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ONCODESIGN (Paris:ALONC) (FR0011766229 - ALONC), a biotechnology company serving the pharmaceutical industry in the discovery of new therapeutic molecules to fight cancer and other serious illnesses with no known effective treatment, has announced the opening of a period of exclusive negotiations to acquire Bertin Pharma's service businesses in Metabolism, Pharmacokinetics, Bio-analysis and Translational Medicine. These activities in the fields of immunology and infectiology will be an ideal fit with Oncodesign group's current service offering. The business portfolio under discussion has some 48 employees, with 2016 revenue of €5.3 million. It complements Oncodesign in many technological and regulatory areas and would contribute to the acceleration of Oncodesign group's 2017-2020 strategic plan for its service business. This project, which has been the subject of an information and consultation process with employee representative bodies, could be completed in the summer of 2017. At present it is not certain that any agreement will be reached nor that the transaction will be completed. No further comment will be made until an agreement is finalized. Founded over 20 years ago by Dr Philippe Genne, the Company’s CEO and Chairman, Oncodesign is a biotechnology company that maximises the pharmaceutical industry’s chances of success in discovering new therapeutic molecules to fight cancer and other serious illnesses with no known effective treatment. With its unique experience acquired by working with more than 600 clients, including the world’s largest pharmaceutical companies, along with its comprehensive technological platform combining state-of-the-art medicinal chemistry, advanced animal modelling and medical imaging, Oncodesign is able to predict and identify, at a very early stage, each molecule's therapeutic usefulness and potential to become an effective drug. Applied to kinase inhibitors, which represent a market estimated at over $46 billion in 2016 and accounting for almost 25% of the pharmaceutical industry’s R&D expenditure, Oncodesign’s technology has already enabled the targeting of several promising molecules with substantial therapeutic potential, in oncology and elsewhere, along with partnerships with pharmaceutical groups such as Bristol-Myers Squibb and UCB. Oncodesign is based in Dijon, France, in the heart of the town’s university and hospital hub, and within the Paris-Saclay cluster, Oncodesign has 165 employees and subsidiaries in Canada and the USA.


News Article | May 8, 2017
Site: www.eurekalert.org

New research from Boston Children's Hospital and Beth Israel Deaconess Medical Center (BIDMC) shows that chronic sleep loss increases pain sensitivity. It suggests that chronic pain sufferers can get relief by getting more sleep, or, short of that, taking medications to promote wakefulness such as caffeine. Both approaches performed better than standard analgesics in a rigorous study in mice, described in the May 8, 2017 issue of Nature Medicine. Pain physiologist Alban Latremoliere, PhD, of Boston Children's and sleep physiologist Chloe Alexandre, PhD, of BIDMC precisely measured the effects of acute or chronic sleep loss on sleepiness and sensitivity to both painful and non-painful stimuli. They then tested standard pain medications, like ibuprofen and morphine, as well as wakefulness-promoting agents like caffeine and modafinil. Their findings reveal an unexpected role for alertness in setting pain sensitivity. The team started by measuring normal sleep cycles, using tiny headsets that took electroencephalography (EEG) and electromyography (EMG) readings. "For each mouse, we have exact baseline data on how much they sleep and what their sensory sensitivity is," says Latremoliere, who works in the lab of Clifford Woolf, PhD, in the F.M. Kirby Neurobiology Center at Boston Children's. Next, unlike other sleep studies that force mice to stay awake walking treadmills or falling from platforms, Alexandre, Latremoliere and colleagues deprived mice of sleep in a way that mimics what happens with people: They entertained them. "We developed a protocol to chronically sleep-deprive mice in a non-stressful manner, by providing them with toys and activities at the time they were supposed to go to sleep, thereby extending the wake period," says Alexandre, who works in the lab of Thomas Scammell, MD, at BIDMC. "This is similar to what most of us do when we stay awake a little bit too much watching late-night TV each weekday." To keep the mice awake, researchers kept vigil, providing the mice with custom-made toys as interest flagged while being careful not to overstimulate them. "Mice love nesting, so when they started to get sleepy (as seen by their EEG/EMG pattern) we would give them nesting materials like a wipe or cotton ball," says Latremoliere. "Rodents also like chewing, so we introduced a lot of activities based around chewing, for example, having to chew through something to get to a cotton ball." In this way, they kept groups of six to 12 mice awake for as long as 12 hours in one session, or six hours for five consecutive days, monitoring sleepiness and stress hormones (to make sure they weren't stressed) and testing for pain along the way. Pain sensitivity was measured in a blinded fashion by exposing mice to controlled amounts of heat, cold, pressure or capsaicin (the agent in hot chili peppers) and then measuring how long it took the animal to move away (or lick away the discomfort caused by capsaicin). The researchers also tested responses to non-painful stimuli, such as jumping when startled by a sudden loud sound. "We found that five consecutive days of moderate sleep deprivation can significantly exacerbate pain sensitivity over time in otherwise healthy mice," says Alexandre. "The response was specific to pain, and was not due to a state of general hyperexcitability to any stimuli." Surprisingly, common analgesics like ibuprofen did not block sleep-loss-induced pain hypersensitivity. Even morphine lost most of its efficacy in sleep-deprived mice. These observations suggest that patients using these drugs for pain relief might have to increase their dose to compensate for lost efficacy due to sleep loss, thereby increasing their risk for side effects. In contrast, both caffeine and modafinil, drugs used to promote wakefulness, successfully blocked the pain hypersensitivity caused by both acute and chronic sleep loss. Interestingly, in non-sleep-deprived mice, these compounds had no analgesic properties. "This represents a new kind of analgesic that hadn't been considered before, one that depends on the biological state of the animal," says Woolf, director of the Kirby Center at Boston Children's. "Such drugs could help disrupt the chronic pain cycle, in which pain disrupts sleep, which then promotes pain, which further disrupts sleep." The researchers conclude that rather than just taking painkillers, patients with chronic pain might benefit from better sleep habits or sleep-promoting medications at night, coupled with daytime alertness-promoting agents to try to break the pain cycle. Some painkillers already include caffeine as an ingredient, although its mechanism of action isn't yet known. Both caffeine and modafinil boost dopamine circuits in the brain, so that may provide a clue. "This work was supported by a novel NIH program that required a pain scientist to join a non-pain scientist to tackle a completely new area of research," notes Scammel, professor of neurology at BIDMC. "This cross-disciplinary collaboration enabled our labs to discover unsuspected links between sleep and pain with actionable clinical implications for improving pain management." "Many patients with chronic pain suffer from poor sleep and daytime fatigue, and some pain medications themselves can contribute to these co-morbidities," notes Kiran Maski, MD, a specialist in sleep disorders at Boston Children's. "This study suggests a novel approach to pain management that would be relatively easy to implement in clinical care. Clinical research is needed to understand what sleep duration is required and to test the efficacy of wake-promoting medications in chronic pain patients." Alexandre (BIDMC) and Latremoliere (Boston Children's) were co-first authors on the paper. Woolf (Boston Children's) and Scammell (BIDMC) were co-senior authors. Ashley Ferreira and Giulia Miracca of Boston Children's and Mihoko Yamamoto of BIDMC were coauthors. This work was supported by grants from the NIH (R01DE022912, R01NS038253). The Neurodevelopmental Behavior and Pharmacokinetics Cores at Boston Children's Hospital, the metabolic Physiology Core at BIDMC (P30DK057521) and P01HL09491 also supported this study. Boston Children's Hospital is home to the world's largest research enterprise based at a pediatric medical center, where its discoveries have benefited both children and adults since 1869. More than 1,100 scientists, including seven members of the National Academy of Sciences, 11 members of the Institute of Medicine and 10 members of the Howard Hughes Medical Institute comprise Boston Children's research community. Founded as a 20-bed hospital for children, Boston Children's today is a 404-bed comprehensive center for pediatric and adolescent health care. Boston Children's is also the primary pediatric teaching affiliate of Harvard Medical School. For more, visit our Vector and Thriving blogs and follow us on our social media channels @BostonChildrens, @BCH_Innovation, Facebook and YouTube. Beth Israel Deaconess Medical Center is a patient care, teaching and research affiliate of Harvard Medical School and consistently ranks as a national leader among independent hospitals in National Institutes of Health funding. BIDMC is in the community with Beth Israel Deaconess Hospital-Milton, Beth Israel Deaconess Hospital-Needham, Beth Israel Deaconess Hospital-Plymouth, Anna Jaques Hospital, Cambridge Health Alliance, Lawrence General Hospital, MetroWest Medical Center, Signature Healthcare, Beth Israel Deaconess HealthCare, Community Care Alliance and Atrius Health. BIDMC is also clinically affiliated with the Joslin Diabetes Center and Hebrew Rehabilitation Center and is a research partner of Dana-Farber/Harvard Cancer Center and the Jackson Laboratory. BIDMC is the official hospital of the Boston Red Sox. For more information, visit http://www. .


