GW prepping for mid-2018 CBD epilepsy candidate approval in US
Epidiolex, and oral solution of pure plant-derived cannabidiol, or CBD, is GW’s lead candidate in development for severe, orphan, treatment-resistant epilepsy syndromes such as Dravet syndrome and Lennox-Gastaut syndrome (LGS).
Last month the London, UK-headquartered firm submitted its New Drug Application (NDA) for Epidiolex to the US Food and Drug Administration (FDA) to review, and speaking on a Q4 financial call yesterday said it is hopeful the drug will be approved next year.
“We expect to hear from the FDA at day 60, around the end of December, regarding whether the agency will accept the filing. At this time, we would expect to receive confirmation of an expedited review of the NDA. If so, this would lead to an expected PDUFA date in mid-2018,” said CEO Justin Gover.
He confirmed the firm’s manufacturing capabilities were prepared for a pre-approval FDA inspection, having operated to commercial GMP standard for over a decade.
“We’re inspection ready,” he told stakeholders. “We’ve been inspected by many authorities over the last decade or so, most recently in December by the UK authorities. So, we are in good shape for the FDA inspection as and when they walk through the door.”
The firm grows its own raw materials – about 200 tonnes of cannabis plants per year - in UK Government-approved greenhouses and extracts the CBD and delta-9-tetrahydrocannabinol (THC) for its marketed spasticity treatment Sativex (nabiximols) and its pipeline products, including Epidiolex. Finished products are shipped to a DEA-approved storage facility run by contract development and manufacturing organisation (CDMO) Catalent in the US.
And in preparation for approval, GW has invested in its capabilities this year with capital expenditure of $10m to $20m relating to manufacturing expansion, according to CFO Scott Giacobello.
For the three months ending September 30, GW reported sales of $2.9m, up 71% on the same period 2016. However, the firm’s operating loss increased 166% to $64m.