News Article | March 2, 2017
Melanie Lee, PhD, est depuis novembre 2014 directrice scientifique de BTG plc, une entreprise de médecine interventionnelle en maladies vasculaires, oncologie et pneumologie. Après sa carrière universitaire, elle a passé dix ans chez Glaxo/GlaxoWellcome (1988-1998). En 1998, Melanie Lee a rejoint Celltech plc en tant que Directeur exécutif chargé de la Recherche. Celltech plc a ensuite été acquise par UCB, dont Melanie Lee a été nommée Vice-Président exécutif, Recherche et Développement. Après avoir quitté UCB en 2009, elle est devenue directrice générale de Syntaxin Ltd, une biotech basée au Royaume-Uni et, à la suite de la vente de l'entreprise à Ipsen, a fondé en 2014 NightstaRx Ltd, une entreprise soutenue par Syncona. Melanie Lee est diplômée en biologie de l'Université de York et titulaire d'un doctorat du National Institute for Medical Research de Londres. Elle a poursuivi des études post-doctorales en génétique moléculaire, tout d'abord sur les levures à l'Imperial College de Londres puis, à partir de 1985, aux côtés du prix Nobel Sir Paul Nurse, aux Lincoln's Inn Laboratories de l'Imperial Cancer Research Fund. Melanie Lee a été élevée en 2009 au grade de commandeur dans l'ordre de l'Empire britannique (CBE) pour service rendu à la science médicale. Bernard Charlès est depuis mai 2016 Vice-président Directeur Général de Dassault Systèmes, leader mondial dans le domaine des logiciels 3D avec plus de 220 000 clients dans 12 secteurs de l'économie. Il était Directeur Général de Dassault Systèmes depuis septembre 1995. Ayant rejoint l'entreprise en 1983, il y crée le département Nouvelles technologies, Recherche et Stratégie et, en 1988, est nommé Directeur Stratégie, Recherche et Développement. Inspirateur des concepts de maquette digitale, gestion de cycle de vie du produit et 3DEXPERIENCE®, Bernard Charlès a contribué à mettre en place une dynamique d'innovation permanente pour asseoir la puissance scientifique de Dassault Systèmes et inscrire la science dans l'identité de l'entreprise. Bernard Charlès est membre de l'Académie des Technologies (France) et de la National Academy of Engineering (Etats-Unis). Ancien élève de l'Ecole Normale Supérieure de Cachan, il est agrégé et docteur en mécanique, spécialisé dans l'ingénierie de l'automatisation et des sciences informatiques. Sanofi, l'un des leaders mondiaux de la santé, s'engage dans la recherche, le développement et la commercialisation de solutions thérapeutiques centrées sur les besoins des patients. Sanofi est organisé en cinq entités globales : Diabète et Cardiovasculaire, Médecine générale et Marchés émergents, Sanofi Genzyme, Sanofi Pasteur et Santé Grand Public. Sanofi est coté à Paris (EURONEXT: SAN) et à New York (NYSE: SNY).
News Article | March 2, 2017
Sanofi's Board of Directors Proposes Appointment of Melanie Lee, PhD and Bernard Charlès as New Independent Directors Paris, France - March 2,2017 - At its meeting held on March 2, 2017, the Board of Directors of Sanofi proposed the appointment of Melanie Lee, PhD and Bernard Charlès as new independent Directors during the General Shareholders' meeting of May 10, 2017, as well as the renewal of the term of Fabienne Lecorvaisier. Melanie Lee, PhD, CBE, is Chief Scientific Officer at BTG plc (since November 2014), a company which operates in interventional medicine in vascular disease, oncology and pulmonology. Following her academic career she spent 10 years at Glaxo/GlaxoWellcome (1988-1998). In 1998, Melanie joined Celltech plc as Executive Director of Research. Celltech plc was subsequently acquired by UCB where she became Executive Vice President, Research and Development. After leaving UCB in 2009 she had a successful tenure as CEO at Syntaxin Ltd, a UK based biotech and following the sale to Ipsen, founded NightstaRx Ltd, a Syncona backed company in 2014. Melanie received an undergraduate degree in Biology from the University of York and then a Ph.D. at National Institute for Medical Research in London. She worked as a molecular genetics postdoc, first at Imperial College London on yeast and then from 1985 with Sir Paul Nurse, a Nobel Prize winner, at the Imperial Cancer Research Fund's Lincoln's Inn Laboratories. Melanie received her CBE for services to medical science in 2009. Bernard Charlès has served since May 2016 as Vice-Chairman and Chief Executive Officer of Dassault Systèmes, a world leader in 3D software with over 220,000 customers in 12 industry sectors. He has been CEO of Dassault Systèmes since September 1995. He joined the company in 1983 and created the New Technology, Research and Strategy division, before being appointed Director for Strategy, Research and Development in 1988. Through his contributions to digital mock-up, product lifecycle management and 3DEXPERIENCE®, Bernard Charlès helped instill a culture of ongoing innovation to further consolidate Dassault Systèmes' scientific capabilities and make science part of the company's identity. Bernard Charlès is a member of the Academy of Technology (France) and of the National Academy of Engineering (United States). He is a graduate of the Ecole Normale Supérieure engineering school in Cachan and has a Ph.D. in mechanical engineering majoring in automation engineering and information science. He also holds an Aggregation in mechanical engineering; this is the most senior teaching qualification achievable in France. "Melanie Lee is a renowned scientific expert with a deep knowledge of the pharmaceutical industry and Bernard Charlès has made Dassault Systèmes an international success. They will bring their strengths to further reinforce the capabilities of the Board and contribute significantly to Sanofi's strategy, both in the area of innovation and to the leveraging of opportunities afforded by digital development," said Serge Weinberg, Chairman of the Board, Sanofi. Sanofi, a global healthcare leader, discovers, develops and distributes therapeutic solutions focused on patients' needs. Sanofi is organized into five global business units: Diabetes and Cardiovascular, General Medicines and Emerging Markets, Sanofi Genzyme, Sanofi Pasteur and Consumer Healthcare. Sanofi is listed in Paris (EURONEXT: SAN) and in New York (NYSE: SNY).
