Best Seller; NBC; Campaigns: Google Health, General Mills, Pfizer; John Whyte, MD: "Is this Normal" by Rodale Press; Discovery Communications; Campaigns: Johnson & Johnson; Lily; Vijay Vad, MD: "Stop Pain" Hay House; Alan Xenakis, MD: "Heart Truth" CBS; Eric Fisher, PhD: "Eddie and the Emoticons"; CNN; Jingdaun Yang, MD: "Facing East" Designer Norma Kamali, HarperCollins; Christine Dumas, PhD: "Today Show"; Giovanni Campaniele, MD "Sicilian Diet"; Alexis Abramson, PhD: (CNN); Julio Gallo, MD: Dr. Gallo & Co. Frogwater Media; Dr. Aaron Spitz "The Penis Book"; Dr. Stephen T. Greenberg "Plan B"; Dr. Rocco Monto "60 is the new 30"; "The Sainted" by Michael Medico J. Boylston & Company. In literary, (books to TV and Film Packaging, as well as Shopping Channels for commercial products). In the corporate sector, Mr. Morell consulting corporate relationships (include advising start up small cap CEOs and Board of Directors, incubation companies for exit to Fortune 500 companies via strategic partnerships, bid-out, mergers and buy out strategy) e.g. TREN, The 24 Hour Real Estate Network; NETCAST; Home and Kitchen Network LLC; Pfizer, Premier Model Management, D'Alessio Law Group, EB5 Studio, Premier Mission, ICBII; New Cells Sciences; ProGena Cell, Panther Biotech, Central Europe Genomics Center (CEGC); Private Access; PepsiCo, General Mills, NBC, and Google. Mr. Morell represents fiction and non-fiction Authors works to Publishers and for Film and Television Networks (which are featured exclusively on NETCAST, Creative Management Partners network) e.g. "Aztec Diet" by Dr. Bob Arnot, HarperCollins; New York Times Best Seller; Alan Trustman: The Thomas Crown Affair, Bullitt, and They Call Me Mr. Tibbs!, "Judas,"His Brother Keeps Her; Chasing The Ghost: The Life and Times of Charles The Ghost Kennedy by Bill Malinowski; "Escape From Plauen" by Renate Stoever iBooks to Solaris Entertainment for film; "Frankie Avalon Italian Family Cook Book" by Frankie Avalon, St. Martin's Press; Clio Award winning Producer, Director Richard D'Alessio for projects with Micromax Canvas Turbo with Hugh Jackman; "Jerry Seinfeld for American Express"; "Jay Leno for Jay Leno's Garage"; "God and Man on Wall Street" by CNBC Craig Columbus Brick Tower Press; "Man on the Eat" with Chef Michael Love, Frogwater Media, Zodiak for Food Network; Emmy Award Producer Mike Morris "Dinners Drive'In's and Dives' Food Network; Emmy-nominated actor Thaao Penghlis, "Day of Our Lives" NBC; "Stop Pain" by Dr. Vijay Vad, Hay House Publisher; PBS Pledge Special; "Hazel's Masquerade" by Sarah Trautvetter, Milk and Cookies Publisher; "Is This Normal" by Dr. John Whyte, Rodale Publisher, Discovery Channel; "Salvage Chef" by Chef Michael Love, Skyhorse Publishing; "The Art of Empowered Parenting"; Eric Fisher, PhD, CNN "Tower of Thieves" AIG by Andrew Spencer, J. Boylston & Company; "Bear Trap" Fall of Bear Sterns by Andrew Spencer, Brick Tower Press; "The Greek Diet" by Maria Loi and Sarah Tolland, William Morrow; "Finding the SuperModel in You by Claudia Mason, Skyhorse Publishing; "U-Boats in the Bahamas and Turks & Caicos" by Eric T. Wiberg, Brick Tower Press; "Eddie and the Emoticons" by Eric Fisher PhD, Milk and Cookies "Being Uncle Charlie," Bobby Deasy Story: Random House; "Seducing Celebrities One Meal at a time" by Thaao Penghlis Brick Tower Press; "U.S. Immigration A-Z" by Lorraine D'Alessio Esq, IBooks; "Lose Your Heart, Not Your Mind: The Smart Women's Guide to Marriage by Aliette H. Carolan, Esq.; "Read...Set..Risk!" by Daniella Levitt, J. Boylston & Co.; "Drink Right" by Dr. Bob Arnot, HarperCollins William Morrow; "The Oxygen Plan" by Eric Lucas iBOOKS; "Exposing the Wall Street Boys' Club" by James Goldberg, with Danny Espinosa, Esq.; "Chefs Run Wild", Frogwater Media Inc,Tim Troke, IMG Distribution, NatGeo; "Escape From Plauen" optioned for film Solaris Entertainment; "she effin hates me" by Scarlett Savage, Skyhorse Publishing, Optioned for Legitimate theatre. "Osceola's Revenge": Phenomena of Indian Gaming by Gary Green. Gemini Award-nominated and Primetime Emmy Award nominated voice performer Dwayne Hill: "Cat" in the PBS anchored "Peg + Cat." "Venus Prime" rights held J. Boylston and Company Option to Purchase to Low Spark Films; "The Secret": The Treasure Hunt Motion Picture TV Media Rights held by iBooks to Claxson Interactive Group. Mr. Morell has a rich history with Broadway, where he served as the Executive Producer of the Broadway shows "The Boys Next Door" and "I Never Sang For My Father," as well as the commercial rights agent for "The Buddy Holly Story," "Into the Woods," "M. Butterfly" and "Meet Me In St. Louis." Mr. Morell was the first executive to bring naming rights to the Great White Way, with the branding and sponsorship of Philip Morris International. Mr. Morell supports the humanitarian efforts of Darfur; Clinton Foundation, Haiti Relief; Sconset Trust; MSPCA; serves on the Board of Leadership for Mass General Hospital and is a graduate of the University of Florida. Mr. Morell's book "Social Media: Rebranding Outside the Clutter" (working title) will be released in fall 2017 by iBooks.


News Article | December 15, 2016
Site: www.eurekalert.org

For many children, December often is linked to presents and excitement, but when a young child doesn't seem all that enthused about getting gifts, it could be a sign that something is wrong. Measuring brain waves, researchers at Washington University School of Medicine in St. Louis have found that clinically depressed children don't respond to rewards the same way as other children do. Previous research from the same group of scientists found that a reduced ability to experience joy is a key sign of clinical depression in young children. The findings in the new study could help explain the biological underpinnings of the earlier discovery. "These findings may show us how the brain processes emotions in young children with depression," said senior investigator Joan L. Luby, MD, director of Washington University's Early Emotional Development Program. "The pleasure we derive from rewards -- such as toys and gifts -- motivates us to succeed and seek more rewards. Dampening the process early in development is a serious concern because it may carry over to how a person will approach rewarding tasks later in life." The new findings are published in the December 2016 issue of the Journal of the American Academy of Child & Adolescent Psychiatry. "A blunted response to reward frequently is seen in the brains of depressed adults and adolescents," said first author Andrew C. Belden, PhD, an assistant professor of child psychiatry. "In this study, we were interested in learning whether preschoolers also had that blunted response to reward, and in fact, the brains of children as young as 4 showed very similar responses. That's consistent with other findings in that many neurobehavioral aspects of depression remain consistent throughout the lifespan." The research, involving 84 children, was conducted as part of a larger study of clinical depression in children ages 3 to 7. The principal investigators of that larger study, which includes therapy and functional brain scanning, are Luby and Deanna M. Barch, PhD, chair of Washington University's Department of Psychological & Brain Sciences in Arts & Sciences and the Gregory B. Couch Professor of Psychiatry at the School of Medicine. The children wore a device that resembles a shower cap but is hooked to wires that measure electrical activity in the brain using an electroencephalogram machine (EEG). Then, the children played a computer game that involved choosing between two doors shown on the screen. Choosing one door won them points, but choosing the other resulted in a loss of points. Researchers have tested this idea in adults and teens by allowing them to win cash. In this study, however, young children who picked the correct door enough times won a toy that they were able to pick from a basket of figures, balls and plush items they had been shown before the computer session began. While the brains of clinically depressed children responded similarly to those of nondepressed children when points were lost, the response when the correct door was chosen was blunted. "The EEG results showed that their brains did not react as robustly from the pleasurable event of choosing the correct door on the screen," Belden said. "It was not that their brains somehow overreacted to making the wrong choice. The brains of both depressed and nondepressed children reacted the same way to making the wrong choice. The differences we observed were specific to the reward response." Luby and Belden next plan to see whether the blunted response to reward changes after treatment. "It may or may not normalize," said Luby, the Samuel and Mae S. Ludwig Professor of Child Psychiatry. "But we suspect the reward response will improve." Luby and Belden said that when a very young child doesn't seem to be excited by rewards, such as toys and gifts, it may be a sign that the child is depressed or prone to depression. If the condition persists, they suggest parents talk to a pediatrician. "There are clear risk factors," Luby explained. "Decreased ability to enjoy activities and play is a key sign. Kids who feel excessively guilty about wrongdoing and those who experience changes in sleep and appetite also may be at risk. If they're persistently sad, irritable or less motivated, those are markers that may indicate depression, even in kids as young as 3 or 4, and we would recommend that parents get them evaluated." Belden AC, Irgin K, Hajcak G, Kappenman ES, Kelly D, Karlow S, Luby JL, Barch DM. Neural correlates of reward processing in depressed and healthy preschool-age children. Journal of the American Academy of Child & Adolescent Psychiatry, vol. 55 (12), pp 1081-1089. Dec. 2016. http://dx. This work was supported by the National Institute of Mental Health of the National Institutes of Health (NIH), grant numbers 1R01 MH098454-01A1 and 3R01 MH098454-03S1. Dr. Luby has received royalties from Guilford Press. Dr. Barch has served as a consultant for Pfizer, Amgen, Roche and Takeda and has a contract to analyze imaging date from Pfizer. Washington University School of Medicine's 2,100 employed and volunteer faculty physicians also are the medical staff of Barnes-Jewish and St. Louis Children's hospitals. The School of Medicine is one of the leading medical research, teaching and patient-care institutions in the nation, currently ranked sixth in the nation by U.S. News & World Report. Through its affiliations with Barnes-Jewish and St. Louis Children's hospitals, the School of Medicine is linked to BJC HealthCare.


News Article | February 16, 2017
Site: www.prnewswire.co.uk

Global Prostacyclin Industry 2017 Research Report initially provides a basic overview of the industry that covers definition, applications and manufacturing technology, post which the report explores into the international players in the market. Browse tables and figures, 11 company profiles spread across 103 pages at http://www.reportsnreports.com/reports/863463-global-prostacyclin-market-research-report-2017.html . Global Prostacyclin Market Report 2017 is a professional and in-depth survey on the current state of the Prostacyclin industry. The report provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Prostacyclin market analysis is provided for the international market including development history, competitive landscape analysis, and major regions' development status. Market Segment by Regions, this report splits Global into several key Region, with production, consumption, revenue, market share and growth rate of Prostacyclin in these regions, from 2012 to 2022 (forecast), like North America, China, Europe, Japan, India, Southeast Asia split by product type, with production, revenue, price, market share and growth rate of each type Split by application, this report focuses on consumption, market share and growth rate of Prostacyclin in each application. This report studies Prostacyclin in global market, focuses on top manufacturers in global market, with sales, price, revenue and market share for each manufacturer, covering Actelion Pharmaceuticals, United Therapeutics Corporation, Gilead, Bayer AG, SteadyMed, GlaxoSmithKline, Pfizer, Reata Pharmaceuticals, Arena Pharmaceuticals and Merck. Order a copy at http://www.reportsnreports.com/purchase.aspx?name=863463 . "The Global Prostacyclin Market Research Report" is a professional and in-depth study on the current state of the global Prostacyclin industry with a focus on the global market. The report provides key statistics on the market status of the Prostacyclin manufacturers and is a valuable source of guidance and direction for companies and individuals interested in the industry. Firstly, the report provides a basic overview of the industry including its definition, applications and manufacturing technology. Then, the report explores the international major industry players in detail. In this part, the report presents the company profile, product specifications, capacity, production value, and 2011-2016 market shares for each company. Through the statistical analysis, the report depicts the global total market of Prostacyclin industry including capacity, production, production value, cost/profit, supply/demand. The total market is further divided by company, by country, and by application/type for the competitive landscape analysis. The report then estimates 2016-2021 market development trends of Prostacyclin industry. Analysis of upstream raw materials, downstream demand, and current market dynamics is also carried out. The United States Prostacyclin Industry 2016 Market Research Report is a professional and in-depth study on the current state of the Prostacyclin Analogs industry. Firstly, the report provides a basic overview of the industry including definitions, classifications, applications and industry chain structure. The Prostacyclin Analogs market analysis is provided for the United States market including development history, competitive landscape analysis, and major regions' development status. Secondly, development policies and plans are discussed as well as manufacturing processes and cost structures. 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News Article | December 15, 2016
Site: www.biosciencetechnology.com

In five studies being presented today during the 58th American Society of Hematology (ASH) Annual Meeting and Exposition in San Diego, researchers are applying advanced biomedical engineering methods to improve the delivery of life-saving treatments to patients with a variety of medical conditions. These new methods are designed to carry therapies directly to the sites in the body where they are needed most, which could provide a substantial advantage over traditional, systemic methods. The studies highlight the benefits of emerging technological tools such as nanotechnology and engineered drug delivery vehicles. “All of these studies represent substantial advances resulting from biomedical engineering. They build upon established science with bioengineering strategies that could make therapies significantly more effective if they are pursued and refined,” said Armand Keating, M.D., press briefing moderator, professor of medicine and biomedical engineering, and director of the Cell Therapy Program, University Health Network in Toronto, Canada. “I believe each of these has the potential to change practice.” Researchers have developed the first artificial red blood cells designed to emulate vital functions of natural red blood cells. If confirmed safe for use in humans, the nanotechnology-based product could represent an innovative alternative to blood transfusions that would be especially valuable on the battlefield and in other situations where donated blood is difficult to obtain or store. The artificial cells, called ErythroMer, are designed to be freeze-dried, stored at ambient temperatures, and simply reconstituted with water when needed. “One key goal is to advance field resuscitation of civilian trauma victims in remote settings and soldiers who are wounded in austere environments without access to timely evacuation,” said lead study author Allan Doctor, MD, of Washington University in Saint Louis. “ErythroMer would be a blood substitute that a medic can carry in his or her pack and literally take it out, add water, and inject it. There are currently no simple, practical means to bring transfusion to most trauma victims outside of hospitals. Delays in resuscitation significantly impact outcomes; it is our goal to push timely, effective care to field settings.” Proof-of-concept studies in mice, conducted in partnership with Greg Hare M.D., Ph.D., at the University of Toronto, demonstrate that the artificial cells capture oxygen in the lungs and release it to tissues — the main functions of red blood cells — in a pattern that is indistinguishable from that seen in a control group of mice injected with their own blood. In rats, ErythroMer effectively resuscitated animals in shock following acute loss of 40 percent of their blood volume. The donut-shaped artificial cells are formulated with nanotechnology, in partnership with Dipanjan Pan, Ph.D., at the University of Illinois at Urbana-Champaign, and are about one-fiftieth the size of human red blood cells. A special lining encodes a control system that links ErythroMer oxygen binding to changes in blood pH, thus enhancing oxygen acquisition in the lungs and then dispensing oxygen in tissues with the greatest need. Tests show ErythroMer matches this vital oxygen binding feature of human red blood cells within 10 percent, a level the researchers say should be sufficient to stabilize a bleeding patient until a blood transfusion can be obtained. So far, tests suggest ErythroMer has overcome key barriers that halted development of previous blood substitutes, including efficacy and blood vessel narrowing. The team’s next steps are testing in larger animals, ongoing safety assessment, optimizing pharmacokinetics, and ultimately conducting in-human clinical trials. The researchers are also pursuing methods for scaling up production. If further testing goes well, they estimate ErythroMer could be ready for use by field medics and emergency responders within 10-12 years. ErythroMer development has been supported by the Children’s Discovery Institute at Washington University and St. Louis Children’s Hospital, the Skandalaris Center at Washington University and the BioSTL Fundamentals Program. Gene Therapy Could Potentially Improve Quality of Life for Hemophilia Patients Preliminary data from an ongoing Phase I/II trial suggest that patients with hemophilia B, who are born unable to produce the blood-clotting protein factor IX (FIX), began producing FIX at sufficient levels after receiving a single infusion of an investigational gene therapy product called SPK-9001. The results show the highest and most consistent levels of FIX production of any gene therapy tested to date, according to the researchers. FIX is crucial to the formation of blood clots and prevention of life-threatening uncontrolled bleeding. This ongoing trial involves nine previously treated adult patients with a baseline FIX of less than 2 percent, which is considered extremely deficient. As of the November 30, 2016, data cut off, seven of the nine patients who have progressed to at least 12 weeks post-vector administration showed FIX levels in the range of 12-46 percent with a mean steady-state level greater than 28 percent, a range the researchers say is close enough to normal (at least 50% in healthy adults). Maintaining a minimum level of 12 percent is considered necessary to prevent minor, chronic bleeding in the joints, a common cause of disability in patients with hemophilia. SPK-9001 uses an inactive virus to deliver into a patient’s cells a small section of DNA that, when stabilized in the patient’s own liver cells, allows the body to produce FIX. Current standard of care for hemophilia B requires patients to self-administer intravenous infusions of laboratory-produced FIX at regular intervals, typically one to two times a week. A key downside of this standard regimen is that it causes FIX levels to fluctuate widely, and patients may need to limit their activities to avoid breakthrough bleeding when their FIX levels are low. The FIX levels achieved with SPK-9001 to date in this study have been sufficient to allow patients to engage in normal daily activities without the need for FIX infusions. Eight of the infused patients have required no factor IX concentrates to prevent or control bleeding events since the day after vector administration. One participant with severe joint disease self-administrated a precautionary infusion two days after administration of SPK-9001 for a suspected ankle bleed and again at week 35 post the data cut-off date and despite a factor IX activity level of 36, for a suspected knee bleed. In addition, six patients reported increased physical activity and improved quality of life. “One of the potential innovations with a gene therapy for hemophilia B, compared to factor IX infusions, is that once an individual establishes a stable factor activity level, then they may remain at that level for an extended time,” said Katherine A. High, MD, of Spark Therapeutics, Inc. in Philadelphia. “At the factor IX levels seen in this study, most normal activities of daily living should be open to people with hemophilia. It could be a potential paradigm shift in the treatment of hemophilia.” Two participants recently suffered an autoimmune response and were put on corticosteroids. Despite the immune response and decline in FIX activity level, these two participants have not had any bleeds or required replacement FIX. The researchers will continue to track patient outcomes for at least five years. Funding for the study was provided by Spark Therapeutics and Pfizer, Inc. Microcapsules Could Be Game-Changer for Hemophilia Patients Prone to Immune Response A new drug delivery technology uses the body’s natural processes to supply the blood-clotting protein factor VIII (FVIII) directly to the site of a developing clot to stop bleeding in patients with hemophilia A. The approach, in which small amounts of FVIII are encased within microscopic capsules that are injected into the bloodstream, could significantly improve outcomes for the approximately 30 percent of patients with severe hemophilia A in which direct infusion of FVIII triggers an immune response. People with hemophilia A do not produce FVIII, a protein necessary for forming blood clots, putting them at risk of dangerous uncontrolled bleeding. The standard treatment for these patients is intravenous infusion of FVIII; however, if the patient’s immune system attacks the infused FVIII, the drug’s effectiveness is greatly reduced. These patients often require several infusions a day to control a single bleeding event. In vitro experiments show the new microcapsules act as a shield that allows the FVIII payload to fly under the immune system’s radar and potentially stem bleeding with only one or two injections. In addition, the microcapsules are designed to go directly to the site where FVIII is needed by hitchhiking on platelets, cell fragments present in blood that play a key role in clot formation. “This is a completely new way to target delivery of a biologic drug, capitalizing on the natural functions of cells that are already in your body,” said Caroline E. Hansen, a graduate student in the laboratory of bioengineer and pediatric hematologist Wilbur A. Lam, MD, PhD, of the Georgia Institute of Technology and Emory University in Atlanta. “We’re utilizing platelets’ natural behavior to accomplish targeting and delivery. Because platelets are so heavily relied upon in the clot formation process, they could actually carry these microcapsules to the forming clot or the site of injury.” After binding to platelets and traveling to a forming clot, the microcapsules are designed to burst open, releasing FVIII. This bursting occurs when platelets join a clot and contract. The FVIII then stimulates the formation of fibrin at the site, creating a mesh network that holds the blood clot together. The researchers recently tested their microcapsules in laboratory experiments that model sites of blood vessel injuries, comparing the amount of fibrin formed when FVIII was delivered via microcapsules versus traditional systemic infusions. They found that the microcapsules resulted in 2.7 times as much fibrin formation compared to a systemic FVIII infusion when immune antibodies were present, a test that mimicked what happens when FVIII infusions trigger an immune response in a person with hemophilia A. After further examination of how the microcapsules influence the formation of fibrin, the team plans to test the microcapsules in mouse models. Funding for the study was provided by the NIH and the NSF. New Chemotherapy Delivery Method Improves Survival After Bone Marrow Transplant in Older Acute Myeloid Leukemia Patients A new analysis shows older patients with acute myeloid leukemia (AML) survived longer after receiving an allogeneic stem cell transplant if they were first treated with the experimental chemotherapy delivery method known as CPX-351 instead of the standard “7+3” administration of chemotherapy drugs cytarabine and daunorubicin. Researchers say the findings are encouraging for improving survival among high-risk AML patients who currently have limited treatment options and poor survival rates. The new study is a subgroup analysis of a large Phase III randomized controlled trial completed earlier this year that found CPX-351 nearly doubled overall survival compared to the 7+3 regimen. The researchers examined survival and other health outcomes among trial participants who received chemotherapy and then hematopoietic stem cell transplantation, a treatment that provides healthy replacement stem cells to the bone marrow to better equip patients to fight the disease on their own. Of 309 total trial participants, 91 received an allogeneic stem cell transplant, including 52 in patients who received CPX-351 compared with 39 in patients receiving 7+3. CPX-351-treated patients were also more likely to undergo transplantation while in a remission state (75 percent of CPX-351 vs. 62 percent of 7+3). In the first 100 days after transplantation there were 53 percent fewer deaths among patients receiving CPX-351 compared with those receiving 7+3 therapy. The active ingredients of CPX-351 are the same as those in the 7+3 regimen, but in contrast to 7+3 in which cytarabine and daunorubicin are delivered separately, CPX-351 encapsulates the drugs into a single delivery vehicle in a fixed synergistic molar ratio. “The two drugs together are delivered to the cell in the proper synergistic ratio that optimizes the cell-killing ability of these two drugs,” said lead study author Jeffrey E. Lancet, MD, of the Moffitt Cancer Center in Tampa, Fla. “We think that by doing this, we can improve delivery to the cancer cells at the proper ratio.” The trial focused on the group of AML patients considered at high risk; all participants were older than 60 and had AML related to prior chemotherapy, AML arising from MDS, or AML MDS-related cytogenetic abnormalities. The study was funded by Celator Pharmaceuticals, Inc., a subsidiary of Jazz Pharmaceuticals plc. New CAR-T Treatment Holds Promise for Children and Young Adults with Hard-to-Treat Leukemia Children and young adults with relapsed or refractory ALL who receive chimeric antigen receptor (CAR) T-cell therapy targeting CD22, a protein found on the surface of leukemic cells, appear to mount a clinical response and, in some cases, achieve remission. Researchers from the Pediatric Oncology Branch of the National Cancer Institute of the National Institutes of Health genetically altered patients’ own T cells to track down and kill cancer cells expressing CD22. The study — the first to evaluate CAR targeting CD22 in humans — also gives a first glimpse into how patients who already received CAR-T therapy directed at a different antigen, CD19, might fare when given a second immunotherapy. Data are presented for 16 patients who received the new anti-CD22 therapy. One of the six patients treated at a lower dose initially set by the U.S. Food and Drug Administration (FDA) and other agencies attained remission. The majority – eight of 10 – participants treated at a higher dose level (a dose comparable to that used by current CD19 CAR programs) attained a complete remission without evidence of residual disease after one month of their infusion. There have since been relapses among six out of nine patients who achieved remission, the majority of which are due to drops in CD22 expression on the cells, which has similarly been observed with CD19 CAR therapy. So far, one patient remains in remission beyond one year. “We’ve been able to show that you can give a second CAR therapy that is directed against a different antigen and have it be safe and effective,” said study author Terry J. Fry, MD, of the Center for Cancer Research, National Cancer Institute in Bethesda, MD. Dr. Fry said this adds to the notion that a single antigen-directed CAR immunotherapy probably won’t be sufficient for long-term durable remissions in many patients and points to the potential for targeting multiple cancer-related proteins (also called bispecific targeting). Participants in this Phase 1 trial had relapsed or treatment-resistant ALL and were either CAR naïve or previously treated with anti-CD19 CAR T cells and/or blinatumomab therapy and some who became resistant to CD19 CAR due to loss of CD19. The patients, ranging in age from 7– 22 years old, all had CD22+ ALL and had previously undergone at least one allogeneic stem cell transplant. A majority of participants (11 out of 16) had relapsed after receiving anti-CD19 CAR T cell before entering the trial. Researchers collected T cells from eligible patients and modified them to recognize and bind to CD22. Patients then received an infusion of their own modified cells and were evaluated for response and adverse effects after an average of 28 days. The primary adverse event was cytokine release syndrome, a common, potentially dangerous reaction to this type of infusion, which Dr. Fry reports was mild in all cases; fever and low blood pressure were the main symptoms. There was one death due to sepsis that occurred after resolution of cytokine release syndrome. While the trial is continuing to accrue patients, these early results raise new questions about how anti-CD22 CAR therapy might best be used; for example, if it is better to wait for relapse after initial CAR therapy or preempt it by co-treating it. Dr. Fry and his team plan to investigate the combined use of anti-CD19 and CD22 CAR targeting approaches with the hypothesis that this will increase the likelihood of sustained remission. This study was funded by the National Institutes of Health.