News Article | February 22, 2017
Site: www.prweb.com

NDA Partners Chairman Carl Peck, MD, announced today that Dr. Daniel Spyker, PhD, MD former Acting Deputy Director in the FDA CDRH Division of Cardiovascular, Respiratory, and Neurological Devices and Medical Officer in CDER’s Pilot Drug Evaluation Staff has joined the company as an Expert Consultant. In Dr. Spyker’s accomplished career, he held positions as Senior Director of Drug Safety and Pharmacovigilance at Alexza Pharmaceuticals; Director, Pharmacokinetics and Pharmacodynamic Sciences, Genentech, where he established the clinical pharmacology unit; and Senior Medical Director, Clinical Risk Assessment and Coordination Department at Purdue Pharma. Dr. Spyker was a member of the Internal Medicine faculty in the Division of Clinical Pharmacology at the University of Virginia for 10 years, where he fostered and nurtured the Blue Ridge Poison Center. He was also founder and CEO of a software company specializing in poison center data collection and Bayesian pharmacokinetic applications. “Dr. Daniel Spkyer’s knowledge and expertise of cardiovascular, respiratory, and neurological devices at FDA and in the Industry, in addition to his expertise in quantitative clinical pharmacology and toxicology, make him an excellent addition to NDA Partners. He will bring great value to our medical device clients and we are very pleased to welcome him,” said Dr. Feigal, who heads NDA Partners’ Medical Device Practice. Dr. Spyker earned his PhD from the University of Minnesota in Electrical Engineering and Mathematics, his MD from the University of Virginia, and MS from Purdue University. He is board certified in Internal Medicine, a diplomate of the American Board of Medical Toxicology, and diplomate of the American Board of Clinical Pharmacology. About NDA Partners NDA Partners is a strategy consulting firm specializing in expert product development and regulatory advice to the medical products industry and associated service industries such as law firms, investment funds and government research agencies. The highly experienced Principals and Premier Experts of NDA Partners include three former FDA Center Directors; the former Chairman of the Medicines and Healthcare Products Regulatory Agency (MHRA) in the UK; an international team of more than 100 former pharmaceutical industry and regulatory agency senior executives; and an extensive roster of highly proficient experts in specialized areas including nonclinical development, toxicology, pharmacokinetics, CMC, medical device design control and quality systems, clinical development, regulatory submissions, and development program management. Services include product development and regulatory strategy, expert consulting, high-impact project teams, and virtual product development teams.