News Article | February 15, 2017
The company announces move to further expand New York Office NEW YORK, NY--(Marketwired - February 15, 2017) - Sinequa, a leader in cognitive search and analytics, today announced that the company achieved a record performance for the fiscal year 2016 ending on December 31, 2016, including strong double-digit growth and the addition of important new customers and partners. Worldwide software bookings grew more than 51% compared to the last fiscal year. Sinequa's North American operations based in New York have registered exceptional growth, and are already generating more than 68% of the company's software business. During this period, the company's subscription-based license fees grew by 89%. As a result of the significant growth in the U.S., Sinequa will move into its expanded New York office located in the heart of the Flatiron District in March. "We are delighted to see that in the last fiscal year, our customers and partners continue to expand the use of our platform. They are realizing how strategic cognitive search and analytics can be for their business, as it has allowed them to achieve a successful digital transformation and safeguard their leadership in a highly complex and competitive environment. This digital transformation hinges on the ability of large enterprises and public organizations to extract value from their data of all kinds -- and this is where we excel," said Fabrice de Salaberry, COO of Sinequa. During fiscal year 2016, Sinequa achieved the following significant milestones: Staff Expansion During the fiscal year, Sinequa grew its worldwide team and expanded its executive leadership team with the appointment of Stéphane Kirchacker as vice president, Sales EMEA. With 20 years of sales, project management and business development experience gained in the U.S. and Europe, Kirchacker joins Sinequa from ASG Software Solutions where he was senior vice president, Business Development Infrastructure Software. Kirchacker holds an executive MBA from ESCP Europe as well as a Master degree in Artificial Intelligence from the University of Paris 6. In addition, Sinequa appointed Jeff Evernham as director of Consulting, North America. Evernham joined Sinequa from Knowledgent where he served as the practice lead for the company's Analytics and Visualization practice. Evernham has also held executive leadership positions with North Highland Data and Analytics and Synygy. He holds a Master of Engineering degree from MIT. About Sinequa Recognized as a leader in the Gartner Magic Quadrant for Enterprise Search and other analysts' reports, Sinequa provides a cognitive search and analytics platform for Fortune Global 2000 companies and government agencies. Using advanced Natural Language Processing (NLP) and Machine Learning algorithms, the solution offers insights extracted from structured and unstructured data. Millions of users in the world's largest and most information-intensive organizations, including Airbus, AstraZeneca, Atos, Biogen, UCB, Credit Agricole, Mercer, and Siemens, rely on Sinequa to put business-critical information at the fingertips of their employees. Sinequa develops its expertise and its business around the world with a broad network of technology and business partners. Sinequa is a founding sponsor of the Cognitive Computing Consortium. For more information, visit www.sinequa.com.
