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Genzyme Announces Successful Phase III Results for Alemtuzumab (LEMTRADA(TM*)) 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 -

http://www.businesswire.com/news/genzyme/20111113005072/en

In this randomized trial involving 840 patients, a 49 percent reduction in relapse rate was observed in patients treated with alemtuzumab 12 mg compared to interferon beta-1a over two years of study (p<0.0001). Importantly, there was also a 42 percent reduction in the risk of sustained accumulation (worsening) of disability as measured by the Expanded Disability Status Scale (EDSS) (p=0.0084). Analysis of the full CARE-MS II data is ongoing and results will be presented at a forthcoming scientific meeting.

The safety profile observed in the trial was consistent with previous alemtuzumab use in MS and adverse events continued to be manageable.... Approximately 16 percent of alemtuzumab-treated patients developed an autoimmune thyroid-related adverse event and approximately one percent developed immune thrombocytopenia during the two-year study period.