GW Pharmaceuticals and U.S. Subsidiary Greenwich Biosciences to Present Data on Epidiolex (cannabidiol oral solution) at the 2018 American Academy of Neurology Annual Meeting
GW Pharmaceuticals plc (Nasdaq: GWPH, “GW,” “the Company” or “the Group”), 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 that the Company will present data from the pivotal Phase 3 trials of Epidiolex® (cannabidiol oral solution) in Lennox-Gastaut syndrome (LGS) and Dravet syndrome, along with other supportive data, at the American Academy of Neurology (AAN) Annual Meeting, April 21-27, 2018, in Los Angeles, California.
Highlights of the data to be presented include:
“We look forward to sharing additional findings from our Epidiolex clinical program with the broader neurology community at AAN and expect that the significant continued flow of data should be supportive for neurologists as they grow their understanding of our medicine,” said Justin Gover, GW’s Chief Executive Officer. “With regulatory applications for Epidiolex accepted for review in both the U.S. and Europe, and an expected U.S. launch in the second half of this year, this is a very exciting time for our Company and those awaiting this new potential treatment option.”
Sunday, April 22, 2018
Poster Session P1
11:30 a.m. – 5:30 p.m. PT
Monday, April 23
Session S19: Epilepsy/Clinical Neurophysiology (EEG) II
3:30 p.m. – 5:30 p.m. PT
Monday, April 23
Poster Session P2
11:30 a.m. – 7:00 p.m. PT
Friday, April 27
Poster Session P6
11:30 a.m. – 5:00 p.m. PT
Friday, April 27
Session S53: Epilepsy/Clinical Neurophysiology (EEG) III
3:30 p.m. – 5:30 p.m. PT
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, which has been assigned a goal date of 27 June 2018 and, if approved, the medicine is expected to be available by prescription in the second half of 2018. GW has also submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) with an expected decision date in early 2019. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, TSC and 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, Dravet syndrome, West syndrome and TSC. GW is currently evaluating additional clinical development programs in other orphan seizure disorders including Phase 3 trials in Tuberous Sclerosis Complex and Infantile Spasms.
About GW Pharmaceuticals plc and Greenwich Biosciences
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, along with its U.S. subsidiary Greenwich Biosciences, is advancing an orphan drug program in the field of childhood-onset epilepsy with a focus on Epidiolex (cannabidiol), for which GW has submitted regulatory applications in the U.S. and Europe for the adjunctive treatment of Lennox-Gastaut syndrome and Dravet syndrome. The Company continues to evaluate Epidiolex in additional rare epilepsy conditions and currently has ongoing clinical trials in Tuberous Sclerosis Complex and Infantile Spasms. GW commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex® (nabiximols), which is approved for the treatment of spasticity due to multiple sclerosis in numerous countries outside the United States and for which the company is now planning a US Phase 3 trial. The Company has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for epilepsy, glioblastoma, and schizophrenia. For further information, please visit www.gwpharm.com.