News Article | February 21, 2017
Dr. Thomas Hanke, LAB282 Expert-in-Residence und Head of Academic Partnerships bei Evotec, kommentierte: "Es freut mich sehr, dass wir aus der Liste der Bewerbungen für die erste Runde der LAB282-Förderung zwei herausragende und wirklich translationale Projekte auswählen konnten. Meine herzlichen Glückwünsche gehen an Prof. Bhattacharya und Dr. Ahel mit ihren Teams für ihre ausgezeichnete Arbeit. Ich freue mich besonders darauf, eng mit der Oxford University und den Evotec-Teams zusammenzuarbeiten, um in den geförderten Projekten beschleunigt solide Wirkstoffkandidaten zu finden." Shoumo Bhattacharya, British Heart Foundation Chair of Cardiovascular Medicine an der Oxford University und führender Wissenschaftler im Evasine-Projekt, sagte: "Die Finanzierung durch LAB282 bringt Evotecs weltweit führende Expertise bei der Entwicklung neuartiger Peptid-Therapeutika auf dem Gebiet der Entzündungskrankheiten mit dem Evasin-Projekt zusammen. Dies wird die Entwicklung der sogenannten "Drugs from Bugs", beschleunigen, mit denen seltene Autoimmunerkrankungen wie Myokarditis behandelt werden können." Carolyn Porter, Deputy Head of Technology Transfer, Oxford University Innovation, fügte hinzu: "Die LAB282-Partnerschaft wurde etabliert, um die Wirkstoffforschung an der Oxford University zu beschleunigen. Durch die Finanzierung wird das Evasin-Projekt schneller in die klinische Phase kommen - zum Nutzen der Patienten mit kardiovaskulären Autoimmunerkrankungen, für die es noch keine Heilung gibt. Durch die Validierung der Rolle von DarTG beim Wachstum und in der Funktion von Bakterien könnte unser zweites Projekt eine neue Strategie für die Entwicklung von Antibiotika aufzeigen." Mit über 2.500 Forschern und mehr als 2.800 Studenten ist der Bereich einer der größten biomedizinischen Forschungszentren in Europa. Die Oxford University ist weltweit führend im Bereich Medizin und beheimatet die höchstplatzierte Medical School in UK. Oxford ist Vorreiter in der medizinischen Forschung, von der Genetik und molekularen Grundlage von Krankheiten bis zu neuesten Fortschritten im Bereich Neurowissenschaften. Die Universität verfügt über das größte Portfolio klinischer Studien in UK sowie umfangreiche Expertise im Voranbringen von Forschungsansätzen in die Klinik. Partnerschaften mit lokalen NHS Trusts ermöglichen es Patienten, an dieser engen Verbindung zwischen medizinischer Forschung und Gesundheitsversorgung teilzuhaben. Eine große Stärke dieses Bereichs an der Oxford University besteht in dem langjährigen Netzwerk aus klinischen Forschungseinrichtungen in Asien und Afrika, so dass weltweit führende Forschung hinsichtlich der größten Herausforderungen der globalen Gesundheit wie Malaria, TB, HIV/AIDS und Grippe betrieben werden kann. Oxford ist darüber hinaus bekannt für seine großangelegten Studien, die die Auswirkungen von Rauchen, Alkoholkonsum und Ernährung auf Krebs- und Herzerkrankungen sowie weitere Erkrankungen untersuchen. Oxford University Innovation unterstützt alle Aktivitäten der Bereiche der University, darunter die Verwaltung von Technologietransfers und Beratungsaktivitäten, und bietet Kunden weltweit Leistungen im Bereich Management von Innovationen. Wir bieten Zugang zu Technologien von Oxford-Wissenschaftlern durch die Lizenzierung von geistigem Eigentum, Unternehmensausgründungen und Verkäufen sowie zu akademischer Expertise durch unser Consulting Services-Team. Das New Venture Support & Funding-Team ermöglicht Investoren oder Stiftungen Anteile an frühphasigen Unternehmen zu erwerben und verwaltet das Oxford Angels Network. Unser Startup-Inkubator unterstützt Mitglieder und ehemalige Mitglieder Universität dabei, Unternehmen zu gründen und voranzubringen, die keine Ausgründungen der Universität sind. Oxford University Innovation ist führend unter den Universitäten in Hinblick auf die Anzahl der Patente in UK und ist mit über 140 neuen Unternehmen in 25 Jahren Nummer eins bezüglich Universitätsausgründungen. Im letzten veröffentlichten Geschäftsjahr wurden 529 Lizenzen und Beratungsvereinbarungen abgeschlossen. Isis Enterprise, unsere Beratungseinheit für Innovationsmanagement, arbeitet eng mit Universitäten, der Regierung sowie industriellen Kontakten weltweit zusammen. Um Neuigkeiten zu Innovationen von Oxford zu erhalten, können Sie Oxford University Innovation auf LinkedIn und Twitter folgen oder besuchen Sie den folgenden Link: http://innovation.ox.ac.uk/about/contact-us. Für weitere Informationen oder Interviews: Gregg Bayes-Brown, Marketing and Communications Manager, Oxford University Innovation T: +44 (0)1865 280867 | E: firstname.lastname@example.org Evotec ist ein Wirkstoffforschungs- und -entwicklungsunternehmen, das in Forschungsallianzen und Entwicklungspartnerschaften mit führenden Pharma- und Biotechnologieunternehmen, akademischen Einrichtungen, Patientenorganisationen und Risikokapitalgesellschaften innovative Ansätze zur Entwicklung neuer pharmazeutischer Produkte zügig vorantreibt. Wir sind weltweit tätig und bieten unseren Kunden qualitativ hochwertige, unabhängige und integrierte Lösungen im Bereich der Wirkstoffforschung an. Dabei decken wir alle Aktivitäten vom Target bis zur klinischen Entwicklung ab, um dem Bedarf der Branche an Innovation und Effizienz in der Wirkstoffforschung begegnen zu können (EVT Execute). Durch das Zusammenführen von erstklassigen Wissenschaftlern, modernsten Technologien sowie umfangreicher Erfahrung und Expertise in wichtigen Indikationsgebieten wie zum Beispiel Neurowissenschaften, Diabetes und Diabetesfolgeerkrankungen, Schmerz und Entzündungskrankheiten, Onkologie und Infektionskrankheiten ist Evotec heute einzigartig positioniert. Auf dieser Grundlage hat Evotec ihre Pipeline bestehend aus mehr als 70 verpartnerten Programmen in klinischen, präklinischen und Forschungsphasen aufgebaut (EVT Innovate). Evotec arbeitet in langjährigen Forschungsallianzen mit Partnern wie Bayer, CHDI, Sanofi oder UCB zusammen. Darüber hinaus verfügt das Unternehmen über Entwicklungspartnerschaften u. a. mit Janssen Pharmaceuticals im Bereich der Alzheimer'schen Erkrankung, mit Sanofi im Bereich Diabetes, mit Pfizer auf dem Gebiet Organfibrose und mit Celgene im Bereich neurodegenerative Erkrankungen.. Weitere Informationen finden Sie auf unserer Homepage. www.evotec.com.
