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Teriflunomide in Adjunct to Interferon Beta Significantly Improved Outcomes of Multiple Sclerosis Patients
Date:6/5/2010

PARIS, June 5, 2010 /PRNewswire-FirstCall/ --

- One-Year Phase II Data Presented at the 2010 ACTRIMS Meeting

Sanofi-aventis (EURONEXT: SAN and NYSE: SNY) reported today new one-year data from a Phase II study with teriflunomide, a novel oral disease modifier being investigated for the treatment of relapsing multiple sclerosis (RMS). Study results demonstrated an improvement in outcomes, with a consistent safety profile with the data from a previous Phase II monotherapy study, in patients treated with interferon beta (IFN-[BETA]) - a standard therapy in RMS - and receiving teriflunomide 7mg or 14mg, compared with patients treated with IFN-[BETA] and receiving oral placebo.

The findings were the subject of the leading oral presentation at the American Committee for Treatment and Research in Multiple Sclerosis meeting (ACTRIMS) in San Antonio, TX, USA. This study is part of a comprehensive clinical development program for teriflunomide both in monotherapy and in adjunct therapy in MS patients.

Although this Phase II study (n=116) was not powered to test for efficacy, patients taking 7mg or 14mg teriflunomide in adjunct to stable dose IFN-[BETA] experienced a significant relative risk reduction (86%; p=0.0005 and 82.8%; p<0.0001 respectively) in the number of gadolinium enhancing T1 (T1-Gd) lesions on brain magnetic resonance imaging compared with patients taking stable dose IFN-[BETA] with placebo. No unexpected safety findings have been showed with teriflunomide during the one-year period of the study as compared to the initial six-month period. Discontinuations due to treatment-emergent adverse e
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SOURCE Sanofi-aventis
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