Dublin, March 02, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Fortune 500 Outside Counsel Legal Fee Profile Report" report to their offering. The 2016 Fortune 500 Outside Counsel Rate Report identifies the Law Firms hired by the largest Corporations in the United States and what hourly rates were paid to them. The Fortune 500 Companies have huge legal spends individually and collectively. Their demand for legal work continues to grow faster than other market segments in the United States but hourly rates are not growing as fast, according the Report. This is due to the sophistication of the buyer, the Fortune 500 company, through its extensive use of e-billing and analysis and also due to legal services still being a buyer's market, i.e., the Fortune 500 Company can name its price for routine legal work and even negotiate lower rates for more complex engagements. Key Topics Covered: 1. Rates by Fortune 500 Company 2. Rates by Firm 3. Rates by Practice Area by Company 4. Rates by Industry by Company Companies Mentioned - ADP - AT&T - Adams and Reese LLP - Aetna - Akerman LLP - Akin Gump Strauss Hauer & Feld LLP - Allen Matkins Leck Gamble Mallory & Natsis LLP - Allstate - Ally Financial - Alphabet - Alston & Bird LLP - Amazon.com - Anglin Flewelling Rasmussen Campbell & Trytten, LLP - Anthony & Partners, LLC - Apple - Autoliv - Baker & Hostetler LLP - Baker & McKenzie LLP - Baker Hughes - Balch & Bingham LLP - Ballard Spahr LLP - Bank of America Corp. - Bank of New York Mellon Corp. - Banner & Witcoff, Ltd. - Barrasso Usdin Kupperman Freeman & Sarver, L.L.C. - Bed Bath & Beyond - Beirne, Maynard & Parsons, L.L.P. - Benesch, Friedlander, Coplan & Aronoff LLP - Blank Rome LLP - Boeing - Bradley Arant Boult Cummings LLP - Bryan Cave LLP - Buchanan Ingersoll & Rooney PC - Burr & Forman LLP - CBS - CHS - Cades Schutte - Capital One Financial - Caplin & Drysdale, Chartered - Cardinal Health - Carlson Dash, LLC - Carlton Fields Jorden Burt, P.A. - Caterpillar - Chevron - Cigna - Coblentz Patch Duffy & Bass, LLP - Coca-Cola - Cognizant Technology Solutions - Colgate-Palmolive - ConocoPhillips - Cooley LLP - Corr Cronin Michelson Baumgardner & Preece LLP - Cravath, Swaine & Moore, LLP - Crowley & Lamb P.C. - d'Arcambal Ousley & Cuyler Burk LLP - DISH Network - DLA Piper - Dentons - Dickinson Wright LLP - Disney - Dollar Tree - Dominion Resources - Drinker Biddle & Reath LLP - Durbin, Larimore and Bialick, P.C. - Dykema Gossett PLLC - Eastman Chemical - Energy Future Holdings - Exxon Mobil - Facebook - Faegre Baker Daniels - Fannie Mae - Fish & Richardson PC - Fisher & Phillips LLP - Foley & Lardner LLP - Ford Motor - Fox Rothschild LLP - Freddie Mac - Garan Lucow Miller P.C. - Gardere Wynne Sewell LLP - General Electric - General Motors - Gibson, Dunn & Crutcher LLP - Gilead Sciences - Glynn & Finley, LLP - Godfrey & Kahn, S.C. - Goldberg Kohn - Golenbock Eiseman Assor Bell & Peskoe LLP - Gordon Rees Scully Mansukhani, LLP - Greenberg Traurig LLP - Hagan, Noll & Boyle, LLC - Hartford Financial Services Group - Herron Ortiz, P.A. - Hills Legal Group, Ltd. - Hinshaw & Culbertson LLP - Holland & Hart LLP - Holland & Knight LLP - Holmes Weddle & Barcott - Hughes Gorski Seedorf Odsen & Tervooren, LLC - Humana - Husch Blackwell LLP - IBM - Intel - J.P. Morgan Chase - Jackson Lewis LLP - Jaffe & Asher LLP - Jeffer Mangels Butler & Mitchell LLP - Jenner & Block LLP - Johnson DeLuca Kurisky & Gould, P.C. - Jones Day - Jones Walker LLP - K&L Gates LLP - Katten Muchin Rosenman LLP - Kaye Scholer LLP - Kean Miller LLP - Keesal, Young? & Logan - Kirkland & Ellis LLP - Klevansky Piper, LLP - Kohner Mann & Kailas, S.C. - Kohut & Kohut LLP - Kutak Rock, LLP - Latham & Watkins LLP - Lathrop & Gage LLP - Law Offices of Peter A. Jaffe, LLC - Lawrence & Russell, PLC - Lewis Brisbois Bisgaard & Smith LLP - Liberty Mutual Insurance Group - Lincoln National - Littler Mendelson P.C. - Locke Lord Edwards - Loeb & Loeb LLP - Lowenstein Sandler PC - MGM Resorts International - Mackie Wolf Zientz & Mann, P.C. - Manley Deas Kochalski, LLC - McDermott Will & Emery LLP - McDowell Knight Roedder & Sledge, LLC - McElroy, Deutsch, Mulvaney & Carpenter, LLP - McGlinchey Stafford PLLC - McGuireWoods LLP - McIntosh Schwartz, PL - McKesson - MetLife - Microsoft - Milbank, Tweed, Hadley & McCloy LLP - Miles & Stockbridge, P.C. - Miller, Johnson, Snell & Cummiskey, P.L.C. - Montgomery Willard, LLC - Morgan Stanley - Morgan, Lewis & Bockius LLP - Morrison & Foerster LLP - Mosaic - Moye White LLP - Munger, Tolles & Olson LLP - Nationwide - New York Life Insurance - Newport Trial Group APC - Nike - Nixon Peabody LLP - Ogletree, Deakins, Nash, Smoak & Stewart, P.C. - Oracle - Orrick, Herrington & Sutcliffe LLP - PNC Financial Services Group - PVH - Pachulski Stang Ziehl & Jones LLP - Pacific Life - Paul Hastings LLP - Perkins Coie LLP - Pfizer - Phillips 66 - Pirkey Barber PLLC - Post & Schell PC - Progressive - Proskauer Rose LLP - Quilling, Selander, Lownds, Winslett & Moser, P.C. - R.R. Donnelley & Sons - RCO Legal, P.S. - Reed Smith LLP - Regions Financial - Reynolds American - Sanchez-Medina, Gonzalez, Quesada, Lage, Crespo, Gomez - Sanchez-Medina, Gonzalez, Quesada, Lage, Crespo, Gomez & Machado LLP - Schoeman Updike Kaufman Stern & Ascher LLP - Sherwin-Williams - Sidley Austin LLP - Simcox and Barclay LLP - Sirote & Permutt, PC - Snell & Wilmer LLP - Spencer Fane Britt & Browne LLP - Spotts Fain PC - Squire Patton Boggs - State Farm Insurance Cos. - State Street Corp. - Stevens & Lee - Stinson Leonard Street LLP - Stryker - Sullivan & Cromwell LLP - Swift, Currie, McGhee & Heirs, LLP - The Carlson Law Office, PLLC - The Hustead Law Firm - Thompson & Knight LLP - Thompson Hine LLP - Thrivent Financial for Lutherans - Tompkins, McGuire, Wachenfeld & Barry LLP - U.S. Bancorp - USAA - UnitedHealth Group - Unum Group - Vandeventer Black LLP - Viacom - Visa - Visteon - Vorys, Sater, Seymour and Pease LLP - Walgreens Boots Alliance - Waller Lansden Dortch & Davis LLP - Walmart - Warner Norcross & Judd LLP - Weinstein Radcliff Pipkin LLP - Wells Fargo - Wheeler Trigg O'Donnell LLP - Whirlpool - Williams, Venker & Sanders, L.L.C. - Wilmer Cutler Pickering Hale and Dorr LLP - Wilson Sonsini Goodrich & Rosati, PC - Wilson, Elser, Moskowitz, Edelman & Dicker LLP - Zimmer Biomet Holdings For more information about this report visit http://www.researchandmarkets.com/research/vm8wrb/fortune_500


Research and Markets has announced the addition of the "Breakthrough Therapies: Market Dynamics and Investment Opportunities" report to their offering. The Global Market for Breakthrough Therapy Designation Drugs Should Reach $99.2 Billion by 2022 from $48.8 Billion in 2017 at a CAGR of 15.2% This report highlights the challenges and opportunities of developing breakthrough therapies, it compares and contrasts difference fast track drug development approaches (logistics, criteria, and implications) and the potential risk and rewards of gaining BTD. It analyzes BTD in different therapy areas (cardiovascular, central nervous systems and neurology, rare diseases, oncology and other diseases), leading companies, approved and pipeline products, pricing market access and product revenues. It reviews BTD successes and failures and discusses the different business strategies that companies have adopted in order to maximize the competitive advantage of BTD. It summarizes the current regulatory framework and the potential application of BTD in other regions of the world, and the potential to combine BTD with early access to medicine schemes to improve patient access to medicine to treat rare diseases and address areas of high unmet clinical need. - An overview of the global markets for breakthrough therapies, their dynamics, and investment opportunities - Analyses of global market trends, with data from 2015, 2016, and projections of compound annual growth rates (CAGRs) through 2022 - A look at the materials used in the industry ranging from inorganic clays and concrete to iron and steel, and to commodity and specialty polymers - The challenges and opportunities of developing breakthrough therapies - A compare and contrast of different fast track drug development approaches (logistics, criteria and implications) and the potential risk and rewards of gaining break through designation - Profiles of major players in the industry Key Topics Covered: 1: Introduction - Study Goals And Objectives - Reasons For Doing The Report - Scope Of Report - Intended Audience - Methodology And Information Sources 2: Summary 3: Overview - Defining Breakthrough Therapy Designation 4: Commercial Application Of Breakthrough Therapy Designation - Introduction - Cardiovascular - Central Nervous System And Neurological Disorders - Infectious Diseases - Oncology - Rare Diseases - Other Diseases 5: Implications Of Breakthrough Therapy Designation On Business Strategy - Introduction 6: Regulatory Implications And Breakthrough Therapy Designation - Expedited Programs - Significance Of Btd For The Pharmaceutical And Biotechnology Industries 7: Company Profiles - Abbvie Inc. - Acadia Pharmaceuticals Inc. - Adaptimmune Therapeutics Plc - Aduro Biotech Inc. - Aimmune Therapeutics Inc. - Alexion Pharmaceuticals Inc. - Allergan Plc - Amgen Inc. - Anatara Lifesciences Limited - Ariad Pharmaceuticals Inc. - Astrazeneca Plc - Avexis Inc. - Boehringer Ingelheim Gmbh - Celldex Therapeutics Inc. - Clovis Oncology Inc. - Daiichi Sankyo Company, Limited - DBV Technologies - Eisai Co. Ltd. - Eli Lilly And Company - Exelixis Inc. - F. Hoffmann-La Roche Ltd. - Gilead Sciences Inc. - Glaxosmithkline Plc - Immunomedics Inc. - Individor Plc - Jazz Pharmaceuticals - Johnson & Johnson - Juno Therapeutics Inc. - Kite Pharma Inc. - Merck & Co. Inc. - Merck Kgaa - Novartis AG - Pfizer Inc. - Pharmacyclics Inc. - Progenics Pharmaceuticals Inc. - Regeneron Pharmaceuticals Inc. - Rhythm Pharmaceuticals Inc. - Syndax Pharmaceuticals Inc. - Syneurx International Corporation - Teva Pharmaceuticals Inc. - Trevena Inc. - Vertex Pharmaceuticals Inc. - Vtesse Inc. - Wellstat Therapeutics Corporation 8: References 9: Acronyms 10: Endnotes For more information about this report visit http://www.researchandmarkets.com/research/6369n3/breakthrough


Research and Markets has announced the addition of the "Global Antifungal infection Therapeutics Market Analysis & Trends - Drug Type (Allylamines, Polyenes, Echinocandins and Azoles) - Forecast to 2025" report to their offering. This industry report analyzes the global markets for Antifungal infection Therapeutics across all the given segments on global as well as regional levels presented in the research scope. The study provides historical market data for 2013, 2014 revenue estimations are presented for 2015 and forecasts from 2016 till 2025. Some of the prominent trends that the market is witnessing include huge number of infections are caused by aspergillus and candida fungus, introduction of new drugs, recent technological developments of Antifungal infection Therapeutics and growth opportunities/investment opportunities. The study focuses on market trends, leading players, supply chain trends, technological innovations, key developments, and future strategies. With comprehensive market assessment across the major geographies such as North America, Europe, Asia Pacific, Middle East, Latin America and Rest of the world the report is a valuable asset for the existing players, new entrants and the future investors. - The report provides a detailed analysis on current and future market trends to identify the investment opportunities - Market forecasts till 2025, using estimated market values as the base numbers - Key market trends across the business segments, Regions and Countries - Key developments and strategies observed in the market - Market Dynamics such as Drivers, Restraints, Opportunities and other trends - In-depth company profiles of key players and upcoming prominent players - Growth prospects among the emerging nations through 2025 - Market opportunities and recommendations for new investments Key Topics Covered: 1 Market Outline 2 Executive Summary 3 Market Overview 3.1 Current Trends 3.1.1 Huge Number of Infections are Caused by Aspergillus and Candida Fungus 3.1.2 Introduction of New Drugs 3.1.3 Recent Technological Developments of Antifungal infection Therapeutics 3.1.4 Growth Opportunities/Investment Opportunities 3.2 Drivers 3.3 Constraints 3.4 Industry Attractiveness 4 Antifungal infection Therapeutics Market, By Drug Type 4.1 Allylamines 4.2 Polyenes 4.3 Echinocandins 4..4 Azoles 5 Antifungal infection Therapeutics Market, By Geography  6 Key Player Activities 6.1 Mergers & Acquisitions 6.2 Partnerships, Joint Venture's, Collaborations and Agreements 6.3 Product Launch & Expansions 6.4 Other Activities 7 Leading Companies 7.1 Novartis 7.2 Gilead 7.3 Asperqillus 7.4 Glaxosmithkline 7.5 Kramer Laboratories 7.6 Alternaria 7.7 Sanofi-Aventis 7.8 Pfizer 7.9 Enzon Pharmaceuticals 7.10 Abbott Laboratories 7.11 SCYNEXIS Inc. 7.12 Bayer Healthcare 7.13 Merck & Co. 7.14 Astellas Pharma Inc. For more information about this report visit http://www.researchandmarkets.com/research/vjh6w2/global_antifungal


CDJ & Associates Names 5 Top Leaders to Their Executive Advisory Board for 2017; New Team Joins the Slate of Incumbent Board Members CDJ & Associates is pleased to announce the addition of five new members to their Executive Advisory Board. CDJ & Associates extended an on-boarding invitation to each selected candidate. Each has accepted their seats with the official start of the tenure being January 1st, 2017. Southfield, MI, November 04, 2016 --( The Board-elect includes [in alphabetical order]: Kenneth Dobson, (Oakland County, MI) Director of Government Relations at Wayne County Airport Authority Maria Graves, (Wayne County, MI) Communications & Logistics Specialist, Office of Talent Development and Performance Management, City of Detroit Kathleen (Katie) Marinelli, (Royal Oak, MI) Lead of Compliance Oversight, Pfizer, INC. Kordilia Noble, (Hazel Park, MI) Coordinator, Employment & Career Services at Baker College Omega Tennant (Atlanta, Georgia) Project Manager, Regal Software | CEO & Lead Instructor of OmegaMind The team is already excited to go full steam ahead in the 2017 business year. “I look forward to networking with other business professionals who share the mindset of success giving back to the community,” states Board member-elect Kordilia Noble. Board member-elect Maria Graves shares, “My expertise is in areas of marketing/graphic design and communications/content management, which can support CDJA in a variety of project efforts.” The distinguished board-elect is made up of acclaimed executives who look to inject another layer of dynamic connections, clientele, and strategic direction for the already successful and thriving consulting firm. Board-Elect Ken Dobson states, “I look forward to lending my expertise in helping to grow the Crisis Management division of the firm.” In discussing motivation for being a part of an entrepreneurial project like CDJ & Associates, Board Member-Elect Katie Marinelli shares, “In a global economy where the landscape of the workforce is changing it is critical that we look at business differently.” “I hope to bring perspectives, suggestions and resources to the advisory board table that will add a fire and ingenuity to help CDJ & Associates reach and in fact surpass their business goals,” states Board-elect member, Omega Tennant. CEO, Camille Jamerson said, “I am extremely honored to have this team join the ranks of our board. Their expertise, connection and enthusiasm will help me catapult CDJA to the next level.” CDJ & Associates is a boutique business management consulting firm specializing in Strategy, Crisis & Reputation management, Event management and Branding Development. The Board elect joins the board slate which will include current 2016 board members Camille Jamerson (CEO), Tricia Jamerson (Secretary), Katrina Mitchell, Breona Powell, Cheryl Pozek and C. Patrick Sparks (Vice Chair). For further information, interviews or quotes, email the organization directly. Southfield, MI, November 04, 2016 --( PR.com )-- CDJ & Associates is pleased to announce the addition of five new members to their Executive Advisory Board. After an exhaustive search and interview process, numerous exceptional leaders emerged as being optimally suited for the role. After significant consideration and collaboration with the needs and strategic plan of the organization, CDJ & Associates extended an on-boarding invitation to each selected candidate. Each has accepted their seats with the official start of the tenure being January 1st 2017.The Board-elect includes [in alphabetical order]:Kenneth Dobson, (Oakland County, MI) Director of Government Relations at Wayne County Airport AuthorityMaria Graves, (Wayne County, MI) Communications & Logistics Specialist, Office of Talent Development and Performance Management, City of DetroitKathleen (Katie) Marinelli, (Royal Oak, MI) Lead of Compliance Oversight, Pfizer, INC.Kordilia Noble, (Hazel Park, MI) Coordinator, Employment & Career Services at Baker CollegeOmega Tennant (Atlanta, Georgia) Project Manager, Regal Software | CEO & Lead Instructor of OmegaMindThe team is already excited to go full steam ahead in the 2017 business year. “I look forward to networking with other business professionals who share the mindset of success giving back to the community,” states Board member-elect Kordilia Noble. Board member-elect Maria Graves shares, “My expertise is in areas of marketing/graphic design and communications/content management, which can support CDJA in a variety of project efforts.”The distinguished board-elect is made up of acclaimed executives who look to inject another layer of dynamic connections, clientele, and strategic direction for the already successful and thriving consulting firm. Board-Elect Ken Dobson states, “I look forward to lending my expertise in helping to grow the Crisis Management division of the firm.”In discussing motivation for being a part of an entrepreneurial project like CDJ & Associates, Board Member-Elect Katie Marinelli shares, “In a global economy where the landscape of the workforce is changing it is critical that we look at business differently.”“I hope to bring perspectives, suggestions and resources to the advisory board table that will add a fire and ingenuity to help CDJ & Associates reach and in fact surpass their business goals,” states Board-elect member, Omega Tennant.CEO, Camille Jamerson said, “I am extremely honored to have this team join the ranks of our board. Their expertise, connection and enthusiasm will help me catapult CDJA to the next level.”CDJ & Associates is a boutique business management consulting firm specializing in Strategy, Crisis & Reputation management, Event management and Branding Development. The Board elect joins the board slate which will include current 2016 board members Camille Jamerson (CEO), Tricia Jamerson (Secretary), Katrina Mitchell, Breona Powell, Cheryl Pozek and C. Patrick Sparks (Vice Chair).For further information, interviews or quotes, email the organization directly.