News Article | February 21, 2017
HAMBURG, Germany--(BUSINESS WIRE)--Evotec AG (Frankfurt Stock Exchange: EVT, TecDAX, ISIN: DE0005664809) is pleased to announce that LAB282, the £ 13 m (over EUR 15 m) drug discovery partnership with Oxford University, has made its first wave of awards, backing projects targeting cardiovascular diseases and infectious diseases. Launched last year in November as a partnership between Oxford University, Evotec, Oxford University Innovation Ltd and Oxford Sciences Innovation plc, LAB282 aids the rapid translation of research outputs into new drug discovery and development programmes. It draws on expertise provided by Evotec and combines it with pre-clinical proof-of-concept grant funding to accelerate projects into a position where they can be commercialised and scaled up efficiently and effectively. Out of a pool of high-quality project proposals across various therapeutic areas and encompassing different therapeutic modalities, two projects were chosen. The two grant winners will be conducting further research into: - "Drugs from bugs" - A project developing evasins, a potential treatment for cardiovascular and autoimmune diseases derived from the saliva of ticks; - DarTG - A potential new target for the development of antibiotics that could shut down tuberculosis and several other pathogens. Evotec will exclusively contribute its drug discovery expertise and platforms to the selected projects and together with Oxford University and its academic researchers develop them further with the aim to have a pre-clinical proof of concept for new drugs. The next round of grants awards is due in June 2017. Dr Thomas Hanke, LAB282 Expert-in-Residence and Head of Academic Partnerships at Evotec, commented: "I am excited and very pleased we were able to select two outstanding and truly translational projects from a panel of high-quality applications for the first round of LAB282 awards. My cordial congratulations go to Prof. Bhattacharya and Dr Ahel and their teams for their excellent work. I am very much looking forward to closely collaborating with the Oxford University and Evotec teams in accelerating bona fide drug discovery from the awarded projects." Shoumo Bhattacharya, British Heart Foundation Chair of Cardiovascular Medicine at Oxford University and lead academic on the evasins project, said: "The LAB282 funding, which brings Evotec's world-class expertise in the development of peptide therapeutics and in inflammation to the evasin project, will help the development of new therapeutics - 'drugs from bugs' - that can treat orphan autoimmune diseases such as myocarditis." Carolyn Porter, Deputy Head of Technology Transfer, Oxford University Innovation, added: "The LAB282 partnership was established to accelerate drug discovery at Oxford University. This funding will enable the evasin project to enter the clinic more rapidly for the benefit of patients with cardiovascular autoimmune disorders for which there is no cure. Through validation of DarTG role in bacterial growth and function, our second funded project could uncover a new strategy for development of antibiotics." The "drugs from bugs" project will be looking to develop evasins, which are peptides derived from the saliva of ticks. Ticks have been around since the time of the dinosaurs, and have been evolving these peptides to block chemokines, which are proteins in the body that recruit inflammatory cells to the site of injury. The research team led by Professor Shoumo Bhattacharya have developed a new "Bug-to-Drug" technology to find these tick peptides in order to treat inflammatory and fibrotic diseases that are currently incurable. In this project, they will use these peptides to target chemokines that cause giant cell myocarditis ("GCM"), a rare autoimmune disease with no cure. GCM usually affects young adults, progressing rapidly to heart failure and death. There is no specific treatment except for a heart transplant. The second project, with Dr Ivan Ahel, looks to validate translational research on DarTG toxin-antitoxin system, a pathway found in tuberculosis. Essentially a back door around tuberculosis' defences, DarTG could be a potential target for small molecules, which could shut down the bacteria. If the project demonstrates that DarTG is the pathogen's Achilles' Heel, it will pave the way for a new class of antibiotics. Aside from offering a potential new therapy for tuberculosis, which will become a greater threat as antibiotic resistance increases, DarTG could also be a weakness in Escherichia coli, superbug Klebsiella pneumonia, and other gram-negative pathogens. LAB282, initiated in November 2016, is a new £ 13 m partnership between the Oxford University, Oxford University Innovation Ltd, Oxford Sciences Innovation plc and Evotec AG created to identify and develop new approaches to treating serious diseases, which originate from the Oxford University. The goal is to accelerate the achievement of pre-clinical proof of concept for new drugs and to generate new spin-out companies. The name derived from the pantone colour code of "Oxford Blue". For more information, please visit www.lab282.org. The Division is one of the largest biomedical research centres in Europe, with