Aubagio (Sanofi/Genzyme) results in TENERE trial for Multiple Sclerosis

Sanofi-Aventis and its subsidiary Genzyme reported top-line results from TENERE, a Phase III clinical trial comparing the effectiveness, safety and tolerability of once-daily oral teriflunomide to interferon beta-1a (Rebif), an approved injectable therapy, in people with relapsing forms of multiple sclerosis (RMS). The TENERE trial, which included 324 patients, is the second completed study of five efficacy studies of teriflunomide in MS, making the clinical program one of the largest and broadest of any multiple sclerosis agent under development. No statistical superiority was observed between the Rebif and teriflunomide arms (7mg and 14mg) on risk of treatment failure, the primary composite endpoint of the study. Risk of treatment failure was defined as the occurrence of a confirmed relapse or permanent treatment discontinuation for any cause, whichever came first. In the study, 48.6 percent of patients receiving 7mg of oral teriflunomide (n=109) and 37.8 percent of patients receiving 14 mg of oral teriflunomide (n=111) reached the primary endpoint, versus 42.3 percent of patients receiving interferon beta 1-a (n=104). The teriflunomide 14 mg daily dose (0.259) and Rebif (0.216) were not distinguishable on the endpoint of estimated annual relapse rate. Genzyme anticipates presenting detailed TENERE study findings at a forthcoming medical meeting. The company will also include the results in its application with the EMA for marketing authorization in the European Union, along with results from its successful Phase lll TEMSO trial. The company expects to file an application for marketing authorization with the EMA in the first quarter of 2012. The FDA application for teriflunomide was accepted for review by the FDA in October 2011.