GW Pharma debuts first Rx cannabis medicine, Sativex, in the UK; NICE gives preliminary backing for Amgen's osteo drug Prolia

Following UK approval of the product just last Friday, GW Pharmaceuticals today announced the UK launch of Sativex, its prescription-only oromucosal spray for the treatment of spasticity due to multiple sclerosis (MS).

Sativex is the world's first prescription cannabis medicine and the UK is the first country to grant a full regulatory authorization for the product, news of which saw GW's shares leap 11% to a four-year high of 141 pence on Friday. The drug is cleared for use in neuropathic pain in Canada, and the full UK approval has triggered a payment of £10 million ($14.8 million) from German drug major Bayer, which has rights to the product in Canada and also to market it in the UK.

European marketing partner Spain's Almirall is also expected to receive clearance of the drug shortly, after outstanding issues were resolved with the health authority (The Pharma Letter May 20), and this will mean a £2.5 million milestone for GW. Further submissions will be made in additional European countries during the second half of 2010 under the mutual recognition procedure.