Dublin, Dec. 15, 2016 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of the "Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming Opportunities, 2016-2026 " report to their offering. The "Antibacterial Drug Resistance: Market Landscape, Challenges and Upcoming Opportunities, 2016-2026" report provides an extensive study of the current landscape and the growing pipeline of new generation antibiotics targeting drug-resistant bacteria. As indicated earlier, owing to the over-prescription of antibiotics due to improper diagnosis, lack of adherence to proper dosage regimens, their widespread availability as over-the-counter (OTC) drugs, and overuse in agriculture and poultry farming, most antibiotics have been rendered ineffective. Moreover, there currently exists an expanding lag between the pace at which drug resistant bacteria evolve and the time taken for new drugs to reach the market. As a result, antibiotic drug resistance has escalated into a global threat. There are concerns that the lack of effective drugs in this domain may soon trigger the relapse of the pre-antibiotic era, in which individuals died due to day-to-day bacterial infections. According to certain studies, currently, an estimated 700,000 deaths annually are known to occur due to anti-microbial resistance worldwide. In future, the growing threat of antibiotic resistance is anticipated to prove to be more fatal than cancer. The current scenario depicts an urgent need for new antibiotics with novel mechanisms of action, having the ability to combat antibiotic resistance. The US and EU governments have amended their action plans and conducted many conferences to raise awareness about the situation among both experts in the domain and the general public. Such initiatives are addressed to support R&D strategies of companies engaged in the development of drugs to combat antibiotic resistance. Efforts are underway to assist drug developers in their clinical trial design issues, and even the simplification of regulatory pathways to expedite the time to market for such drugs. In addition, such initiatives endorse public-private partnerships in advancing scientific and clinical efforts in this domain, aid the setting up of surveillance programs to track the widespread use of antibiotics and the development of resistance, and track the growing economic burden due to this phenomenon as well. The new generation antibiotics pipeline comprises of several molecules that target infections caused by deadly pathogens classified under ESKAPE or as urgent threats by the CDC. Several start-ups have entered the market and undertaken various initiatives to develop novel antibiotics with unique mechanisms of action. The report features: - An overview of the current state of the market with respect to the key players involved, phase of development of pipeline products (clinical and preclinical/discovery), target classes of pathogens (Gram-negative versus Gram-positive), drug classes and key disease indications. In addition, we have included an insightful representation of the developer landscape, highlighting the geographical presence of key players in the industry. - Detailed profiles of approved drugs, as well as those in phase III of clinical development, highlighting information on clinical trials, their current status of development, recent developments and associated collaborations. - Insights on novel alternative therapies that are being explored/evaluated to target antibiotic resistant pathogenic bacteria; these include teixobactin, anti-microbial peptides, antisense antibacterials, quorum sensing inhibition, nano-metal based therapies and anti-biofilm agents. - Details on the most popular therapeutic areas, namely acute bacterial skin and skin structure infections (ABSSSIs), community-acquired pneumonia (CAP) Clostridium difficile infections (CDIs), complicated intra-abdominal infections (cIAIs), complicated urinary tract infections (cUTIs) and hospital-acquired pneumonia/ventilator-associated pneumonia (HAP/VAP). For each indication, we have provided a brief description of the disease, information on its epidemiology, available treatment plans and active comparator studies of approved drug candidates that are prescribed for the aforementioned indications. - An illustrative grid representation and a bulls-eye analysis of the pipeline molecules, based on their development stage, spectrum of activity and the key indications. - Future commercial potential of the market based on a detailed opportunity analysis, for the period between 2016 and 2026. The research, analysis and insights presented in this report include potential sales of approved antibiotics and those in late stages of development. Key Topics Covered: 1. Preface 2. Executive Summary 3. Introduction 4. Antibiotic Drug Resistance: Development Pipeline and Market Landscape 5. Clinical Development Analysis and Key Comparator Studies 6. New Generation Antibiotics: Marketed Drugs 7. New Generation Antibiotics: Phase III Drugs 8. Emerging Therapies to Combat Antibiotic Resistance 9. Key Therapeutic Areas 10. Market Forecast and Opportunity Analysis 11. Conclusion 12. Interview Transcripts 13. Appendix 1: Tabulated Data 14. Appendix 2: List of Companies and Organization - AAIPharma Services - ABAC Therapeutics - ANTABIO - Abbott Laboratories - Abgentis - Absynth Biologics - Achaogen - Acino Holdings - Actavis - Actelion Pharmaceuticals - Adenium Biotech - Adimab - Aequor - AiCuris - Alaxia Pharma - Albany Molecular Research (AMRI) - Allecra Therapeutics - Allergan - Angelini - Antibio Tx - Antibiotic Adjuvant - Aphios - Appili Therapeutics - Arietis Pharma - Arpida - Arsanis - Assembly Biosciences - AstraZeneca - Austell Laboratories - Aventis Pharma - BKG Pharma - BUGWORKS - Basilea Pharmaceutica - Bayer Pharma - BioVersys - Biocidium Biopharmaceuticals - Biocon - Biosearch Italia - Biovertis - Blueberry Therapeutics - C3 Jian - Calixa Therapeutics - Cantab Anti-infectives - Cardiome Pharma - Cellceutix Corporation - Cempra - Cerexa - Clinigen Group - ContraFect - Crestone - Crystal Genomics - Cubist Pharmaceuticals - CyDex Pharmaceuticals - DSM Sinochem Pharmaceuticals - Da Volterra - Daiichi Sankyo - Debiopharm International - Deinove - Demuris - Discuva - Dong Wha Pharmaceuticals - Dong-A Pharmaceutical - Durata Therapeutics - Eli Lilly - Eligo Bioscience - EnBiotix - Entasis Therapeutics - Eurofarma Laboratórios - Evolva Holding - Evotec - Eydo Pharma - FOB Synthesis - Fedora Pharmaceuticals - Forest Laboratories - Fujisawa Pharmaceuticals - GSK - Galapagos - GangaGen - GeneWEAVE - Hikma Pharmaceuticals - IASO Pharma - iNtRON Biotechnology - Immuron - Indel Therapeutics - Institute of Metagenomics and Microbial Technologies (IMMT) - InterMune - Ionis Pharmaceuticals - Isis Pharmaceuticals - Janssen-Ortho - Japan Radio Company - Johnson & Johnson - Kyorin Pharmaceutical - LegoChem Biosciences - Ligand Pharmaceuticals - Lyndra - MGB Biopharma - Macrolide Pharmaceuticals - MarBiLeads - Matinas BioPharma - MedImmune - Meiji Seika Pharma - Melinta Therapeutics - MerLion Pharmaceuticals - Merck - MethylGene - Microbecide - MicuRx Pharmaceuticals - Mirati Therapeutics - Monash University - MorphoSys - Morphochem - Motif Bio - Mutabilis - Nabriva Therapeutics - Naicon - NanoSafe Coatings - Nanotherapeutics - Navigen Pharmaceuticals - Nemesis Bioscience - Nexgen Biosciences - Nobelex Biotech - Northeastern University - Northern Antibiotics - Nosopharm - NovaBiotics - NovaDigm Therapeutics - Novexel - NovoBiotic Pharmaceuticals - Nuprim - OJ-Bio - Optimer Biotechnology - Optimer Pharmaceuticals - Osel - PENDOPHARM - Pacific Beach BioSciences - Par Pharmaceutical - Paratek Pharmaceuticals - Patheon - Peninsula Pharmaceuticals - Peptilogics - Pfizer - Pherecydes Pharma - Phico Therapeutics - Polyphor - Procarta Biosystems - Pure Actives - R-Pharm - RQx Pharmaceuticals - RaQualia Pharma - Rebiotix - Redx Pharma - Rempex Pharmaceuticals - RexC Pharmaceuticals - Rib-X Pharmaceuticals - Roche - Rx3 Pharmaceuticals - Sanofi-Aventis - SciClone Pharmaceuticals - Sequella - Seres Therapeutics - SetLance - Shionogi - Shire - SinSa Labs - Specialised Therapeutics Australia - Spero Therapeutics - Sumitomo Dainippon Pharma (DSP) - Summit Therapeutics - Synamp Pharmaceuticals - Synthetic Biologics - TAXIS Pharmaceuticals - TaiGen Biotechnology - Takeda Pharmaceutical - Talon Pharmaceuticals - Targanta Therapeutics - TechnoPhage - Techulon - Tetraphase Pharmaceuticals - The Medicines Company - TheraBor Pharmaceuticals - Theravance Biopharma - Treat Systems - Trius Therapeutics - University of Michigan Life Sciences Institute - University of Pittsburgh - Vaxdyn - VenatoRx Pharmaceuticals - Versicor Pharmaceuticals - VibioSphen - Vicuron Pharmaceuticals - ViroPharma - Vitas Pharma - Vyome Biosciences - Wakunaga Pharmaceutical - Warner Chillcott - Wockhardt - Yamanouchi Pharmaceutical - Zavante Therapeutics For more information about this report visit http://www.researchandmarkets.com/research/gtt9s3/antibacterial


MarketStudyReport.com adds “Global Travel Vaccines Market 2016-2020” new report to its research database. The report spread across 60 pages with table and figures in it. The Report analysts forecast the global travel vaccines market to grow at a CAGR of 6.83% during the period 2016-2020. About Travel Vaccines As the world continues to move toward globalization, the international travels will keep increasing. This fuels the demand for travel vaccines as the prevalence of infectious diseases are specifically region prone, unlike that of other indications. As vaccines are largely used as a preventive measure against these known infectious diseases, the travelers are advised to follow the region-specific immunization plan. The market is growing because various government bodies have mandated the immunization of travelers visiting the infectious-prone areas with various types of vaccines. This, in turn, prevents the spread of infection and averts any chances of epidemic outbreaks. Browse full table of contents and data tables at https://www.marketstudyreport.com/reports/global-travel-vaccines-market-2016-2020/ The report covers the present scenario and the growth prospects of the global travel vaccines market for 2016-2020. To calculate the market size, the report considers the revenue generated from the sales of various vaccines administered to actively immunize meningococcal disease, Japanese encephalitis, rabies, typhoid, yellow fever, hepatitis B, and hepatitis A. The report also considers the revenues to be generated from the sales of vaccines that are expected to be launched into the market during the forecast period. The market is divided into the following segments based on geography:  Americas APAC EMEA The Report Global Travel Vaccines Market 2016-2020, has been prepared based on an in-depth market analysis with inputs from industry experts. The report covers the market landscape and its growth prospects over the coming years. The report also includes a discussion of the key vendors operating in this market. Key vendors  GlaxoSmithKline Merck Pfizer Sanofi Other prominent vendors  Abbott AstraZeneca Bavarian Nordic Baxter Beijing Minhai Biotechnology Bharat Biotech Bharat Immunologicals and Biologicals Bio-Med Seqirus CSL Crucell CSL Dynavax Technologies Emergent BioSolutions GlycoVaxyn GreenSignal Bio Pharma Hualan Biological Engineering Imunoloski Zavod Indian Immunologicals Janssen Pharmaceuticals JN International Medical Kaketsuken LG Life Sciences Lupin Mitsubishi Tanabe Pharma Novavax Nuron Biotech Panacea Biotec Pfizer Protein Sciences Roche SK Chemicals Serum Institute of India Shenzhen Kangtai Biological Products Sinovac Biotech Takeda Pharmaceutical Vacunas Finlay Valeant Pharmaceuticals Valneva, Zydus Cadila Market driver  Growing demand among travelers  For a full, detailed list, view our report  Market challenge  Requires specific storage and distribution system  For a full, detailed list, view our report  Market trend  Combination vaccines For a full, detailed list, view our report  Key questions answered in this report  What will the market size be in 2020 and what will the growth rate be? What are the key market trends? What is driving this market? What are the challenges to market growth? Who are the key vendors in this market space? What are the market opportunities and threats faced by the key vendors? What are the strengths and weaknesses of the key vendors? To receive personalized assistance, write to us @ [email protected] with the report title in the subject line along with your questions or call us at +1 866-764-2150


News Article | August 21, 2016
Site: www.fastcompany.com

After decades of inconclusive results, researchers backed by Pfizer and Massachusetts General Hospital revealed that they had identified several genetic markers associated with depression earlier this month. It was the largest study of its kind, using data from more than 120,000 people. In February, a new paper explored the role that genetics plays on an individual being a morning person or a night owl, and in April another study looked at resilience to Mendelian childhood diseases, such as cystic fibrosis. Each of these studies used insights gathered from customers of 23andMe, the Google-backed company that makes a direct-to-consumer genetic test kit. Perhaps best known for its battles with regulators over its consumer genetics test in 2013, 23andMe has quietly expanded its business to include brokered access to its database of more than 1 million people’s DNA. Everyone who uses the company's $199 test kit receives a request to participate in research. If they agree, their health data is added to a separate database. With 80% of customers consenting, the company has amassed a health data gold mine—and researchers are eager to study it. 23andMe has now hired a team just shy of 70 academics who collaborate with researchers on their studies, many of which are published in top scientific journals. The researchers get access to genetic data coupled with "phenotypic" characteristics or traits, as well as feedback from online surveys. That's a juicy prospect for researchers. 23andMe is one of a growing number of companies that are developing consumer-friendly tools for researchers, although it is one of a small number focused on genomics. Large academic hospitals like Stanford Medicine and Duke are currently using Apple's ResearchKit to collect health information via iPhones. Fitbit is also investing in this area: Researchers are increasingly incorporating its step and heart rate data into large population health studies. Traditionally, clinical trials require raising a large sum of money and recruiting participants to get their genome sequenced, followed by in-person surveys. If a person can't get to one of the research sites, they won't be included. That means it's difficult, and costly, to get large numbers of participants to take part. 23andMe, in contrast, has partially sequenced some 1.2 million genomes already. And it conducts survey via mobile phone, which can be done anytime and almost anywhere. But despite those advantages, many researchers are still skeptical about the tools used by 23andMe. Not everyone will answer truthfully when asked about their weight or alcohol consumption, for instance—even in the privacy of a mobile phone survey. "Serious academic researchers, when they have money available, almost always gravitate toward more expensive scientifically advanced tools," says Matthew Amsden, CEO of ProofPilot, a startup that helps researchers conduct clinical trials. Maxine Mackintosh, a health data researcher at University College London in the U.K., adds that there's historically been a "discomfort and distrust" among academics with industry collaborations, but that's starting to change. 23andMe's research director Joyce Tung admits that it was an uphill battle to convince researchers of the merits of the data, despite that consumers have answered some 350 million survey questions so far. Yet her team's efforts are starting to bear fruit. "Academics were worried that the quality of the self-reported data wouldn't be good," she says, although the company has been experimenting with new ways to improve the accuracy. For a recent research study related to celiac disease, an autoimmune disorder where eating gluten leads to damage in the small intestine, participants responded in unusually large numbers to say that they had been diagnosed with the disease. Tung chalked that up to the growing trend around gluten-free diets. She didn't throw out the survey responses, but instead asked a follow-up question (something that 23andMe can easily do, since it doesn't require another on-site visit): "Have you ever been diagnosed with celiac disease through an intestinal biopsy?" The numbers then dropped to far more realistic levels. Tung says her team now can hardly keep up with the demand from academics. 23andMe had 25 applications from researchers in the fall of 2013, and that number jumped to 45 in the fall of 2014. The numbers aren't yet available for 2015 and 2016, but a company spokesman did share that the team received nearly 20 requests from academics to study the data in the wake of the depression study, which was published just two weeks ago. The company holds biannual meetings to review the applications and determine how many they will collaborate on in given year. The team tends to favor studies on factors that many would be surprised to learn have a genetic component, like taste preferences. The company also works with an external institutional review board, or "IRB," agency to determine any potential risks associated with the research and ensure that the participants understand what they're agreeing to. The database is now large enough that it's not all Caucasians with a European background, a group that is typically overrepresented in research. "We are at the point where we can run reasonable genome-wide association studies in non-European groups," says Tung. That's a big deal. Studying one ethnic group limits our knowledge about diseases that impact one ethnic group more than another, such as sickle cell anemia. The company can now also start to research how certain various factors will impact how an individual is likely to respond to a drug. For this kind of research, known as pharmacogenetics, researchers need a massive cohort. Out of 1 million people, only a small number are likely to be taking a certain drug. Of those, a smaller percentage still will be experiencing a side effect. Ideally, researchers would then want to study that by gender, ethnicity, and so on. Pharma will pay big bucks for that kind of information. While 23andMe is still making most of its money through sales of its consumer testing kit—the price of which increased $100 in October of 2015—its collaborations with drug makers like Genentech (to study Parkinson's disease) and Pfizer (inflammatory bowel disease and lupus) are a big part of its future growth. As 23andMe looks to monetize the health data gathered from its consumers, some patient advocates suggest that the company should consider sharing revenues with its participants. Tung says she has considered some kind of financial incentive in the past, but has some ethical concerns. Her biggest is the potential for coercion: "You can imagine that the level of pressure is unevenly distributed based on economic status," says Tung. But she hasn't ruled it out entirely. "We would consider everything that's ethical and what consumers want."


SOUTH SAN FRANCISCO, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals, Inc.® (NASDAQ:PTLA) today provided a corporate update and reported its financial results for the fourth quarter and year ended December 31, 2016. “We are working towards gaining approval of both betrixaban, our investigational oral Factor Xa inhibitor, and andexanet alfa, our investigational antidote for oral Factor Xa inhibitors, in the United States and Europe over the next year,” said Bill Lis, chief executive officer of Portola. “Each has the potential to become the first product approved for their respective indications and both are highly anticipated by the medical community. We are confident in the robust clinical data for both products, and are focused on addressing the regulatory risks that remain.” Betrixaban – an oral Factor Xa inhibitor anticoagulant in development for extended prophylaxis of venous thromboembolism (VTE) in acute medically ill patients with risk factors for VTE; designated Fast Track status by the U.S. Food and Drug Administration (FDA) AndexXa™ (andexanet alfa) – a Factor Xa inhibitor antidote in development for patients treated with a Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding; designated a Breakthrough Therapy and an Orphan Drug by the FDA Cerdulatinib – an oral, dual Syk/JAK inhibitor in development to treat resistant or relapsed hematologic cancer patients Fourth Quarter and Year-End Financial Results Collaboration and license revenue earned under Portola's collaboration and license agreements with Bristol-Myers Squibb Company and Pfizer, Bayer Pharma and Janssen Pharmaceuticals, Daiichi Sankyo and Dermavant Sciences was $13.7 million for the fourth quarter of 2016 compared with $4.4 million for the fourth quarter of 2015. Collaboration and license revenue for the year ended December 31, 2016, was $35.5 million compared with $12.1 million for the year ended December 31, 2015. Total operating expenses for the fourth quarter of 2016 were $68.9 million compared with $70.7 million for the same period in 2015. Total operating expenses for the fourth quarter of 2016 included $7.9 million in stock-based compensation expense compared with $6.8 million for the same period in 2015. Total operating expenses for the year ended December 31, 2016, were $305.1 million compared with $239.2 million for 2015. Total operating expenses for the full year ended December 31, 2016, included $30.4 million in stock-based compensation expense compared with $22.9 million for 2015. Research and development expenses for the fourth quarter of 2016 were $56.0 million compared with $59.8 million for the same period in 2015. Research and development expenses were $246.9 million for the year ended December 31, 2016, compared with $200.4 million for 2015. The increase in R&D expenses was primarily due to increased program costs to advance andexanet alfa of $64.7 million, including a $27.3 million one-time charge to write off certain prepaid manufacturing costs and increased program costs to support cerdulatinib and early research programs of $3.8 million, partially offset by decreased program costs related to betrixaban of $22.0  million following the completion of the APEX clinical trial enrollment. Selling, general and administrative expenses for the fourth quarter of 2016 were $12.9 million compared with $10.9 million for the same period in 2015. Selling, general and administrative expenses for the year ended December 31, 2016, were $58.2 million compared with $38.9 million for 2015. The increase in SG&A expenses was primarily due to increased headcount-related costs, commercial launch preparation activities and business development-related costs, and costs associated with professional and accounting fees of $2.0 million. For the fourth quarter of 2016, Portola reported a net loss of $53.8 million, or $0.95 net loss per share, compared with a net loss of $66.1 million, or $1.23 net loss per share, for the same period in 2015. Shares used to compute net loss per share attributable to common stockholders were 56.5 million for the fourth quarter of 2016 compared with 53.6 million for the same period in 2015. Net loss for the year ended December 31, 2016, was $269.0 million, or $4.76 net loss per share, compared with a net loss of $226.5 million, or $4.36 net loss per share, for the same period in 2015. Shares used to compute net loss per share attributable to common stockholders were 56.5 million for 2016 compared with 52.0 million for 2015. Cash, cash equivalents and investments at December 31, 2016, totaled $318.8 million compared with cash, cash equivalents and investments of $460.2 million as of December 31, 2015. 2017 Annual Financial Guidance For the fiscal year 2017, Portola expects total GAAP operating expenses to be between $323 million and $344 million. For the fiscal year 2017, Portola expects total pro-forma operating expenses to be between $290 million and $310 million, excluding stock-based compensation. These expenses will be primarily for manufacturing of both andexanet and betrixaban, support of ongoing clinical trials and preparation for the potential commercial launches of betrixaban and AndexXa. Non-GAAP Financial Projection This press release and the reconciliation table included herein include a non-GAAP projection of 2017 operating expenses, excluding stock-based compensation. A reconciliation to projected GAAP 2017 operating expenses is provided in the accompanying table entitled "Reconciliation of GAAP to Non-GAAP Projected Operating Expenses." Portola management believes this non-GAAP information is useful for investors because it provides information about the Company's ability to independently fund and advance its operations with existing capital resources. Share-based compensation is not an expense that requires cash settlement, and therefore, the Company excludes these charges for purposes of evaluating our ability to fund future operations. Conference Call Details The live conference call today, Tuesday, February 28, 2017, at 4:30 p.m. Eastern Time, can be accessed by phone by calling (844) 452-6828 from the United States and Canada or 1 (765)-507-2588 internationally and using the passcode 71935945. The webcast can be accessed live on the Investor Relations section of the Company's website at http://investors.portola.com. It will be archived for 30 days following the call. About Portola Pharmaceuticals, Inc.     Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three programs, including betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma. Forward-looking Statements  Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, anticipated product approvals, the potential of our product candidates to advance the field of thrombosis and benefit patients and the timing of our regulatory events and statements regarding the timing and ability to achieve other milestones and events, including those described under the section "Recent Achievements, Upcoming Events and Milestones" and “2017 Annual Financial Guidance."  Risks that contribute to the uncertain nature of the forward-looking statements include: failure to obtain FDA and/or EMA approval for one or more of our product candidates, our expectation that we will incur losses for the foreseeable future and will need additional funds to finance our operations; the accuracy of our estimates regarding our ability to initiate and/or complete our clinical trials and the timing and expense of these trials; the results of our clinical trials related to the efficacy and safety of our product candidates; our potential inability to manufacture our product candidates on a commercial scale in a timely or cost-efficient manner; the accuracy of our estimates regarding expenses and capital requirements; our ability to successfully build a hospital-based sales force and commercial infrastructure; regulatory developments in the United States and foreign countries; our ability to obtain and maintain intellectual property protection for our product candidates; and our ability to retain key scientific or management personnel. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


