3Q16 Update
GW Pharmaceuticals plc Reports 3Q16 Financial Results and Operational Progress
- Positive Phase 3 Epidiolex pivotal trial in Lennox-Gastaut Syndrome (LGS) -
- Positive FDA pre-NDA meeting - NDA for Dravet syndrome and LGS on track for H1 2017 submission -
LONDON, Aug. 09, 2016 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPH) (GWP.L) (GW, the Company or the Group), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announced financial results for the third quarter ended 30 June 2016.
“We have now reported two positive Phase 3 trials for Epidiolex and are on track for an NDA filing that includes both the Dravet syndrome and Lennox-Gastaut Syndrome indications. We believe that these Phase 3 data show that Epidiolex has the potential to provide a robust and clinically meaningful reduction in seizures in these highly treatment-resistant populations together with an acceptable safety and tolerability profile,” stated Justin Gover, GW’s Chief Executive Officer. “Our recent successful financing has provided GW with the necessary capital to move forward with confidence in preparing to execute a highly successful launch.”
RECENT OPERATIONAL HIGHLIGHTS
*Epidiolex® (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut --Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and infantile spasms (IS)
Phase 3 development programs:
Positive results in first Phase 3 Dravet syndrome trial
Positive results in first Phase 3 LGS trial
Data presentations expected at upcoming American Epilepsy Society Annual Meeting in December
Positive Dravet syndrome Pre-NDA meeting held with FDA
NDA on track for H1 2017 submission for both Dravet and LGS indications
Data from second LGS trial expected at end of Q3
Second Phase 3 Dravet syndrome trial ongoing
Phase 3 trial in TSC ongoing
Phase 3 trial in IS to commence in Q4 2016
Expanded access program and open label extension:
Over 1,000 patients now on Epidiolex treatment under Expanded Access Treatment INDs, U.S. State programs, and open label extension trial
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