Genzyme's alemtuzumab Phase 2 trial data in MS to be presented at AAN meeting

Apr 8 2011

Genzyme, a subsidiary of sanofi-aventis Group (EURONEXT: SAN and NYSE: SNY), announced today that it will present new data from its completed Phase 2 trial of the investigational drug alemtuzumab for multiple sclerosis (MS) at the American Academy of Neurology's (AAN) 63rd Annual Meeting in Hawaii, April 9 - 16, 2011. Included among the additional Phase 2 trial safety and efficacy data at AAN will be presentations on the clinically-active disease status of patients through five-years of patient follow-up as well as data describing a measure of vision improvement.

"We are excited to present new alemtuzumab data at AAN that further reflects alemtuzumab's potential as an MS treatment," said Michael Panzara, Genzyme Group Vice President and Therapeutic Area Head for Multiple Sclerosis and Immune Diseases. "We look forward to the availability of Phase 3 results in the middle of this year."

Alemtuzumab is a humanized monoclonal antibody being studied as a potential therapy for relapsing-remitting multiple sclerosis (RRMS). Genzyme is currently conducting two pivotal Phase 3 trials to evaluate alemtuzumab in the treatment of MS. CARE-MS I is a randomized trial comparing alemtuzumab to the approved MS therapy Rebif® (high dose interferon beta-1a) in early, active RRMS patients who have received no prior therapy. CARE-MS II, which also compares alemtuzumab to Rebif, is studying RRMS patients who relapsed while on other MS therapies. Data from these trials are expected to be available beginning in mid-2011.

Genzyme's CAMMS223 Phase 2 trial, first reported in the New England Journal of Medicine in 2008, compared alemtuzumab to Rebif in early, active, RRMS patients who had received no prior therapy. In the trial, which was larger and longer than most Phase 2 MS clinical trials, alemtuzumab was given to patients in two or three annual cycles of not more than five days per cycle, while Rebif was given to patients three times per week, every week for three years. The study included an extended phase for collection of long-term efficacy and safety data.

Alemtuzumab data to be presented at AAN:

Abstract titles

• More Alemtuzumab Relapsing−Remitting Multiple Sclerosis Patients Are Free of Clinical Disease Activity at Five Years (Poster PD6.003, April 14)
• Alemtuzumab Improves Contrast Sensitivity in Relapsing−Remitting Multiple Sclerosis Patients (Presentation S31.001, April 13)
• Alemtuzumab Positively Affects Disability Outcomes Using a One−Year−Sustained Criterion for Relapsing−Remitting Multiple Sclerosis Patients in CAMMS223 (Poster P01.216, April 11)
• Effect of Alemtuzumab vs. Interferon beta−1a on Brain Atrophy in Patients with Early, Active Relapsing−Remitting Multiple Sclerosis (Poster P05.042, April 13)
• Analysis of Innate Immune Cells Following Alemtuzumab Treatment in Human CD52 Transgenic Mice (Poster P02.201, April 12)
• Alemtuzumab and Thyroid Autoimmunity in Relapsing−Remitting Multiple Sclerosis Patients in CAMMS223 (Poster P03.242, April 12)