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GW Pharmaceuticals plc Reports Fiscal Third Quarter 2017 Financial Results and Operational Progress

- Epidiolex® NDA submission process underway -
- Conference call today at 4:30 p.m. EDT -

LONDON and CARLSBAD, Calif., Aug. 07, 2017 (GLOBE NEWSWIRE) -- GW Pharmaceuticals plc (GWPH) (GW, the Company or the Group), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces financial results for the third quarter ended 30 June 2017.

“I am pleased to report the NDA submission process for Epidiolex is now underway with the final sections of the submission expected to be completed in October. With a clear view now towards our anticipated approval, we are making excellent progress with preparations to ensure a highly successful launch in 2018,” stated Justin Gover, GW’s Chief Executive Officer. “Following the recent publication of our first Phase 3 trial in The New England Journal of Medicine, we look forward to additional Epidiolex data publications and presentations in the second half of the year. In addition to Epidiolex, we continue to keep focus on our growing and innovative cannabinoid pipeline where we have advanced a number of additional exciting clinical programs.”

OPERATIONAL HIGHLIGHTS

• Epidiolex (CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS)

  • Regulatory progress:
    - NDA rolling submission for both Dravet and LGS indications underway. Pre-clinical module submitted; Clinical module submission in progress; CMC module submission expected in October
    - EMA pre-submission meetings held. Expected EU regulatory submission in Q4 2017

  • Further clinical progress:
    - Phase 3 Dravet syndrome trial published in The New England Journal of Medicine
    - Quality of Life in Childhood Epilepsy published in Epilepsia
    - Phase 3 trial in Tuberous Sclerosis Complex ongoing
    - Part A of two-part Phase 3 trial in Infantile Spasms ongoing
    - Numerous abstracts submitted to American Epilepsy Society annual meeting


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