Sativex regulatory approval received in Austria
7 February 2012
Porton Down, UK; 7 February 2012: GW Pharmaceuticals plc (AIM: GWP) today announces a regulatory update for Sativex® (Delta-9-Tetrahydrocannabinol (THC) and Cannabidiol (CBD) oromucosal spray.
Sativex® 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 S.A.
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 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.