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Saturday, March 26, 2011
Friday, March 25, 2011,
GW Pharmaceuticals plc (AIM:GWP) and Almirall S.A. (ALM) announce the successful completion of the European Mutual Recognition Procedure (MRP) for Sativex oromucosal spray in the treatment of spasticity due to Multiple Sclerosis (MS).
Following initial approvals obtained in the UK and Spain during 2010, the objective of this MRP was to expand the approval of Sativex to six additional European countries. The MRP has now closed successfully with the regulatory authorities in all six countries confirming that Sativex meets their requirements for approval. The countries involved in the MRP and in which Sativex is now expected to be approved are Germany, Italy, Denmark, Sweden, Austria and the Czech Republic.
The next step in the regulatory process involves separate national phases in each country to finalise local wording on product packaging and related documents and also to agree any other country-specific requirements. Following completion of the national step, we expect each country to then issue a national marketing authorisation. We anticipate launch before the end of 2011 in Germany, Denmark and Sweden with the remaining countries expected in 2012.
Following the conclusion of this MRP, a further MRP submission will be made later in 2011 with a view to expanding the approval of Sativex to additional European countries.