News Article | December 5, 2016
Site: www.newsmaker.com.au

Wiseguyreports.Com Adds “Healthcare Supply Chain -Market Demand, Growth, Opportunities and analysis of Top Key Player Forecast to 2021” To Its Research Database This report studies sales (consumption) of Healthcare Supply Chain in Global market, especially in United States, China, Europe, Japan, focuses on top players in these regions/countries, with sales, price, revenue and market share for each player in these regions, covering Market Segment by Regions, this report splits Global into several key Regions, with sales (consumption), revenue, market share and growth rate of Healthcare Supply Chain in these regions, from 2011 to 2021 (forecast), like United States China Europe Japan Split by product Types, with sales, revenue, price and gross margin, market share and growth rate of each type, can be divided into Type I Type II Type III Split by applications, this report focuses on sales, market share and growth rate of Healthcare Supply Chain in each application, can be divided into Application 1 Application 2 Application 3 Global Healthcare Supply Chain Sales Market Report 2016 1 Healthcare Supply Chain Overview 1.1 Product Overview and Scope of Healthcare Supply Chain 1.2 Classification of Healthcare Supply Chain 1.2.1 Type I 1.2.2 Type II 1.2.3 Type III 1.3 Application of Healthcare Supply Chain 1.3.1 Application 1 1.3.2 Application 2 1.3.3 Application 3 1.4 Healthcare Supply Chain Market by Regions 1.4.1 United States Status and Prospect (2011-2021) 1.4.2 China Status and Prospect (2011-2021) 1.4.3 Europe Status and Prospect (2011-2021) 1.4.4 Japan Status and Prospect (2011-2021) 1.5 Global Market Size (Value and Volume) of Healthcare Supply Chain (2011-2021) 1.5.1 Global Healthcare Supply Chain Sales and Growth Rate (2011-2021) 1.5.2 Global Healthcare Supply Chain Revenue and Growth Rate (2011-2021) 7 Global Healthcare Supply Chain Manufacturers Analysis 7.1 Bayer 7.1.1 Company Basic Information, Manufacturing Base and Competitors 7.1.2 Healthcare Supply Chain Product Type, Application and Specification 7.1.2.1 Type I 7.1.2.2 Type II 7.1.3 Bayer Healthcare Supply Chain Sales, Revenue, Price and Gross Margin (2011-2016) 7.1.4 Main Business/Business Overview 7.2 Pfizer 7.2.1 Company Basic Information, Manufacturing Base and Competitors 7.2.2 119 Product Type, Application and Specification 7.2.2.1 Type I 7.2.2.2 Type II 7.2.3 Pfizer Healthcare Supply Chain Sales, Revenue, Price and Gross Margin (2011-2016) 7.2.4 Main Business/Business Overview 7.3 Merck Corporation 7.3.1 Company Basic Information, Manufacturing Base and Competitors 7.3.2 130 Product Type, Application and Specification 7.3.2.1 Type I 7.3.2.2 Type II 7.3.3 Merck Corporation Healthcare Supply Chain Sales, Revenue, Price and Gross Margin (2011-2016) 7.3.4 Main Business/Business Overview 7.4 BASF 7.4.1 Company Basic Information, Manufacturing Base and Competitors 7.4.2 Dec Product Type, Application and Specification 7.4.2.1 Type I 7.4.2.2 Type II 7.4.3 BASF Healthcare Supply Chain Sales, Revenue, Price and Gross Margin (2011-2016) 7.4.4 Main Business/Business Overview 7.5 Bachem 7.5.1 Company Basic Information, Manufacturing Base and Competitors 7.5.2 Product Type, Application and Specification 7.5.2.1 Type I 7.5.2.2 Type II 7.5.3 Bachem Healthcare Supply Chain Sales, Revenue, Price and Gross Margin (2011-2016) 7.5.4 Main Business/Business Overview 7.6 Johnson & Johnson 7.6.1 Company Basic Information, Manufacturing Base and Competitors 7.6.2 Million USD Product Type, Application and Specification 7.6.2.1 Type I 7.6.2.2 Type II 7.6.3 Johnson & Johnson Healthcare Supply Chain Sales, Revenue, Price and Gross Margin (2011-2016) 7.6.4 Main Business/Business Overview 7.7 Decartis 7.7.1 Company Basic Information, Manufacturing Base and Competitors 7.7.2 Pharma & Healthcare Product Type, Application and Specification 7.7.2.1 Type I 7.7.2.2 Type II 7.7.3 Decartis Healthcare Supply Chain Sales, Revenue, Price and Gross Margin (2011-2016) 7.7.4 Main Business/Business Overview 7.8 Roche 7.8.1 Company Basic Information, Manufacturing Base and Competitors 7.8.2 Product Type, Application and Specification 7.8.2.1 Type I 7.8.2.2 Type II 7.8.3 Roche Healthcare Supply Chain Sales, Revenue, Price and Gross Margin (2011-2016) 7.8.4 Main Business/Business Overview 7.9 Sanofi-Aventis 7.9.1 Company Basic Information, Manufacturing Base and Competitors 7.9.2 Product Type, Application and Specification 7.9.2.1 Type I 7.9.2.2 Type II 7.9.3 Sanofi-Aventis Healthcare Supply Chain Sales, Revenue, Price and Gross Margin (2011-2016) 7.9.4 Main Business/Business Overview 7.10 GSK 7.10.1 Company Basic Information, Manufacturing Base and Competitors 7.10.2 Product Type, Application and Specification 7.10.2.1 Type I 7.10.2.2 Type II 7.10.3 GSK Healthcare Supply Chain Sales, Revenue, Price and Gross Margin (2011-2016) 7.10.4 Main Business/Business Overview 7.11 Astrazeneca 7.12 Eli Lilly 7.13 AMPAC Fine Chemicals


News Article | December 2, 2016
Site: www.newsmaker.com.au

Wiseguyreports.Com Adds “Anti-Infective Drugs -Market Demand, Growth, Opportunities and analysis of Top Key Player Forecast to 2021” To Its Research Database This report studies Anti-Infective Drugs in Global market, especially in North America, Europe, China, Japan, Southeast Asia and India, with production, revenue, consumption, import and export in these regions, from 2011 to 2015, and forecast to 2021. This report focuses on top manufacturers in global market, with production, price, revenue and market share for each manufacturer, covering By types, the market can be split into Antibiotic Antiviral Antifungal Others By Application, the market can be split into Hospital use Clinic Household Others By Regions, this report covers (we can add the regions/countries as you want) North America China Europe Southeast Asia Japan India Global Anti-Infective Drugs Market Professional Survey Report 2016 1 Industry Overview of Anti-Infective Drugs 1.1 Definition and Specifications of Anti-Infective Drugs 1.1.1 Definition of Anti-Infective Drugs 1.1.2 Specifications of Anti-Infective Drugs 1.2 Classification of Anti-Infective Drugs 1.2.1 Antibiotic 1.2.2 Antiviral 1.2.3 Antifungal 1.2.4 Others 1.3 Applications of Anti-Infective Drugs 1.3.1 Hospital use 1.3.2 Clinic 1.3.3 Household 1.3.4 Others 1.4 Market Segment by Regions 1.4.1 North America 1.4.2 China 1.4.3 Europe 1.4.4 Southeast Asia 1.4.5 Japan 1.4.6 India 8 Major Manufacturers Analysis of Anti-Infective Drugs 8.1 GlaxoSmithKline 8.1.1 Company Profile 8.1.2 Product Picture and Specifications 8.1.2.1 Type I 8.1.2.2 Type II 8.1.2.3 Type III 8.1.3 GlaxoSmithKline 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.1.4 GlaxoSmithKline 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.2 Merck 8.2.1 Company Profile 8.2.2 Product Picture and Specifications 8.2.2.1 Type I 8.2.2.2 Type II 8.2.2.3 Type III 8.2.3 Merck 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.2.4 Merck 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.3 Pfizer 8.3.1 Company Profile 8.3.2 Product Picture and Specifications 8.3.2.1 Type I 8.3.2.2 Type II 8.3.2.3 Type III 8.3.3 Pfizer 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.3.4 Pfizer 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.4 Novartis AG 8.4.1 Company Profile 8.4.2 Product Picture and Specifications 8.4.2.1 Type I 8.4.2.2 Type II 8.4.2.3 Type III 8.4.3 Novartis AG 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.4.4 Novartis AG 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.5 Gilead Sciences 8.5.1 Company Profile 8.5.2 Product Picture and Specifications 8.5.2.1 Type I 8.5.2.2 Type II 8.5.2.3 Type III 8.5.3 Gilead Sciences 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.5.4 Gilead Sciences 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.6 Abbott 8.6.1 Company Profile 8.6.2 Product Picture and Specifications 8.6.2.1 Type I 8.6.2.2 Type II 8.6.2.3 Type III 8.6.3 Abbott 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.6.4 Abbott 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.7 Wyeth 8.7.1 Company Profile 8.7.2 Product Picture and Specifications 8.7.2.1 Type I 8.7.2.2 Type II 8.7.2.3 Type III 8.7.3 Wyeth 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.7.4 Wyeth 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.8 Sanofi-Aventis 8.8.1 Company Profile 8.8.2 Product Picture and Specifications 8.8.2.1 Type I 8.8.2.2 Type II 8.8.2.3 Type III 8.8.3 Sanofi-Aventis 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.8.4 Sanofi-Aventis 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.9 Bristol-Myers Squibb 8.9.1 Company Profile 8.9.2 Product Picture and Specifications 8.9.2.1 Type I 8.9.2.2 Type II 8.9.2.3 Type III 8.9.3 Bristol-Myers Squibb 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.9.4 Bristol-Myers Squibb 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.10 Johnson 8.10.1 Company Profile 8.10.2 Product Picture and Specifications 8.10.2.1 Type I 8.10.2.2 Type II 8.10.2.3 Type III 8.10.3 Johnson 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.10.4 Johnson 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.11 Roche Pharma AG 8.11.1 Company Profile 8.11.2 Product Picture and Specifications 8.11.2.1 Type I 8.11.2.2 Type II 8.11.2.3 Type III 8.11.3 Roche Pharma AG 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.11.4 Roche Pharma AG 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.12 Nanosphere 8.12.1 Company Profile 8.12.2 Product Picture and Specifications 8.12.2.1 Type I 8.12.2.2 Type II 8.12.2.3 Type III 8.12.3 Nanosphere 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.12.4 Nanosphere 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.13 NanoViricides 8.13.1 Company Profile 8.13.2 Product Picture and Specifications 8.13.2.1 Type I 8.13.2.2 Type II 8.13.2.3 Type III 8.13.3 NanoViricides 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.13.4 NanoViricides 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.14 Novabay Pharmaceuticals 8.14.1 Company Profile 8.14.2 Product Picture and Specifications 8.14.2.1 Type I 8.14.2.2 Type II 8.14.2.3 Type III 8.14.3 Novabay Pharmaceuticals 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.14.4 Novabay Pharmaceuticals 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.15 Obetech 8.15.1 Company Profile 8.15.2 Product Picture and Specifications 8.15.2.1 Type I 8.15.2.2 Type II 8.15.2.3 Type III 8.15.3 Obetech 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.15.4 Obetech 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.16 Optimer Pharmaceuticals 8.16.1 Company Profile 8.16.2 Product Picture and Specifications 8.16.2.1 Type I 8.16.2.2 Type II 8.16.2.3 Type III 8.16.3 Optimer Pharmaceuticals 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.16.4 Optimer Pharmaceuticals 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.17 Basilea Pharmaceutica AG 8.17.1 Company Profile 8.17.2 Product Picture and Specifications 8.17.2.1 Type I 8.17.2.2 Type II 8.17.2.3 Type III 8.17.3 Basilea Pharmaceutica AG 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.17.4 Basilea Pharmaceutica AG 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.18 Daiichi Sankyo 8.18.1 Company Profile 8.18.2 Product Picture and Specifications 8.18.2.1 Type I 8.18.2.2 Type II 8.18.2.3 Type III 8.18.3 Daiichi Sankyo 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.18.4 Daiichi Sankyo 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.19 MerLion Pharma 8.19.1 Company Profile 8.19.2 Product Picture and Specifications 8.19.2.1 Type I 8.19.2.2 Type II 8.19.2.3 Type III 8.19.3 MerLion Pharma 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.19.4 MerLion Pharma 2015 Anti-Infective Drugs Business Region Distribution Analysis 8.20 Theravance 8.20.1 Company Profile 8.20.2 Product Picture and Specifications 8.20.2.1 Type I 8.20.2.2 Type II 8.20.2.3 Type III 8.20.3 Theravance 2015 Anti-Infective Drugs Sales, Ex-factory Price, Revenue, Gross Margin Analysis 8.20.4 Theravance 2015 Anti-Infective Drugs Business Region Distribution Analysis


SOUTH SAN FRANCISCO, Calif., Dec. 19, 2016 (GLOBE NEWSWIRE) -- Portola Pharmaceuticals Inc.® (Nasdaq:PTLA) today announced it has signed a $50 million loan agreement with Bristol-Myers Squibb Company (NYSE:BMY) and Pfizer Inc. (NYSE:PFE) that provides additional funding toward development and clinical studies of AndexXa™ (andexanet alfa), an investigational compound that is a potential antidote for Factor Xa inhibitors.  “This agreement reflects the commitment and support of the andexanet alfa program by our long-standing partners BMS and Pfizer and helps Portola to continue moving rapidly toward our goal of gaining regulatory approval in 2017,” said Tao Fu, chief commercial and business officer of Portola. “We are committed to working with the FDA to bring AndexXa to market as patients currently have no approved antidote available to reverse Factor Xa inhibitors.” Under the terms of the agreement, Bristol-Myers Squibb and Pfizer will each loan Portola $25 million. The principal and interest will be repaid primarily through royalties on AndexXa commercial sales. No shares, warrants, options or other equity components were or will be issued in connection with the loan. The non-secured loan does not involve any transfer of patent ownership or licenses. AndexXa, a U.S. Food and Drug Administration (FDA)-designated Breakthrough Therapy, is in development for patients treated with a direct (apixaban, rivaroxaban or edoxaban) or indirect (enoxaparin) Factor Xa inhibitor when reversal of anticoagulation is needed due to life-threatening or uncontrolled bleeding. On August 17, 2016, Portola received a Complete Response Letter from the FDA regarding its Biologics License Application for AndexXa. Portola expects to resubmit the BLA in 2017. Portola previously entered into two separate clinical collaboration agreements with Bristol-Myers Squibb and Pfizer to support Phase 2 and registrational studies of andexanet alfa in the United States and Europe. Bristol-Myers Squibb and Pfizer also have a collaboration agreement with Portola to develop and commercialize andexanet alfa in Japan. Portola retains all rights, including full commercial and financial rights, for andexanet alfa outside of Japan. About AndexXa  AndexXa (andexanet alfa), an investigational drug, is a modified human Factor Xa molecule that acts as a decoy to target and sequester with high specificity both oral and injectable Factor Xa inhibitors in the blood. Once bound, the Factor Xa inhibitors are unable to bind to and inhibit native Factor Xa, thus potentially allowing for the restoration of normal hemostatic processes. AndexXa is the first compound being studied as an antidote for Factor Xa inhibitors that directly and specifically reverses anti-Factor Xa activity – the anticoagulant mechanism of these agents. AndexXa is currently being evaluated in the ongoing Phase 3b/4 ANNEXA™-4 study in patients with Factor Xa inhibitor-associated acute major bleeding. Results of a preliminary analysis of interim data were presented in a Late-Breaking Science Hot Line session at the European Society of Cardiology 2016 Congress and published simultaneously online by The New England Journal of Medicine. In the EU, the European Medicines Agency (EMA) is reviewing the Marketing Authorization Application for andexanet alfa for reversal of Factor Xa inhibition in patients experiencing a life-threatening or uncontrolled bleed and for patients requiring urgent or emergency surgery. A decision is expected in 2017. About Portola Pharmaceuticals, Inc.  Portola Pharmaceuticals is a biopharmaceutical company developing product candidates that could significantly advance the fields of thrombosis and other hematologic diseases. The Company is advancing three programs, including betrixaban, an oral, once-daily Factor Xa inhibitor; AndexXa™ (andexanet alfa), a recombinant protein designed to reverse the anticoagulant effect in patients treated with an oral or injectable Factor Xa inhibitor; and cerdulatinib, a Syk/JAK inhibitor in development to treat hematologic cancers. Portola's partnered program is focused on developing selective Syk inhibitors for inflammatory conditions. For more information, visit www.portola.com and follow the Company on Twitter @Portola_Pharma. Forward-looking Statements  Statements contained in this press release regarding matters that are not historical facts are "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Such statements include, but are not limited to, statements regarding the timing of our development efforts for andexanet alfa and the projected need for a Factor Xa inhibitor antidote. Risks that contribute to the uncertain nature of the forward-looking statements include the risk that our data fail to demonstrate safety and efficacy of andexanet alfa to the satisfaction of the FDA or similar regulatory authorities outside the United States, such as the EMA, and the risks that we will not successfully manufacture andexanet alfa on a commercial scale or be able to obtain the capital needed to fund our operations. These and other risks and uncertainties are described more fully in our most recent filings with the Securities and Exchange Commission, including our most recent quarterly report on Form 10-Q, which was filed on November 7, 2016. All forward-looking statements contained in this press release speak only as of the date on which they were made. We undertake no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.


ReportsnReports.com adds "Chronic Obstructive Pulmonary Disease (COPD) - Pipeline Review, H2 2016" to its store providing comprehensive information on the therapeutics under development for Chronic Obstructive Pulmonary Disease (COPD) (Respiratory), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Complete report on H2 2016 pipeline review of Chronic Obstructive Pulmonary Disease (COPD) with 172 market data tables and 16 figures, spread across 577 pages is available at http://www.reportsnreports.com/reports/743409-chronic-obstructive-pulmonary-disease-copd-pipeline-review-h2-2016.html . Companies discussed in this Chronic Obstructive Pulmonary Disease (COPD) Pipeline Review, H2 2016 report include AB2 Bio Ltd., Abeona Therapeutics, Inc., Ache Laboratorios Farmaceuticos S/A, Achillion Pharmaceuticals, Inc., Adamis Pharmaceuticals Corporation, Advinus Therapeutics Ltd, AlgiPharma AS, Allinky Biopharma, Alteogen Inc., Amakem NV, Ampio Pharmaceuticals, Inc., Angion Biomedica Corp., Apellis Pharmaceuticals Inc, Aridis Pharmaceuticals LLC, Astellas Pharma Inc., AstraZeneca Plc, Asubio Pharma Co., Ltd., Axikin Pharmaceuticals, Inc., Bayer AG, Beech Tree Labs, Inc., Bioneer Corporation, Biotie Therapies Corp., Boehringer Ingelheim GmbH, C4X Discovery Holdings PLC, Carolus Therapeutics, Inc., Cellular Biomedicine Group, Inc., Chiesi Farmaceutici SpA, Circassia Pharmaceuticals Plc, CSL Limited, Cytokinetics, Inc., Daiichi Sankyo Company, Limited, Diffusion Pharmaceuticals Inc., Domainex Limited, Elsalys Biotech SAS, enGene, Inc, Errant Gene Therapeutics, LLC, F. Hoffmann-La Roche Ltd., Foresee Pharmaceuticals, LLC, Galapagos NV, Gilead Sciences, Inc., GlaxoSmithKline Plc, Hanmi Pharmaceuticals, Co. Ltd., iCeutica, Inc., InMed Pharmaceuticals Inc., Innate Pharma S.A., INVENT Pharmaceuticals, Inc., Invion Limited, Jiangsu Hansoh Pharmaceutical Co., Ltd., Johnson & Johnson, KaloBios Pharmaceuticals, Inc., Kissei Pharmaceutical Co., Ltd., Kyowa Hakko Kirin Co., Ltd., Ligand Pharmaceuticals, Inc., Medestea Research & Production S.p.A., Merck & Co., Inc., Mereo Biopharma Group Plc, Meridigen Biotech Co., Ltd., Microbion Corporation, Novartis AG, Odan Laboratories Ltd., OPKO Health, Inc., Orion Oyj, Panmira Pharmaceuticals, LLC., Pfizer Inc., PharmaLundensis AB, Pharmaxis Limited, Pila Pharma AB, Polyphor Ltd., Promedior, Inc., ProMetic Life Sciences Inc., Proteostasis Therapeutics, Inc., Pulmagen Therapeutics LLP, Pulmatrix, Inc., Quark Pharmaceuticals, Inc., Re-Pharm Limited, Recipharm AB, Respira Therapeutics Inc, Respiratorius AB, rEVO Biologics, Inc., Rhizen Pharmaceuticals S.A., SATT North SAS, Selvita S.A., Seoul Pharma Co., Ltd., Spring Bank Pharmaceuticals, Inc., Stelic Institute & Co., Inc., sterna biologicals Gmbh & Co KG, Sucampo Pharmaceuticals, Inc., Sun Pharma Advanced Research Company Ltd., Sunovion Pharmaceuticals Inc., Synovo GmbH, Syntrix Biosystems, Inc., Takeda Pharmaceutical Company Limited, Teva Pharmaceutical Industries Ltd., TGV-Laboratories, Therabron Therapeutics, Inc., Theravance Biopharma, Inc., Torrent Pharmaceuticals Limited, U.S. Stem Cell, Inc., Unizyme Laboratories A/S, Vectura Group Plc, Verona Pharma Plc, Vertex Pharmaceuticals Incorporated, Yuhan Corporation, Yungjin Pharm. Co., Ltd. and Zambon Company S.p.A. The Chronic Obstructive Pulmonary Disease (COPD) (Respiratory) pipeline guide also reviews of key players involved in therapeutic development for Chronic Obstructive Pulmonary Disease (COPD) and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Filing rejected/Withdrawn, Phase III, Phase II, Phase I, Preclinical, Discovery and Unknown stages are 4, 1, 13, 40, 29, 81, 25 and 5 respectively for Similarly, the Universities portfolio in Preclinical and Discovery stages comprises 5 and 3 molecules, respectively for Chronic Obstructive Pulmonary Disease (COPD). Chronic Obstructive Pulmonary Disease (COPD) (Respiratory) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. The report helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. ReportsnReports.com is your single source for all market research needs. Our database includes 500,000+ market research reports from over 100+ leading global publishers & in-depth market research studies of over 5000 micro markets. With comprehensive information about the publishers and the industries for which they publish market research reports, we help you in your purchase decision by mapping your information needs with our huge collection of reports. Connect With Us on:


