GW Pharmaceuticals is pushing ahead with its important Epidiolex launch, and it just achieved an industry first.
England's influential cost watchdogs endorsed that drug and another GW product, Sativex, making the meds the first plant-derived cannabis-based drugs to secure a recommendation for routine use by NHS England.
GW Chief Operating Officer Chris Tovey said in a statement it’s a “momentous occasion” for patients and “proof that cannabis-based medicines can successfully go through extensive randomized placebo-controlled trials and a rigorous NICE evaluation process to reach patients.”
GW’s Epidyolex—the med carries a slightly different branded name in Europe than in the U.S.—won European approval in September. The National Institute for Health and Care Excellence (NICE) initially rejected the drug.
This time around, NICE backed it to treat seizures associated with Lennox Gastaut syndrome or Dravet syndrome. Sativex is approved to treat spasticity stemming from multiple sclerosis.
Epidyolex's list price in England is confidential until January 2020, and the company offered a discount to secure access. The drug carries a list price of $32,500 per patient per year in the U.S.
On a conference call last week, GW execs said the U.S. Epidiolex launch was gaining steam and that the company is launching in several European markets. The company is now on the market in France, Germany and the U.K. It’s planning rollouts in Italy and Spain next year.
Since its U.S. launch last November, more than 15,000 patients have taken the drug, and 3,000 new patients received treatment during the third quarter of this year. Still, after the drug posted third-quarter revenues of $86.1 million that slightly beat analyst estimates, investors sold off and sent shares down by 15%.
Aside from the med’s original indications, GW plans to submit an FDA application in 2020 to treat tuberous sclerosis complex and is testing the med against Rett syndrome in a phase 3 study.