German approval for GW and Almirall's Sativex for spasticity due to MS

Spain’s leading drugmaker Almirall (ALM) and UK-based originator of the cannabis based product GW Pharmaceuticals (AIM: GWP) say that the health authorities in Germany have granted regulatory approval for Sativex (delta-9-tetrahydro-cannabinol and cannabidiol) oromucosal spray as an add-on therapy for the treatment of moderate to severe spasticity due to multiple sclerosis (MS) in patients who have not responded adequately to other anti-spasticity medication. Sativex is expected to be launched in Germany in July 2011.

Sativex is a first in class endocannabinoid system modulator for the treatment of spasticity in MS and is delivered by an oromucosal spray (sprayed into the mouth either onto the inside of the cheek or under the tongue). The medicine is already available for MS patients in the UK and Spain.

Approval in Germany follows successful completion in March 2011 of the European Mutual Recognition Procedure (MRP) with all six countries involved recommending approval. These countries were Germany, Denmark, Sweden, Italy, Czech Republic and Austria. In addition to Germany, launch is also expected before the end of 2011 in Denmark and Sweden. Launches in Italy, Czech Republic and Austria are expected in 2012. A further MRP submission is expected to be made later in 2011 with a view to expanding the approval of Sativex to additional European countries.