Biotech Values

[DewDiligence]

SNY Reports Top-Line Phase-3 Data for Teriflunomide in RRMS

[The study in question tested teriflunomide monotherapy vs placebo. This PR does not say much beyond the fact that the primary endpoint was met and the safety profile of both teriflunomide doses was consistent with prior studies. The full dataset will be presented at a medical conference on 10/15/10.]

http://finance.yahoo.com/news/Teriflunomide-Significantly-prnews-2722772754.html?x=0&.v=1

›Teriflunomide Significantly Reduced Annualized Relapse Rate and was Well Tolerated in MS Patients

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

Monday August 30, 2010, 12:59 am EDT

PARIS, August 30, 2010 /PRNewswire-FirstCall/ 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.

About Teriflunomide

Teriflunomide is a new oral disease modifier for RMS that blocks de novo pyrimidine synthesis thus reducing T- and B-cells proliferation with no cytotoxicity. A comprehensive clinical development program for teriflunomide has been launched in monotherapy. First Phase II study results of the safety and efficacy of teriflunomide monotherapy in MS were published in Neurology in 2006. In addition to the TEMSO trial, two other Phase III trials, TOWER and TENERE, are ongoing in RMS. A Phase III study, TOPIC, is also underway in early MS or Clinically Isolated Syndrome (CIS). Teriflunomide has also been evaluated as an adjunct therapy to either interferon 1-beta or glatiramer acetate in two Phase II studies. Results of these studies were presented earlier this year during the American Committee for Treatment and Research in Multiple Sclerosis meeting (ACTRIMS) congress, and the American Academy of Neurology (AAN) meeting respectively. Phase II studies with teriflunomide (7mg and 14mg) in adjunct with interferon 1-beta demonstrated an improvement in outcomes, with a consistent safety profile in patients treated with the adjunct treatment compared with patients treated with IFN-beta and receiving placebo. In the other Phase II study, teriflunomide in adjunct to glatiramer acetate (GA) was well-tolerated compared to patients receiving GA and placebo. Although there was a numerical trend for the reduction in number and volume of gadolinium enhancing T-1 brain MRI lesions in the adjunct arm compared to placebo with GA, the relative effect was not as robust as that observed for teriflunomide with IFN-beta.

About TEMSO Study

TEMSO is a 2-year randomized, double-blind, placebo controlled study including 1088 RMS patients worldwide, aged 18-55 years, with an Expanded Disability Status Scale (EDSS) <= 5.5 and at least one relapse over the previous year or at least 2 relapses over the preceding 2 years. Patients were randomized to placebo or teriflunomide, 7mg or 14mg, once daily. The primary endpoint was annualized relapse rate defined as the number of confirmed relapses per patients-year. The key secondary endpoint was the time to disability progression measured by EDSS. Safety and tolerability evaluations were based on treatment emergent adverse events, physical examinations, vital signs and laboratory investigations.‹