Sanofi-aventis Initiates Phase III Study with Teriflunomide as Adjunct Therapy with Interferon Beta to Further Explore Clinical Benefits in Multiple Sclerosis

PARIS, October 26, 2010 /PRNewswire via COMTEX/ — Sanofi-aventis announced today the initiation of a multinational Phase III study evaluating the efficacy and safety of two doses of once daily teriflunomide (7mg or 14mg) versus placebo in patients with relapsing multiple sclerosis (RMS) treated with interferon beta (IFN beta). Teriflunomide is a novel oral disease modifier developed by sanofi-aventis which is being investigated in a large Phase III clinical development program. It includes studies of teriflunomide in monotherapy for the treatment of RMS and in clinically isolated syndrome as well as adjunct therapy.

“Initiation of the TERACLES study is a tremendous milestone as it is the first ever Phase III study of an oral drug in adjunct therapy to be launched in multiple sclerosis,” said Marc Cluzel, M.D., Ph.D., Executive Vice President, Research & Development, sanofi-aventis. “We are confident that teriflunomide is an excellent candidate for assessing innovative adjunct therapy in multiple sclerosis considering the positive effect observed when it was used in adjunct with interferon beta in the Phase II study.”

Specifically, the TERACLES study will evaluate whether once daily oral teriflunomide 14 or 7mg, in patients treated for at least 6 months on a stable dose of IFN beta prior to randomization, can reduce the annualized relapse rate (primary endpoint) compared to IFN beta plus oral placebo tablets. The main secondary endpoints of the study are to document the disease activity measured by MRI, the time to disability progression and overall safety.