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OPERATIONAL HIGHLIGHTS
Epidiolex (cannabidiol)
Regulatory:
FDA approval for the treatment of seizures associated with LGS or Dravet syndrome
Epidiolex rescheduling expected within 90 days of FDA approval
European submission under review by the EMA with decision expected in Q1 2019
FDA issuance of a priority review voucher (PRV) for Epidiolex.
Manufacturing
Commercial product being manufactured and prepared for shipping to the U.S.
Continued investment in expanded facilities to meet anticipated long-term demand
Commercial:
U.S. sales organization fully recruited comprising two national directors, eight regional managers plus 66 Neurology Account Managers
Active engagement with U.S. payors ongoing with clinical presentations to plans that cover over 80% of covered lives in the U.S.
U.S. supply chain platform in place which will employ a closed model distribution network of five Specialty Pharmacy Providers (SPP’s)
Commercial footprint in place in 5 major European markets in readiness for 2019 European launches
Epilepsy Clinical trials
Three Phase 3 clinical trials published - two in The New England Journal of Medicine and one in The Lancet
Phase 3 trial in Tuberous Sclerosis Complex ongoing with data expected H1 2019
Autism
Decision to expand target indications for Epidiolex beyond epilepsy to autism. IND expected to be submitted for pivotal Rett Syndrome study in Q4 18.
Expanded access program and open label extension:
Over 2,000 patients now have been exposed to Epidiolex treatment
Life-cycle management
Several new formulations of CBD in development including modified oral solution, capsule and an intravenous formulation
Exclusivity
7-year orphan exclusivity confirmed by FDA, 6-month pediatric extension expected
Key favorable patent grants by USPTO related to the use of CBD in epilepsy, including claims for the treatment of relevant seizure types associated with LGS and Dravet syndrome, as well as the use of CBD with clobazam
Patents align directly with new Epidiolex FDA label and to be listed in Orange Book
Patent expiry dates to 2035
Additional patent applications under review and being filed as new data is generated
Pipeline progress
Sativex® (nabiximols)
U.S. development and commercialization rights wholly owned by GW
Initial U.S. target indication: Multiple Sclerosis spasticity. Three positive Phase 3 trials completed in Europe
Plans to meet with FDA in H2 18 to determine MS spasticity regulatory pathway in the U.S.
Over 20 placebo-controlled trials already completed in other indications, representing significant U.S. lifecycle management opportunities
CBDV
10-patient investigator-initiated expanded access program for seizures associated with autism underway
Investigator-led 100 patient placebo-controlled trial in autism spectrum disorder due to commence in Q3 18
Open label study in Rett syndrome and seizures due to commence Q3 18
CBD:THC in Glioblastoma
Recent data presented from the Phase 2 study showed significant increase in median survival for patients taking CBD:THC of 662 days compared to 369 days on placebo
Pivotal clinical development program plans under development
Orphan Drug Designation from both FDA and EMA for CBD:THC to treat glioblastoma
Neonatal Hypoxic-Ischemic Encephalopathy (NHIE) intravenous CBD program
Phase 1 trial complete
Orphan Drug and Fast Track Designations granted from FDA and EMA
Phase 2 trial in planning
FINANCIAL HIGHLIGHTS
Cash and cash equivalents at 30 June 2018 of £334.0 million ($440.2 million) compared to £241.2 million as at 30 September 2017
Revenue for the nine months ended 30 June 2018 of £10.7 million ($14.2 million) compared to £6.1 million for the nine months ended 30 June 2017
Loss for the nine months ended 30 June 2018 of £136.7 million ($180.2 million) compared to £90.3 million for the nine months ended 30 June 2017... " ENDE ZItat
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