News Article | November 22, 2016
Site: www.prnewswire.co.uk

ReportsnReports.com adds "Muscular Dystrophy - Pipeline Review, H2 2016" to its store, providing comprehensive information on the therapeutics under development for Muscular Dystrophy, complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The report also covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Additionally, the report provides an overview of key players involved in therapeutic development for Muscular Dystrophy and features dormant and discontinued projects. Muscular dystrophy is a group of diseases in which muscle fibers are unusually susceptible to damage. These damaged muscles become progressively weaker. Symptoms usually appear before age 6 and may appear as early as infancy. They may include fatigue, learning difficulties, intellectual disability, muscle weakness and progressive difficulty walking. Complete report on Global Muscular Dystrophy Market Research with 44 market data tables and 15 figures, spread across 144 pages is available at http://www.reportsnreports.com/reports/755879-muscular-dystrophy-pipeline-review-h2-2016.html . Company Analysis and Positioning discussed in this research are Acceleron Pharma, Inc., AMO Pharma Limited, Asahi Kasei Pharma Corp., aTyr Pharma, Inc., Benitec Biopharma Limited, Bio Blast Pharma Ltd., Biophytis SAS, Corcept Therapeutics Incorporated, Evotec AG, F. Hoffmann-La Roche Ltd., Genethon, Ionis Pharmaceuticals, Inc., Marina Biotech, Inc., Medestea Research & Production S.p.A., Novogen Limited, Pfizer Inc., Prothelia, Inc., SanBio, Inc., Santhera Pharmaceuticals Holding AG, Sarepta Therapeutics, Inc., Selecta Biosciences, Inc., Strykagen Corporation, Takeda Pharmaceutical Company Limited and WAVE Life Sciences Ltd. Drug Profiles mentioned in this research are  ACE-083, Antisense Oligonucleotide to Inhibit DM1 Protein Kinase for Myotonic Dystrophy, Antisense RNAi Oligonucleotides for Myotonic Dystrophy, ATYR-1940, baliforsen, BIO-103, domagrozumab, Drugs for Merosin-Deficient Congenital Muscular Dystrophy Type 1A, elcatonin, Gene Therapy for Muscular Dystrophy and Liver Diseases, Gene Therapy to Activate Dysferlin for Duchenne and Limb Girdle Muscular Dystrophies, Gene Therapy to Activate Dysferlin for Dysferlinopathies, Gene Therapy to Activate Dystrophin for Muscular Dystrophy, IUCT-169, IUCT-290, IUCT-309, ketoprofen, LR-08, MED-1101, mexiletine hydrochloride, Oligonucleotide 1 to Target Dystrophia Myotonica Protein Kinase for Myotonic Dystrophy, Oligonucleotides to Inhibit DM1 Protein Kinase for Myotonic Dystrophy, omigapil, Pabparna, poloxamer, PRT-01, Recombinant Protein to Activate Utrophin for Muscular Dystrophies, RNAi Gene Therapy to Inhibit Myotilin for LGMD, RP-33, SB-308, SIWA-318, Small Molecule to Inhibit DUX4 for Muscular Dystrophy, Small Molecule to Target CUG RNA for Myotonic Dystrophy 1, Small Molecule to Target RNA for Myotonic Dystrophy, Small Molecules for Dysferlinopathies, Small Molecules for Facioscapulohumeral Muscular Dystrophy, Small Molecules for Myotonic Dystrophy, Small Molecules for Myotonic Dystrophy Type 1, Small Molecules to Activate SMCHD1 for Facioscapulohumeral Dystrophy, Small Molecules to Antagonize Glucocorticoid Receptor II for Muscular Dystrophy, Small Molecules to Inhibit MBNL1 for Myotonic Dystrophy Type I, Small Molecules to Target RNA for Myotonic Dystrophy, SRT-149, SRT-152, Stem Cell Therapy for Muscular Dystrophy, Stryka-232, Stryka-234, Stryka-425, Stryka-533, Stryka-978, tideglusib, trehalose, TXA-127, VAL-0411 and VAL-1205. The Muscular Dystrophy (Musculoskeletal Disorders) pipeline guide also reviews of key players involved in therapeutic development for Muscular Dystrophy and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Phase III, Phase II, Phase I, Preclinical and Discovery stages are 1, 5, 2, 24 and 14 respectively. Similarly, the Universities portfolio in Phase II, Phase I, Preclinical and Discovery stages comprises 1, 1, 3 and 4 molecules, respectively.Muscular Dystrophy. Muscular Dystrophy (Musculoskeletal Disorders) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Direct’s proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. ReportsnReports.com is your single source for all market research needs. Our database includes 500,000+ market research reports from over 100+ leading global publishers & in-depth market research studies of over 5000 micro markets. With comprehensive information about the publishers and the industries for which they publish market research reports, we help you in your purchase decision by mapping your information needs with our huge collection of reports. Connect With Us on:


— Chronic Lymphocytic Leukemia (CLL) Pipeline Market Companies Involved in Therapeutics Development are 4SC AG, AbbVie Inc, Acetylon Pharmaceuticals Inc, Aeglea BioTherapeutics Inc, Altor BioScience Corp, Amgen Inc, Aprea AB, Aptevo Therapeutics Inc, Arno Therapeutics Inc, ArQule Inc, Astellas Pharma Inc, Astex Pharmaceuticals Inc, Baliopharm AG, Bayer AG, BeiGene Ltd, Bellicum Pharmaceuticals Inc, Biogen Inc, Bionomics Ltd, Bionovis SA, Biothera Pharmaceutical Inc, Boehringer Ingelheim GmbH, Bristol-Myers Squibb Company, Celgene Corp, Cellectis SA, Cellular Biomedicine Group Inc, Coherus BioSciences Inc, CrystalGenomics Inc, Cyclacel Pharmaceuticals Inc, Daiichi Sankyo Company Ltd, Eli Lilly and Company, F. Hoffmann-La Roche Ltd, GeneaMed Ltd, Genentech Inc, Genor BioPharma Co Ltd, Gilead Sciences Inc, Grupo Ferrer Internacional SA, Hutchison MediPharma Ltd, Hybrigenics SA, Igenica Biotherapeutics Inc, Immatics Biotechnologies GmbH, ImmunoGen Inc, Immunomedics Inc, Incyte Corp, Inflection Biosciences Ltd, Innate Pharma SA, Innovent Biologics Inc, Johnson & Johnson, Juno Therapeutics Inc, Kancera AB, Karyopharm Therapeutics Inc, Kite Pharma Inc, Les Laboratoires Servier SAS, LFB SA, Lymphocyte Activation Technologies SA, Medicenna Therapeutics Inc, MENTRIK Biotech LLC, Merck & Co Inc, Merck KGaA, Mesoblast Ltd, Millennium Pharmaceuticals Inc, MorphoSys AG, NantKwest Inc, Nordic Nanovector ASA, Novartis AG, Oncternal Therapeutics, Inc., Ono Pharmaceutical Co Ltd, Panacea Biotec Ltd, PEP-Therapy SAS, Pfizer Inc, Pharmacyclics Inc, PIQUR Therapeutics AG, Portola Pharmaceuticals Inc, Redx Pharma Plc, Respiratorius AB, Revitope Oncology, Inc., Rhizen Pharmaceuticals SA, Sandoz International GmbH, Sanofi, Selvita SA, Simcere Pharmaceutical Group, Sorrento Therapeutics Inc, Supratek Pharma Inc, Takeda Pharmaceutical Company Ltd, Targazyme Inc, TG Therapeutics Inc, The International Biotechnology Center (IBC) Generium, Theravectys SA, Tolero Pharmaceuticals Inc, TRACON Pharmaceuticals Inc, Tragara Pharmaceuticals Inc, Trillium Therapeutics Inc, United BioPharma, Inc., Unum Therapeutics Inc, Verastem Inc, VioQuest Pharmaceuticals Inc, Viralytics Ltd, Xencor Inc, ZIOPHARM Oncology Inc and Zymeworks Inc. This research provides comprehensive information on the therapeutics under development for Chronic Lymphocytic Leukemia (CLL) (Oncology), complete with analysis by stage of development, drug target, mechanism of action (MoA), route of administration (RoA) and molecule type. The guide covers the descriptive pharmacological action of the therapeutics, its complete research and development history and latest news and press releases. Inquire more about this research report at http://www.reportsnreports.com/contacts/inquirybeforebuy.aspx?name=774108 The Chronic Lymphocytic Leukemia (CLL) (Oncology) pipeline guide also reviews of key players involved in therapeutic development for Chronic Lymphocytic Leukemia (CLL) and features dormant and discontinued projects. The guide covers therapeutics under Development by Companies /Universities /Institutes, the molecules developed by Companies in Pre-Registration, Phase III, Phase II, Phase I, Phase 0, IND/CTA Filed, Preclinical, Discovery and Unknown stages are 5, 5, 43, 45, 1, 3, 54, 13 and 1 respectively. Similarly, the Universities portfolio in Phase II, Phase I, Preclinical and Discovery stages comprises 4, 6, 8 and 7 molecules, respectively. Chronic Lymphocytic Leukemia (CLL) (Oncology) pipeline guide helps in identifying and tracking emerging players in the market and their portfolios, enhances decision making capabilities and helps to create effective counter strategies to gain competitive advantage. The guide is built using data and information sourced from Global Markets Directs proprietary databases, company/university websites, clinical trial registries, conferences, SEC filings, investor presentations and featured press releases from company/university sites and industry-specific third party sources. Additionally, various dynamic tracking processes ensure that the most recent developments are captured on a real time basis. Note: Certain content / sections in the pipeline guide may be removed or altered based on the availability and relevance of data. Buy a copy of this research report at http://www.reportsnreports.com/purchase.aspx?name=774108 • The pipeline guide provides a snapshot of the global therapeutic landscape of Chronic Lymphocytic Leukemia (CLL) (Oncology). • The pipeline guide reviews pipeline therapeutics for Chronic Lymphocytic Leukemia (CLL) (Oncology) by companies and universities/research institutes based on information derived from company and industry-specific sources. • The pipeline guide covers pipeline products based on several stages of development ranging from pre-registration till discovery and undisclosed stages. • The pipeline guide features descriptive drug profiles for the pipeline products which comprise, product description, descriptive licensing and collaboration details, R&D brief, MoA & other developmental activities. • The pipeline guide reviews key companies involved in Chronic Lymphocytic Leukemia (CLL) (Oncology) therapeutics and enlists all their major and minor projects. • The pipeline guide evaluates Chronic Lymphocytic Leukemia (CLL) (Oncology) therapeutics based on mechanism of action (MoA), drug target, route of administration (RoA) and molecule type. • The pipeline guide encapsulates all the dormant and discontinued pipeline projects. • The pipeline guide reviews latest news related to pipeline therapeutics for Chronic Lymphocytic Leukemia (CLL) (Oncology) • Procure strategically important competitor information, analysis, and insights to formulate effective R&D strategies. • Recognize emerging players with potentially strong product portfolio and create effective counter-strategies to gain competitive advantage. • Find and recognize significant and varied types of therapeutics under development for Chronic Lymphocytic Leukemia (CLL) (Oncology). • Classify potential new clients or partners in the target demographic. • Develop tactical initiatives by understanding the focus areas of leading companies. • Plan mergers and acquisitions meritoriously by identifying key players and it’s most promising pipeline therapeutics. • Formulate corrective measures for pipeline projects by understanding Chronic Lymphocytic Leukemia (CLL) (Oncology) pipeline depth and focus of Indication therapeutics. • Develop and design in-licensing and out-licensing strategies by identifying prospective partners with the most attractive projects to enhance and expand business potential and scope. • Adjust the therapeutic portfolio by recognizing discontinued projects and understand from the know-how what drove them from pipeline. For more information, please visit http://www.reportsnreports.com/reports/774108-chronic-lymphocytic-leukemia-cll-pipeline-review-h2-2016.html


Grant
Agency: GTR | Branch: EPSRC | Program: | Phase: Research Grant | Award Amount: 159.46K | Year: 2015

Drug development is a time consuming and expensive process. From the time a compound is identified as having possible therapeutic benefits through to being available in the clinic, takes not only the order of a decade, but 100s of millions of pounds of investment. Successful testing of a compound in the laboratory does not imply that it will be successful in animal or human trials, and even successful animal tests can lead to failure in human trials - a result of the complexity of biology at different scales. On average only one in nine drug compounds is fully developed and approved by US and European regulatory authorities. This low attrition rate is poor for drug companies, both in terms of time and costs, and ultimately us as a society. Understanding on the single cell scale does not easily translate to the same behaviour in human tissue, organs, whole humans and the overall population given individual differences. We wish to design drugs for large scale population use whilst accounting for the variation between individuals within a population. One technology available to us for tackling this issue is quantitative methods such as mechanistic mathematical modelling and data analysis. Current knowledge of a biological system can be used to develop mathematical models to identify key laboratory experiments, reduce reliance on animals and identify earlier which compounds are most likely to fail or succeed. The integration of subcellular information into whole individual mechanistic mathematical models to specifically assist in the development of pharmaco-therapeutics has been termed Quantitative Systems Pharmacology (QSP). Quantitative because the area uses quantitated processes and data to make predictions and Systems because the approach is holistic across the system (single cell to organ to whole individual). This is a new area of science which will require strong interactions between theoretical modellers (mathematicians, statisticians, engineers) and life and pharmaceutical scientists to ensure its success. Individual researchers from each of these areas can be found in both UK academic institutions and leading biopharmaceutical and biotechnology sectors and need to be brought together to allow this new field to thrive and develop in the UK. To meet this need we will establish a UK Network in QSP. The network will bring together UK pharmaceutical scientists from industry and academia, with theoretical scientists to exchange knowledge and tackle problems in QSP. The network will be arranged around three workshops (one per year), two of which will share knowledge through talks, poster sessions and group discussion on key topics in this burgeoning field. A third workshop will bring mathematical modelling expertise to bear on QSP problems highlighted by the academic and industrial network members. Satellite meetings will allow participants to further explore ideas generated from the main workshops. Our network already has strong support from biopharmaceutical and biotechnology sectors, with sites in the UK, and leading academic institutions. The network will lead to: (i) new collaborations; (ii) project applications (grant, studentship, fellowship); (iii) scientific publications; (iv) open access mathematical models and their associated code; (v) greater awareness of QSP in the UK pharmaceutical, life and physical science communities; (vi) education and training for those based in industry (and academia) on modelling tools and techniques to support; (vii) greater public awareness of QSP in the development of new drugs and therapeutic agents; (viii) foster the development of mathematical models as surrogates for the ex-vivo and in-vivo animal systems currently used to extrapolate efficacy and toxicity responses to drugs; and (ix) develop and strengthen international links between the UK and other key international initiatives in Systems Pharmacology research.


The invention relates to administration of an anti-CTLA-4 antibody, particularly human antibodies to human CTLA-4, such as those having amino acid sequences of antibodies 3.1.1, 4.1.1, 4.8.1, 4.10.2, 4.13.1, 4.14.3, 6.1.1, 11.2.1, 11.6.1, 11.7.1, 12.3.1.1, 12.9.1.1, and MDX-010, in combination with an immunostimulatory nucleotide, i.e., CpG ODN PF3512676, for treatment of cancer. The invention relates to administering a combination of an anti-CTLA-4 antibody and CpG ODN PF3512676 as neoadjuvant, adjuvant, first-line, second-line, and third-line therapy of cancer, whether localized or metastasized, and at any point(s) along the disease continuum (e.g., at any stage of the cancer).


Patent
Coley Pharmaceutical Gmbh, Pfizer and Coley Pharmaceutical Group | Date: 2012-05-14

Immunostimulatory oligonucleotides, which contain a CpG immunostimulatory motif and a second motif that is capable of forming secondary structure, including duplex and higher order structures in vitro and in vivo, are disclosed. They include nucleic acids, or pharmaceutically acceptable salts thereof, having base sequences that include 5 TCGTCGTTTTCGGCGCGCGCCGT 3 (SEQ ID NO: 1), in which each C is unmethylated and 3 refers to the 3 end of the nucleic acid. The oligonucleotides activate B cells and NK cells and induce expression of type I interferon and interferon-. The oligonucleotides are useful for treating a variety of disorders and conditions, including allergy, asthma, infection, and cancer. In addition to their use as single agents and as combination therapies, the disclosed oligonucleotides are useful as adjuvants in vaccines.


Grant
Agency: Cordis | Branch: FP7 | Program: MC-ITN | Phase: FP7-PEOPLE-2011-ITN | Award Amount: 3.63M | Year: 2011

The aims of InnHF project are to offer a multidisciplinary training in the field of risk assessment and maintenance management integrated with human factors, in tight contact with companies and universities within this consortium; to strengthen and structure initial training of researchers in system engineering at European level; to attract students to scientific careers; to provide trained researchers with the necessary skills to work in industry; and to improve career perspectives by broad skills development. The INNHF scientific main objective is thus to formalize an approach and make it possible to integrate the current and developing assessment methods recommended or required by recognized industrial standards and methodologies, with an easy to use but complete human factors and system health management approach, the following goals will be achieved: 1) Review of the applicability of most recent generation standards that are not yet fully acquired by different industries and verification of their effectiveness in safety assessment. 2) Devising a method to account qualitatively and quantitatively for the human factor in the wider applied risk assessment methodologies. Verifying how a proper account of the impact of human and organizational factors (H&OF) in the operational phase may provide a sensitive change in the results of the assessments. 3) Reviewing the methods to account qualitatively and quantitatively for maintenance effectiveness, taking also into account HOFs, verifying how a proper account of the maintenance strategy may provide a sensitive change in the results of the assessments. 4) To translate the results of the analysis performed through the novel approach in a factual design improvement initiative for new or existing plant or machinery able to provide leverage for competitive advantage (maximum availability, minimum unscheduled shutdowns of production, economic maintenance, minimum incident incident and accident).


Grant
Agency: Cordis | Branch: FP7 | Program: MC-ITN | Phase: FP7-PEOPLE-2011-ITN | Award Amount: 3.52M | Year: 2012

TRAIN-ASAP addresses a very urgent public health issue. The lack of effective antibacterial drugs against resistant bacteria poses a serious threat to human health and has huge economical consequences to the healthcare system. The objective of this ITN is to fill the current gap between the burden of infections due to resistant bacteria and the strong need for alternative solutions to combat antibiotic resistance in both humans and animals. Young researchers will be trained in the scientific and complementary skills needed to implement a broad range of antibacterial approaches including discovery of new antibiotics, synthesis of antimicrobial peptides with improved pharmacological properties, improvement of the clinical efficacy of currently known drugs, and alternative strategies based on phages and bacteriocin-producing organisms. TRAIN-ASAP is a multidisciplinary and intersectorial ITN dedicated to the scientific and professional training of 14 early-stage researchers, including 2 financed by the University of Copenhagen, with the aim to develop novel antibacterial solutions for humans and animals. The consortium includes 7 academic institutions, 9 private enterprises and 2 national research centres representing 9 countries. The training programme is characterized by a unique innovative and multidisciplinary approach based on the use of front line research tools in molecular biology, combinatorial chemistry and in vivo pharmacology, an appropriate balance between scientific and generic skills training, and a strong contribution by the private partners in the form of mentoring, courses and secondments. Considering the urgent need for new drugs to combat antibiotic resistance and the growing demand for skilled scientists specialised in antibacterial drug discovery, TRAIN-ASAP is expected to have a strong impact on the careers of the trainees and result in a lasting collaboration between the partners and political, societal and economical benefits to Europe.


Grant
Agency: GTR | Branch: BBSRC | Program: | Phase: Training Grant | Award Amount: 91.93K | Year: 2011

Monoclonal IgGs have been one of the most successful discoveries in biotechnology and are used as reagents in biochemistry, diagnostics and treatment of human disease. Despite their successes, IgG molecules have practical limitations as they are large (~150 kDa) tetrameric structures. Their size and structural complexity renders them problematic to manufacture and expensive to distribute due to the need for cold storage. The limitations of the IgG have stimulated the investigation of other, recently discovered, immune proteins such as the shark VNAR (variable domain of the IgNAR, or Novel Antigen Receptor). IgNARs are a unique class of protein that have been identified in the serum of cartilaginous fish. The VNAR can be isolated as a monomeric binding domain of 12-15 kDa in size, and their smaller size makes them an attractive alternative to IgG as they have the potential to penetrate dense tissues that may be inaccessible to IgG. In addition, VNARs have been identified as possible biotherapeutics based on their robustness and solubility, propensity to bind to antigen clefts and block active sites of enzymes, and high binding affinities for a range of antigens. Pfizer has therefore developed designer synthetic libraries based on the VNAR domain. While technological relatives like the camelid VHH have been well characterized and are in clinical trials for a number of applications, the VNAR is much less well understood structurally and biophysically. The VNAR domain shares structural features with the T-cell receptor Va and the IgG Vk-chain, but sequence homology with these domains is low (~35%). The VNAR contains a relatively short CDR1 loop (CDR = Complementarity Determining Region) and a longer CDR3 loop, which create the main binding surface of the domain. Pfizer has developed large libraries of VNAR containing synthetic diversity in these key binding loops and has used these libraries to derive domains which recognise and antagonise a wide variety of drug targets, including the Receptor for Advanced Glycation End-products (RAGE). RAGE is a multi-ligand member of the immunoglobulin super-family that is implicated in the septic response. This project will investigate synthetic VNARs known to target the RAGE protein and establish a structural understanding of synthetic VNAR CDR loops and their mechanism of antigen binding. As the CDR loops have come from random amino acid diversity, rather than natural D-segment encoded diversity, their structures are likely to be novel and cannot be predicted a priori. Indeed, even for natural IgNARs, the CDRs have shown evidence for induced fit in co-crystal structures. The project will therefore focus on deriving the structures of a number of RAGE-specific synthetic VNARs via solution NMR. The structure of each clone will be derived in both the free and antigen-complexed states. Project plan: 1.Synthetic VNAR targeting RAGE were identified previously via phage display. They therefore express well in bacteria and will be cloned for overexpression in E. coli. 2.The RAGE ectodomain and a number of sequential domain deletions will be expressed and purified for use in binding assays with the purified VNARs from (1). These assays will identify domain-specificity among the VNARs and the subsequent choice of RAGE sub domains to be expressed with isotopic labels (according to established protocols in Dixon lab). 3.The expressed proteins from (1) and (2) will be used to derive solution NMR structures, investigating the structure, dynamics and antigen recognition modality of the CDR loops. 4.A lead VNAR clone will be chosen based on data from (3). This clone will undergo a 6 month process of display-based affinity maturation (placement period for the student, in Pfizer laboratories Dublin). 5.Repeat (1-3) using the affinity matured synthetic VNARs that have acquired mutations in the CDR regions, to investigate dynamics of CDR structure and mechanism of antigen recognition.


