GW Pharmaceuticals shares hit high after cannabis medicine trial

Epidiolex could be ready for submission to US and European regulators in 2016

Shares in British drugs specialist GW Pharmaceuticals have hit an all-time high after an experimental cannabis drug produced promising results in a small study of children with hard-to-treat epilepsy.

The company, which grows cannabis under licence at a secret location in Britain, is developing a range of so-called cannabinoid medicines. It already sells Sativex for spasticity caused by multiple sclerosis across Europe.

The latest findings for its new product Epidiolex follow an assessment of 27 children and young adults with treatment-resistant epilepsy who were given the drug in two US hospitals under an expanded access programme.

Epidiolex is given as a strawberry-lime flavoured syrup twice a day. The medicine contains the cannabinoid CBD but none of the psychoactive ingredient THC that makes marijuana smokers high.

GW said that results after 12 weeks of therapy in the open-label study were "encouraging", with a reduction in seizure frequency of more than 50 per cent. It now plans to start a Phase II/III clinical trial in the second half of the year.

Justin Gover, GW's chief executive, said he expected Epidiolex would be ready for submission to US and European regulators in 2016.

Epidiolex has been granted "orphan drug" status by the US Food and Drug Administration, which may ease its path to market and also offers GW additional exclusivity.

The designation reflects the unmet need for new approaches to help children with severe epilepsy syndromes such as Dravet and Lennox-Gastaut, where seizures often persist despite high doses of multiple anti-epileptic drugs.

Excitement over prospects for Epidiolex has been a driver for GW's shares, which have surged since the company tapped into a new US shareholder base by listing on Nasdaq a year ago.

"It has become a central part of our valuation - there is no doubt about that," Gover said in an interview. "That reflects a number of reasons: the fact there is so much interest among physicians and patients, the fact it is an orphan development programme and the fact we own all the commercial rights worldwide."

Shares in GW gained 15%to a record high of 429p.

http://www.standard.co.uk 18/06/2014