Sativex, a ground-breaking cannabis-based drug for treating symptoms of multiple sclerosis (MS), could be approved in the UK by the end of June, its creator said on Thursday.
GW Pharmaceuticals has been developing Sativex, which eases muscle stiffness associated with MS, for more than a decade and on Thursday the drug maker said the medicine could be approved and launched in Britain by the end of next month.
A regulatory green light in Spain is expected shortly after, according to the company, which added that all major and minor issues relating to the application for Sativex's approval had been resolved.
The approval is now in its final stage, which involves finalising the wording on the product's packaging.
Sativex, 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 said both partners were well advanced in preparations for the Sativex launch and GW has manufactured stocks of Sativex for distribution immediately upon UK approval.
Sativex became the world's first cannabis medicine to win regulatory approval when it was given the go-ahead in Canada in 2005.
But, its roll-out in Britain, Spain and other European markets thereafter represents a much larger commercial opportunity.
Sativex is also being developed to treat pain in people with advanced cancer in partnership with Japanese company, Otsuka.
Dr Geoffrey Guy, the chairman of GW, said on Thursday: "The first six months of this year have proven the most important in GW's history in which we have made material progress towards Sativex's launch in Europe and generated positive cancer pain data."
GW Pharma reported a loss of £2.7m for the six months to end of March, compared to a £4m profit in the first half of 2009 when it had received an £8m milestone payment.
Analysts at Piper Jaffray said that UK regulatory approval would trigger first commercial sales and a £10m milestone payment from marketing partner, Bayer.
The broker anticipates that sales of Sativex in MS spasticity could reach £107m in Europe alone.
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