Patent
Pfizer, Coley Pharmaceutical Group and Coley Pharmaceutical GmbH | Date: 2013-05-15

Immunostimulatory oligonucleotides, which contain a CpG immunostimulatory motif and a second motif that is capable of forming secondary structure, including duplex and higher order structures in vitro and in vivo, are disclosed. They include nucleic acids, or pharmaceutically acceptable salts thereof, having base sequences that include 5 TCGTCGTTTTCGGCGCGCGCCGT 3 (SEQ ID NO: 1), in which each C is unmethylated and 3 refers to the 3 end of the nucleic acid. The oligonucleotides activate B cells and NK cells and induce expression of type I interferon and interferon-gamma. The oligonucleotides are useful for treating a variety of disorders and conditions, including allergy, asthma, infection, and cancer. In addition to their use as single agents and as combination therapies, the disclosed oligonucleotides are useful as adjuvants in vaccines.


News Article | November 21, 2016
Site: globenewswire.com

WALTHAM, Mass., Nov. 21, 2016 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat and SNDX-6352 in multiple cancer indications, today announced that Chief Executive Officer Briggs W. Morrison, M.D., will present at the 28th Annual Piper Jaffray Healthcare Conference on November 30, 2016 at 9:50 am EST at the Lotte New York Palace Hotel. A live webcast of the Company’s presentation can be accessed from the Investor section of the Company's website at www.syndax.com, where a replay of the event will also be available for a limited time. Syndax is a clinical stage biopharmaceutical company focused on developing an innovative pipeline of combination therapies in multiple cancer indications. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Syndax is developing entinostat, which has direct effects on both cancer cells and immune regulatory cells, and SNDX-6352, an anti-CSF-1R monoclonal antibody, to potentially enhance the body's immune response on tumors that have shown sensitivity to immunotherapy. Entinostat is being evaluated as a combination therapeutic in Phase 1b/2 clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma, with Genentech, Inc. for TNBC, and with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. SNDX-6352 is being evaluated in a single ascending dose Phase 1 clinical trial and is expected to be developed to treat a variety of cancers. For more information on Syndax, please visit www.syndax.com.


SAN DIEGO--(BUSINESS WIRE)--Seattle Genetics, Inc. (Nasdaq: SGEN), a global biotechnology company, today presented data from a phase 2 clinical trial evaluating ADCETRIS (brentuximab vedotin) combination therapy in frontline diffuse large B-cell lymphoma (DLBCL) at the 58th American Society of Hematology (ASH) Annual Meeting and Exposition taking place in San Diego, California, December 3-6, 2016. ADCETRIS is an antibody-drug conjugate (ADC) directed to CD30, expressed on several types of non-Hodgkin lymphoma. ADCETRIS is currently not approved for the treatment of DLBCL. Data from the phase 2 study in newly diagnosed intermediate-high or high-risk DLBCL included the evaluation of ADCETRIS in combination with either rituximab (Rituxan), cyclophosphamide, doxorubicin, vincristine and prednisone (referred to as RCHOP) in 51 patients (Part 1); or RCHP (removing the vincristine) in 11 patients (Part 2). In Part 1, the objective response rate was 83 percent, including 69 percent complete remissions. In Part 2, the objective response rate was 91 percent, including 82 percent complete remissions. The most common adverse events in Part 1 and 2 were fatigue, peripheral sensory neuropathy, diarrhea, nausea, alopecia and constipation. “The data from this phase 2 trial demonstrate that ADCETRIS is an active agent in the treatment of frontline DLBCL,” said Jonathan Drachman, M.D., Chief Medical Officer and Executive Vice President, Research and Development at Seattle Genetics. “However, based on prioritization of our pipeline, we are discontinuing this trial and have decided not to pursue a registrational pathway for ADCETRIS in frontline DLBCL. We continue to evaluate ADCETRIS in the treatment of relapsed or refractory DLBCL through an ongoing randomized phase 2 trial, as well as more broadly for other CD30-expressing lymphomas, including the ECHELON-1 and ECHELON-2 phase 3 trials in frontline classical Hodgkin lymphoma and frontline mature T-cell lymphoma, respectively.” Results of an Ongoing Phase 2 Study of Brentuximab Vedotin with RCHP as Frontline Therapy in Patients with High-Intermediate/High-Risk Diffuse Large B-Cell Lymphoma (Abstract #104, oral presentation at 9:45 a.m. PT) Data were reported from Parts 1 and 2 of the phase 2 clinical trial for intermediate-high or high-risk frontline DLBCL. In Part 1, 51 patients were treated once every three weeks with up to six cycles of either 1.2 milligrams per kilogram (mg/kg) or 1.8 mg/kg of ADCETRIS plus RCHOP. In Part 2, 11 patients were treated once every three weeks with up to six cycles of 1.8 mg/kg of ADCETRIS plus RCHP. The median age of patients in Part 1 was 67 years and in Part 2 was 59 years. More than 90 percent of patients had stage III or IV disease. ADCETRIS is being evaluated broadly in more than 70 ongoing clinical trials, including three phase 3 studies, the ongoing ECHELON-1 trial in frontline classical Hodgkin lymphoma and the ongoing ECHELON-2 trial in frontline mature T-cell lymphomas, as well as the completed ALCANZA trial in cutaneous T-cell lymphoma for which a supplemental BLA is planned in the first half of 2017. ADCETRIS is an ADC comprising an anti-CD30 monoclonal antibody attached by a protease-cleavable linker to a microtubule disrupting agent, monomethyl auristatin E (MMAE), utilizing Seattle Genetics’ proprietary technology. The ADC employs a linker system that is designed to be stable in the bloodstream but to release MMAE upon internalization into CD30-expressing tumor cells. ADCETRIS for intravenous injection has received approval from the FDA for three indications: (1) regular approval for the treatment of patients with classical Hodgkin lymphoma after failure of autologous hematopoietic stem cell transplantation (auto-HSCT) or after failure of at least two prior multi-agent chemotherapy regimens in patients who are not auto-HSCT candidates, (2) regular approval for the treatment of classical Hodgkin lymphoma patients at high risk of relapse or progression as post-auto-HSCT consolidation, and (3) accelerated approval for the treatment of patients with systemic anaplastic large cell lymphoma (sALCL) after failure of at least one prior multi-agent chemotherapy regimen. The sALCL indication is approved under accelerated approval based on overall response rate. Continued approval for the sALCL indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Health Canada granted ADCETRIS approval with conditions for relapsed or refractory Hodgkin lymphoma and sALCL. ADCETRIS was granted conditional marketing authorization by the European Commission in October 2012 for two indications: (1) for the treatment of adult patients with relapsed or refractory CD30-positive Hodgkin lymphoma following autologous stem cell transplant (ASCT), or following at least two prior therapies when ASCT or multi-agent chemotherapy is not a treatment option, and (2) the treatment of adult patients with relapsed or refractory sALCL. The European Commission extended the current conditional approval of ADCETRIS and approved ADCETRIS for the treatment of adult patients with CD30-positive Hodgkin lymphoma at increased risk of relapse or progression following ASCT. ADCETRIS has received marketing authorization by regulatory authorities in 65 countries. See important safety information below. Seattle Genetics and Takeda are jointly developing ADCETRIS. Under the terms of the collaboration agreement, Seattle Genetics has U.S. and Canadian commercialization rights and Takeda has rights to commercialize ADCETRIS in the rest of the world. Seattle Genetics and Takeda are funding joint development costs for ADCETRIS on a 50:50 basis, except in Japan where Takeda is solely responsible for development costs. Seattle Genetics is an innovative biotechnology company that develops and commercializes novel antibody-based therapies for the treatment of cancer. The company’s industry-leading antibody-drug conjugate (ADC) technology harnesses the targeting ability of antibodies to deliver cell-killing agents directly to cancer cells. ADCETRIS® (brentuximab vedotin), the company’s lead product, in collaboration with Takeda Pharmaceutical Company Limited, is the first in a new class of ADCs commercially available globally in 65 countries for relapsed classical Hodgkin lymphoma and relapsed systemic anaplastic large cell lymphoma (sALCL). Seattle Genetics is also advancing vadastuximab talirine (SGN-CD33A; 33A), an ADC in a phase 3 trial for acute myeloid leukemia. Headquartered in Bothell, Washington, Seattle Genetics has a robust pipeline of innovative therapies for blood-related cancers and solid tumors designed to address significant unmet medical needs and improve treatment outcomes for patients. The company has collaborations for its proprietary ADC technology with a number of companies including AbbVie, Astellas, Bayer, Genentech, GlaxoSmithKline and Pfizer. More information can be found at www.seattlegenetics.com Progressive multifocal leukoencephalopathy (PML): JC virus infection resulting in PML and death can occur in patients receiving ADCETRIS. ADCETRIS is contraindicated with concomitant bleomycin due to pulmonary toxicity (e.g., interstitial infiltration and/or inflammation). In two uncontrolled single-arm trials of ADCETRIS as monotherapy in 160 patients with relapsed classical HL and sALCL, the most common adverse reactions (≥20%), regardless of causality, were: neutropenia, peripheral sensory neuropathy, fatigue, nausea, anemia, upper respiratory tract infection, diarrhea, pyrexia, rash, thrombocytopenia, cough and vomiting. In a placebo-controlled trial of ADCETRIS in 329 patients with classical HL at high risk of relapse or progression post-auto-HSCT, the most common adverse reactions (≥20%) in the ADCETRIS-treatment arm (167 patients), regardless of causality, were: neutropenia, peripheral sensory neuropathy, thrombocytopenia, anemia, upper respiratory tract infection, fatigue, peripheral motor neuropathy, nausea, cough, and diarrhea. Concomitant use of strong CYP3A4 inhibitors or inducers, or P-gp inhibitors, has the potential to affect the exposure to monomethyl auristatin E (MMAE). MMAE exposure and adverse reactions are increased in patients with moderate or severe hepatic impairment or severe renal impairment. Avoid use. Advise females of reproductive potential to avoid pregnancy during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS. Advise males with female sexual partners of reproductive potential to use effective contraception during ADCETRIS treatment and for at least 6 months after the final dose of ADCETRIS. Advise patients to report pregnancy immediately and avoid breastfeeding while receiving ADCETRIS. For additional Important Safety Information, including Boxed WARNING, please see the full Prescribing Information for ADCETRIS at www.seattlegenetics.com or www.ADCETRIS.com. Certain of the statements made in this press release are forward looking, such as those, among others, relating to the therapeutic and commercial potential of ADCETRIS, including ADCETRIS’ potential as a treatment for DLBCL and the anticipated benefits of Seattle Genetics’ ADCETRIS clinical development program. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. Factors that may cause such a difference include the risks of adverse events associated with ADCETRIS use, negative or unexpected results from the clinical trials with ADCETRIS even after promising results in earlier company- and investigator-sponsored trials, and adverse regulatory actions affecting ADCETRIS, all of which could result in Seattle Genetics being unable to expand ADCETRIS’ labeled indications of use. Seattle Genetics may also experience delays in the conduct of and obtaining data from ADCETRIS clinical trials, in each case for a variety of reasons, including the inherent difficulty and uncertainty of pharmaceutical product development. More information about the risks and uncertainties faced by Seattle Genetics is contained under the caption “Risk Factors” included in the company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2016 filed with the Securities and Exchange Commission. Seattle Genetics disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.


Encore 601 refractory melanoma cohort to proceed to second stage of Phase 2; pre-specified objective response criteria satisfied Enrollment of the first stage of both NSCLC cohorts completed; decision whether to progress each cohort into the second stage of Phase 2 anticipated in 1H2017 WALTHAM, Mass., March 02, 2017 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, Inc. ("Syndax," the "Company" or "we") (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat and SNDX-6352 in multiple cancer indications, today reported its financial results for the fourth quarter and year ended December 31, 2016. In addition, the Company provided a pipeline update as well as a review of upcoming milestones. As of December 31, 2016, Syndax had $105.3 million in cash, cash equivalents and short-term investments. "We’re pleased to report that the melanoma cohort of ENCORE 601 has met the pre-specified objective response threshold to advance into the second stage of the phase 2 trial and will re-open enrollment immediately,” said Briggs W. Morrison, M.D., Chief Executive Officer of Syndax.  “The goal of the first stage of the trial was to determine whether the combination of entinostat and Merck’s anti-PD-1 therapy, KEYTRUDA® (pembrolizumab), could generate a meaningful response in patients enrolled in each cohort. Specifically, in the cohort of melanoma patients who had experienced disease progression while on a PD-1 antagonist, a minimum of 2 out of 13 patients needed to demonstrate a confirmed objective response for this cohort to advance to the next stage. The trial will now enroll an additional 21 patients, with accrual targeted to be completed by the end of the fourth quarter of this year.” "This is an encouraging early signal for entinostat combined with KEYTRUDA®, as this population of patients is poorly served by existing therapies. We are looking forward to seeing the stage one results of this combination in the non-small cell lung cancer cohorts of ENCORE 601 as well," said Michael L. Meyers, M.D., Ph.D., Chief Medical Officer of Syndax. Syndax Expects to Participate in the Following Upcoming Conferences As of December 31, 2016, Syndax had cash, cash equivalents and short-term investments of $105.3 million and 18,223,723 shares issued and outstanding. Fourth quarter 2016 research and development expenses increased to $8.5 million from $2.6 million for the comparable period in the prior year. Research and development expenses for the year ended December 31, 2016 increased to $31.7 million compared to $9.5 million for the prior year. These increases were primarily due to increased patient accrual costs in E2112, higher expenses associated with the Phase 2 expansion of ENCORE 601, and the commencement of ENCORE 602 as well as the upfront payment related to expanding the pipeline with SNDX-6352 and initiation of a Phase 1 trial. General and administrative expenses totaled $3.0 million during the fourth quarter of 2016 and $13.3 million for the year, similar to the $2.4 million and $11.6 million expense level for the respective prior year periods. For the three months ended December 31, 2016, Syndax reported a net loss attributable to common stockholders of $10.8 million or $0.59 per share compared to $8.8 million or $105.57 per share for the comparable prior year period. For the year ended December 31, 2016, Syndax reported a net loss attributable to common stockholders of $47.1 million or $3.22 per share, compared to $103.8 million or $1,519.27 per share for the prior year period. In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET today, Thursday, March 2, 2017. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website at www.syndax.com.  Alternatively, the conference call may be accessed through the following: For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company's website, www.syndax.com. Syndax is a clinical stage biopharmaceutical company focused on developing an innovative pipeline of combination therapies in multiple cancer indications. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Syndax is developing entinostat, which has direct effects on both cancer cells and immune regulatory cells, and SNDX-6352, an anti-CSF-1R monoclonal antibody, to enhance the body's immune response on tumors that have shown sensitivity to immunotherapy. Entinostat is being evaluated as a combination therapeutic in Phase 1b/2 clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma; with Genentech, Inc. for TNBC; and with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. SNDX-6352 is being evaluated in a single ascending dose Phase 1 clinical trial and is expected to be developed to treat a variety of cancers. For more information on Syndax, please visit www.syndax.com. This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of SNDX-6352 to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


WALTHAM, Mass., Feb. 16, 2017 (GLOBE NEWSWIRE) -- Syndax (Nasdaq:SNDX) announced today that it will release its fourth quarter 2016 financial results on Thursday, March 2, 2017, after the close of the U.S. financial markets. In connection with the earnings release, Syndax's management team will host a conference call and live audio webcast at 4:30 p.m. ET on Thursday, March 2, 2017, to discuss the Company's financial results and provide a general business update. The live audio webcast and accompanying slides may be accessed through the Events & Presentations page in the Investors section of the Company's website at www.syndax.com.  Alternatively, the conference call may be accessed through the following: For those unable to participate in the conference call or webcast, a replay will be available for 30 days on the Investors section of the Company's website, www.syndax.com. About Syndax Pharmaceuticals, Inc. Syndax is a clinical stage biopharmaceutical company focused on developing an innovative pipeline of combination therapies in multiple cancer indications. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Syndax is developing entinostat, which has direct effects on both cancer cells and immune regulatory cells, and SNDX-6352, an anti-CSF-1R monoclonal antibody, to enhance the body's immune response on tumors that have shown sensitivity to immunotherapy. Entinostat is being evaluated as a combination therapeutic in Phase 1b/2 clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma; with Genentech, Inc. for TNBC; and with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. SNDX-6352 is being evaluated in a single ascending dose Phase 1 clinical trial and is expected to be developed to treat a variety of cancers. For more information on Syndax, please visit www.syndax.com. Syndax’s Cautionary Note on Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as "may," "will," "expect," "plan," "anticipate," "estimate," "intend," "believe" and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Syndax's expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include, but are not limited to, statements about the progress, timing, clinical development and scope of clinical trials and the reporting of clinical data for Syndax's product candidates, and the potential use of SNDX-6352 to treat various cancer indications. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during preclinical or clinical studies, clinical trial site activation or enrollment rates that are lower than expected, changes in expected or existing competition, changes in the regulatory environment, failure of Syndax's collaborators to support or advance collaborations or product candidates and unexpected litigation or other disputes. Other factors that may cause Syndax's actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Syndax's filings with the U.S. Securities and Exchange Commission, including the "Risk Factors" sections contained therein. Except as required by law, Syndax assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.


News Article | February 17, 2017
Site: www.businesswire.com

L'ERC de phase 3, conduit auprès de 220 patients atteints de la maladie de Crohn, avait pour objet de comparer le CT-P13 à l'infliximab de référence à l'aune de l'indice d'activité de la maladie de Crohn (CDAI), une mesure utilisée pour quantifier les symptômes des patients atteints de cette maladie. Les données émanant de l'essai sur 6 semaines et sur 30 semaines ont permis d'observer une rémission clinique et des taux de CDAI-70 et de CDAI-100 similaires dans les groupes traités par le CT-P13 et par l'infliximab de référence.1 Celltrion Healthcare a également présenté des données provenant de deux études d'observation. La première a évalué l'efficacité et l'innocuité du CT-P13 chez 74 patients pédiatriques atteints de la maladie de Crohn (dont 26 n'avaient jamais été traités et 25 étaient en période de transition entre deux traitements) ou de colite ulcéreuse (CU) (dont 16 n'avaient jamais été traités et 7 étaient en période de transition entre deux traitements). Les données observées montrent que le CT-P13 est efficace après 30 semaines, chez les patients dont c'est le premier traitement comme chez les autres, et qu'il est bien toléré.2 La seconde étude a examiné 204 patients atteints de la maladie de Crohn (dont 24 étaient atteints de la maladie de Crohn fistulisante et 180 de la maladie de Crohn à un degré sévère à modéré) en Corée du Sud de juillet 2012 à 2016. Le CT-P13 a présenté une efficacité clinique cohérente avec celle de l'infliximab de référence et a été bien toléré jusqu'à six mois chez les deux types de patients.3 Les retombées économiques concrètes associées à l'utilisation du CT-P13 dans le cadre de toutes ses prescriptions ont été étudiées dans cinq pays européens entre début 2015 et la fin du premier semestre 2016. Selon les données présentées à l'ECCO, les économies totales observées pour l'Allemagne, l'Italie, l'Espagne et le Royaume-Uni se sont élevées à 32,4 millions d'euros, ce qui laisse penser que 5 428 patients supplémentaires par an pourraient bénéficier de cette thérapie biologique de premier plan. En France, les tarifs de l'infliximab biosimilaire et de référence sont les mêmes, et aucune économie n'a donc été enregistrée. Il convient toutefois de noter une hausse de l'utilisation du CT-P13 dans ce pays.4 Man Hoon Kim, président et CEO de Celltrion Healthcare, déclare « Chez Celltrion, notre mission est de répondre aux besoins de la communauté clinique en conduisant des analyses scientifiques fiables. Cet ERC pivot sur le traitement de la maladie de Crohn en est une parfaite illustration, et ses conclusions corroborent nos autres ERC et nombreuses études de cas appliqués aux MII. Il est également gratifiant de constater l'impact économique positif du CT-P13 sur les systèmes de santé financièrement limités d'Europe. » Celltrion Healthcare se charge de la commercialisation, la vente et la distribution de médicaments biologiques mis au point par Celltrion, Inc. à travers un réseau mondial couvrant plus de 120 pays. Les produits de Celltrion Healthcare sont fabriqués dans des installations de pointe destinées à la culture de cellules de mammifères et conformes aux normes de bonnes pratiques de fabrication de la FDA américaine et de l’EMA. Pour de plus amples renseignements, visitez le site : http://www.celltrionhealthcare.com/ L'étude est un essai de phase 3 randomisé en double aveugle avec groupes parallèles dont l'objet est de comparer l'efficacité et l'innocuité du CT-P13 et de l'infliximab de référence auprès de patients atteints de la maladie de Crohn. 220 patients ont été répartis aléatoirement dans 58 centres d'études à travers 16 pays. 214 d'entre eux ont poursuivi le traitement jusqu'à la semaine 6 pour l'analyse primaire, et les 180 restants ont poursuivi le traitement jusqu'à la semaine 30. L'étude a été financée à parts égales par Celltrion et Pfizer. Le CT-P13 est développé et fabriqué par Celltrion, Inc. et a été le premier anticorps monoclonal biosimilaire approuvé par l’Agence européenne des médicaments (EMA). Il est indiqué pour le traitement de huit maladies auto-immunes, notamment la polyarthrite rhumatoïde et les maladies inflammatoires de l’intestin. Le CT-P13 a été approuvé par l’EMA sous le nom commercial Remsima® en septembre 2013 et lancé en Europe début 2015. La FDA a approuvé le CT-P13 de Celltrion en avril 2016 sous le nom commercial Inflectra™. Le CT-P13 de Celltrion est approuvé dans plus de 79 pays (au mois de janvier 2017), y compris les États-Unis, le Canada, le Japon et dans toute l’Europe. 1 Kim, Y.H. et al. Phase Ⅲ Randomised, Double-blind, Controlled Trial to Compare Biosimilar Infliximab (CT-P13) with innovator Infliximab (INX) in Patients with Active Crohn’s Disease: Early Efficacy and Safety Results. Congrès de l'Organisation Européenne de la Maladie de Crohn et de la Colite (ECCO) 2017. DOP061 2 Choe, Y.H. et al. Effectiveness and Safety of CT-P13 under Routine Care in Paediatric Patients with Inflammatory Bowel Disease. Congrès de l'Organisation Européenne de la Maladie de Crohn et de la Colite (ECCO) 2017. P487 3 Choe, Y.H. et al. Effectiveness and Safety in Crohn’s Disease Patients Who Were Treated with CT-P13. Congrès de l'Organisation Européenne de la Maladie de Crohn et de la Colite (ECCO) 2017. P500. 4 Han, S. et al. The pharmacoeconomic impact of biosimilar infliximab (CT-P13) in Europe from January 2015 to June 2016. Congrès de l'Organisation Européenne de la Maladie de Crohn et de la Colite (ECCO) 2017. P582 5 Molodecky NA, et al. Increasing incidence and prevalence of the inflammatory bowel diseases with time, based on systematic review. Gastroenterology. 2012; 142(1)46–54. Consultable à l'adresse : www.gastrojournal.org/article/S0016-5085(11)01378-3/pdf [Dernière visite janvier 2017]. 6 Burisch J, et al. The burden of inflammatory bowel disease in Europe. Journal of Crohn's and Colitis (2013) 7, 322-337.


