Genzyme announces that the EMA accepts the application for marketing authorization of oral teriflunomida for the treatment of multiple sclerosis

Cambridge (EE.)(UU.), February 2012.- Genzyme, a business of Sanofi (EURONEXT: SAN and NYSE: SNY), announced that the European Medicines Agency (EMA) has accepted the dossier for application for marketing authorisation for oral teriflunomida, once a day, for the treatment of recurrent forms of multiple sclerosis (MS). The acceptance of the application for marketing authorization begins the process of evaluation by the EMA.

The presentation represents another important milestone for teriflunomida and puts us closer to offer a new therapeutic option for patients with relapsing Ms ”, stated Bill Sibold, Assistant Vice President and head of multiple sclerosis in Genzyme. as oral treatment with a promising clinical profile, the teriflunomida is extremely well positioned to compete with injectable treatments, which constitute approximately 80 per cent of the market of the Ma ”. It is subject to approval by the EMA.

The purpose of the application for marketing authorisation is to ensure the drug’s approval, allowing doctors prescription of teriflunomida in the European Union, in line with the national implementing legislation. The application is based on data from two key trials of phase III completed, TEMSO and TENERE. These trials are two of the five studies of effectiveness of teriflunomida in Ma that are completed or in progress, making this program clinical one of the most comprehensive and far-reaching for any treatment in development for Ms.
The FDA of the United States.UU., is reviewing a request for marketing of teriflunomida in this country.

About teriflunomida

Teriflunomida is a drug administered by oral route, immunomodulator and modifier of the disease with anti-inflammatory properties, which is under investigation for the treatment of Ms. The teriflunomida prevents the proliferation and the operation of activated T and B lymphocytes believed that a Mitochondrial enzyme are particularly harmful in MS, to inhibit in a selective and reversible manner. Teriflunomida not usually affects lymphocytes in slow Division or at rest, which is why the response of the immune system to infection is not affected.

Teriflunomida is being studied in the context of a great clinical program that is expected to include more than 5,000 participants in 36 countries. Five clinical trials of efficacy of teriflunomida are completed or ongoing, making this program clinical one of the most comprehensive and far-reaching for any treatment in development for Ms. In addition to TEMSO and TENERE trials underway TOWER, a trial phase III controlled placebo in people with recurrent forms of Ms. Another study phase III, TOPIC, being undertaken in early stages of MS or SCA (isolated clinical syndrome). Teriflunomida also is being evaluated as an adjunctive treatment of interferon-β in the trial phase III TERACLES. With 10 years of continuous use in a phase II extension, teriflunomida has the most extensive of any treatment in research clinical experience for MS by mouth.
Teriflunomida, approval as medicine and clinical indications, is subject to review and approval by the EMA. In any case, until its approval as a drug, Teriflunomida is a research product and any use of the product should take place in the framework of authorised clinical trials or access programs authorized by the competent authorities.

About Genzyme, a company Sanofi

Genzyme has led the development and delivery of transformative therapies for patients with rare and debilitating diseases for more than thirty years. We reached our goals thanks to research of the highest quality and compassion and commitment of our employees. We focus on rare diseases and multiple sclerosis, and are committed to produce a positive impact on the lives of patients and families to whom we provide services. That is the objective that helps us guide and inspiration every day. The portfolio of transforming therapies of Genzyme, marketed in countries around the world, is the result of progress vital pioneers in medicine. As company Sanofi, Genzyme is benefiting from the scope and resources of one of the biggest pharmaceutical in the world, with a common commitment to improve the lives of patients. More information on www.genzyme.com. Genzyme ® is a registered trademark of Genzyme Corporation. All rights reserved.