BRITISH cannabis firm GW Pharmaceuticals is close to securing European approval for its Epidiolex drug after seeing its success in the U.S. lead to record sales.
NASDAQ-listed GW Pharmaceuticals announced its second quarter results with revenue topping $72 million, far above the $3.3 million in the same period, last year – and surpassing analysts’ expectations of around $50 million. Its Epidiolex drug, which received FDA approval in late 2018, was the key driver of this stellar performance accounting for more than $68 million of sales.
12,000 U.S. Patients To Date
Epidiolex, which treats certain forms of epilepsy, has been prescribed by more than, 2,500 doctors and more than 12,000 patients have received it since its U.S. launch, says the company in a market release.
GW Pharmaceuticals said it achieved a profit of almost $80 million for the quarter ending June 30 – compared to a loss of $84 million in the same period last year. This was mainly the result of a one-off of gain of $104 million on the sale of an FDA-approved drug review voucher, it said.
Widespread Insurance Coverage
The market announcement highlighted how the cost of the drug, at around $30,000 a year, is not deterring insurance firms with over 90% of plans including it. GW Pharmaceuticals also announced that Epidiolex has become the first cannabis drug to win European medical approval.
The European Medicines Agency has recommended that Epidiolex be approved, and the European Commission will make its final decision in two months, with this being seen as a rubber-stamping exercise, reports The Daily Telegraph.
Epidiolex is mainly used to treat children who suffer from two severe forms of epilepsy: Lennox-Gastaut syndrome and Dravet syndrome, and it is thought around 40,000 European patients could benefit.
GW says Epidiolex will be launched in France and Germany first, followed closely by the U.K., where GW has been in price negotiations with The National Institute for Health and Care Excellence (NICE), the body that decides which drugs the NHS will pay for.
Chris Tovey, chief operating officer at GW, said in a market conference call that some 800 European patients had already benefited from an early access program for Dravet syndrome and Lennox-Gastaut syndrome.
“As a result, we’re launching into an environment where a large number of clinicians have already developed important clinical management experience with Epidiolex,” he said.