On Friday, Genzyme Corp. (GENZ) presented encouraging four-year follow-up phase II data on alemtuzumab, which is being developed for the treatment of multiple sclerosis (MS). Results showed durable reductions in relapse rate and sustained accumulation of disability even three years after patients received their last course of alemtuzumab.

The company presented these efficacy and safety data at the annual meeting of the European Committee for Treatment and Research in Multiple Sclerosis in Germany. This CAMMS223 study was conducted in early, relapsing-remitting MS patients, who were randomized to receive either alemtuzumab or Pfizer/Serono’s (PFE) Rebif.

Patients taking once-yearly cycles of alemtuzumab reduced their risk of relapse by 72% and the risk of sustained accumulation of disability by 73% compared to patients receiving Rebif. Additionally, the annualized relapse rate and disability risk measured from year three to four remained at the same low level observed in prior years of the study. These results confirm the ability of alemtuzumab to extend the duration of response in patients with relapsing MS.

Alemtuzumab (trade name Campath) is available in the U.S. as a single agent for the treatment of B-cell chronic lymphocytic leukemia (B-CLL), and outside the U.S. for the treatment of B-CLL in patients who have been treated with alkylating agents and for whom fludarabine combination therapy is not appropriate.

Alemtuzumab is currently in two pivotal phase III studies for the MS indication. Positive results from these studies, expected in 2011, could lead to approval in 2012. The MS market is huge – according to the National Multiple Sclerosis Society, there are approximately 400,000 MS patients in the US. Worldwide, MS is estimated to affect more than 2.5 million people.

Currently available treatments include Biogen Idec‘s (BIIB) Avonex and Tysabri, Teva Pharmaceuticals‘ (TEVA) Copaxone and Pfizer/Serono’s Rebif. Biogen is a leading player in the MS market with its Avonex posting sales of $2,203 million in 2008.

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