News Article | November 17, 2016
Site: globenewswire.com

« Le développement de Sodexo se poursuit, porté par une croissance vigoureuse en Services sur Site en Amérique du Nord et au Royaume-Uni, et en Services Avantages et Récompenses. Cette performance s'inscrit  dans une conjoncture défavorable sur les marchés de matières premières, qui a pesé sur la performance en Bases-Vie, et une situation difficile en France. Hors Bases-Vie, la croissance interne est de + 4 %. En outre, le Groupe a atteint une nouvelle fois l'objectif de croissance du résultat opérationnel, en hausse de + 8,2 % sur l'exercice (avant coûts exceptionnels et hors effet de change), ce qui représente une progression de la marge opérationnelle de + 30 points de base. La nouvelle organisation par segments mondiaux de clientèle porte ses fruits dès cette année avec la signature d'un contrat majeur avec Rio Tinto en mars, suivie par les contrats signés avec Shell et Seadrill, et par l'extension géographique des contrats avec Pfizer ou Unilever. Nous sommes fiers de ces partenariats majeurs, qui reflètent les investissements réalisés depuis 10 ans dans notre offre de services intégrés, et la reconnaissance de notre expertise technique. Ils traduisent parfaitement notre promesse d'amélioration de la qualité de vie des femmes et des hommes que nous servons. Nous regardons l'avenir avec confiance, et prévoyons, pour l'exercice 2016-2017, une croissance interne du chiffre d'affaires autour de 3 % et une amélioration du résultat opérationnel avant coûts exceptionnels liés au Programme d'adaptation et de simplification, comprise entre 8 % et 9 % (hors effet de change) ». Le Conseil d'administration et le Comité exécutif sont confiants dans le potentiel de développement du Groupe. Au cours de l'exercice 2016-2017, la stabilisation des marchés des matières premières à laquelle on assiste depuis plusieurs trimestres devrait offrir un point d'appui à l'activité Bases-Vie du Groupe, le segment Éducation aux États-Unis bénéficiera des nouveaux contrats signés avec des écoles, et la base de comparaison sera plus favorable en France. Le Programme d'adaptation et de simplification est bien engagé. Une revalorisation du real brésilien semble s'amorcer. La Direction Générale de Sodexo donne la priorité à l'accélération de la croissance et à l'amélioration des marges. À propos de Sodexo Créé en 1966 à Marseille par Pierre Bellon, Sodexo est le leader mondial des services de Qualité de Vie, facteur essentiel de performance des individus et des organisations. Présent dans 80 pays, Sodexo sert chaque jour 75 millions de consommateurs avec une offre unique de Services sur Site, de Services Avantages et Récompenses et de Services aux Particuliers et à Domicile. Avec plus de 100 métiers, Sodexo propose à ses clients une offre intégrée de services, fruit de 50 ans d'expérience : de la restauration à l'accueil, la propreté, l'entretien et la maintenance technique des matériels et installations ; des Pass Repas, Pass Cadeaux et Pass Transports pour les salariés jusqu'aux services d'aide à domicile, de crèches et de conciergerie. La réussite et la performance de Sodexo reposent sur son indépendance, son modèle économique durable, ainsi que sa capacité à assurer le développement et l'engagement de ses 425 000 collaborateurs à travers le monde. Sodexo est membre des indices CAC 40 et DJSI. Au cours de l'exercice 2015-2016, l'ensemble des activités a contribué à la croissance interne[13] de + 2,5 %, à l'exception des Bases-Vie, en repli de - 16 % du fait d'un net ralentissement de l'activité des secteurs minier et pétrolier. Hors Bases-Vie, la croissance interne atteint + 4 %, soutenue à hauteur de + 0,5 % par les effets de la Coupe du Monde de Rugby au Royaume-Uni au premier trimestre et du fait de la bonne tenue des Services Avantages et Récompenses. Par région, on constate une accélération de la croissance en Amérique du Nord, une progression vigoureuse au Royaume-Uni et en Irlande. L'Europe continentale affiche une hausse de + 1,0 % avec une amélioration en Entreprises et Administrations, et une croissance soutenue en Allemagne et Russie, mais impactée par une situation difficile en France, notamment au quatrième trimestre. Le résultat opérationnel hors effets de change et coûts exceptionnels[14], ressort en hausse de + 8,2 %, en ligne avec l'objectif fixé au début de l'exercice. La marge opérationnelle s'est améliorée de + 30 points de base, hors effet de change, soutenue par des gains de productivité et les premiers résultats du Programme d'adaptation et de simplification lancé au début de l'exercice.  Des coûts exceptionnels de 108 millions d'euros  ont été enregistrés au cours de l'exercice au titre de ce programme. Les frais financiers nets ont légèrement augmenté compte tenu d'une indemnité exceptionnelle de 21 millions d'euros liée au remboursement par anticipation d'emprunts souscrits auprès d'investisseurs américains ; Cette opération s'inscrit dans le cadre d'un programme de restructuration de la dette visant à étendre les maturités et à diminuer les taux de financement. Le taux d'imposition a également légèrement augmenté à 33,7 % par rapport au taux exceptionnellement bas de 31,1 % enregistré l'année dernière. Par conséquent, le résultat net part du Groupe diminue de - 9 %. Le résultat net avant ces éléments non récurrents[15] et hors variations de change, s'est inscrit en hausse de + 5,2 %. Au cours de l'exercice 2015-2016, les liquidités générées par les opérations se sont élevées à 595 millions d'euros, après des investissements opérationnels inhabituellement élevés liés à la mobilisation du contrat Rio Tinto et à un décalage dans le temps entre les encaissements et les décaissements liées à la Coupe du Monde de Rugby. L'endettement net[16] est en légère hausse à 407 millions d'euros, mais le bilan reste solide avec un taux d'endettement net[17] de 11 % et un ratio d'endettement net[18] de 0,3. En mars, Sodexo a remporté un contrat de dix ans d'un montant estimé à près de 2,5 milliards de dollars australiens (environ 1,8 milliard d'euros) auprès du conglomérat minier international Rio Tinto pour délivrer une large gamme de services intégrés de facilities management sur les nombreux sites opérationnels du groupe dans la région de Pilbara, en Australie. Il s'agit du plus gros contrat de cette nature jamais signé par Sodexo. Les actifs de Rio Tinto dans cette région regroupent des ports, des communes, des aérodromes, des sites d'exploitation, des sites d'hébergement, des bâtiments commerciaux et des biens résidentiels. Sodexo a remporté ce contrat après avoir fait la démonstration de plusieurs de ses points forts dans des domaines essentiels : cohérence et qualité des services, démarche d'amélioration de la qualité de vie dans les villages et engagement fort en faveur des communautés locales. Les équipes de Sodexo assureront ainsi la gestion de projets, l'entretien des bâtiments et des espaces verts, les services d'hébergement et de restauration, les services communaux, le nettoyage, l'exploitation des aérodromes, les transports et la gestion du domaine. Les différentes phases de mobilisation progressent conformément aux prévisions et la mise en oeuvre complète du contrat devrait être effective au cours de l'exercice 2016-2017. La capacité de l'équipe mondiale du segment Energie et Ressources à mobiliser plus de 100 experts à tous les niveaux du Groupe a été déterminante dans l'obtention de ce contrat d'un montant exceptionnel. La crise qui touche le secteur de l'énergie et des ressources a incité les clients à prendre conscience des avantages dont ils peuvent bénéficier en confiant des contrats mondiaux à leurs prestataires de services. De fait, le Groupe a signé en septembre le renouvellement de deux contrats : l'un Seadrill, spécialiste de premier plan des forages en mer, et l'autre avec Shell. Le premier, d'un montant total de 200 millions d'euros, couvre 90 % de la flotte mondiale de Seadrill pour une durée de cinq ans. Le contrat avec Shell représente 135 millions d'euros dans cinq régions du monde. Ces succès s'appuient sur l'engagement du Groupe en matière de sécurité et de performance, son exceptionnelle culture du service, son expertise technique et son approche globale de la Qualité de Vie. Sodexo continue également de renforcer ses relations avec ses clients existants partout dans le monde. Sodexo a ainsi signé des contrats de services intégrés de facilities management avec Danone et Unilever en Indonésie, Huawei en Roumanie, en Colombie et en Malaisie ou encore Pfizer dans 12 pays asiatiques. L'offre pour les salons et clubs des compagnies aériennes proposée au niveau mondial attire des clients tels qu'United Airlines. Dans tous ces exemples, la clé de la réussite du Groupe réside dans l'intérêt pour le client de bénéficier d'une offre de services intégrés, homogène au niveau mondial mais aussi adaptée à l'environnement local. Le Groupe a signé son premier contrat sur le marché australien de la justice pour une durée de cinq ans (reconductible pour deux autres périodes de cinq ans) avec le gouvernement d'Australie-Occidentale pour assurer la gestion et l'exploitation du nouvel établissement pour femmes à Melaleuca, un centre de détention provisoire et de réinsertion de 254 places. Dans le cadre de ce contrat, qui prend effet en décembre 2016, Sodexo va développer des partenariats avec des organisations non gouvernementales pour proposer des services et des programmes de réhabilitation et de réinsertion adaptés aux spécificités culturelles locales, afin d'aider les détenues à réussir leur réinsertion au sein de la société, et de réduire ainsi le risque de récidive. La longue et fructueuse expérience acquise par le Groupe, qui assure la gestion et l'exploitation de plus de 120 établissements dans le secteur de la justice à l'international, a été un facteur décisif dans l'obtention de ce contrat. De fait, l'expérience accumulée pendant 20 ans dans la gestion de l'ensemble des services dans des établissements pénitentiaires pour femmes au Royaume-Uni a constitué un élément essentiel de l'offre. Dans le cadre de son offre Clinical Technology Solutions, Sodexo a installé et assure maintenant l'exploitation d'un lithotripteur (appareil permettant la pulvérisation et l'élimination de calculs rénaux) pour le Makati Medical Center, un des meilleurs hôpitaux des Philippines. Pour ce contrat de 5 ans, Sodexo a recommandé l'équipement, acquis l'appareil, formé le personnel et réalise à présent les lithotripsies et les services associés. Cette réussite n'aurait pas été possible sans l'expertise et le partage d'expérience des équipes de ce segment. Le taux d'engagement des employés a progressé de + 9 points depuis 2014 pour atteindre 68 %. La dernière enquête d'engagement a été réalisée pour la première fois auprès de l'ensemble des collaborateurs du Groupe ayant plus de six mois d'ancienneté, au niveau mondial. Avec un taux de réponse de 57 % et une amélioration de neuf points du taux d'engagement à 68 %, cette enquête en ligne est une réussite, dépassant à la fois la moyenne externe de 60 % et l'objectif interne du Groupe qui était fixé à 65 %. Parmi les autres enseignements de l'enquête : 80 % des employés considèrent Sodexo comme une entreprise responsable d'un point de vue social et environnemental, et 88 % d'entre eux préfèrent travailler pour Sodexo que pour un concurrent. A l'occasion de la réunion annuelle consacrée aux Principes d'autonomisation des Femmes des Nations Unies, Michel Landel, Directeur Général du Groupe, et Janet Awad, Présidente de la région Amérique latine, ont remporté le CEO Leadership Award pour leur engagement exemplaire et la mise en oeuvre de politiques en faveur de l'avancement et de l'autonomisation des femmes au travail et dans la communauté. L'ONU a tout particulièrement mis en avant le Sodexo Women's International Forum for talent (SWIFt), au coeur de la stratégie de Sodexo en faveur du renforcement de la mixité au sein du Groupe. Sodexo et le WWF ont travaillé ensemble à la conception et à la mise en oeuvre de bonnes pratiques visant à réduire l'impact environnemental des prestations du Groupe sur les sites de ses clients, parmi lesquelles un programme de réduction des déchets alimentaires et le déploiement de technologies permettant de diminuer de la consommation d'énergie de 12 % à 45 %. L'écart de change est déterminé en appliquant les taux de change moyens de l'exercice précédent aux montants de l'exercice en cours à l'exception du bolivar vénézuélien pour l'activité Services Avantages et Récompenses. Toutes les données en VEF pour les exercices 2015-2016 et 2014-2015 ont été converties au taux de change de 1 USD = 645 VEF vs. 199 VEF utilisé pour l'exercice 2014-2015. Durant l'exercice 2015-2016, le taux de fidélisation des clients est resté stable à 93,1 %. En effet, l'amélioration enregistrée en Amérique du Nord et au Royaume-Uni où le Groupe signe des contrats de plus en plus importants renouvelés moins fréquemment, a été compensée par une baisse du taux de fidélisation dans le Reste du Monde, notamment en Amérique latine. Le taux de développement (gain de nouveaux contrats) est ressorti à 7,2 %, en baisse de 30 points de base : les nouveaux contrats importants signés dans le Reste du Monde (dont le contrat Rio Tinto) ont été contrebalancés par un faible développement dans les Universités en Amérique du Nord, ainsi qu'au Royaume-Uni et en Irlande, compte tenu des nombreux démarrages des contrats remportés au cours de l'exercice 2014-2015. Dans les autres régions, les gains de nouveaux contrats sont restés relativement stables. La croissance sur sites existants ressort à +2,1 %, un niveau similaire aux +2,2 % enregistrés pour l'exercice 2014-2015. La baisse significative des volumes en Bases-Vie a été compensée par une augmentation des extensions de contrats dans les services intégrés de facilities management dans les sites existants sur l'ensemble des autres segments. En Europe Continentale, le chiffre d'affaires s'élève à 5,7 milliards d'euros, un niveau stable par rapport à l'exercice précédent. La croissance interne ressort à + 1,0 % avec une certaine reprise de l'activité en Entreprises et Administrations dans la plupart des pays matures de la région, ainsi qu'une croissance soutenue en Allemagne, Russie et dans les économies en développement. Cette performance est impactée par une situation difficile en France sur l'ensemble de l'exercice, et plus particulièrement au quatrième trimestre en raison des grèves, des inondations et des attentats terroristes. Sur le segment Entreprises et Administrations, la croissance interne de + 1,7 % s'explique par une croissance modeste du chiffre d'affaires sur site en Europe du sud et dans les pays nordiques mais progression vigoureuse dans les économies en développement, notamment en Russie et en Turquie, grâce au succès continu de l'offre de services intégrés. En France, le secteur de la Justice est impacté par la perte d'un contrat, tandis que le segment Sports et Loisirs, en particulier le tourisme fluvial sur la Seine, a été sévèrement touché par une saison touristique décevante cet été à Paris, liée aux inondations de juin et aux attentats terroristes de novembre 2015 et juillet 2016. La contraction de - 1,3 % du chiffre d'affaires du segment Santé et Seniors résulte principalement d'une faible croissance sur site et de l'approche sélective adoptée pour les nouveaux contrats, notamment en France. Le marché français est par ailleurs impacté par des programmes de réductions de coûts et par l'absence de nouvelles opportunités de développement sur le segment des hôpitaux publics. La montée en puissance du contrat Korian signé l'année dernière sur le segment Seniors se déroule de manière satisfaisante. Sodexo enregistre de bons résultats dans les pays nordiques, avec la mobilisation du contrat pour la fourniture de matériel médical à domicile pour la population de la province d'Östergötland en Suède. En Entreprises et Administrations, la croissance interne du chiffre d'affaires s'élève à + 14,2 %. Cette très bonne performance s'explique en grande partie par la Coupe du Monde de Rugby qui contribue au chiffre d'affaires durant le premier trimestre, à hauteur de 131 millions d'euros, et à la croissance interne pour + 8,3 %. Toutefois, même si l'on exclut cet élément, la croissance reste solide à + 5,9 % grâce à la mobilisation progressive d'importants contrats remportés durant l'exercice 2014-2015 (Transforming Rehabilitation, Diageo.) ainsi qu'aux extensions de contrats pour une gamme élargie de services de facilities management auprès de nos clients existants. Le développement commercial est plus modeste en 2015-2016 compte-tenu du niveau élevé des mobilisations réalisées sur les contrats signés au cours de l'exercice précédent. En Santé et Seniors, la croissance interne s'établit à + 19,4 %, tirée par de nouveaux succès commerciaux et par la croissance sur sites existants, en particulier en Amérique latine et en Asie. Le chiffre d'affaires de l'activité Services Avantages et Récompenses s'élève à 780 millions d'euros, en baisse de - 5,7 %, sous l'effet notamment de la forte dépréciation du real brésilien. La croissance interne du volume d'émission s'inscrit en hausse de + 6,9 %, grâce à la relative bonne tenue de l'ensemble des régions, avec une forte augmentation de la valeur faciale au Brésil, une croissance soutenue en Europe et une progression particulièrement vigoureuse au Mexique, au Chili et en Turquie. La croissance interne du chiffre d'affaires est cependant plus modeste. Elle s'établit à + 4,7 %, en raison d'une forte concurrence sur les prix au Brésil, notamment de la part des acteurs plus modestes, et de la faiblesse exceptionnelle des taux d'intérêt en Europe. En Europe et en Asie, les volumes d'émission ont enregistré une croissance interne solide de + 6,2 %. La croissance interne du chiffre d'affaires a cependant été plus modeste à + 3,1 %. L'écart de croissance entre les volumes d'émission et le chiffre d'affaires s'explique principalement par le niveau historiquement faible des taux d'intérêt dans les pays européens matures. La demande de produits existants et nouveaux est restée forte sur l'ensemble des marchés, le taux de pénétration a continué à progresser en Asie, et la dynamique est restée vigoureuse en Turquie. Le résultat opérationnel avant coûts exceptionnels s'élève à 1 203 millions d'euros pour l'exercice 2015-2016, en hausse de + 8,2 % hors effet de change et en ligne avec l'objectif du Groupe pour l'exercice. La marge opérationnelle avant coûts exceptionnels ressort à 5,9 % et progresse de + 10 points de base par rapport à l'exercice précédent. Hors effet de change, et notamment la faiblesse du real brésilien, l'amélioration de la marge atteint +30 points de base. Le résultat opérationnel et la marge opérationnelle de l'activité Services Avantages et Récompenses ont été impactés par la forte variation de change du real brésilien, en baisse de - 18,9 % par rapport à l'euro. Hors effet de change, la progression est de + 8,8 % pour le résultat opérationnel et de + 110 points de base pour la marge opérationnelle. Cette solide performance s'explique par une bonne maîtrise des frais de structure et l'optimisation continue des charges opérationnelles. Par conséquent, le résultat net part du Groupe s'établit à 637 millions d'euros, en recul de - 9 %. Le résultat net part du Groupe avant éléments non récurrents (nets d'impôts) s'élève à 721 millions d'euros, en progression de + 3,0 %, soit + 5,2 % hors effet de change. Les éléments non récurrents comprennent 108 millions d'euros de coûts exceptionnels et 21 millions d'euros liés à l'indemnité résultant du remboursement anticipé de la dette, soit respectivement 71 millions d'euros et 13 millions d'euros nets d'impôts. Le bénéfice net par action avant éléments non récurrents s'élève à 4,77 euros, en hausse de + 3,7 %, et à 4,21 euros, en baisse de - 8,5 % après éléments non récurrents. Cette modeste relution par rapport à la variation du résultat net (- 9 %) est due à l'effet du rachat d'actions de 300 millions d'euros effectué au cours de l'exercice, net de la réduction de l'autocontrôle, entraînant la diminution du nombre moyen pondéré d'actions. Sur l'exercice 2015-2016, le Groupe a renforcé sa présence sur le marché portugais des Services Avantages et Récompenses. En Services aux Particuliers et à Domicile, la filiale Comfort Keepers a renforcé sa présence aux États-Unis et en Irlande. L'investissement total en acquisitions en 2015-2016 s'élève à 42 millions d'euros, net de quelques ventes d'activités. Au 31 août 2016, l'endettement net s'élève à 407 millions d'euros et représente 11 % des capitaux propres du Groupe (contre 9 % au 31 août 2015). La situation financière du Groupe reste solide, les liquidités générées par les opérations suffisant à couvrir la majeure partie des investissements et le dividende, ainsi que le Programme de rachat d'actions de 300 millions d'euros. Durant l'exercice 2015-2016, le Groupe a également remboursé 526 millions d'euros de dette, dont un remboursement anticipé de 184 millions d'euros, dans le cadre d'un Programme de restructuration de la dette visant à étendre les maturités et à profiter de l'opportunité offerte par des taux d'intérêt extrêmement bas. Ainsi la trésorerie et la dette brute sont en diminution par rapport au 31 aout 2015. Les frais financiers moyens ont été ramenés de 3,8 % pour l'exercice 2014-2015 à 3,2 % durant l'exercice 2015-2016, et le taux pro forma après refinancement est estimé à 2,7 %. En Europe, la base de comparaison sera plus favorable en France, mais plus difficile au Royaume-Uni, en l'absence de la Coupe du Monde de Rugby. Ailleurs, la lente reprise des économies matures et la dynamique vigoureuse des pays en développement devraient se poursuivre. Le Programme d'adaptation et de simplification est en passe de générer des économies beaucoup plus importantes en 2016-2017 que durant l'exercice 2015-2016. L'objectif de 200 millions d'euros d'économies devrait être atteint durant l'exercice 2017-2018. Ces initiatives permettront d'améliorer la rentabilité et de libérer des ressources pour poursuivre le développement des plateformes opérationnelles de services, de solutions numériques innovantes centrées sur le consommateur et de l'offre de services intégrés de Qualité de Vie. Les coûts exceptionnels représentent les coûts de la mise en oeuvre du Programme d'adaptation et de simplification et du Programme d'amélioration de l'efficacité opérationnelle (108 millions d'euros pour l'exercice 2015-2016, néant pour l'exercice 2014-2015 et 27 millions d'euros pour l'exercice 2013-2014). Les coûts exceptionnels représentent les coûts de la mise en oeuvre du Programme d'adaptation et de simplification et du Programme d'amélioration de l'efficacité opérationnelle (108 M€ pour l'exercice 2015-2016, néant pour l'exercice 2014-2015 et 27 M€ pour l'exercice 2013-2014) Pour les économies en situation d'hyperinflation l'ensemble des chiffres sont convertis au dernier taux de clôture pour les deux périodes. De ce fait, pour les Services Avantages et Récompenses, toutes les données en bolivar vénézuélien pour les exercices 2015-2016 et 2014-2015 ont été converties au taux de change de 1 USD = 645 VEF (vs. 199 VEF pour l'exercice 2014-2015). Les éléments non récurrents au titre de l'exercice 2015-2016 comprennent, dans le résultat opérationnel les coûts exceptionnels liés au Programme d'adaptation et de simplification pour 108 millions d'euros, et dans le résultat financier l'indemnité résultant du remboursement anticipé de la dette pour 21 millions d'euros, soit respectivement 71 millions d'euros et 13 millions d'euros nets d'impôts. Aucun élément n'était considéré comme non récurrent pour l'exercice 2014-2015. Résultat net publié avant éléments non récurrents (pour l'exercice 2015-2016, les coûts exceptionnels et l'indemnité pour remboursement anticipé, tous deux nets d'impôts de 71 millions d'euros et 13 millions d'euros et néant pour l'exercice 2014-2015). [3] Les éléments non récurrents comprennent 108 millions d'euros de coûts exceptionnels et 21 millions d'euros liés à l'indemnité résultant du remboursement anticipé de la dette, soit respectivement 71 millions d'euros et 13 millions d'euros net d'impôts. [8] Éléments non récurrents : 108 millions d'euros de coûts exceptionnels et 21 millions d'euros liés à l'indemnité résultant du remboursement anticipé de la dette, soit respectivement 71 millions d'euros et 13 millions d'euros net d'impôts. [13] Croissance interne : variation du chiffre d'affaires à taux de change (conversion des chiffres de l'exercice 2015-2016 aux taux de l'exercice 2014-2015) et périmètre constants, à l'exception du bolivar vénézuélien en Services Avantages et Récompenses (le chiffre d'affaires et le volume d'émission pour les exercices 2015-2016 et 2014-2015 ont été convertis au taux de change de 1 USD = 645 VEF vs. 199 VEF pour l'exercice 2014-2015). [15] Éléments non récurrents : 108 millions d'euros de coûts exceptionnels et 21 millions d'euros liés à l'indemnité résultant du remboursement anticipé de la dette, soit respectivement 71 millions d'euros et 13 millions d'euros net d'impôts. [19] Croissance interne : variation du chiffre d'affaires à taux de change constants (conversion des chiffres de 2015-2016 aux taux de l'exercice 2014-2015)  et périmètre constants, à l'exception du bolivar vénézuélien en Services Avantages et Récompenses. Le chiffre d'affaires et le volume d'émission  pour les exercices 2015-2016 et 2014-2015 ont été convertis au taux de change de 1 USD = 645 VEF vs. 199 VEF pour l'exercice 2014-2015. [21] Croissance interne : variation du chiffre d'affaires à périmètre et taux de change constants à l'exception du bolivar vénézuélien (le chiffre d'affaires et le volume d'émission pour les exercices 2015-2016 et 2014-2015 ont été convertis au taux de change de 1 USD = 645 VEF vs. 199 VEF pour l'exercice 2014-2015).


