Sativex (r) recommended for adoption in ten countries, after the European mutual recognition regulatory process.

– expected release in Belgium, Finland, Iceland, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal and Slovakia from the end of 2012

Barcelona, Spain; Porton Down, UK, may 2012.- Almirall, S.A. (ALM) and GW Pharmaceuticals plc (AIM: GWP) have announced on Tuesday completed successfully a procedure of mutual recognition (PRM) for approval of Sativex ® mouth spray in the treatment of the symptoms of spasticity by multiple sclerosis (MS).

After the success of the first presentations regulatory United Kingdom, Spain, Germany, Italy, Sweden Denmark, Austria and Czech Republic, presented a PRM for expanding the availability of Sativex ® in ten additional European countries. The PRM has now closed successfully and regulatory authorities of all the countries involved confirm Sativex ® meets the requirements for adoption.

The countries included in this procedure, and which is expected that Sativex ® is approved are: Belgium, Finland, Iceland, Ireland, Luxembourg, Netherlands, Norway, Poland, Portugal and Slovakia.

“For Almirall, this second European Sativex ® regulatory process successful completion is very good news and reinforces our commitment to expanding the availability of this innovative medication to a greater number of people with MS in Europe.” “Sativex ® is the first treatment specifically indicated for symptoms of spasticity in patients with MS,” said Bertil Lindmark, Director Ejecutivo Almirall Científico.

The next step in the regulatory process is the so-called national phase in each country in which ultima is the drafting of the packaging of the product and related documents, and remember any other specific requirements of each country. After the completion of the national stage, expected for each of the countries to issue a marketing authorisation. The time until the release depends on local regulations on negotiation of pricing and reimbursement procedures. He is expected that Sativex ® is available in these ten new countries from the end of 2012 onwards.

Dr. Stephen Wright, Director of r & d of GW commented: “today’s news means that a total of eighteen European countries regulatory authorities have recommended Sativex ® for approval.” The success of this last PRM supports the quality, safety and efficacy of this drug. “Sativex ® plays an important role in meeting needs of people with MS and we collaborate with our partner Almirall in order to make the drug available to European patients.”

In Europe, Sativex ® is already approved and marketed for this indication in the United Kingdom, Spain, Germany and Denmark. Also expected to launch the product in Sweden, Italy, Austria and Czech Republic, as well as ten new European markets included in this PRM.

Sativex ®, which has been developed by GW Pharmaceuticals, is currently in phase III clinical development for the treatment of cancer pain.

Almirall owns the marketing of this medication in Europe (except United Kingdom) and Mexico.

Sativex ®

Sativex ® is a modulator of the endocannabinoid system composed mainly by two active principles – THC (delta-9-tetrahydrocannabinol) and CBD (cannabidiol)-, developed and manufactured under the license of the Ministry of the Interior of the United Kingdom by GW Pharmaceuticals plc., will be marketed by Almirall in Europe (except the United Kingdom) and Mexico.

Sativex ® is indicated as adjunctive treatment for the symptomatic improvement in patients with moderate or severe spasticity due to multiple sclerosis (MS) that have not responded adequately to other anti-spasticity drugs and who have shown a clinically significant improvement in symptoms related spasticity during an initial trial period of treatment [i]. Sativex ® is effective in all kinds of EM, regardless of the level of disability (according to the Expanded Disability Status Scale – EDSS, in its acronym in English, a valuation system often used to classify and standardize the level of disability for people with multiple sclerosis).(1)

Sativex ® contains a few so-called active ingredients ‘ cannabinoid ’, extract of cannabis plants grown and processed in strictly controlled conditions. Cannabinoids react with cannabinoid receptor found throughout the body, including the brain.(2) A receiver of neurons in the brain is a place where certain substances can be joined together for a time. When this happens, the Union has an effect on the cell and nerve impulses that produces, which leads to an improvement of the symptoms of spasticity. In patients who respond to Sativex ®, this effect is causing the improvement in symptoms of spasticity and helping them to cope with their usual daily activities.(3)

This drug is currently in phase III clinical development for the treatment of cancer pain.

Spasticity

In the five main markets of the EU there are about 500,000 people with EMii. Spasticity is a symptom defined by patients and caregivers as muscle spasms, stiffness, rigidity or difficulty to move the muscles and is one of the most common symptoms of Ms that occurs in up to 75% of people with MS in the course of their disease. Spasticity can affect many aspects of the daily life of the patients with MS and is one of the main factors that contribute to her distress and disability.(3)

Almirall

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referencia:

(1) A randomized, double-blind, placebo-controlled, parallel-group, enriched-design study of nabiximols (Sativex ®), as
Add-on therapy, in subjects with refractory spasticity caused by multiple sclerosis – Novotná a. et to theEuropean
Journal of Neurology 2011 – Sept; 18 (9): 1122-31.

(3) MA Rizzo et to the. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004; 10: 589 – 595.