EMA accepts MAA filing of Genzyme's teriflunomide for MS

Genzyme, a Sanofi company (EURONEXT: SAN and NYSE: SNY), announced today the European Medicines Agency (EMA) has accepted the filing of the marketing authorization application (MAA) for once-daily oral teriflunomide for the treatment of relapsing forms of multiple sclerosis (MS). Acceptance of the MAA starts the EMA's review process.

"The filing represents another important milestone for teriflunomide and brings us one step closer to offering a new treatment option to patients with relapsing MS," said Bill Sibold, Senior Vice President, Head of Multiple Sclerosis, Genzyme. "As an oral therapy with a promising clinical profile, teriflunomide is extremely well positioned to provide an alternative therapeutic option to patients who are currently taking injectable therapies. Those injectable therapies make up approximately 80 percent of the MS market today."

The purpose of the MAA is to secure approval to market and allow prescription of teriflunomide in the European Union based on data from two completed pivotal Phase III trials, TEMSO and TENERE. These trials represent two of five efficacy studies of teriflunomide in MS that are completed or underway, making the clinical program one of the largest and broadest of any MS therapy in development.

An application to market teriflunomide in the United States is under review by the U.S. Food & Drug Administration.