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Sanofi MS Drug Lemtrada Drug Effective In One-year Extended Late-stage Trail

Genzyme, a biotech subsidiary of French drugmaker Sanofi SA (SNY, SNYNF), announced Thursday that its multiple sclerosis drug Lemtrada or alemtuzumab remained effective in the one-year extension study of its pivotal late-stage trials.

The company was providing the interim results from the first year of the extension study of Lemtrada being developed for the treatment for multiple sclerosis (MS).

The extended study showed that elapse rates and sustained accumulation of disability remained low among patients who had previously received Lemtrada. In more than 70 percent of patients, disability scores improved or remained stable over three years.

However, more than 80 percent of patients did not receive further treatment with Lemtrada during the first year of the extension study.

"These results underscore the tremendous promise that LEMTRADA holds for MS patients. We're pleased to be able to present these three-year results that provide us with important new information," Genzyme President and CEO David Meeker said in a statement.

Lemtrada is a monoclonal CD52 antibody in development for the treatment of relapsing multiple sclerosis. The injectable drug is chemically known as alemtuzumab.

Treatment with alemtuzumab results in the depletion of circulating T and B cells thought to be responsible for the damaging inflammatory process in MS. Alemtuzumab has minimal impact on other immune cells.

The acute anti-inflammatory effect of alemtuzumab is immediately followed by the onset of a distinctive pattern of T and B cell repopulation that continues over time, rebalancing the immune system in a way that potentially reduces MS disease activity.

A supplemental Biologics License Application or BLA, was accepted by the U.S. Food and Drug Administration (FDA) for standard review in late January, seeking approval of Lemtrada as treatment for relapsing multiple sclerosis. The FDA decision on the BLA is expected in the second half of 2013.

Meanwhile, Genzyme has also submitted its marketing authorization application for Lemtrada to the European Medicines Agency (EMA) and the review process is underway. The Committee for Medicinal Products for Human Use (CHMP) opinion for Lemtrada is expected in Q2 2013.

Genzyme is developing Lemtrada in MS in collaboration with Bayer Healthcare, a unit of German drug maker Bayer AG (BAYRY, BAYZF,BYR.L).

Genzyme holds the worldwide rights to alemtuzumab and has primary responsibility for its development and commercialization in multiple sclerosis. Bayer HealthCare retains an option to co-promote alemtuzumab in multiple sclerosis.

With Lemtrada, Sanofi is looking to restore its growth after losing several of its blockbuster drugs to generic rivals. Lemtrada was earlier sold until September 2012 under the name Campath as treatment for leukemia. It was then withdrawn from the market to now be touted as a treatment for MS. However, the drug remains available free of charge to leukemia patients.

SNY closed Thursday's regular trading session at $49.96, down $0.77 or 1.52% on a volume of 6.25 million shares.

by RTTNews Staff Writer

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