GW Pharma's cannabis drug Sativex wins landmark approval

After a long and complex R&D odyssey, GW Pharmaceuticals (GWP) has finally won UK approval for Sativex, a drug derived from cannabis that can now be used to treat spasticity in MS patients.

GW had hoped to get an approval in Britain back in 2003 but faced a long series of regulatory hurdles in its quest. Up until now GW has had to content itself with a 2005 approval in Canada. But Europe appears to be opening up. GW says that Spain appears ready to hand out an approval soon and other European nations are likely to follow suit. GW and Bayer--which now owes GW a $15 million milestone payment--will market the drug in the UK with Almirall taking the reins in Spain. The approval helped buoy GW's shares by about eight percent, according to Reuters, which broke the news.

An even bigger market could be opened up if GW wins an approval to use Sativex to treat cancer pain. Analysts say that a European approval for MS on top of the Canadian market would generate about 121 million pounds in annual sales while a cancer approval on the continent would be worth close to $500 million a year in sales.

GW has focused on the cancer pain indication for its application to the FDA. In March the developer announced positive Phase IIb cancer pain data with its U.S. partner Otsuka. Researchers are planning a Phase III trial for cancer pain.

- here's the story from Reuters