TEMSO Phase III Trial shows ARR reduction in multiple sclerosis patients

Aug 30 2010

First Results From the TEMSO Phase III Trial to be Presented During the ECTRIMS Congress in October 2010

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) announced today that the investigational once-daily oral drug teriflunomide significantly reduced annualized relapse rate (ARR) at 2 years versus placebo in patients with relapsing multiple sclerosis (RMS), thus achieving the primary endpoint in the TEMSO phase III trial. Both the 7mg and 14mg doses of teriflunomide were well tolerated with a similar number of patients reporting either treatment-emergent adverse events (TEAEs) or TEAEs leading to treatment discontinuation in the treatment arms versus placebo.

Effects on other clinical and MRI related outcomes further support the primary outcome. The safety profile was in line with previous clinical experience.

The TEMSO trial is the first study of a large phase III clinical development program to produce results on teriflunomide as monotherapy. Study findings from TEMSO will be presented during the platform presentation scheduled for October 15, 2010, starting at 9:15 a.m. CET at the 26th Annual Meeting of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS) in Gothenburg, Sweden. The TEMSO study results are embargoed until this oral presentation.