Epidiolex preliminary success encourages GW Pharma to proceed to Phase II/III for Dravet Syndrome

GW Pharmaceuticals plc has announced physician reports of efficacy and safety data on 27 children and young adults with treatment-resistant Epilepsy who have been treated with GW�s investigational cannabidiol (CBD) product candidate, Epidiolex, for a period of 12 weeks. The treatment-resistant patients suffer from a range of epilepsies in which current anti-epileptic drugs have been unsuccessful in adequately controlling seizures, and included such severe forms of epilepsy as Dravet syndrome and Lennox-Gastaut syndrome. Uncontrolled data from two hospital sites in the United States that were generated under expanded access Investigational New Drug applications (INDs) authorized by the FDA were made available to the Company. Of the patients who have responded to Epidiolex, a high proportion show a reduction in seizure frequency of greater than 50% and a portion of these patients were reported to be seizure-free at the end of 12 weeks of treatment. These signals of efficacy, together with the side effect profile observed to date, support GW�s decision to advance Epidiolex into a formal development program and the company will commence a Phase II/III clinical trial of Epidiolex in Dravet syndrome in the second half of 2014.