European Commission approves Genzyme’s once-daily, oral multiple sclerosis treatment Aubagio® (teriflunomide)

Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today that the European Commission has granted marketing authorization for Aubagio® (teriflunomide) 14 mg, a once-daily, oral therapy indicated for the treatment of adult patients with relapsing remitting multiple sclerosis (RRMS).

“The fact that Aubagio 14 mg has demonstrated a positive effect on disability progression in two phase III clinical studies underscores its importance as a new treatment option for relapsing remitting MS patients,” said Professor Ludwig Kappos, MD, Chair of Neurology, University Hospital, Basel, Switzerland. “As a new once-daily, oral treatment option with well-characterized safety and tolerability, Aubagio could be an attractive option for patients dissatisfied with traditional injectable therapies.”

The EU approval of Aubagio was based on data from the Phase III TEMSO (TEriflunomide Multiple Sclerosis Oral) and TOWER (Teriflunomide Oral in people With relapsing remitting multiplE scleRosis) trials. In these trials, Aubagio significantly reduced the annualized relapse rate and the time to disability progression at two years versus placebo.

“Aubagio’s efficacy, safety and convenient dosing may provide an attractive treatment option for patients,” said Genzyme CEO and President, David Meeker, M.D. “Today’s approval of Aubagio is another step forward for Genzyme as we work to develop important new treatments that can address the diverse needs of the MS community.”

Multiple sclerosis is estimated to affect more than 2.1 million people globally. There are approximately 630,000 people affected by MS in Europe.

The development of Aubagio reflects more than a decade of work by the Sanofi R&D organization.

Aubagio is approved to treat relapsing MS in the United States, Australia, Argentina, Chile and South Korea, and is under review by additional regulatory agencies.

About Aubagio® (teriflunomide)

Aubagio is an immunomodulator with anti-inflammatory properties. Although the exact mechanism of action for Aubagio is not fully understood, it may involve a reduction in the number of activated lymphocytes in the central nervous system (CNS). Aubagio is supported by one of the largest clinical programs of any MS therapy, with more than 5,000 trial participants in 36 countries. Some patients in extension trials have been treated for up to 10 years.

EU Indication and Usage

Aubagio (teriflunomide) 14 mg is a once-daily, oral therapy indicated in the European Union for the treatment of adult patients with relapsing remitting multiple sclerosis.

U.S. Indication and Usage

Aubagio (teriflunomide) is a once-daily, oral therapy indicated in the U.S. for the treatment of adult patients with relapsing forms of multiple sclerosis. The recommended dose of Aubagio is 7 mg or 14 mg orally once daily.

Important Safety Information About Aubagio

The Aubagio label includes the risk of hepatotoxicity and, teratogenicity (based on animal data).

In MS clinical studies with Aubagio, the incidence of serious adverse events were similar among Aubagio and placebo-treated patients. The most common adverse events associated with Aubagio in MS patients included increased ALT levels, alopecia, diarrhea, influenza, nausea and paresthesia. Teriflunomide is the principal active metabolite of leflunomide, which is indicated in the U.S. and Europe for the treatment of rheumatoid arthritis. Severe liver injury including fatal liver failure has been reported in patients treated with leflunomide.

Leflunomide has an estimated 2.1 million patient years of exposure in rheumatoid arthritis globally since its launch.

Aubagio is contraindicated in patients with severe hepatic impairment, pregnant women and women of childbearing potential who are not using reliable contraception, breast feeding women, patients with immunodeficiency states, patients with significantly impaired bone marrow function or significant anaemia, leucopenia, neutropenia or thrombocytopenia, patients with severe active infection until resolution, patients with severe renal impairment undergoing dialysis and patients with hypoproteinaemia.

For full prescribing information and more information about Aubagio for EU patients, please visit: http://ec.europa.eu/health/documents/community-register/html/alfregister.htm

For full prescribing information and more information about Aubagio for U.S. patients, please visit: http://products.sanofi.us/aubagio/aubagio.pdf