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

Dublin, Feb. 21, 2017 (GLOBE NEWSWIRE) -- Research and Markets has announced the addition of Jain PharmaBiotech's new report "Therapeutic Drug Monitoring - Technologies, Markets, and Companies" to their offering. This report deals with therapeutic drug monitoring, a multi-disciplinary clinical specialty, aimed at improving patient care by monitoring drug levels in the blood to individually adjust the dose of drugs for improving outcome. TDM is viewed as a component of personalized medicine that interacts with several other disciplines including pharmacokinetics and pharmacogenetics. One chapter is devoted to monitoring of drugs of abuse (DoA). Various technologies used for well-known DoA are described. A section on drug abuse describes methods of detection of performance-enhancing drugs. TDM market is analyzed from 2015 to 2025 according to technologies as well as geographical distribution. Global market for DoA testing was also analyzed from 2016 to 2026 and divided according to the area of application. Unmet needs and strategies for development of markets for TDM are discussed. The report contains profiles of 27 companies involved in developing tests and equipment for drug monitoring along with their collaborations. The text is supplemented with 18 tables, 6 figures and 190 selected references from literature. Benefits of this report: - Up-to-date one-stop information on therapeutic drug monitoring - Description of 27 companies involved with their collaborations in this area - Market analysis 2016-2026/ - Market values in major regions - Strategies for developing markets for therapeutic drug monitoring - A selected bibliography of 190 publications - Text is supplemented by 18 tables and 6 figures Who should read this report? - Biotechnology companies developing assays and equipment for drug monitoring - Reference laboratories providing drug monitoring services - Pharmaceutical companies interested in companion tests for monitoring their drugs - Clinical pharmacologists interested in integrating therapeutic drug monitoring with pharmacogenetics for development of personalized medicine Key Topics Covered: Executive Summary 1. Introduction Definitions Historical Landmarks in the development of TDM Pharmacology relevant to TDM Pharmacokinetics Pharmacodynamics Pharmacogenetics Pharmacogenomics Pharmacoproteomics Drug receptors Protein binding Therapeutic range of a drug Variables that affect TDM Indications for TDM Multidisciplinary nature of TDM 2. Technologies for TDM Introduction Sample preparation Proteomic technologies Mass spectrometry Liquid chromatography MS Matrix-Assisted Laser Desorption/Ionization Mass Spectrometry Combining capillary electrophoresis with MS Gas-liquid chromatography Tissue imaging mass spectrometry New trends in sample preparation Pressure Cycling Technology Desorption electrospray ionization imaging High Performance Liquid Chromatography (HPLC) Ultra performance LC TDM using dry blood spots Analysis of dried blood spots for drugs using DESI Quantitative analysis of drugs in dried blood spot by paper spray MS Immunoassays Enzyme-linked immunosorbent assay Cloned Enzyme Donor Immunoassay Enzyme Multiplied Immunoassay Technique Fluorescence Polarization Immunoassay Particle Enhanced Turbidimetric Inhibition Immunoassay Radioimmunometric assays Biosensors Nanosensors Biochips & Microarrays Introduction Microchip capillary electrophoresis Phototransistor biochip biosensor Microchip-based fluorescence polarization immunoassay for TDM Cellular microarrays Microfluidics for TDM Lab-on-a-chip Micronics' microfluidic technology Rheonix CARD technology Nano-interface in a microfluidic chip Levitation of nanofluidic drops with physical forces Nanoarrays Nanobiotechology NanoDx Biomarkers Applications of biomarkers in drug safety studies Genomic technologies for toxicology biomarkers Proteomic technologies for toxicology biomarkers Metabonomic technologies for toxicology biomarkers Integration of genomic and metabonomic data to develop toxicity biomarkers Toxicology studies based on biomarkers Biomarkers of hepatotoxicity Biomarkers of nephrotoxicity Cardiotoxicity Neurotoxicity Biomarkers in clinical trials Molecular diagnostics 3. Drug Monitoring Instruments Introduction Description of important instruments AB SCIEX instruments AB SCIEX LC/MS/MS Abbott instruments ARCHITECT c16000 ARCHITECT c4000 ARCHITECT c8000 ARCHITECT ci16200 Integrated System ARCHITECT ci4100 Integrated System ARCHITECT ci8200 integrated with the ARCHITECT i2000SR ARCHITECT i1000SR ARCHITECT i4000SR AxSYM Agilent's 6400 Series Triple Quadrupole LC/MS Alfa Wassermann's ACE Alera AMS Diagnostics' LIASYS Awareness Technology's STAT FAX 4500 Beckman Coulter instruments Beckman Coulter Unicel Series AU5800 automated chemistry systems AU480 Binding Site ESP600 bioMerieux Mini Vidas Carolina BioLis 24i Chromsystems' HPLC instruments Grifols Triturus ABX Pentra 400 Medica EasyRA Nova Biomedical Critical Care Xpress Ortho Clinical Diagnostics' VITROS® family of systems Immunodiagnostic systems Randox intruments Randox RX Imola Roche instruments Cobas® 8000 COBAS INTEGRA® Systems Siemens instruments ADVIA 1200 ADVIA Centaur XP immunoassay system EMIT® II Plus Syva® Viva® Drug Testing Systems Dimension® Xpand® Plus Integrated Chemistry System Thermo Scientific instruments Indiko Tosoh AIA-Series 4. Applications of TDM Introduction Pharmaceutical research and drug development Clinical trials Computerized clinical decision support systems for TDM and dosing Medication-related interferences with measurements of catecholamines Polymorphisms of genes affecting drug metabolism TDM for drug safety TDM in special groups The aged Children Pregnancy TDM of prophylactic therapy Monitoring of vitamin D levels Monitoring of RBC folic acid levels during pregancy Personalized medicine Role of TDM in personalized medicine Applications according to various conditions Anesthesia and critical care Optimizing antimicrobial dosing for critically ill patients TDM monitoring of thiopental continuous infusion in critical care Role of TDM in critical care cardiac patients. Cancer Epilepsy Personalized approach to use of AEDs Infections Virus infections Fungal infections Pain management Role of TDM in pain management Monitoring of analgesic drugs in urine samples AEDs as analgesics Triptans for migraine Psychiatric disorders Guidelines for use of TDM in psychiatric patients TDM of psychotropic drugs Transplantation TDM of Tacrolismus in transplantation TDM of cyclosporine A in transplantation Monitoring of immunosuppression with mycophenolate mofetil Emergency toxicology Future prospects of TDM 5. Drugs Requiring Monitoring Introduction Antiepileptics Carbamazepine TDM of carbamazepine Gabapentin Lacosamide Lamotrigine TDM of lamotrigine Levetiracetam TDM of levetiracetam Phenobarbital TDM of phenobarbital Phenytoin TDM of phenytoin Primidone TDM of primidone Topiramate TDM of topiramate Valproic acid TDM of valproic acid TDM of multiple antiepileptic drugs in plasma/serum Antimicrobials Antibiotics Amikacin Anti-tuberculosis drugs Chloramphenicol Gentamicin Tobramycin Vancomycin Norvancomycin Antiviral agents Anti-HIV drugs Antifungal agents Voriconazole Antidepressants TDM of selective serotonin reuptake inhibitors Antipsychotics Aripiprazole Quetiapine TDM of risperidone TDM of AEDs in psychiatric disorders TDM of multiple drugs in psychiatry Bronchodilators Theophylline Cardiovascular drugs Antiarrhythmic drugs Anticoagulants Dabigatran Antihypertensive drugs ß-blockers Cardiotonic drugs Digoxin TDM of statins for hypercholesterolemia Chemotherapy for cancer TDM of 5-FU TDM of Methotrexate TDM of imitanib Drugs used for treatment of Alzheimer disease Donepezil Galantamine Memantine Drugs used for treatment of Parkinson disease Monitoring of levodopa and carbidopa therapy Catechol-O-methyltransferase inhibitors Drugs for treatment of attention-deficit hyperactivity disorder Atomoxetine Methylphenidate Hypnotic-sedative drugs Benzodiazepines Propofol Immunosuppressive drugs TDM of mycophenolic acid for the treatment of lupus nephritis Steroids Prednisone Miscellaneous drugs Azathioprine Sildenafil 6. Monitoring of Biological Therapies Introduction Cell therapy In vivo tracking of cells Molecular imaging for tracking cells MRI technologies for tracking cells Superparamagnetic iron oxide nanoparticles as MRI contrast agents Visualization of gene expression in vivo by MRI Gene therapy Application of molecular diagnostic methods in gene therapy Use of PCR to study biodistribution of gene therapy vector PCR for verification of the transcription of DNA In situ PCR for direct quantification of gene transfer into cells Detection of retroviruses by reverse transcriptase (RT)-PCR Confirmation of viral vector integration Monitoring of gene expression Monitoring of gene expression by green fluorescent protein Monitoring in vivo gene expression by molecular imaging Monoclonal antibodies Natalizumab 7. Monitoring of Drug Abuse Introduction Tests used for detection of drug abuse Forensic applications of detection of illicit drugs in fingerprints by MALDI MS MS for doping control Randox assays for DoA Drugs of Abuse Array V Urine drug testing TDM of drugs for treatment of substance abuse-related disorders Drug testing to monitor treatment of drug abuse Minimum requirement for drug testing in patients Analgesic abuse ?-blockers as doping agents Detection of ß-blockers in urine Chronic alcohol abuse Cocaine CEDIA for cocaine in human serum Detection of cocaine molecules by nanoparticle-labeled aptasensors Infrared spectroscopy for detection of cocaine in saliva Marijuana Use of marijuana and synthetic cannabinoids Detection of cannabinoids ELISA for detection of synthetic cannabinoids Drug abuse for performance enhancement in sports Historical aspects of drug abuse in sports Drugs used by athletes for performance enhancement Techniques used for detection of drug abuse by athletes Mass spectrometry for detection of peptide hormones miRNAs for the detection of erythropoiesis-stimulating agents Detection of anabolic steroids Body fluids and tissues used for detection of drug abuse in sports Urine drug testing Spray (sweat) drug test kits Hair drug testing Gene doping in sports Gene transfer methods used for enhancing physical performance Misuse of cell therapy in sport Challenges of detecting genetic manipulations in athletes Drug abuse testing in race horses Limitations and future prospects Role of pharmaceutical industry in anti-doping testing 8. Markets for TDM Introduction Methods for market estimation and future forecasts Markets for TDM tests Markets for TDM and DoA testing equipment Geographical distribution of markets for TDM tests Drivers for growth of TDM markets Markets for DoA testing Unmet needs in TDM Cost-benefit studies Simplifying assays and reducing time and cost Strategies for developing markets Physician education Supporting research on TDM Biomarker patents for drug monitoring 9. Companies Profiles of companies Collaborations 10. References For more information about this report visit http://www.researchandmarkets.com/research/g4tq2x/therapeutic_drug


