Genzyme demonstrates depth of MS pipeline at AAN with results from Miltiple Sclerosis Phase III trials

Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme announced today that 12 data presentations, including six platform presentations, from the company’s multiple sclerosis (MS) clinical trial programs for alemtuzumab and teriflunomide will be featured at the American Academy of Neurology’s (AAN) 64th Annual Meeting in New Orleans, La., April 21-28. Presentations will include full data results from CARE-MS II (The Comparison of alemtuzumab and Rebif® Efficacy in Multiple Sclerosis), a Phase III trial investigating alemtuzumab in MS patients who had relapsed while receiving prior MS therapy, as well as new findings from the teriflunomide clinical program, one of the largest and broadest of any MS therapy in development.

“Genzyme’s robust development programs for alemtuzumab and teriflunomide were designed to understand how these therapies can best address significant unmet medical needs of people living with MS,” said David Meeker, M.D., President and CEO, Genzyme. “We are committed to becoming a long-term partner to the MS community with the goal of raising the expectation of what life with MS can be.”

Marketing applications for teriflunomide for the treatment of relapsing forms of MS are under review by the U.S. Food & Drug Administration (FDA) and European Medicines Agency (EMA). Genzyme is on track to submit applications to the FDA and EMA for approval of alemtuzumab to treat relapsing forms of MS in the second quarter of this year.

Following are selected scientific abstracts highlighting new results from the Phase III CARE-MS II and CARE-MS I trials for alemtuzumab, as well as the Phase III TEMSO (Study of Teriflunomide in Reducing the Frequency of Relapses and Accumulation of Disability in Patients With Multiple Sclerosis) trial for teriflunomide.

ALEMTUZUMAB CARE-MS II Platform Presentation:

• Efficacy and Safety Results From Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis II (CARE−MS II): A Phase III Study in Relapsing−Remitting Multiple Sclerosis Patients Who Relapsed on Prior Therapy (Platform Presentation S01.004; April 24; 1:45 p.m. CT, 2:45 p.m. ET)

ALEMTUZUMAB CARE-MS I Platform Presentations:

• Efficacy and Safety Results From Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis I (CARE−MS I): A Phase III Study in Relapsing−Remitting Treatment−Naïve Patients (Platform Presentation S01.006; April 24; 2:15 p.m. CT, 3:15 p.m. ET)
• Effect of Alemtuzumab vs. Rebif on Brain MRI Measurements: Results of CARE−MS I, a Phase III Study (Platform Presentation S11.006; April 24; 4:15 p.m. CT, 5:15 p.m. ET)
• Incidence of Autoimmunity in a Phase III Trial: Comparison of Alemtuzumab and Rebif in Multiple Sclerosis I (CARE−MS I) (Platform Presentation S41.006; April 26; 2:15 p.m. CT, 3:15 p.m. ET)
• Infections in Phase III Study: Comparison of Alemtuzumab and Rebif Efficacy in Multiple Sclerosis I (CARE−MS I) (Platform Presentation S41.007; April 26; 2:30 p.m. CT, 3:30 p.m. ET)

TERIFLUNOMIDE TEMSO Platform Presentation:

• Effect of Teriflunomide on Relapses With Sequelae and Relapse Leading to Hospitalization in a Population With Relapsing Forms of Multiple Sclerosis: Results From the TEMSO Study (Platform Presentation S30.003; April 25; 2:30 p.m. CT, 3:30 p.m. ET)

Additional Genzyme MS portfolio data to be presented include:

ALEMTUZUMAB:

• Relapse Outcomes With Alemtuzumab vs. Rebif in Treatment−Naïve Relapsing−Remitting Multiple Sclerosis (CARE−MS I): Secondary and Tertiary Endpoints (Poster Discussion PD5.004; April 25; 2:00 p.m. CT, 3:00 p.m. ET)
• Activity of an Anti−Murine CD52 Antibody in Experimental Autoimmune Encephalomyelitis (Poster P05.117; April 25; 2:00 p.m. CT, 3:00 p.m. ET)

TERIFLUNOMIDE:

• Effect of Repeated Doses of Teriflunomide on a Single Oral Dose of Bupropion in Healthy Male Subjects (Poster P04.143; April 25; 7:30 a.m. CT, 8:30 a.m. ET)
• Teriflunomide Increases the Proportion of Patients Free From Disease Activity in the TEMSO Phase III Study (Poster Discussion PD5.007; April 25; 2:00 p.m. CT, 3:00 p.m. ET)
• Pregnancy Outcomes From the Teriflunomide Clinical Development Program: Retrospective Analysis of a Global Pharmacovigilance Database (Poster P06.190; April 26; 7:30 a.m. CT, 8:30 a.m. ET)
• Impact of Relapses With Sequelae on Disability, Health−Related Quality of Life, and Fatigue in a Population With Relapsing Forms of Multiple Sclerosis Using Data From TEMSO, a Pivotal Phase III Teriflunomide Trial (Poster P07.082; April 26; 2:00 p.m. CT, 3:00 p.m. ET)