* UK, Spanish regulators expected to approve Sativex in Q2
* No major outstanding issues, talks now on patient leaflet
* Sativex to be marketed by Bayer and Almirall
* GW shares up 12 percent at four-year high
(Adds analyst comment, latest shares)
By Ben Hirschler
LONDON, March 18 (Reuters) - A pioneering — but much delayed — cannabis-based medicine for multiple sclerosis is now on track to win regulatory approval in Britain and Spain in the second quarter of 2010, its maker said on Thursday.
GW Pharmaceuticals GWP.L said regulators in both countries had concluded there were no major quality, safety or efficacy issues remaining to be resolved. Talks are now focused on points of clarification related to the patient information leaflet.
Approval of the dug Sativex in Britain and Spain will be a landmark for the British drugmaker, whose shares jumped more than 12 percent to a four-year high on the news by 0940 GMT.
GW will get a 10 million pounds ($15.4 million) milestone payment from Bayer on British approval, while a further 2.5 million pounds is payable by Almirall following both regulatory and pricing approval in Spain.
Clinical trials have shown GW’s drug Sativex reduces spasticity in multiple sclerosis patients who do not respond adequately to existing therapies.
It became the world’s first cannabis medicine to win regulatory approval when it was approved in Canada in 2005.
GW had originally hoped to win approval in 2003 for its drug — which is extracted from marijuana plants grown at secret locations in the English countryside — but the medicine has been hit by a string of regulatory delays in Europe.
Samir Devani, an analyst at Nomura Code, said Thursday’s announcement was “a major positive” for GW but questions still remained about Sativex’s commercial potential.
In particular, the rate of uptake in Britain will be limited until the National Institute for Health and Clinical Excellence (NICE) decides whether it should be reimbursed on the National Health Service (NHS), which Devani said would be challenging.
He sees peak sales of Sativex in multiple sclerosis at just 50 million pounds a year. Other analysts are a lot more upbeat, with Piper Jaffray forecasting Sativex sales in MS spasticity could reach 107 million pounds in Europe alone, with GW taking net royalties of 25 to 30 percent.
Further clinical trials need to be completed before the medicine is ready for submission for approval in the United States, where GW’s partner is Otsuka of Japan. ($1=.6511 Pound) (Editing by Hans Peters)