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

OTTAWA, ONTARIO--(Marketwired - Feb. 23, 2017) - PhytoPain Pharma (PPP), a subsidiary of Tetra BioPharma Inc. ("Tetra" or the "Company") (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce the launch of its Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers. The Phase I clinical research is a classical pharmaceutical study in the development of a new drug. The trial activities will occur over a 3 to 4-month period and involve site initiation, subject recruitment and enrolment, a single daily ascending dose phase and a 7-day multiple daily ascending dose phase, followed by study termination. Algorithme Pharma has already begun recruiting subjects for the Phase I trial. This study is a pivotal safety trial as it will allow Tetra to understand the adverse effects of smoking Cannabis and associate the outcomes, such as cognitive function, to plasma levels of THC and CBD. The study will provide Tetra with the data necessary to discuss with Health Canada and FDA the potential risks in patient populations and discuss marketing requirements for specific indications. The pharmacokinetic profile and safety data generated by the Phase I trial will allow Tetra to finalize the design of its Phase II-III clinical trial that will assess the safety and efficacy of PPP001 in cancer patients with uncontrolled pain. PPP001 is being developed for cancer patients with moderate-to-severe pain and that are not adequately controlled with the standard of care. Approximately 50% of cancer patients suffer from pain and more than 600,000 of these patients suffer from moderate-to-severe pain. In the USA, there are over 4 million cancer patients and this pain market is valued at over $5 billion USD. "We are very pleased to announce that the start of the Phase I clinical trial activities as this keeps the company on track in its development of PPP001", commented Mr, Andre Rancourt. "With PPP001 and the mucoadhesive AdVersa® controlled-release tablet, Tetra is positioning itself to become a major player in the cancer pain therapy market," added Mr. Rancourt. The Canadian Securities Exchange ("CSE") has not reviewed this news release and does not accept responsibility for its adequacy or accuracy. Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.


