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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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).
Sativex® is indicated as an add-on 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.i
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.ii 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.iii
In the five main EU markets there are around 500,000 people suffering from MSiv and in Spain around 40,000 cases of the disease have been reported. Spasticity is a symptom defined by patients and carers as muscle spasms, seizing-up, stiffness and/or difficulty in moving muscles and it is one of the most common symptoms of MS, occurring in up to 75% of MS sufferers in the course of the disease. Spasticity can affect many aspects of the daily lives of patients with MS and is one of the main factors contributing to their distress and disability.v
Almirall is an international pharmaceutical company based on innovation and committed to health. Headquartered in Barcelona, Spain, it researches, develops, manufactures and commercialises its own R&D and licensed drugs with the aim of improving people’s health and wellbeing.
Almirall focuses its research resources on therapeutic areas related to the treatment of asthma, COPD (Chronic Obstructive Pulmonary Disease), rheumatoid arthritis, multiple sclerosis, psoriasis and other dermatological conditions.
Almirall’s products are currently present in over 70 countries while it has direct presence in Europe and Latin America through 12 affiliates.
For further information please visit the website at: www.almirall.com
About GW Pharmaceuticals
GW Pharmaceuticals plc (AIM:GWP) was founded in 1998 and is listed on the AiM, a market of the London Stock Exchange. Operating under licence from the UK Home Office, the company researches and develops cannabinoid pharmaceutical products for patients who suffer from a range of serious ailments, in particular MS and cancer pain. GW has assembled a large in-house scientific team with expertise in cannabinoid science as well as experience in the development of both plant based prescription pharmaceutical products and medicines containing controlled substances. GW occupies a world leading position in cannabinoids and has developed an extensive international network of the most prominent scientists in the field.
For further information, please visit www.gwpharm.com
This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including development and regulatory clearance of the GW’s products. Forward-looking statements involve risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex® and other products by consumer and medical professionals.
i Patient leaflet
ii GW Pharmaceuticals: Cannabinoid Science: Mechanism of action. Available at. http://www.gwpharm.com/mechanism-of-action.aspx (latest access: 11/08/2010).
iii GW Pharmaceuticals: Cannabinoid Science: Cannabinoid Compounds. Available at http://www.gwpharm.com/types-compounds.aspx (Last accessed: 01/07/10).
iv Multiple Sclerosis International Federation: European map of ms database. ©2010 EMSP, MSIF. Available at: www.europeanmapofms.org (latest access: 11/08/2010). Top five EU countries include: France, Germany, Italy, Spain and UK.
v Rizzo MA et al. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004;10:589–595.
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