June 18, 2010
* Drugs regulators MHRA says Sativex granted British licence
* GW in line for 10 mln pounds milestone payment from Bayer
* Shares up 11 percent at four-year high
(Adds GW Pharma statement, analyst comment, updates shares)
LONDON, June 18 (Reuters) – GW Pharmaceuticals Plc’s (GWP.L) cannabis-derived medicine Sativex has been approved in Britain for treating spasticity in patients with multiple sclerosis, in a landmark decision for the small drugmaker.
The much-delayed product was finally granted a British licence on Thursday, an official from the Medicines and Healthcare products Regulatory Agency (MHRA) told Reuters on Friday.
The company later issued a statement confirming the move.
Clinical trials have shown GW’s Sativex, which is sprayed under the tongue, reduces spasticity in multiple sclerosis (MS) in patients who do not respond adequately to existing therapies.
It became the world’s first cannabis medicine to win regulatory clearance when it was approved in Canada in 2005 for neuropathic pain but its roll-out in Britain — and other European markets thereafter — is a larger sales opportunity.
GW and Germany‘s Bayer (BAYGn.DE), which will market the drug in Britain, plan to hold a press conference on Sativex on June 21.
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