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GW Pharmaceuticals Commences Phase 2/3 Clinical Trial of Epidiolex(R) as a Potential Treatment for Epilepsy in Dravet Syndrome

LONDON, Oct. 30, 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 it has commenced a Phase 2/3 clinical trial of Epidiolex® (cannabidiol or CBD) for the treatment of Dravet syndrome, a rare and catastrophic treatment-resistant form of childhood epilepsy.

"The results of our open-label trial of Epidiolex in children with Dravet syndrome have been very encouraging and we are excited to begin this important placebo-controlled clinical trial," stated Orrin Devinsky MD, Professor of Neurology, Neurosurgery, and Psychiatry at NYU School of Medicine, and Principal Investigator of the trial.

"As one of the largest epilepsy centers in the country, our focus has always been to find new and innovative ways to treat and cure children with various forms of epilepsy," said Dr. Angus Wilfong, neurologist at Texas Children's Hospital. "Initial trials of Epidiolex have shown promising signals of efficacy in children with treatment- resistant epilepsy, and we are pleased to have the opportunity to partner with GW Pharmaceuticals in the first worldwide trial for this group of patients with such a catastrophic form of epilepsy," he continued.

"We are pleased to have advanced Epidiolex into the pivotal stage of clinical development. The start of this Phase 2/3 trial represents a significant milestone for children that suffer with Dravet syndrome for which there remains a substantial unmet medical need," stated Justin Gover, GW's Chief Executive Officer. "Epidiolex is the first plant-based CBD medicine to be studied in a FDA-authorized, placebo-controlled trial and we look forward to working with leading pediatric epilepsy centers across the U.S. to advance this clinical program as rapidly as possible."

The Phase 2/3 trial is a two-part randomized double-blind, placebo-controlled parallel group safety, tolerability, pharmacokinetic and efficacy trial of single and multiple doses of Epidiolex to treat Dravet syndrome in children who are being treated with other anti-epileptic drugs. Part one comprises the pharmacokinetic and dose-finding elements of the trial in a total of 30 patients over a three week treatment period. Part two is a placebo-controlled safety and efficacy evaluation of Epidiolex over a three month treatment period in a total of 80 patients. All patients who complete the study will be eligible to receive Epidiolex under a long term open label extension study.

GW anticipates commencing an additional Phase 3 trial in Dravet syndrome in the first quarter of 2015 in parallel with part two of the first Phase 2/3 trial. The company also expects to commence two Phase 3 clinical trials in Lennox-Gastaut syndrome in the first quarter of 2015.

To obtain information about this clinical trial or eligibility criteria the treating physician should contact: medicaldirector@gwpharm.com

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 27 countries outside the United States. Sativex is also in Phase 3 clinical development as a potential treatment of pain associated with advanced cancer. This Phase 3 program has received Fast Track Designation from the U.S. Food and Drug Administration (FDA) and is intended to support the submission of a New Drug Application for Sativex in cancer pain with the FDA and in other markets around the world. GW has a deep pipeline of additional cannabinoid product candidates, including Epidiolex® in the treatment of childhood epilepsy, which has received Fast Track Designation from the FDA for Dravet syndrome as well as Orphan Drug Designations from the FDA in both the treatment of Dravet syndrome and Lennox-Gastaut syndrome and Orphan Designation from the European Medicines Agency for Dravet syndrome. 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.

Forward-looking statements

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding our clinical goals, our plans for a clinical trial, the ability to conduct clinical trials sufficient to achieve positive completion, and the therapeutic and commercial value of the company's compounds. To the degree we are able to conduct clinical trials, we may have difficulty in enrolling candidates for testing and we may not be able to achieve the desired results. 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® 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.

Enquiries:

GW Pharmaceuticals plc (Today) + 44 20 3727 1000
Justin Gover, Chief Executive Officer (Thereafter) + 44 1980 557000
Stephen Schultz, VP Investor Relations (U.S.) 917 280 2424 / 401 500 6570
FTI Consulting (Media Enquiries)
Ben Atwell / Simon Conway / John Dineen (UK) + 44 20 3727 1000
Robert Stanislaro (U.S.) 212 850 5657
Trout Group, LLC (U.S. investor relations)
Todd James / Chad Rubin 646 378 2900
Peel Hunt LLP (UK NOMAD)
James Steel / Clare Terlouw + 44 20 7418 8900

Source:GW Pharmaceuticals plc