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

San Diego, CA, February 28, 2017 --( Elite began operations in 1997, focused on the rapidly growing biotechnology market in San Diego, California. Within the first year, the company expanded operations nationally, and within 2 years had several global clients. As a niche, boutique agency, Elite has achieved success by delivering stellar experiences for clients and candidates throughout the entire recruitment process. Elite has achieved goals and milestones through its ongoing commitment to excellence coupled with strong client loyalty. Lisa De Benedittis, Elite Executive Search’s President, reflected on the company’s 20th anniversary by stating “Twenty years has flown by, I can recall the excitement of going out on my own and wanting to be different from other search firms that were mostly generalists. From day one, Elite was focused on the life sciences sector. I started by crafting a corporate philosophy based on ethics, rolling out the red carpet for clients and candidates, and always going the extra mile a.k.a. putting a cherry on top. That philosophy has remained our paramount priority, and has served Elite well. It has become our brand.” Offering Retained, Engaged, and Contingent search terms; Elite partners with exceptional life science organizations, uniting them with high caliber leaders and scientific experts. The company’s clients range from start-up ventures to Fortune 100 pharmaceutical companies. Specialty divisions include Clinical, Commercial, Research and Development, Regulatory Affairs, Drug Safety/Pharmacokinetics, Diagnostics, Engineering, Market Access, Reimbursement, Laboratory, Medical Affairs, Marketing, Manufacturing, Quality, Physicians, Nurses, and Sales. Lisa De Benedittis added: “We’ve weathered challenging market cycles, clients going out of business, and an ever-changing economic landscape. Thanks to our dedicated employees, loyal clients, and exceptional candidates, we’ve been able to thrive and grow. When you build teams that drive value and results for your clients, they reward you with more business, it’s a win-win.” About Elite Executive Search: Elite Executive Search is a national executive search firm specializing exclusively in the life science industries. Offering Retained, Engaged, and Contingent search terms, Elite is the partner of choice for some of the world’s leading biotechnology, pharmaceutical, medical device, and healthcare companies throughout the US. Elite is focused on sourcing scientific and healthcare experts including Directors, Vice Presidents, M.D.'s and C-Suite candidates, for all departments. Elite has an enormous life sciences network and approaches recruitment with unmatched passion, focused on delivering results. If it exits, Elite will find it. www.EliteExecSearch.com San Diego, CA, February 28, 2017 --( PR.com )-- Elite Executive Search is proud to announce its twentieth year as a leading national search firm, specializing in biotechnology, pharmaceutical, medical device and healthcare. In a highly competitive market, Elite has achieved two decades of successful placements, long-term contract /consultant assignments and steady growth. The company has been commemorating the occasion by offering a promotional discount for the month of February, 2017, for new and current clients.Elite began operations in 1997, focused on the rapidly growing biotechnology market in San Diego, California. Within the first year, the company expanded operations nationally, and within 2 years had several global clients. As a niche, boutique agency, Elite has achieved success by delivering stellar experiences for clients and candidates throughout the entire recruitment process. Elite has achieved goals and milestones through its ongoing commitment to excellence coupled with strong client loyalty.Lisa De Benedittis, Elite Executive Search’s President, reflected on the company’s 20th anniversary by stating “Twenty years has flown by, I can recall the excitement of going out on my own and wanting to be different from other search firms that were mostly generalists. From day one, Elite was focused on the life sciences sector. I started by crafting a corporate philosophy based on ethics, rolling out the red carpet for clients and candidates, and always going the extra mile a.k.a. putting a cherry on top. That philosophy has remained our paramount priority, and has served Elite well. It has become our brand.”Offering Retained, Engaged, and Contingent search terms; Elite partners with exceptional life science organizations, uniting them with high caliber leaders and scientific experts. The company’s clients range from start-up ventures to Fortune 100 pharmaceutical companies. Specialty divisions include Clinical, Commercial, Research and Development, Regulatory Affairs, Drug Safety/Pharmacokinetics, Diagnostics, Engineering, Market Access, Reimbursement, Laboratory, Medical Affairs, Marketing, Manufacturing, Quality, Physicians, Nurses, and Sales.Lisa De Benedittis added: “We’ve weathered challenging market cycles, clients going out of business, and an ever-changing economic landscape. Thanks to our dedicated employees, loyal clients, and exceptional candidates, we’ve been able to thrive and grow. When you build teams that drive value and results for your clients, they reward you with more business, it’s a win-win.”About Elite Executive Search:Elite Executive Search is a national executive search firm specializing exclusively in the life science industries. Offering Retained, Engaged, and Contingent search terms, Elite is the partner of choice for some of the world’s leading biotechnology, pharmaceutical, medical device, and healthcare companies throughout the US. Elite is focused on sourcing scientific and healthcare experts including Directors, Vice Presidents, M.D.'s and C-Suite candidates, for all departments.Elite has an enormous life sciences network and approaches recruitment with unmatched passion, focused on delivering results.If it exits, Elite will find it.www.EliteExecSearch.com Click here to view the list of recent Press Releases from Elite Executive Search


