November 14, 2011

Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADATM*) in Multiple Sclerosis

- Significant efficacy of alemtuzumab over interferon beta-1a (Rebif®) observed on both relapse and disability co-primary endpoints in treatment-experienced MS patients -

- Genzyme confirms Q1 2012 regulatory submission objective -

 

Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADATM*) in Multiple Sclerosis
- Significant efficacy of alemtuzumab over interferon beta-1a (Rebif®) observed on both relapse and disability co-primary endpoints in treatment-experienced MS patients -

Paris, France – November 14, 2011 – Sanofi (EURONEXT: SAN and NYSE: SNY) and its subsidiary Genzyme report today that the Phase lll CARE-MS ll trial met both of its co-primary endpoints. Relapse rate and sustained accumulation (worsening) of disability (SAD) were significantly reduced in multiple sclerosis patients receiving alemtuzumab (LEMTRADA™) as compared with Rebif® (44 mcg subcutaneous interferon beta-1a). Results for both of these coprimary endpoints were highly statistically significant. CARE-MS II is the randomized Phase III clinical trial comparing the investigational drug alemtuzumab to interferon beta-1a in patients with relapsing-remitting multiple sclerosis (RRMS). Patients were required to have experienced a relapse while on a prior therapy to be eligible for CARE-MS II. Genzyme is developing alemtuzumab in MS in collaboration with Bayer HealthCare.