GW Pharmaceuticals plc (GWP) and Almirall S.A. (ALM), an international pharmaceutical company based on innovation and committed to health, have successfully completed the European Mutual Recognition Procedure (MRP) for Sativex oromucosal spray in the treatment of spasticity due to multiple sclerosis (MS).
Sativex is an endocannabinoid modulator made of two actives - THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol)-, which was developed and is manufactured by GW Pharmaceuticals plc, UK., Almirall holds marketing rights in Europe (except United Kingdom) and Mexico.
Sativex is already available in the UK, Spain, Germany and Denmark. Launches currently in preparation in Italy, Sweden, Austria and Czech Republic.
Recommendation for approval now received in Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia. Launches expected from the end of 2012 onwards.
Sativex is indicated as a treatment for patients with moderate to severe spasticity due to multiple sclerosis (MS) who have not adequately responded to other anti-spasticity medications and who have demonstrated a clinically significant improvement in symptoms related to spasticity during an initial treatment testing period. Sativex is effective in all types of MS, independently of the disability status (as per Expanded Disability Status Scale -EDSS-, a rating system that is frequently used for classifying and standardizing the condition of people with multiple sclerosis).
Following previous positive regulatory submissions in the UK, Spain, Germany, Italy, Denmark Sweden, Austria, Czech Republic, a MRP application was made to expand the availability of Sativex to ten additional European countries. The MRP has now closed successfully with regulatory authorities in all ten countries confirming that Sativex meets their requirements for approval. The countries involved in the MRP and in which Sativex is expected to be approved are: Belgium, Finland, Iceland, Ireland, Luxembourg, the Netherlands, Norway, Poland, Portugal and Slovakia.
“For Almirall, the successful completion of this second MRP regulatory process for Sativex represents very good news and reinforces our commitment to expand this innovative medicine to MS patients across Europe. Sativex is the first treatment specifically indicated for the treatment of spasticity, and related symptoms, in MS patients” said Bertil Lindmark, chief scientific officer at Almirall.
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, each country is then expected to issue a national marketing authorisation. Launch timing in these ten new countries is dependent on national pricing and reimbursement procedures. Launches are anticipated from the end of 2012 onwards.
Dr Stephen Wright, GW’s R&D Director, said, “Today’s news means that regulatory authorities in a total of eighteen European countries have now recommended Sativex for approval. The successful outcome of this most recent regulatory process provides further endorsement of the quality, safety and efficacy of Sativex. Sativex has an important role in meeting the needs of people with multiple sclerosis and we look forward to working with our partners Almirall to make the medicine available to patients across Europe.”
In Europe, Sativex is approved and marketed for MS spasticity in the UK, Spain, Germany, and Denmark. In addition to the ten new European markets included in this MRP, launches are also currently being planned in Sweden, Italy, Austria and the Czech Republic.
In addition to MS spasticity, Sativex, which has been developed by GW Pharmaceuticals, is also in phase III clinical development for the treatment of cancer pain. Almirall holds the marketing rights to this medicine in Europe (except the United Kingdom) and Mexico.
Sativex contains active ingredients known as ‘cannabinoids’ which are extracted from the plant C. Sativa grown and processed under strictly controlled conditions. Cannabinoids react with cannabinoid receptors that exist naturally throughout our body, including the brain. A receptor is a site located in a brain cell in which certain substances can stick or “bind” for a while. If this happens, this binding has an effect on the cell and the nerve impulses it produces, causing a ‘dimming-down’ of the spasticity symptom. In patients who respond to Sativex, this is the effect that improves their spasticity symptoms and helps them cope with their daily activities.