GW Pharma Reports Positive Epidiolex Pre-NDA Meeting with FDA

GW Pharma Epidiolex

GW Pharmaceuticals plc Reports Third Quarter 2016 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 –
-Conference call today at 8:30 a.m. EDT, 1:30 p.m. BST –

LONDON, Aug. 09, 2016 (GLOBE NEWSWIRE) — GW Pharmaceuticals plc (NASDAQ:GWPH) (AIM:GWP) (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.

Justin gover gw pharma ceo
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
  • Advanced clinical programs in multiple cannabinoid pipeline product candidates:
    • CBDV Phase 2 partial-onset epilepsy study in adults ongoing. Part A complete and Part B underway with data expected H1 2017
    • CBDV pre-clinical research ongoing within field of autism spectrum disorders. Initial open-label clinical evaluation expected to commence in H2 2016, with Phase 2 trials expected to commence in H1 2017
    • Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD Phase 1 clinical program expected to commence in Q4 2016
      • Orphan Drug and Fast Track Designations granted from FDA and EMA
    • THC:CBD Phase 1b/2a study for the treatment of Recurrent Glioblastoma Multiforme (GBM) fully enrolled with data expected in Q4 2016
    • Sativex® Phase 2 study in children with spasticity due to cerebral palsy fully enrolled with data expected Q4 2016
    • THCV Phase 2 study in type 2 diabetes completed, primary endpoint not achieved

FINANCIAL HIGHLIGHTS

  • Loss for the nine months ended 30 June 2016 of £46.7 million ($62.2 million) compared to £32.3 million for the nine months ended 30 June 2015. This increased loss primarily reflects investment in the Epidiolex Phase 3 pivotal trials program.
  • Cash and cash equivalents at 30 June 2016 of £191.2 million ($254.3 million) compared to £234.9 million as at 30 September 2015. Subsequently in July 2016 a follow-on offering raised total net proceeds after expenses of $273.1 million (£206.4 million).

Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast to discuss the third quarter 2016 financial results today at 8:30 a.m. EDT / 1:30 p.m. BST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free):1-877-660-6853, (international):1-201-612-7415. For both dial-in numbers please use conference ID # 13642862.

About GW Pharmaceuticals plc

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 commercialized the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 28 countries outside the United States. GW is advancing an orphan drug program in the field of childhood epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome and Lennox-Gastaut syndrome and which is also expected to enter Phase 3 clinical trials in the treatment of Tuberous Sclerosis Complex. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.

Original press release (with financial tables): http://ir.gwpharm.com/releasedetail.cfm?ReleaseID=983571

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