Sativex r begins another round of European regulatory approvals.

-Sativex ® is a medication indicated for the treatment of spasticity in patients with multiple sclerosis (MS), that have not responded to other treatments anti-spasticity

-Almirall launched Sativex ® in Germany, Denmark and Spain in 2011

Barcelona, February of 2012- Almirall S.A. (ALM)(MC) yesterday announced the start of a new round of registrations for Sativex ® in Europe. The list of countries in which the dossier has been submitted to the health authorities by GW Pharmaceuticals, under a mutual recognition procedure, include: Belgium, Slovakia, Finland, Holland, Ireland, Iceland, Luxembourg, Norway, Poland and Portugal. United Kingdom will act as a Member State of reference in this mutual recognition procedure.

The response of the health authorities is expected in the first half of 2012, and then the procedures continue with the national approval process in each country, according to your local regulations.

We are excited about this opportunity to expand the geographical accessibility of the unique benefits of Sativex in relieving the symptoms of spasticity in patients with Ms ”, says Bertil Lindmark, Director General Executive r & d of Almirall.

Sativex ® offers a new therapeutic option for patients with symptoms of spasticity due to Ms who have not adequately responded to other anti-spasticity drugs, and is currently available in Germany, Denmark, Spain, United Kingdom, Canada and New Zealand. This year, most expected the approval of marketing in three countries: Austria, Italy, Czech Republic and Sweden. Sativex ® is administered in spray of buccal spray (on the inside of the cheek or under the tongue) which allows a flexible dosage regimen, particularly appropriate given the variable nature of spasticity in a patient to another.

Sativex ® has been developed by the company GW Pharmaceuticals plc and is currently in phase III clinical development for the treatment of cancer pain. Almirall holds the marketing rights in Europe (except United Kingdom).

Sativex ®

Sativex ® is a modulator of the endocannabinoid system, the first in its class, indicated as adjunctive treatment for the improvement of symptoms suffered by patients with moderate or severe spasticity due to MS, they have not responded adequately to other antiespásticosi drugs and who have shown a clinically significant improvement in symptoms related spasticity during an initial period the tratamiento.4 test
the main active ingredients, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), extracted from cannabis plants grown and processed in strictly controlled conditions. Sativex ® is administered in spray of buccal spray (on the inner side of the cheek or under the tongue), and has a flexible dosage regimen, particularly appropriate given the variable nature of spasticity and Ms from one patient to another.

Sativex ® is manufactured using a series of controlled processes that give rise to a reproducible finished product produced in accordance with the good manufacturing practices. Each spray of 100 µl contains 2, 7 mg of THC and 2.5 milligrams of CBD. The formulation also contains other arachidonoylethanolamine, Terpenoids and flavonoids in standardized doses, which helps to make a single drug Sativex ®. Sativex ® has been developed by the company GW Pharmaceuticals plc headquartered in United Kingdom.

Sativex ® is a registered trademark of GW Pharmaceuticals plc which is proprietary rights marketing. manufactured by GW Pharmaceuticals plc under license from the Ministry of the British Interior, Sativex ® is marketed in Europe (except United Kingdom) through Almirall, S.A.

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 illness. Spasticity may affect many aspects of the daily life of the patients with MS and is one of the main factors that contribute to their anguish and discapacidad.iii

Almirall

Almirall is an international pharmaceutical company based on innovation and committed to health. With headquarters in Barcelona (Spain), Almirall researches, develops, produces and sells drugs own r & d and licensing with the aim of improving the health and well-being of people.

The therapeutic areas in which concentrates its resources in research are related to the treatment of asthma, COPD (chronic obstructive pulmonary disease), gastrointestinal disorders, psoriasis and other skin complaints forms.

Almirall drugs are now present in more than 70 countries. It has direct presence in Europe and Latin America through subsidiaries 12.

Referencia:

(1) Sativex ® Summary of Product Characteristics, 2011.

(2) Multiple Sclerosis International Federation. European map of ms database. © 2010 PMSCS, MSIF. Available here. Top five EU countries include: France, Germany, Italy, Spain and UK

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