over 2,500 people involved in research and more than 2,800 students. The University is rated the best in the world for medicine, and it is home to the UK's top-ranked medical school. From the genetic and molecular basis of disease to the latest advances in neuroscience, Oxford is at the forefront of medical research. It has one of the largest clinical trial portfolios in the UK and great expertise in taking discoveries from the lab into the clinic. Partnerships with the local NHS Trusts enable patients to benefit from close links between medical research and healthcare delivery. A great strength of Oxford medicine is its long-standing network of clinical research units in Asia and Africa, enabling world-leading research on the most pressing global health challenges such as malaria, TB, HIV/AIDS and flu. Oxford is also renowned for its large-scale studies which examine the role of factors such as smoking, alcohol and diet on cancer, heart disease and other conditions. Oxford Sciences Innovation plc is the world's largest IP investment company dedicated to a single university. Founded in May 2015, we help turn Oxford University's world-leading scientific discovery into innovative science and technology companies that can have a positive impact on society. We provide capital and expertise to businesses driven by intellectual property developed in Oxford's Mathematical, Physical, Life Sciences Division and Medical Sciences Divisions. We are guided and powered by some of the world's leading organisations, including Invesco, Woodford Investment Management, the Wellcome Trust and Lansdowne Partners. Oxford University Innovation supports innovation activities across all University Divisions, managing technology transfer and consulting activities, and providing an innovation management service to clients around the world. We provide access to technology from Oxford researchers through intellectual property licensing, spinout company formation and material sales, and to academic expertise through our Consulting Services team. The New Venture Support & Funding team supports investors or donors with an interest in early-stage ventures, and manages the Oxford Angels Network. Our Startup Incubator supports members and ex-members of the University who wish to start or grow entrepreneur-driven ventures that are not University spinouts. Oxford University Innovation is the highest university patent filer in the UK and is ranked 1st in the UK for university spin-outs, having created over 140 new companies in 25 years. In the last reported financial year we completed 529 licenses and consulting agreements. Isis Enterprise, our innovation management consultancy, works with university, government and industrial clients from offices around the world. For updates on innovations from Oxford, follow Oxford University Innovation on LinkedIn and Twitter or subscribe at http://innovation.ox.ac.uk/about/contact-us. For more information or to arrange interview, please contact: Gregg Bayes-Brown, Marketing and Communications Manager, Oxford University Innovation T: +44 (0)1865 280867 | E: email@example.com Evotec is a drug discovery alliance and development partnership company focused on rapidly progressing innovative product approaches with leading pharmaceutical and biotechnology companies, academics, patient advocacy groups and venture capitalists. We operate worldwide providing the highest quality stand-alone and integrated drug discovery solutions, covering all activities from target-to-clinic to meet the industry's need for innovation and efficiency in drug discovery (EVT Execute). The Company has established a unique position by assembling top-class scientific experts and integrating state-of-the-art technologies as well as substantial experience and expertise in key therapeutic areas including neuroscience, diabetes and complications of diabetes, pain and inflammation, oncology and infectious diseases. On this basis, Evotec has built a broad and deep pipeline of more than 70 partnered product opportunities at clinical, pre-clinical and discovery stages (EVT Innovate). Evotec has established multiple long-term discovery alliances with partners including Bayer, CHDI, Sanofi or UCB and development partnerships with e.g. Janssen Pharmaceuticals in the field of Alzheimer's disease, with Sanofi in the field of diabetes, with Pfizer in the field of tissue fibrosis and Celgene in the field of neurodegenerative diseases. For additional information please go to www.evotec.com. Information set forth in this press release contains forward-looking statements, which involve a number of risks and uncertainties. The forward-looking statements contained herein represent the judgement of Evotec as of the date of this press release. Such forward-looking statements are neither promises nor guarantees, but are subject to a variety of risks and uncertainties, many of which are beyond our control, and which could cause actual results to differ materially from those contemplated in these forward-looking statements. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any such statements to reflect any change in our expectations or any change in events, conditions or circumstances on which any such statement is based.
