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news.GW Pharma has launched oromucosal spray Sativex for the treatment of spasticity due to multiple sclerosis (MS), in UK.
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GW Pharma claimed that Sativex is the first prescription cannabis medicine and the UK is the first country to grant a full regulatory authorisation for the product.
GW Pharma manufactures Sativex under its Home Office licence in UK at an undisclosed location. The company’s UK licensee, Bayer Schering Pharma will market Sativex.
As per the agreement terms with Bayer, GW Pharma is expected to receive a GBP10m milestone payment in respect of the UK approval of Sativex.
GW Pharma said that the two cannabinoids or active ingredients present in Sativex are THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol).
Geoffrey Guy, chairman of GW Pharma, said: “The approval and launch of Sativex in the UK is the first full approval of a cannabis-derived prescription medicine and the product of eleven year’s research by GW into the cannabinoid system.
“GW was founded to address the unmet needs of people with MS and today’s launch of Sativex represents a welcome advance in MS symptom treatment. This launch enables us to progress the development of our pipeline across a range of therapeutic areas.”
Sativex is expected to be approved in Spain shortly. Further submissions are expected to be made in additional European countries during the second half of 2010 under the mutual recognition procedure. Almirall is expected to market Sativex in Europe.