GW Pharmaceuticals has launched Sativex, its oromucosal spray for the treatment of spasticity due to Multiple Sclerosis (MS), in the UK. Sativex is the world's first prescription cannabis medicine and the UK is the first country to grant a full regulatory authorisation for the product.
Sativex contains two cannabinoids: THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol). It is the first cannabinoid medicine derived from whole plant extracts from the cannabis sativa plant.
Sativex was developed by GW in specific response to calls from people with MS for a prescription cannabis-based medicine. It gives MS patients suffering the spasms and cramping associated with spasticity a new treatment option that has been shown to improve their symptoms where current treatments have failed.
Sativex is manufactured by GW under Home Office licence at an undisclosed location in the UK. The medicine is being marketed in the UK by GW's UK licensee, Bayer Schering Pharma.
‘The approval and launch of Sativex in the UK is the world's first full approval of a cannabis-derived prescription medicine and the product of 11 years’ research by GW into the cannabinoid system,’ said Dr Geoffrey Guy, GW's chairman. ‘This is also an historic moment for GW and marks the beginning of the company's transition from a late stage development company to a commercial pharmaceutical business. Today's news validates our cannabinoid technology platform and enables us to progress the development of our pipeline across a range of therapeutic areas with increased confidence.’
Under the terms of the agreement with Bayer, GW will receive a £10m milestone payment in respect of the UK approval of Sativex.
Outside the UK, Sativex is expected to be approved in Spain shortly. Further submissions will be made in additional European countries during the second half of 2010 under the mutual recognition procedure. Almirall will market Sativex in Europe (excluding the UK).