Almirall extends the rights of marketing of Sativex ® to Mexico.
-Sativex ® is marketed by Almirall in various European countries
-The medicinal product is in a second phase of approvals in Europe through a mutual recognition procedure
– Sativex ® is currently in phase III for the treatment of cancer pain
Barcelona, March 2012.- Almirall, S.A. ( Almirall ”) announces the signing with GW Pharma Ltd. ( GW ”) an update on their current agreement of Sativex ®. As part of the new agreement, Almirall has obtained the rights of marketing of Sativex ® in Mexico.
Under the terms of the original license agreement signed in December 2005, Almirall gained exclusive rights to the marketing of Sativex ® in Europe (except United Kingdom). Almirall has now obtained the exclusive rights to market Sativex ® in Mexico, a country which has subsidiary for more than one decade.
Luciano Conde, Director General operating from Almirall, said are very happy with our partnership with GW and the initial response of the market towards Sativex ®. It’s a new therapeutic option to alleviate suffering resulting from physical disability caused by muscle spasticity and Almirall is committed to ensure their availability in Europe, and now also in Mexico ”.
Almirall recently launched Sativex ® as a drug prescription for spasticity in multiple sclerosis in Spain, Germany and Denmark. Future releases will 2012 be held in in Italy, Sweden, Austria and Czech Republic. In addition, currently ongoing a procedure of mutual recognition (PRM) to extend the approval of Sativex ® in other European countries. It is expected that this new PRM process will be completed during 2012.
Sativex ® is approved for the treatment of spasticity in multiple sclerosis. The drug is also in phase III clinical development for the treatment of cancer pain.
Sativex ®
Sativex ® is a modulator of the endocannabinoid system, the first in its class, indicated as an adjunctive treatment for the improvement of symptoms suffered by patients with moderate or severe spasticity due to multiple sclerosis (MS), that have not responded adequately to other antiespásticosi drugs and who have shown a clinically significant improvement in symptoms related spasticity during a initial trial period of treatment.
The main active ingredients, delta-9-tetrahydrocannabinol (THC) and cannabidiol (CBD), extract of cannabis plants grown and processed in strictly controlled conditions. Sativex ® is administered in spray oral spray (in 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 Pharma Ltd. which owns the rights of marketing. manufactured by GW Pharma Ltd. licensed by the Ministry of the Interior of British, 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 disease. Spasticity can affect many aspects of the daily life of 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 forms.
Almirall drugs are now present in more than 70 countries. It has direct presence in Europe and Latin America through 12 subsidiaries.
Referencia:
i Sativex ® Summary of Product Characteristics, 2011.
(ii) Multiple Sclerosis International Federation. European map of ms database. © 2010 PMSCS, MSIF. Available here.
iii Rizzo MA et to the. Prevalence and treatment of spasticity reported by multiple sclerosis patients. Mult Scler 2004; 10: 589 – 595.