News Article | February 28, 2017
Site: globenewswire.com

ROCKVILLE, Md., Feb. 28, 2017 (GLOBE NEWSWIRE) -- MacroGenics, Inc. (NASDAQ:MGNX), a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases, today provided a corporate progress update and reported financial results for the year ended December 31, 2016. “MacroGenics continues to advance its broad pipeline of clinical compounds, including those in our HER2, B7-H3 and PD-1 franchises as well as the many bispecific product candidates based on our DART® platform,” said Scott Koenig, M.D., Ph.D., President and CEO of MacroGenics. “Across our portfolio of proprietary antibody and DART-based oncology programs, we now have initial evidence of on-target engagement, manageable safety and anti-tumor activity. In addition, I am very encouraged by the biological activity observed in subjects treated with MacroGenics’ autoimmune DART molecule, MGD010. We will continue to advance our robust pipeline in 2017, including defining future development strategies for multiple programs based on data expected later this year.” Margetuximab. Recent highlights related to the Company’s Fc-optimized monoclonal antibody that targets the human epidermal growth factor receptor 2, or HER2, include: B7-H3 Franchise. MacroGenics is developing a portfolio of therapeutics that target B7-H3, a member of the B7 family of molecules involved in immune regulation. The Company is advancing multiple programs that target B7-H3 through complementary mechanisms of action that take advantage of this antigen's broad expression across multiple solid tumor types. These molecules include: PD-1-Directed Immuno-Oncology Franchise. MacroGenics is advancing several PD-1-directed programs, which will enable both a broad set of combination opportunities across the Company’s portfolio and provide further differentiation from existing PD-1-based treatment options. The first of these are: Additional DART Clinical Programs. Additional DART molecules in Phase 1 clinical development include flotetuzumab (CD123 x CD3, also known as MGD006 and S80880); MGD007 (gpA33 x CD3); MGD010 (CD32B x CD79B); duvortuxizumab (CD19 x CD3, also known as MGD011), which is being developed by Janssen; and PF-06671008 (P-cadherin x CD3), which is being developed by Pfizer. At its R&D Day in December 2016, MacroGenics provided an in-depth update on its portfolio of proprietary, clinical DART programs. The Company highlighted the promising features of these DART molecules, including on-target engagement, manageable safety as well as preliminary evidence of biological activity. Updates on three of these programs for which MacroGenics leads development include: MacroGenics will host a conference call today at 4:30 pm (EST) to discuss the 2016 financial results and provide a corporate update. To participate in the conference call, please dial (877) 303-6253 (domestic) or (973) 409-9610 (international) five minutes prior to the start of the call and provide the Conference ID: 58247768. The recorded, listen-only webcast of the conference call can be accessed under "Events & Presentations" in the Investor Relations section of the Company's website at http://ir.macrogenics.com/events.cfm. A replay of the webcast will be available shortly after the conclusion of the call and archived on the Company's website for 30 days following the call. MacroGenics is a clinical-stage biopharmaceutical company focused on discovering and developing innovative monoclonal antibody-based therapeutics for the treatment of cancer, as well as autoimmune disorders and infectious diseases. The Company generates its pipeline of product candidates primarily from its proprietary suite of next-generation antibody-based technology platforms. The combination of MacroGenics' technology platforms and protein engineering expertise has allowed the Company to generate promising product candidates and enter into several strategic collaborations with global pharmaceutical and biotechnology companies. For more information, please see the Company's website at www.macrogenics.com. MacroGenics, the MacroGenics logo and DART are trademarks or registered trademarks of MacroGenics, Inc. Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the Company's strategy, future operations, clinical development of the Company's therapeutic candidates, milestone or opt-in payments from the Company's collaborators, the Company's anticipated milestones and future expectations and plans and prospects for the Company and other statements containing the words "subject to", "believe", "anticipate", "plan", "expect", "intend", "estimate", "project", "may", "will", "should", "would", "could", "can", the negatives thereof, variations thereon and similar expressions, or by discussions of strategy constitute forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation and enrollment of future clinical trials, expectations of expanding ongoing clinical trials, availability and timing of data from ongoing clinical trials, expectations for regulatory approvals, other matters that could affect the availability or commercial potential of the Company's product candidates and other risks described in the Company's filings with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company's views only as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company's views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so, except as may be required by law. These forward-looking statements should not be relied upon as representing the Company's views as of any date subsequent to the date hereof.


News Article | February 27, 2017
Site: globenewswire.com

WALTHAM, Mass., Feb. 27, 2017 (GLOBE NEWSWIRE) -- Syndax Pharmaceuticals, Inc. (Nasdaq:SNDX), a clinical stage biopharmaceutical company focused on developing entinostat and SNDX-6352 in multiple cancer indications, today announced its planned participation in three upcoming investor conferences. The details for the three conferences are: A live webcast of these presentations can be accessed from the Investor section of the Company's website at www.syndax.com, where a replay of the events will also be available for a limited time. Syndax is a clinical stage biopharmaceutical company focused on developing an innovative pipeline of combination therapies in multiple cancer indications. Our lead product candidate, entinostat, which was granted Breakthrough Therapy designation by the FDA following positive results from our Phase 2b clinical trial, ENCORE 301, is currently being evaluated in a Phase 3 clinical trial for advanced hormone receptor positive, human epidermal growth factor receptor 2 negative breast cancer. Syndax is developing entinostat, which has direct effects on both cancer cells and immune regulatory cells, and SNDX-6352, an anti-CSF-1R monoclonal antibody, to enhance the body's immune response on tumors that have shown sensitivity to immunotherapy. Entinostat is being evaluated as a combination therapeutic in Phase 1b/2 clinical trials with Merck & Co., Inc. for non-small cell lung cancer and melanoma; with Genentech, Inc. for TNBC; and with Pfizer Inc. and Merck KGaA, Darmstadt, Germany, for ovarian cancer. SNDX-6352 is being evaluated in a single ascending dose Phase 1 clinical trial and is expected to be developed to treat a variety of cancers. For more information on Syndax, please visit www.syndax.com.


News Article | February 28, 2017
Site: www.businesswire.com

SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ: LGND) announces that it has expanded its license with Sermonix Pharmaceuticals to include worldwide rights to develop and commercialize oral lasofoxifene. Ligand originally licensed the U.S. rights to oral lasofoxifene to Sermonix in February of 2015, and has now expanded the agreement to include the rest of the world. Sermonix is focused on breast and ovarian cancer treatment with oral lasofoxifene, particularly an indication in the treatment of advanced Estrogen Receptor positive (ER+) endocrine-resistant breast cancer. “Lasofoxifene is an asset with a rich heritage originating at Ligand and with a substantial set of global clinical data. This agreement with Sermonix represents an expansion of our relationship and enables further development of oral lasofoxifene on a worldwide basis,” said John Higgins, Chief Executive Officer of Ligand Pharmaceuticals. “This amendment includes an upfront payment, additional commercial milestones and 6% to 10% royalties on ex-US sales and is consistent with our shots-on-goal business model of partnering the development of our assets to create a robust pipeline with limited required R&D spending by Ligand.” Lasofoxifene was discovered through a research collaboration between Ligand and Pfizer that began in 1991. The oral, 0.5 mg form of lasofoxifene tartrate was developed by Pfizer under the trade name Fablyn®, and progressed through regulatory approval in the EU. After Pfizer acquired Wyeth and its drug Conbriza® (bazedoxifene), a similar SERM program, rights to all forms of lasofoxifene reverted to Ligand in 2011. In 2013 Ligand licensed lasofoxifene to Azure Biotech for the development of a novel formulation targeting an underserved market in women's health. Also in 2013, Ligand licensed to Ethicor Pharmaceuticals Ltd rights to manufacture and distribute oral lasofoxifene as an unlicensed medicinal product in the European Economic Area, Switzerland and the Indian Subcontinent. Ligand and Ethicor mutually terminated that agreement in early 2017. Sermonix Pharmaceuticals LLC is a biotechnology company with a targeted focus on bringing female-specific oncology products through proof of concept, clinical development, and regulatory approval. The company was founded in 2014 by David Portman, MD, a leading clinical researcher and expert in women's health, menopause and selective estrogen receptor modulator (SERM) therapy. Sermonix has as its lead product oral lasofoxifene, with exclusive worldwide licensing rights obtained from Ligand Pharmaceuticals, Inc. (NASDAQ: LGND). The Sermonix internal management team, led by Dr. Portman, has significant experience in all stages of the drug development and regulatory process. James Symons, MS, PhD, is Vice President of Clinical Development at Sermonix, and led the global lasofoxifene VVA program while at Pfizer. Paul Plourde, MD, VP Sermonix Oncology Clinical Development, was previously with Astra-Zeneca, where he was instrumental in the development and approval of tamoxifen, Arimidex® and Faslodex®. Barry Komm, PhD, Sermonix Chief Scientific Officer, was former head of the SERM program at Wyeth and Pfizer, playing a key role in the development and approval of bazedoxifene and Duavee®. Elizabeth Attias, MMSc, ScD, is Vice President of Business Development. Miriam Portman, M.D., is the Chief Operating Officer of Sermonix. She is former Co-director and Founder of the Columbus Center for Women's Health Research. Sermonix Non-Executive Chairman of the Board is Anthony Wild, PhD, former president of both Parke-Davis Pharmaceuticals and Warner-Lambert's Pharmaceutical Division. Ligand is a biopharmaceutical company focused on developing or acquiring technologies that help pharmaceutical companies discover and develop medicines. Our business model creates value for stockholders by providing a diversified portfolio of biotech and pharmaceutical product revenue streams that are supported by an efficient and low corporate cost structure. Our goal is to offer investors an opportunity to participate in the promise of the biotech industry in a profitable, diversified and lower-risk business than a typical biotech company. Our business model is based on doing what we do best: drug discovery, early-stage drug development, product reformulation and partnering. We partner with other pharmaceutical companies to leverage what they do best (late-stage development, regulatory management and commercialization) to ultimately generate our revenue. Ligand’s Captisol® platform technology is a patent-protected, chemically modified cyclodextrin with a structure designed to optimize the solubility and stability of drugs. OmniAb® is a patent-protected transgenic animal platform used in the discovery of fully human mono-and bispecific therapeutic antibodies. Ligand has established multiple alliances, licenses and other business relationships with the world's leading pharmaceutical companies including Novartis, Amgen, Merck, Pfizer, Celgene, Gilead, Janssen, Baxter International and Eli Lilly. This news release contains forward-looking statements by Ligand that involve risks and uncertainties and reflect Ligand's judgment as of the date of this release. These include statements regarding Sermonix’s planned development of lasofoxifene including the target indications. Actual events or results may differ from our expectations. For example, Sermonix may choose to abandon lasofoxifene or may choose a different target indication; Sermonix’s clinical development plan may fail for a variety of reasons beyond Ligand’s and Sermonix’s control including increased costs or company priorities; and the safety, tolerability and efficacy data from a new clinical trial or other study in lasofoxifene may conflict with the results of prior clinical trials. The failure to meet expectations with respect to any of the foregoing matters may reduce Ligand's stock price. Additional information concerning these and other important risk factors affecting Ligand can be found in Ligand's prior press releases available at www.ligand.com as well as in Ligand's public periodic filings with the Securities and Exchange Commission, available at www.sec.gov. Ligand disclaims any intent or obligation to update these forward-looking statements beyond the date of this press release, except as required by law. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.


News Article | March 1, 2017
Site: www.prweb.com

On Saturday, March 18, 2017, Henry Ford Museum of American Innovation will host innovator and founder of Black Girls CODE Kimberly Bryant to share her personal story, as part of its Innovator Speakers Series at 1 pm inside the museum plaza. Recognized by the White House as a Champion of Change and a recipient of the American Ingenuity Award in Social Progress, Kimberly Bryant works to introduce young women of color to technology and computer science with a concentration on entrepreneurial concepts. Since 2011 Bryant has helped Black Girls CODE grow from a local organization serving only the Bay Area, to an international organization with seven chapters across the U.S. and in Johannesburg, South Africa. Black Girls CODE has currently reached over 3000 students and continues to grow and thrive. Prior to founding Black Girls CODE, she spent more than 25 years in the pharmaceutical and biotech industries as an Engineering Manager in a series of technical leadership roles for various Fortune 100 companies including Genentech, Merck and Pfizer. Detroit Drones Inc. will also be on-hand that day as part of Henry Ford Museum’s Make Something Saturdays program. Guests will get to experience drone racing on a simulator, dissect a drone to see how it works and get inspired by local entrepreneur Harry Anderson, founder of Detroit Drones Inc., as he demos a tethered drone and shares how his passion for STEM lead him into a successful drone-based business. Make Something Saturdays take place between 10 am – 3 pm and is targeted for youth ages 8-12. Admission to Kimberly Bryant’s talk is free for members. Non-member ticket prices include admission to Henry Ford Museum of American Innovation and are $22 for adults, $20 for seniors 62 and up and $16.25 for youth 3-11. Children two and under are free. For more information, call (313) 982-6001 or visit http://www.thehenryford.org. About The Henry Ford The Henry Ford in Dearborn, Michigan is an internationally-recognized history destination that explores the American experience of innovation, resourcefulness and ingenuity that helped shape America. A national historic landmark with an unparalleled Archive of American Innovation, The Henry Ford is a force for sparking curiosity and inspiring tomorrow’s innovators. Nearly 1.8 million visitors annually experience its five attractions: Henry Ford Museum of American Innovation, Greenfield Village, Ford Rouge Factory Tour, Benson Ford Research Center and The Henry Ford Giant Screen Experience. A continually expanding array of content available online provides anytime, anywhere access. The Henry Ford is also home to Henry Ford Academy, a public charter high school which educates over 500 students a year on the institution’s campus. In 2014, The Henry Ford premiered its first-ever national television series, The Henry Ford’s Innovation Nation, showcasing present-day change-makers and The Henry Ford’s artifacts and unique visitor experiences. Hosted by news correspondent and humorist, Mo Rocca, this Emmy®-winning weekly half-hour show airs Saturday mornings on CBS. For more information, please visit our website thehenryford.org.


News Article | February 17, 2017
Site: www.eurekalert.org

In 2014, more than 93,000 people in the United States died from Alzheimer's disease, according to the Centers for Disease Control and Prevention. The complex nature of Alzheimer's makes it difficult to understand and predict, until it's too late. Boston University professor and neuropsychologist Rhoda Au is trying to change that. Through the use of wearable digital devices, Au is collecting an enormous amount of data on people over time with the hope of finding the minute physical changes that correspond with the slow mental decline of Alzheimer's. Au, who discussed her research at the American Association for the Advancement of Science conference in Boston in February 2017, says that what she really wants is to never do another Alzheimer's test in the lab again. "It's really labor-intensive to bring people [into the lab]," she says, and it doesn't give a full picture of an illness. Cognitive decline can change day-to-day or even hour-to-hour, but lab tests are just a snapshot and don't provide the important nuances. Instead of lab tests, Au wants to use wearable devices to try to detect cognitive decline through how people live their daily lives. It's what she calls her e-cognitive health initiative--the official title is "Precision Monitoring of Preclinical Alzheimer's Disease: Framingham Study of Cognitive Epidemiology"--and she recently received funding from private industry partners, including Pfizer, for 2,200 people to participate in the initiative over three years. This will hopefully provide valuable information on how Alzheimer's and dementia progress. Right now, it is difficult to detect early preclinical Alzheimer's, a term for a progressing mental decline that does not yet meet the strict definition of Alzheimer's. "The idea of preclinical Alzheimer's disease is that, for people who are destined to develop dementia due to Alzheimer's disease, in the years before they become overtly cognitively impaired, there might be subtle things that change in their daily behavior that, if we knew what to look for, would disclose who might be at risk," says David Knopman, a neurologist at the Mayo Clinic in Rochester, Minnesota, who specializes in Alzheimer's disease, dementia, and cognitive impairment. Besides her position at BU, Au is the director of neuropsychology at the Framingham Heart Study (FHS). Since 1948, the FHS has followed over 5,000 participants from Framingham, Massachusetts, throughout their lives. Volunteer participants came in for regular checkups, and, over the years, scientists saw for the first time how cardiac problems progress in populations--what role lifestyle plays in heart disease and the signs leading up to diagnosis. Since then, the FHS has widened its focus to include all chronic diseases and taken on even more participants, including the children and grandchildren of the original 5,000. Au is now giving wearable devices to that second generation of 2,200 participants--although she doesn't know if every one of them will participate--and she has partnered with tech companies like AnthroTronix and Shimmer, an Irish-based company that creates wearables for detecting biophysical data. Over a three-year period, various wearable devices from these companies will measure everything from sleep to balance and fall risk to heart rate. Au even has smartphone apps to test cognitive ability at home. While all this data may hold vital clues to Alzheimer's and dementia, having so much information can present its own challenges. "We always need more terabytes," says Brynna Wasserman (ENG'15), Au's research assistant at the FHS. The digital devices project is only one of many pieces to Au's research--all of which are data-heavy. The neuropsychology group at the FHS has a shared hard drive, says Wasserman. "It has 10 terabytes on it. You'd think that would be enough." It's not. Wasserman says that they are constantly asking for more data storage, a problem that will only get more challenging as the lab collects additional data from the wearable devices. And analyzing the data presents an even bigger hurdle. Right now, Au is focused on how to collect the data, and digging through the information to find the clues to cognitive decline is something she is working on. But, she wrote in an email, that is another reason to partner with private companies. "I look to the academic community to help work through computation barriers that will lead to next-generation tools, but I look to the private companies for much more horsepower in us