GW Pharmaceuticals and its U.S. Subsidiary Greenwich Biosciences Completes Rolling New Drug Application Submission to U.S.

GW Pharmaceuticals plc (GWPH), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, along with its U.S. subsidiary Greenwich Biosciences, today announced it has completed the rolling submission of a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for Epidiolex® (cannabidiol) as adjunctive treatment of seizures associated with Lennox-Gastaut syndrome (LGS) and Dravet syndrome, two highly treatment-resistant forms of childhood-onset epilepsy.

GW has received Rare Pediatric Disease and Orphan Drug Designations from the FDA for Epidiolex in the treatment of both LGS and Dravet syndrome. Additionally, GW has received Fast Track Designation from the FDA for Epidiolex for the treatment of Dravet syndrome.

"The submission of the Epidiolex NDA is an important milestone for patients with LGS and Dravet syndrome in that a potential new treatment option is within sight for these very difficult to treat and devastating conditions," stated Justin Gover, CEO of GW Pharmaceuticals. “On behalf of all those patients, clinicians and GW employees who have supported the Epidiolex program, we are pleased to submit this promising therapy for FDA review and we look forward to working with the FDA throughout the review process. This regulatory submission is a demonstration of GW’s commitment to developing innovative cannabinoid-based treatments that have the potential to address significant unmet medical needs.”

The NDA for Epidiolex is supported by data from three Phase 3 safety and efficacy studies, each of which met their primary endpoint. Epidiolex was generally well tolerated in these trials. The NDA includes safety data on approximately 1,500 patients, with approximately 400 patients on continuous therapy for more than one year. Beyond pivotal safety and efficacy data, the NDA includes a comprehensive clinical pharmacology, pre-clinical and toxicology package. The CMC section of the NDA incorporates the Company’s recently expanded UK manufacturing facilities.

The Company plans to file a Marketing Authorization Application (MAA) in Europe for Epidiolex in the near future.

About Epidiolex® (cannabidiol)

Epidiolex, GW's lead cannabinoid product candidate is a pharmaceutical formulation of purified cannabidiol (CBD), which is in development for the treatment of several rare childhood-onset epilepsy disorders. GW has submitted a New Drug Application with the FDA for Epidiolex as adjunctive treatment for seizures associated with LGS and Dravet syndrome with an expected approval and launch in 2017. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS). Additionally, GW has received Fast Track Designation from the FDA for the treatment of Dravet syndrome and conditional grant of rare pediatric disease designation by FDA. The Company has also received Orphan Designation from the European Medicines Agency, or EMA, for Epidiolex for the treatment of LGS and Dravet syndrome. GW is currently evaluating additional clinical development programs in other orphan seizure disorders including Phase 3 trials in TSC and IS.