Source: GW Pharmaceuticals Press Release, May 06 2014
Position Created to Support U.S. Medical Affairs and Regulatory Activities Related to Epilepsy Programs
LONDON, May 6, 2014 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing, and commercializing novel therapeutics from its proprietary cannabinoid product platform, today announced the appointment of Kenneth Sommerville MD to the newly created position of VP, Clinical Science, based in the United States.
Dr. Sommerville will play an important role in the clinical development, medical affairs, and regulatory activities related to the Company’s epilepsy programs including the ongoing development of Epidiolex®, GW’s product candidate for Dravet and Lennox-Gastaut syndromes. He will also support the late stages of the completion of the investigational plan for Sativex® in cancer pain.
“We are delighted to announce this important appointment and welcome Ken’s extensive industry experience and therapeutic expertise in support of our rapidly evolving programs in the United States,” stated Justin Gover, GW’s Chief Executive Officer. “We have received significant interest from physicians and parents regarding Epidiolex for childhood epilepsy and with the GW-sponsored pivotal trials expected to commence in the second half of this year, Ken will play a leading role in the clinical development of this important product in the U.S. His expertise and depth of knowledge in product development and regulatory matters will serve GW well as we seek to advance Epidiolex through clinical trials and, if successful, obtain FDA approval as rapidly as possible.”
Dr. Sommerville is a board-certified neurologist and joins GW with a significant record of achievement including twenty-three years of experience in the pharmaceutical industry. He has had senior roles at UCB/Schwarz Pharma where he led clinical and regulatory programs in epilepsy and other neurological product development initiatives including NDA submissions to FDA and EMEA for multiple compounds. Most recently, Dr. Sommerville served as Vice President of Clinical Sciences at Pfizer, Inc. where he was Global Clinical Lead for opioids and led a team of physicians and scientists in the development of abuse-deterrent opioids. He also has led teams in multiple medical and scientific areas including, but not limited to, indications of complex partial seizures, basic and rapid infusion of an intravenous anti-convulsant, painful diabetic neuropathy, migraine prophylaxis, Parkinson’s disease, bipolar disorder, personality disorders, and schizophrenia. Dr. Sommerville has made major contributions to over twenty NDA submissions for both the FDA and EMEA and is recognized as an authority in drug development, especially anti-epileptic drugs, pain, and abuse-deterrent opioids.
“This is an exciting time to be joining GW, with a number of important products currently under development for patients in the United States including Sativex and Epidiolex. Specifically, I believe that Epidiolex has the potential to become an important new therapeutic option for children suffering with intractable epilepsy, an area of significant unmet need,” said Dr. Sommerville. “I look forward to working with the GW team to develop new treatments from their proprietary cannabinoid platform.”
Dr. Sommerville earned a M.D. degree from Jefferson Medical College in Philadelphia, Pennsylvania and is an Adjunct Assistant Professor of Medicine at the Duke University Medical Center in Durham, North Carolina. Dr. Sommerville was in the private practice of neurology for 11 years prior to entering the pharmaceutical industry.
About GW Pharmaceuticals plc
Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 25 countries. Sativex is also in Phase 3 clinical development as a potential treatment of pain in people with advanced cancer. This Phase 3 program is intended to support the submission of a New Drug Application for Sativex in cancer pain with the U.S. Food and Drug Administration and in other markets around the world. GW has a deep pipeline of additional cannabinoid product candidates, including Epidiolex which has received Orphan Drug Designation from the FDA for the treatment of Dravet and Lennox-Gastaut syndromes, severe, drug-resistant epilepsy syndromes. GW’s product pipeline also includes compounds in Phase 1 and 2 clinical development for glioma, ulcerative colitis, type‑2 diabetes, and schizophrenia. For further information, please visit www.gwpharm.com.
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the therapeutic and commercial value of the company’s compounds including Sativex® and Epidiolex®, the development and commercialization of Epidiolex, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory approval, the importance of the announced position and the impact of this appointment on clinical programs. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex®, Epidiolex®, and other products by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.
CONTACT: Enquiries: GW Pharmaceuticals plc (Today) + 44 20 3727 1000 Justin Gover, Chief Executive Officer (Thereafter) + 44 1980 557000 Stephen Schultz, VP Investor Relations (US) 401 500 6570 FTI Consulting (Media Enquiries) Ben Atwell / Simon Conway / John Dineen (UK) + 44 20 3727 1000 Robert Stanislaro (US) 212 850 5657 Trout Group, LLC (US investor relations) Todd James / Chad Rubin 646 378 2900
Source: GlobeNewswire (May 6, 2014 – 2:00 AM EDT)