News Article | February 15, 2017
Site: globenewswire.com

New Phase 3 Retrospective Analysis Shows Correlation between Reduction in Disease Substrate (Kidney Interstitial Capillary GL-3) and Improved Diarrhea in Fabry Patients with Amenable Mutations treated with Migalastat Supportive Study for Japanese New Drug Application (J-NDA) Demonstrates Migalastat Exposure is Similar in Japanese and non-Japanese Individuals SAN DIEGO and CRANBURY, N.J., Feb. 14, 2017 (GLOBE NEWSWIRE) -- Amicus Therapeutics (Nasdaq:FOLD), a biotechnology company at the forefront of therapies for rare and orphan diseases, today announced new positive data analyses for the oral small molecule pharmacological chaperone migalastat HCl (“migalastat”) for Fabry disease at WORLDSymposium™ 2017 in San Diego, California. Jay Barth, Chief Medical Officer of Amicus Therapeutics, Inc., stated, “The new analyses highlighted at this year’s WORLDSymposium add to the already significant body of data which demonstrate the multiple benefits of treatment with migalastat in Fabry patients with amenable mutations. Here, the correlation of the reduction in disease substrate with the reduction in diarrhea symptoms provides further evidence that migalastat is having a positive effect on an important gastrointestinal symptom in Fabry. These findings in diarrhea symptoms support our current Fabry regulatory strategy for migalastat in the U.S., which is based upon improvement in diarrhea in this patient population. Also, we remain on track in Japan with our submission to the Pharmaceuticals and Medical Devices Agency based on completed Phase 1 and Phase 3 studies. We also remain committed to providing access to this important medicine to patients in the EU, where it is already approved, in addition to other major geographies.” Data Highlights for Migalastat for Fabry Disease at WORLDSymposium 2017 Phase 3 Retrospective Analysis - Correlation between Substrate Reduction and Reduction in Diarrhea In a poster1 from Study 011 (FACETS) in Fabry patients who were naïve to ERT, a retrospective analysis from baseline to month 6 demonstrated that migalastat reduces disease substrate (KIC GL-3) and improves diarrhea symptoms (GSRS-D) in patients with Fabry disease with amenable mutations. Key highlights were as follows: To support full approval in the U.S., which represents approximately 25% of the global Fabry market, Amicus plans to confirm the clinical beneficial effects of migalastat in a GI symptom study. The GI study is anticipated to begin in 2017 in approximately 35 Fabry patients who are naïve to treatment and who have an amenable mutation and diarrhea and other GI symptoms. More than 50% of patients with Fabry disease report or show GI signs and symptoms, including diarrhea, abdominal pain, constipation, nausea, and vomiting.2 Supportive Pharmacokinetics (PK) Study for Japanese Regulatory Submission As previously announced, Amicus plans to submit a J-NDA in Japan in the first half of 2017. The J-NDA will be based on data from completed clinical studies with migalastat, including two pivotal Phase 3 studies as well as a Phase 1 study that evaluated the pharmacokinetics (PK) of migalastat in Japanese volunteers. The results from this Phase 1 study are being highlighted in a poster3 at WORLDSymposium 2017 with key highlights as follows: Japan represents the second largest Fabry market in the world by country, with approximately 13% of the $1.2B global Fabry ERT sales generated in Japan in 2015.4 The Pharmaceuticals and Medical Devices Agency (PMDA) in Japan previously confirmed that completed studies of migalastat meet J-NDA submission requirements without the need to conduct an additional clinical study in Japan. The PMDA took into account data from Japanese patients included in the Phase 3 program and the similar PK properties in Japanese and non-Japanese individuals. Migalastat is designed to selectively and reversibly bind with high affinity to the active sites of certain mutant forms of alpha-Gal A, the genotypes of which are referred to as amenable mutations. On May 30, 2016, the European Commission granted full approval for migalastat, under the trade name Galafold™, as a first line therapy for long-term treatment of adults and adolescents aged 16 years and older with a confirmed diagnosis of Fabry disease (alpha-galactosidase A deficiency) and who have an amenable mutation. This EU approval may serve as the basis for regulatory approvals in more than two-thirds of the global Fabry market that is outside the U.S. Amicus has commenced the commercial launch of Galafold in Germany and is undergoing the EU country-by-country processes to launch in the majority of EU countries throughout 2016 and 2017. The Company has also initiated expanded access programs (EAP) in the EU and other territories outside the U.S. that provide this mechanism for reimbursed access prior to formal approval. Galafold™ (migalastat) is a first-in-class chaperone therapy approved in the EU as a monotherapy for Fabry disease in patients with amenable mutations. Galafold works by stabilizing the body’s own dysfunctional enzyme, so it can clear the accumulation of disease substrate in patients who have amenable mutations.  A proprietary in vitro assay (Galafold Amenability Assay) was used to classify more than 800 known GLA mutations as “amenable” or “not amenable” to treatment with Galafold. The current EU label includes 313 GLA mutations that have been identified and determined to be amenable based on the Galafold Amenability Assay, which represent between 35% and 50% of the currently diagnosed Fabry population. Healthcare providers in the EU may access the website www.galafoldamenabilitytable.com to quickly and accurately identify which mutations are categorized as “amenable” or “not amenable” to Galafold. Amicus expects to submit updates to the label as additional GLA mutations are identified and tested in the Galafold Amenability Assay. Treatment with GALAFOLD should be initiated and supervised by specialists experienced in the diagnosis and treatment of Fabry disease. GALAFOLD is not recommended for use in patients with a nonamenable mutation. For further important safety information for Galafold, including posology and method of administration, special warnings, drug interactions and adverse drug reactions, please see the European SmPC for Galafold available from the EMA website at www.ema.europa.eu. Fabry disease is an inherited lysosomal storage disorder caused by deficiency of an enzyme called alpha-galactosidase A (alpha-Gal A), which is the result of mutations in the GLA gene. The primary biological function of alpha-Gal A is to degrade specific lipids in lysosomes, including globotriaosylceramide (referred to here as GL-3 and also known as Gb ). Lipids that can be degraded by the action of alpha-Gal A are called "substrates" of the enzyme. Reduced or absent levels of alpha-Gal A activity lead to the accumulation of GL-3 in the affected tissues, including the central nervous system, heart, kidneys, and skin. Progressive accumulation of GL-3 is believed to lead to the morbidity and mortality of Fabry disease, including pain, kidney failure, heart disease, and stroke. The symptoms can be severe, differ from patient to patient, and begin at an early age. All Fabry disease is progressive and may lead to organ damage regardless of the time of symptom onset. Amicus Therapeutics (Nasdaq:FOLD) is a global biotechnology company at the forefront of therapies for rare and orphan diseases. The Company has a robust pipeline of advanced therapies for a broad range of human genetic diseases. Amicus’ lead programs in development include the small molecule pharmacological chaperone migalastat as a monotherapy for Fabry disease, SD-101 for Epidermolysis Bullosa (EB), as well as novel enzyme replacement therapy (ERT) and biologic products for Fabry disease, Pompe disease, and other rare and devastating diseases. 1D. Germain, WORLDSymposium 2017, Effects of Treatment With Migalastat on the Combined Endpoint of Kidney Globotriaosylceramide Accumulation and Diarrhea in Patients With Fabry Disease: Results From the Phase 3 FACETS Study 2Hoffmann B et al. Clin Gastroenterol Hepatol. 2007;5(12):1447-1453. 3F. Johnson, WORLDSymposium 2017, Migalastat exposures in Japanese healthy volunteers and non-Japanese subjects provide evidence that they are similar to Japanese patients with Fabry disease 4Company filings and Amicus estimates Forward Looking Statements This press release contains "forward- looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to data, future studies and ongoing regulatory strategies for migalastat.  Words such as, but not limited to, “look forward to,” “believe,” “expect,” “anticipate,” “estimate,” “intend,” "confidence," "encouraged," “potential,” “plan,” “targets,” “likely,” “may,” “will,” “would,” “should” and “could,” and similar expressions or words identify forward-looking statements.  The forward looking statements included in this press release are based on management's current expectations and belief's which are subject to a number of risks, uncertainties and factors, including that the data reported herein will not be predictive of future results, that later study results will not support  further development of migalastat, or even if such later  results are favorable, that the Company will not be able to successfully complete the development of, obtain regulatory approval for, or successfully commercialize migalastat.  In addition, all forward looking statements are subject to the other risks and uncertainties detailed in our Annual Report on Form 10-K for the year ended December 31, 2015 and Quarterly Report on 10-Q for the Quarter ended September 30, 2016.  As a consequence, actual results may differ materially from those set forth in this press release or the accompanying conference call or webcast.  You are cautioned not to place undue reliance on these forward looking statements, which speak only of the date hereof.  All forward looking statements are qualified in their entirety by this cautionary statement and we undertake no obligation to revise this press release to reflect events or circumstances after the date hereof.


