GW Pharmaceuticals Receive Orphan Drug Designation from FDA

GW Pharmaceuticals Receive Orphan Drug Designation from FDA for Cannabidiol for the Treatment of Tuberous Sclerosis Comp

LONDON, April , 2016 
GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (“GW” or “the Company”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, has announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation for cannabidiol (CBD) for the treatment of Tuberous Sclerosis Complex (TSC).  TSC is a rare genetic disorder, the most common symptom of which is epilepsy. Epilepsy occurs in around 80-90% of TSC patients and is a significant cause of morbidity and mortality. TSC is the third orphan indication that GW is targeting within its Epidiolex clinical development program, which includes four Phase 3 pivotal trials in Dravet syndrome and Lennox-Gastaut syndrome, both rare and catastrophic forms of childhood-onset epilepsy. On April 11, 2016, GW announced it has commenced a Phase 3 clinical trial of Epidiolex as an adjunctive therapy for the treatment of seizures associated with TSC. GLOBE NEWSWIRE