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Positive phase III MS results from Sanofi

Sanofi and its subsidiary Genzyme have announced positive results from a phase III trial of investigational MS therapy alemtuzumab

Sanofi and its subsidiary Genzyme have announced positive top-line results from a phase III trial of investigational therapy alemtuzumab when compared with the approved drug Rebif (interferon beta-1a) for the treatment of patients with relapsing remitting multiple sclerosis (RRMS).  
Alemtuzumab in MS is being developed by Genzyme in collaboration with Bayer HealthCare.

This trial, CARE-MS I, is the first of two global, randomised, rater-blinded phase III trials. It enrolled 581 early, active RRMS patients who had received no prior MS therapy who received two annual cycles of alemtuzumab treatment.

Data showed that treatment with alemtuzumab resulted in a 55 per cent reduction in relapse rate when compared with Rebif, and therefore met the primary endpoint. The second primary endpoint of time to six month sustained accumulation of disability, as compared to Rebif, was not met as it did not show statistical significance.

At the two-year time point, 8 per cent of patients treated with alemtuzumab had a sustained increase in their Expanded Disability Status Scale (EDSS) score (or worsening) compared to 11 per cent of those who received Rebif. Patients will have the option to be evaluated over the next threeyears as part of a separate protocol.

"In this two-year comparative study, the effect of alemtuzumab on reducing relapses versus Rebif, a leading drug for the treatment of multiple sclerosis, is impressive, and the safety profile is consistent with the phase II clinical trial experience," said Christopher A Viehbacher, CEO, Sanofi.

A second phase III trial, CARE-MS II, is currently in progress and will evaluate alemtuzumab against Rebif in relapsing-remitting multiple sclerosis patients who have relapsed while on therapy. Preliminary results are expected to be available in the fourth quarter of 2011.

"We look forward to the results from CARE-MS II, which will provide clinical data in patients whose disease was not adequately controlled on other multiple sclerosis therapies. Today's results are an important step forward in the development of alemtuzumab to address the substantial unmet needs for multiple sclerosis patients," Viehbacher added.

Genzyme expects to file for US and EU approval for alemtuzumab in MS at the beginning of 2012. The US Food and Drug Administration (FDA) has granted fast track designation to alemtuzumab.

12th July 2011

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