Taylor R.D.,UCB |
Maccoss M.,Bohicket Pharma Consulting LLC |
Journal of Medicinal Chemistry | Year: 2014
We have analyzed the rings, ring systems, and frameworks in drugs listed in the FDA Orange Book to understand the frequency, timelines, molecular property space, and the application of these rings in different therapeutic areas and target classes. This analysis shows that there are only 351 ring systems and 1197 frameworks in drugs that came onto the market before 2013. Furthermore, on average six new ring systems enter drug space each year and approximately 28% of new drugs contain a new ring system. Moreover, it is very unusual for a drug to contain more than one new ring system and the majority of the most frequently used ring systems (83%) were first used in drugs developed prior to 1983. These observations give insight into the chemical novelty of drugs and potentially efficient ways to assess compound libraries and develop compounds from hit identification to lead optimization and beyond. © 2014 American Chemical Society.
News Article | February 27, 2017
NEW YORK, Feb. 27, 2017 /PRNewswire/ -- Summary This report provides all the information you require to better understand UCB and its partnering interests and activities since 2010.Read the full report: http://www.reportlinker.com/p03605638-summary/view-report.htmlDescriptionThe...
News Article | February 28, 2017
EMERYVILLE, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) -- Adamas Pharmaceuticals, Inc. (Nasdaq:ADMS) today reported recent achievements and financial results for the fourth quarter and full-year ended December 31, 2016. “We expect 2017 to be a pivotal year as we transform from an R&D-focused company to a commercial organization as we anticipate FDA approval of ADS-5102 for the treatment of levodopa-induced dyskinesia. If approved, we expect to launch ADS-5102 in the second half of 2017, providing Parkinson’s patients with the first and only medicine indicated for the treatment of levodopa-induced dyskinesia,” said Gregory T. Went, Ph.D., Chairman and Chief Executive Officer of Adamas Pharmaceuticals, Inc. “In addition, we are continuing to develop ADS-5102 in additional indications, as well as to advance the clinical development of ADS-4101 for the treatment of partial onset seizures in patients with epilepsy, the fourth chrono-synchronous targeted therapy to emerge from our drug development platform.” Fourth Quarter and Full-Year 2016 Financial Results Adamas reported a net loss of $15.0 million, or $0.68 per share, basic and diluted, for the fourth quarter of 2016, compared to a net loss of $10.7 million, or $0.58 per share, basic and diluted, for the fourth quarter of 2015. For the year ended December 31, 2016, Adamas reported a net loss of $60.1 million, or $2.77 per share, basic and diluted, compared to a net loss of $51.8 million, or $2.86 per share, basic and diluted, for 2015. For the quarter ended December 31, 2016, Adamas recorded revenues of $37,000 compared to $0.5 million in the corresponding period of 2015. Adamas recorded total revenues of $0.6 million for the full-year 2016, compared to $1.9 million during the same period of 2015. The decrease reflected the reduction in reimbursements for activities Adamas employees performed related to a license agreement with Allergan. Research and development (R&D) expenses for the quarter ended December 31, 2016, were $7.0 million, including $0.7 million in stock-based compensation expense, compared to $9.7 million for the quarter ended December 31, 2015, which included $0.9 million in stock-based compensation expense. For the full-year 2016, R&D expenses were $31.2 million, including $2.9 million in stock-based compensation expense, compared to $35.9 million for the full-year 2015, which included $3.2 million in stock-based compensation expense. R&D expenses for the full-year declined over the prior period primarily due to the completion of Phase 3 clinical trials of ADS-5102 for LID in patients with Parkinson’s disease. General and administrative (G&A) expenses for the quarter ended December 31, 2016, were $8.3 million, including $2.1 million in stock-based compensation expense, compared to $6.9 million for the same quarter in the prior year, which included $1.9 million in stock-based compensation expense. In the full-year 2016, G&A expenses were $30.3 million, including $7.7 million in stock-based compensation expense, compared to $23.5 million, including $6.8 million in stock-based compensation expense, incurred during the full-year 2015. The increase in G&A expenses for the fourth quarter and full-year was primarily due to increased investment in infrastructure to support the anticipated commercialization of ADS-5102 for LID in Parkinson’s disease. On December 31, 2016, Adamas had $135.9 million of cash, cash equivalents and available-for-sale securities compared to $120.0 million at December 31, 2015. On January 6, 2016, Adamas raised net proceeds of $61.8 million from the sale of 2,875,000 shares of common stock through a follow-on public offering. About Adamas Pharmaceuticals, Inc. Adamas develops new medicines to improve the daily lives of those affected by chronic neurologic disorders, including Parkinson’s disease, multiple sclerosis, epilepsy and Alzheimer’s disease. Adamas has pioneered a platform to develop medicines, called chrono-synchronous therapies, for chronic neurologic disorders based on an understanding of the time-dependent biologic processes responsible for disease activity and drug response to potentially achieve symptomatic relief without tolerability issues. The company’s most advanced product candidate, ADS-5102, is in development for levodopa-induced dyskinesia (LID) in patients with Parkinson’s disease and walking impairment. An NDA supporting ADS-5102 for the treatment of LID in patients with Parkinson’s disease is under review by the FDA, with a PDUFA date of August 24, 2017. Adamas is exploring other indications for ADS-5102 for further development. Adamas is also investigating ADS-4101 for the treatment of partial onset seizures in patients with epilepsy. Additionally, Adamas’ licensed assets, NAMENDA XR® and NAMZARIC®, are currently marketed by Allergan, and Adamas is eligible to receive royalties on sales of these medicines beginning in June 2018 and May 2020, respectively. For more information, please visit www.adamaspharma.com. VIMPAT® is a trademark of UCB. Namenda XR® and Namzaric® are trademarks of Merz Pharma GmbH & Co. KGaA. 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, including but not limited to, statements contained in this press release regarding the potential approval and commercial launch of ADS-5102 for treatment of levodopa-induced dyskinesia in patients with Parkinson’s disease, the potential for additional clinical development programs for ADS-5102 including walking impairment in multiple sclerosis and other indications, that 2017 will be a pivotal year as Adamas transforms from an R&D-focused company to a commercial organization, the advancement of ADS-4101 in clinical development, and the statements under the heading “Anticipated Milestones.” Words such as “expect,” “anticipate,” and similar expressions (as well as other words or expressions referencing future events, conditions, or circumstances) are intended to identify forward-looking statements. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. For a description of risks and uncertainties that could cause actual results to differ from those expressed in forward-looking statements, including risks relating to Adamas’ research, clinical, development and commercial activities relating to ADS-5102 and ADS-4101, the regulatory and competitive environment and Adamas’ business in general, see Adamas’ Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 28, 2017. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release. Adamas undertakes no obligation to update any forward-looking statement in this press release.
