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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 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.
The medicine,which is sprayed under the tongue,is to be marketed in Britain by Germany’s Bayer and in the rest of Europe by Spain’s Almirall.
GW is in line to 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.
Sativex became the world’s first cannabis medicine to win regulatory approval when it was approved in Canada in 2005.
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.
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.