OTTAWA, ONTARIO--(Marketwired - Feb. 16, 2017) - PhytoPain Pharma Inc. (PPP), a subsidiary of Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (CSE:TBP)(CSE:TBP.CN), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce that the Therapeutic Products Directorate (TPD) of Health Canada has approved its Phase I clinical study of smoked cannabis. Tetra has worked with Algorithme Pharma, an Altasciences company, for the preparation of the Clinical Trial Application (CTA) for the conduct of a Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers. The CTA was submitted to Health Canada and the research ethics review board in December 2016. On January 3, 2017, the clinical trial received approval from the Institutional Review Board. TPD issued a Letter of Authorization for the conduct of the Phase I clinical trial on February 16, 2017. Algorithme Pharma will be initiating the clinical trial activities in the coming weeks. ²We are very pleased to announce the authorisation of the Phase I clinical trial by TPD. This is an important milestone in the clinical development of smoked Cannabis in North America and we are proud to be working with Algorithme pharma, a Clinical Research Organization with many years of experience and expertise in the conduct of Phase I clinical studies,² said Dr. Chamberland, Chief Science Officer. "This trial is part of Tetra's commitment to develop medical Cannabis as a prescription drug for patients. The outcome of this trial is going to have significant implications in medical Cannabis research as it is a first pharmaceutical clinical trial assessing the effects of smoked Cannabis on cognitive function in healthy volunteers" said Mr. Rancourt, Chief Executive Officer Earlier this month, Tetra and IntelGenx announced the co-development of Dronabinol AdVersa® Mucoadhesive controlled-release tablet for the management of Breakthrough Cancer Pain. The significant advantage of the Mucoadhesive technology was demonstrated in a Phase I clinical trial. The study demonstrated the delayed-release of THC avoids a rapid increase in the blood. ²With both of these products in clinical development, Tetra is on track with its objective to bring Cannabis-based prescription drugs to the market. Both of these products are promising alternatives in the battle for the reduction of opioids and improving quality of life in patients with chronic pain², added Dr. Chamberland. The Canadian Securities Exchange ("CSE") has not reviewed this news release and does not accept responsibility for its adequacy or accuracy. Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.


OTTAWA, ONTARIO--(Marketwired - Feb. 16, 2017) - PhytoPain Pharma Inc. (PPP), a subsidiary of Tetra Bio-Pharma Inc. ("Tetra" or the "Company") (CSE:TBP)(CSE:TBP.CN)(OTC PINK:GRPOF), a pharmaceutical company focused on developing and commercializing therapeutic cannabis-based products for the treatment of pain is pleased to announce that the Therapeutic Products Directorate (TPD) of Health Canada has approved its Phase I clinical study of smoked cannabis. Tetra has worked with Algorithme Pharma, an Altasciences company, for the preparation of the Clinical Trial Application (CTA) for the conduct of a Double-Blind Phase I Study to Assess Safety, Tolerability, Pharmacodynamics and Pharmacokinetics of Single and Multiple Daily Ascending Doses of Cannabis (Delta-9-tetrahydrocannabinol/ Cannabidiol) by Smoking/Inhalation in Healthy Male and Female Volunteers. The CTA was submitted to Health Canada and the research ethics review board in December 2016. On January 3, 2017, the clinical trial received approval from the Institutional Review Board. TPD issued a Letter of Authorization for the conduct of the Phase I clinical trial on February 16, 2017. Algorithme Pharma will be initiating the clinical trial activities in the coming weeks. ²We are very pleased to announce the authorisation of the Phase I clinical trial by TPD. This is an important milestone in the clinical development of smoked Cannabis in North America and we are proud to be working with Algorithme pharma, a Clinical Research Organization with many years of experience and expertise in the conduct of Phase I clinical studies,² said Dr. Chamberland, Chief Science Officer. "This trial is part of Tetra's commitment to develop medical Cannabis as a prescription drug for patients. The outcome of this trial is going to have significant implications in medical Cannabis research as it is a first pharmaceutical clinical trial assessing the effects of smoked Cannabis on cognitive function in healthy volunteers" said Mr. Rancourt, Chief Executive Officer Earlier this month, Tetra and IntelGenx announced the co-development of Dronabinol AdVersa® Mucoadhesive controlled-release tablet for the management of Breakthrough Cancer Pain. The significant advantage of the Mucoadhesive technology was demonstrated in a Phase I clinical trial. The study demonstrated the delayed-release of THC avoids a rapid increase in the blood. ²With both of these products in clinical development, Tetra is on track with its objective to bring Cannabis-based prescription drugs to the market. Both of these products are promising alternatives in the battle for the reduction of opioids and improving quality of life in patients with chronic pain², added Dr. Chamberland. The Canadian Securities Exchange ("CSE") has not reviewed this news release and does not accept responsibility for its adequacy or accuracy. Some statements in this release may contain forward-looking information. All statements, other than of historical fact, that address activities, events or developments that the Company believes, expects or anticipates will or may occur in the future (including, without limitation, statements regarding potential acquisitions and financings) are forward-looking statements. Forward-looking statements are generally identifiable by use of the words "may", "will", "should", "continue", "expect", "anticipate", "estimate", "believe", "intend", "plan" or "project" or the negative of these words or other variations on these words or comparable terminology. Forward-looking statements are subject to a number of risks and uncertainties, many of which are beyond the Company's ability to control or predict, that may cause the actual results of the Company to differ materially from those discussed in the forward-looking statements. Factors that could cause actual results or events to differ materially from current expectations include, among other things, without limitation, the inability of the Company, through its wholly-owned subsidiary, GrowPros MMP Inc., to obtain a licence for the production of medical marijuana; failure to obtain sufficient financing to execute the Company's business plan; competition; regulation and anticipated and unanticipated costs and delays, and other risks disclosed in the Company's public disclosure record on file with the relevant securities regulatory authorities. Although the Company has attempted to identify important factors that could cause actual results or events to differ materially from those described in forward-looking statements, there may be other factors that cause results or events not to be as anticipated, estimated or intended. Readers should not place undue reliance on forward-looking statements. The forward-looking statements included in this news release are made as of the date of this news release and the Company does not undertake an obligation to publicly update such forward-looking statements to reflect new information, subsequent events or otherwise unless required by applicable securities legislation.


