GW Pharma's Sativex cleared in Austria

The UK’s GW Pharmaceuticals’ (AIM: GWP) Sativex (delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD)) oromucosal spray has received regulatory approval in Austria as a treatment of spasticity due to multiple sclerosis (MS).

The launch of Sativex in Austria is expected to take place during 2012 following completion of the national pricing and reimbursement process. Sativex will be marketed in Austria by GW's marketing partner, Almirall (ALM: MC), Spain’s largest pharmaceutical company.

In addition, further to the November 2011 announcement of the filing of a new regulatory application, under the European Mutual Recognition Procedure (MRP), to expand Sativex approvals to additional European countries, the dossier has been validated and is now under technical review by regulatory authorities in the following countries: Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia. It is expected that this new MRP process should complete around mid 2012.

Sativex is currently available as a prescription medicine in the UK, Spain, Germany, Denmark, Canada (where it is sold by Bayer) and New Zealand. Launches are expected during 2012 in Italy, Sweden, Austria and the Czech Republic.

Sativex has been developed by GW Pharmaceuticals and is marketed in Europe (except the UK) by Almirall. The product is also in Phase III clinical development as a treatment for cancer pain. The UK company also has an exclusive licence agreement with Novartis to commercialize Sativex in Australia and New Zealand, Asia (excluding Japan, China and Hong Kong), Middle East (excluding Israel/Palestine) and Africa.