Released : 22/03/2011
RNS Number : 3504D
GW Pharmaceuticals PLC
22 March 2011
Sativex® Mutual Recognition Procedure Closes with Recommendation for Approval in all Six European Countries Involved
· National approvals expected in Germany, Italy, Denmark, Sweden, Austria and Czech Republic from mid-2011 onwards
· Launches in Germany, Denmark and Sweden expected before end of 2011
· Sativex already approved and marketed in UK and Spain
Barcelona, Spain; Porton Down, UK; 22nd March 2011: GW Pharmaceuticals plc (AIM:GWP) and Almirall S.A. (ALM) today 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.
Dr Stephen Wright, GW's R&D Director, said, "Today's news represents a major step forward for the international commercialisation of Sativex®. Following recent launches in the UK and Spain, GW and Almirall can now look forward to commercialising Sativex® in a further six European countries in the near term. The successful outcome of this regulatory process also provides further endorsement of the quality of the Sativex® clinical data and recognition of the important role Sativex® can play in meeting the needs of people with Multiple Sclerosis."
"For Almirall, the successful completion of the MRP regulatory process for Sativex® represents very good news and reinforces our commitment to offering innovative solutions to patients. Sativex® is the first drug which provides MS patients with a treatment option to mitigate spasticity and other related symptoms" said Bertil Lindmark, Chief Scientific Officer at Almirall.
Sativex®, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain, as the next indication following MS spasticity. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom).
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