News Article | February 28, 2017
-- Planned submission of NDA for glycopyrronium tosylate (formerly DRM04) in 2H17 on schedule after pre-NDA meeting with FDA -- -- Management to host webcast and conference call today 4:30 p.m. ET / 1:30 p.m. PT -- MENLO PARK, Calif., Feb. 28, 2017 (GLOBE NEWSWIRE) -- Dermira, Inc. (NASDAQ:DERM), a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions, today reported financial results for the quarter and year ended December 31, 2016 and provided an update on its clinical development programs and financial guidance for 2017. “I am extremely pleased with the progress Dermira made in 2016, which was a transformational year for our company,” said Tom Wiggans, chairman and chief executive officer of Dermira. “We finished the year on a high note and are off to a strong start in 2017, having started the olumacostat glasaretil Phase 3 program in acne, announced positive data from the final Phase 3 CIMZIA trial in moderate-to-severe chronic plaque psoriasis and held our pre-NDA meeting with the FDA for our glycopyrronium tosylate program in primary axillary hyperhidrosis. These milestones have set the stage for what we hope is another productive year for Dermira. We anticipate submitting marketing applications for CIMZIA and an NDA for glycopyrronium tosylate, continuing enrollment for the olumacostat glasaretil Phase 3 program and establishing an experienced commercial organization that will eventually bring our products, if approved, to the people who need them.” Dermira management will host a webcast and conference call regarding this announcement at 1:30 p.m. PT / 4:30 a.m. ET today. The live call may be accessed by dialing 877-359-9508 for domestic callers and 224-357-2393 for international callers and using the conference code: 77463468. A live webcast and archive of the call will be available from the investor relations sections of the company website at www.dermira.com. A telephone replay of the call will be available by dialing 855-859-2056 for domestic callers or 404-537-3406 for international callers and entering the conference code: 77463468. Dermira is a biopharmaceutical company dedicated to bringing biotech ingenuity to medical dermatology by delivering differentiated, new therapies to the millions of patients living with chronic skin conditions. Dermira is committed to understanding the needs of both patients and physicians and using its insight to identify and develop leading-edge medical dermatology programs. Dermira’s product pipeline includes three Phase 3 product candidates that could have a profound impact on the lives of patients: glycopyrronium tosylate, in development for the treatment of primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab pegol), in development in collaboration with UCB Pharma S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil, in development for the treatment of acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit www.dermira.com. In addition to filings with the Securities and Exchange Commission (SEC), press releases, public conference calls and webcasts, Dermira uses its website (www.dermira.com) and LinkedIn page (https://www.linkedin.com/company/dermira-inc-) as channels of distribution of information about its company, product candidates, planned financial and other announcements, attendance at upcoming investor and industry conferences and other matters. Such information may be deemed material information and Dermira may use these channels to comply with its disclosure obligations under Regulation FD. Therefore, investors should monitor Dermira’s website and LinkedIn page in addition to following its SEC filings, press releases, public conference calls and webcasts.Dermira is a biopharmaceutical company dedicated to bringing unique scientific insights to medical dermatology to identify and develop leading-edge clinical programs. The Company’s goal is to help transform the way skin conditions are treated by serving as the bridge between unmet patient needs and the significant scientific advances being made in understanding skin biology. Dermira is focused on delivering important new treatments to the millions of patients living with chronic skin conditions. Its unique portfolio of three Phase 3 product candidates includes glycopyrronium tosylate (formerly DRM04), a topical anticholinergic in development for primary axillary hyperhidrosis (excessive underarm sweating); CIMZIA® (certolizumab pegol), an injectable Tumor Necrosis Factor (TNF) inhibitor, in development in collaboration with UCB S.A. for the treatment of moderate-to-severe chronic plaque psoriasis; and olumacostat glasaretil (formerly DRM01), a topical sebum inhibitor in development for acne vulgaris. Dermira is headquartered in Menlo Park, Calif. For more information, please visit www.dermira.com. The information in this press release contains forward-looking statements and information within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, which are subject to the “safe harbor” created by those sections. This press release contains forward-looking statements that involve substantial risks and uncertainties, including statements with respect to patient enrollment in Dermira’s CLAREOS-1, CLAREOS-2 and CLARITUDE trials and the successful completion of, and timing expectations for the receipt and announcement of