News Article | February 27, 2017
Site: www.businesswire.com

SAN DIEGO--(BUSINESS WIRE)--Ligand Pharmaceuticals Incorporated (NASDAQ:LGND) announces the completion of enrollment in the Company’s Phase 2 clinical trial with its novel, small-molecule glucagon receptor antagonist LGD-6972 for the treatment of type 2 diabetes mellitus (T2DM). This randomized, double-blind, placebo-controlled study is evaluating the safety and efficacy of LGD-6972 as an adjunct to diet and exercise in subjects with T2DM whose blood glucose levels are inadequately controlled with metformin. The Company expects to report topline results in September 2017. In this Phase 2 study, subjects with T2DM are being treated with one of three doses of LGD-6972 (5 mg, 10 mg, or 15 mg) or placebo once daily for 12 weeks. The primary endpoint is change from baseline in hemoglobin A1c (HbA1c). Secondary endpoints include change from baseline in fasting plasma glucose, insulin, glucagon and GLP-1, as well as changes in lipids, blood pressure and body weight. In a subset of subjects, an oral glucose tolerance test is also being conducted at baseline and at the end of treatment. “We are pleased with the rapid enrollment of patients, an accomplishment that enables us to report topline data by the end of the third quarter of 2017, ahead of our timeline projections,” said John Higgins, Chief Executive Officer. “Antagonism of the glucagon pathway is one of the most promising new therapeutic approaches for type 2 diabetes, and we believe LGD-6972 has potential valuable therapeutic properties. We look forward to obtaining data later this year, and to exploring potential partnerships for this program, consistent with our shots-on-goal business model.” Based on Phase 1 trial results that were published in Diabetes, Obesity and Metabolism in January 20171, Ligand believes LGD-6972 holds potential to have promising and differentiating properties given its potency in lowering plasma glucose in patients with T2DM and its preliminary safety profile. Glucagon is a hormone produced by the pancreas that stimulates the liver to produce glucose (sugar). Overproduction of glucose by the liver is an important cause of high glucose levels in patients with T2DM and is believed to be due in part to inappropriately elevated levels of glucagon. Glucagon receptor antagonists (GRA) are designed to lower glucose levels by reducing the production of glucose by the liver. GRAs are novel molecules that have demonstrated a reduction of glucose and HbA1c in mid-stage clinical trials. Preclinical studies have shown that LGD-6972 is highly potent and selective, that it inhibits glucagon-induced hyperglycemia in both rats and monkeys and that it also significantly lowers glucose in a mouse model of T2DM. Additionally, LGD-6972 significantly lowered fasting and non-fasting glucose levels in a mouse model of type 1 diabetes and reduced HbA1c, ketone bodies and free fatty acids. LGD-6972 also has been shown to have additive effects when used in combination with insulin therapy and may be useful in an insulin-sparing regimen. Diabetes is a growing global epidemic that as of 2015 affected more than 415 million people worldwide2. In North America, approximately 44 million people have diabetes2. If current trends continue, by 2050 fully 33% of the U.S. population will be affected3. People with T2DM either are resistant to the effects of insulin or do not produce enough insulin to maintain a normal glucose level. Sustained high glucose levels can cause diabetic complications such as heart disease, stroke, kidney failure, neuropathy, lower-limb amputations and blindness. Although T2DM is more common in adults, it increasingly affects children as childhood obesity increases. An estimated 90% to 95% of Americans with diabetes have T2DM4. The global market for diabetes drugs is expected to nearly double to $68 billion by 20225 as treatment paradigms shift toward combination therapies and novel non-insulin drugs. Global sales of the top 10 non-insulin diabetes drugs exceeded $15 billion in 2016 and are expected to increase to $20 billion by 20206. 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 the timing of the release of topline results from the Phase 2 clinical trial of LGD-6972 with subjects with T2DM, the potential for LGD-6972 to treat patients with T2DM, the potential for LGD-6972 to exhibit best-in-class properties, Ligand’s ability to partner the program in the future, the number of patients affected by diabetes, the annual total sales of non-insulin diabetes drugs and the expected future sales of such drugs. Actual events or results may differ from our expectations. For example, patients in the Phase 2 clinical trial could drop out during the course of treatment which require additional enrollment to complete the Phase 2 clinical trial; the timing of the data from our third party clinical contractors could be delayed due to circumstances beyond Ligand’s control; Ligand could require additional time to analyze the data prior to release; the clinical trial could fail to reach its primary or secondary endpoints which could result in Ligand’s inability to partner the program; and the safety and tolerability data from a new clinical trial in LGD-6972 may conflict with the results of the Phase 1 clinical trials; the number of patients diagnosed with diabetes may be more or fewer than Ligand believes; and the total sales of non-insulin diabetes drugs is dependent on market acceptance of such drugs. 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. 1. Eric G. Vajda, et al. Pharmacokinetics and pharmacodynamics of single and multiple doses of the glucagon receptor antagonist LGD-6972 in healthy subjects and subjects with type 2 diabetes mellitus, Diabetes Obes Metab 2017; 19(1):24–32. 3. James P Boyle, et al. Projection of the year 2050 burden of diabetes in the U.S. adult population: dynamic modeling of incidence, mortality, and prediabetes prevalence. American Diabetes Association, Population Health Metrics. 2010 Oct 22;8:29

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