Legends of the Fall? GW’s cannabis-based medicine readies for autumn launch
Cambridge UK company GW Pharmaceuticals plans to make history with the US launch of a cannabis-based oral solution to treat seizures in two syndromes as early as this autumn.
Following FDA approval, GW has pulled out all the stops for a launch in the Fall of its Epidiolex® product for patients with Lennox-Gastaut Syndrome and Dravet syndrome.
Chief executive Justin Gover (pictured) confirmed: “We anticipate rescheduling to be completed within 90 days of FDA approval and for product launch to take place in the Fall.
“In preparation for launch, we have now completed the hiring of our US sales organisation and are engaged with patient organisations, physicians and managed care organisations/payors.
“This approval has been a transformative event for GW, not only opening a new chapter as a commercial-stage company, but also validating and reinforcing our world leadership in cannabinoid science, and the potential of our product pipeline.”
Commercial product is being manufactured and prepared for shipping to the US and GW is continuing investment in expanded facilities to meet anticipated long-term demand.
GW has recruited two national directors, eight regional managers plus 66 neurology account managers; active engagement with US payors is ongoing with clinical presentations to plans that cover over 80 per cent of covered lives in the US.
A US supply chain platform is in place which will employ a closed model distribution network of five Specialty Pharmacy Providers. A commercial footprint is also in place in five major European markets in readiness for 2019 European launches.
GW had cash and equivalents at June 30 of £334 million compared to £241.2m at September 30, 2017.
Revenue for the nine months to June 30 were £10.7m compared to £6.1m in the nine months to June 30, 20917 but the loss for the nine months climbed to £136.7m from £90.3m year-on-year.