topline results from, such trials; the anticipated safety and tolerability profile for glycopyrronium tosylate based on a preliminary review of data from the ARIDO trial; the timing and submission of an NDA to the FDA for glycopyrronium tosylate; the timing and submission of marketing applications in the United States, Europe and Canada for CIMZIA; the establishment of an experienced commercial organization in 2017 that will eventually bring Dermira products, if approved, to patients; the potential receipt of regulatory approval for Dermira’s product candidates and the commercial launch of such products; estimates of 2017 collaboration and license revenue, operating expenses, stock-based compensation expense and 2017 year-end cash and investments; anticipated investments in 2017 related to regulatory submissions in 2017, potential product launches in 2018 and the olumacostat glasaretil Phase 3 clinical program; expectations regarding two potential product launches in 2018; and expectations regarding receipt of the $10.7 million final development milestone payment under Dermira’s agreement with UCB. These statements deal with future events and involve known and unknown risks, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from the information expressed or implied by these forward-looking statements. Factors that could cause actual results to differ materially include risks and uncertainties such as those relating to the design, implementation and outcome of Dermira’s clinical trials, including related to further analysis of the results of Dermira’s studies; Dermira’s dependence on third-party clinical research organizations, manufacturers and suppliers; the outcomes of future meetings with regulatory agencies; Dermira’s ability to obtain regulatory approval for its product candidates; Dermira’s ability to attract and retain key employees; Dermira’s ability to obtain necessary additional capital; and Dermira’s ability to continue to stay in compliance with applicable laws and regulations. You should refer to the section entitled “Risk Factors” set forth in Dermira’s Annual Report on Form 10-K, Dermira’s Quarterly Reports on Form 10-Q and other filings Dermira makes with the SEC from time to time for a discussion of important factors that may cause actual results to differ materially from those expressed or implied by Dermira’s forward-looking statements. Furthermore, such forward-looking statements speak only as of the date of this press release. Dermira undertakes no obligation to publicly update any forward-looking statements or reasons why actual results might differ, whether as a result of new information, future events or otherwise, except as required by law.
News Article | February 27, 2017
Sessions in US and EMEA will explore insight engines and the possibilities of extracting value from data NEW YORK, NY--(Marketwired - February 27, 2017) - Sinequa, a leader in Cognitive Search and Analytics, today announced that it will be exhibiting and speaking at the upcoming Gartner Data and Analytics Summit North America (March 6-9) in Grapevine, Texas, and the Gartner Data and Analytics Summit EMEA (March 20-22) in London. Sinequa executives will present "Insight Engines: Infinite Possibilities of Extracting Value from Data" at both events. Business decisions are increasingly driven by data that is growing and diversifying at an exponential rate. Organizations are challenged to extract the right information from that data and provide it to the right people at the right time. Insight engines help them do that by combining human-driven interactions with machine-assisted analysis. They provide a "comprehensive auxiliary brain" to people, offering contextual insights for better decisions, accelerated innovation and improved operational efficiencies. "While enterprise search has been historically how people find information within their digital workplace, significant enhancements are occurring based on user needs," said Laurent Fanichet, VP of Marketing at Sinequa. "Gartner has redefined the next generation enterprise search as 'insight engines,' making search much more than just keyword matching. Thanks to the combination of advanced natural language processing, machine learning and predictive analytics, we are now heading into the age of search results personalization. 2017 will be the breakout year for search and the importance of insight engines within data driven organizations." Sinequa will be presenting at: Recognized as a leader in the Gartner Magic Quadrant for Enterprise Search and other analysts' reports, Sinequa provides a cognitive search and analytics platform for Fortune Global 2000 companies and government agencies. Using advanced Natural Language Processing (NLP) and Machine Learning algorithms, the solution offers insights extracted from structured and unstructured data. Millions of users in the world's largest and most information-intensive organizations, including Airbus, AstraZeneca, Atos, Biogen, UCB, Credit Agricole, Mercer, and Siemens, rely on Sinequa to put business-critical information at the fingertips of their employees. Sinequa develops its expertise and its business around the world with a broad network of technology and business partners. Sinequa is a founding sponsor of the Cognitive Computing Consortium. For more information, visit www.sinequa.com.