“With the Epidiolex NDA for Dravet syndrome and Lennox-Gastaut syndrome submitted, we have entered a very exciting period for GW and look forward to working with the FDA to support its review process. With a decision on the NDA anticipated in mid 2018, we believe we are making excellent progress with preparations to ensure a highly successful US launch if Epidiolex is approved,” stated Justin Gover, GW’s Chief Executive Officer. “We also expect to submit a European regulatory application for Epidiolex for these indications in late 2017 and are now building a European commercial presence to prepare for a potential future launch. During 2017, a substantial body of positive clinical data on Epidiolex was published and presented, including a landmark publication in The New England Journal of Medicine, as well as a wide range of important data presentations and posters at the American Academy of Neurology and American Epilepsy Society annual meetings. Beyond Epidiolex, as a world leader in the field of cannabinoid science, we continue to advance a number of additional exciting pipeline clinical programs.”
OPERATIONAL HIGHLIGHTS
• Epidiolex (cannabidiol or CBD) orphan epilepsy program in Dravet syndrome, Lennox-Gastaut Syndrome (LGS), Tuberous Sclerosis Complex (TSC) and Infantile Spasms (IS)
Regulatory:
- - New Drug Application (NDA) submitted to the FDA for both Dravet syndrome and LGS indications
- - NDA acceptance decision anticipated at end of December 2017
- - If priority review status granted, PDUFA date expected mid 2018
- - European regulatory submission expected in late 2017
- - Phase 3 Dravet syndrome trial published in The New England Journal of Medicine
- - Phase 3 LGS trial accepted by a top tier journal and publication expected in early 2018
- - Over 25 posters presented at American Epilepsy Society Annual Meeting relating to Epidiolex
- - Phase 3 trial in TSC ongoing with data expected H2 2018
- - Second Phase 3 trial in Dravet syndrome enrollment complete with data expected H2 2018
- - Part A of two-part Phase 2/3 trial in IS underway. Data expected in Q1 2018
- - Recently expanded UK manufacturing facility included in NDA submission
- - Preparations on track for FDA GMP pre-approval inspection
- Expanded access program and open label extension:
- - Overall, greater than 1,700 patients now exposed to Epidiolex treatment
- - Over 97 percent of patients who completed Phase 3 trials have entered the company-sponsored long term extension study
- Commercial and medical affairs:
- - U.S. launch preparations on track. Full medical affairs team in place, including 15 epilepsy specialist Medical Science Liaisons (MSLs)
- - Active discussions ongoing with a wide variety of payors and insurance programs
- - European commercial build-out underway
- Life-cycle management
- - Several new formulations of CBD in development including improved liquid formulations, a solid dose form and an intravenous formulation
- Intellectual property
- - Portfolio of intellectual property relating to the use of CBD in epilepsy being prosecuted
- - We expect USPTO to reach a determination on whether to allow a number of pending applications in H1 2018
- CBDV Phase 2 partial-onset epilepsy trial in adults fully enrolled with data expected Q1 2018
- CBDV in Autism Spectrum Disorders
- - Expanded access IND granted by FDA for 10 patients with autism underway
- - Investigator-led 100 patient placebo-controlled trial in autism due to commence in H1 2018
- - Open label study in Rett syndrome and Phase 2 placebo-controlled trial expected to be initiated in 2018
- - Orphan Drug Designation from FDA for CBDV in the treatment of Rett syndrome
- Sativex
- - Late stage negotiations for the return of U.S. development and commercialization rights
- CBD:THC in Glioblastoma
- - Plans being developed on a pivotal clinical development program for CBD:THC in glioblastoma
- Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
- - Phase 1 trial in healthy volunteers complete
- - Orphan Drug Designation from FDA and EMA; Fast Track Designation granted from FDA
FINANCIAL HIGHLIGHTS
Revenue for the twelve months ended 30 September 2017 of £8.2 million ($11.0 million) compared to £10.3 million for the twelve months ended 30 September 2016.
Loss for the twelve months ended 30 September 2017 of £131.7 million ($175.9 million) compared to £63.7 million for the twelve months ended 30 September 2016.
Cash and cash equivalents at 30 September 2017 of £241.2 million ($322.2 million) compared to £374.4 million as at 30 September 2016.
Solely for the convenience of the reader, the above balances have been translated into U.S. dollars at the rate on 30 September 2017 of $1.33577 to £1. These translations should not be considered representations that any such amounts have been, could have been or could be converted into U.S. dollars at that or any other exchange rate as at that or any other date.
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