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Sanofi meets primary endpoint of phase 3 study for MS drug

Published: 16:39 11 Jul 2011 BST

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Sanofi (NYSE:SNY) announced Monday that it met its primary goal from the first of two phase three clinical trials for its alemtuzumab drug to treat multiple sclerosis (MS).

The CARE-MS I trial compared Sanofi's alemtuzumab drug to Rebif, the drug currently approved to treat MS, in patients with the relapsing-remitting form of the disease (RRMS).

The study saw the administration of 12 milligrams of alemtuzumab per day for five days in the first year, and for three days the second year, in 851 RRMS patients who had not received prior MS treatment.

The two-year study found a 55% reduction in relapse rate, compared to Rebif over the two years, and saw only 8% of patients increase, or worsen, their Expanded Disability Status Scale (EDSS) score, which measures the level of disability in patients with MS. Of those who received Rebif in the clinical trial, 11% saw an increase in the EDSS score. 

In addition, the 8% increase seen with alemtuzumab was significantly better than the 13% disability result seen in Sanofi's phase two trial. 

MS is an inflammatory disease caused by the breakdown of the myelin sheath in the brain, impeding the ability of nerve cells in the brain to communicate with those in the spinal cord. The disease is characterized by a loss of sensitivity, muscle weakness, difficulty moving, speaking and in coordination, and fatigue.

The alemtuzumab drug, which Sanofi subsidiary Genzyme co-developed with pharmaceutical giant Bayer, works by depleting the cells that are responsible for damaging the myelin sheath. Early research on the drug has also suggested a re-population of white blood cells in the spinal cord.

"The substantial effect of alemtuzumab on reduction of relapse rate over and above that seen with Rebif confirms out experience gathered over many years and demonstrated in the Phase 2 study," said Alastair Compston, chair of the steering committee that is overseeing the study.

Sanofi and Genzyme, which holds the worldwide rights to the drug, said they expect to file for U.S. and E.U. approval of alemtuzumab for MS in early 2012. The drug has already been granted fast track designation by the FDA.

The second phase three clinical trial, CARE-MS II, is underway and is evaluating the treatment in patients who have previously undergone therapy for the disease.

"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," said Sanofi CEO, Christopher A. Viehbacher.

The Paris, France-based company saw its stock on the New York Stock Exchange slip 3.44%, stemming from its Dermik divestiture to Valeant Pharmaceuticals, trading at $38.40 per share as of 9:15 am EDT.

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