News Feature | September 12, 2014

Sanofi, Genzyme Post Interim Data From Lemtrada Extension Study In MS

By Estel Grace Masangkay

Sanofi and its subsidiary Genzyme shared positive interim results from the second year of its Lemtrada (alemtuzumab) extension study in patients with multiple sclerosis.

Alemtuzumab is a monoclonal antibody that targets CD52, an abundant protein found on T and B cells. The antibody causes the depletion of circulating T and B cells thought to be behind MS’ damaging inflammatory process. Treatment with alemtuzumab rebalances the immune system in a way that potentially cuts down multiple sclerosis activity. The U.S. Food and Drug Administration (FDA) accepted Genzyme’s resubmission of its supplemental Biologics License Application (sBLA) for Lemtrada as treatment for relapsing forms of MS this May.

The company reports that approximately 70 percent of patients improved or kept their disability scores stable for two years more after the pivotal two-year MS Phase III studies CARE-MS I and CARE-MS II. Around 70 percent of patients also did not receive a third course of treatment with Lemtrada through the extension study’s second year.

“These extension study results provide further evidence of the prolonged efficacy of Lemtrada on both relapses and disability. The majority of patients continued to experience reduced disease activity, even though their last Lemtrada treatment was three years earlier,” said Dr. Alasdair Coles, Senior Lecturer at the Department of Clinical Neurosciences in the University of Cambridge.

Genzyme President and CEO, David Meeker, said, “MS is a devastating disease and patients remain in need of new treatment options that may offer greater efficacy. These new data reinforce the transformative potential of Lemtrada. It is encouraging to see the durable efficacy and manageable safety of Lemtrada maintained two years into the extension study.”

Genzyme said it will present the results of the latest studies at the European Committee for Research and Treatment in Multiple Sclerosis (ECTRIMS).

Sanofi said that it plans to expand Genzyme and its pipeline by acquiring related firms and new drugs. Genzyme MS franchise head Bill Sibold told Reuters UK that the company expects a good market performance for both MS drugs Lemtrada and Aubagio, and this in part fuels the company’s hunt for external growth. Genzyme itself was taken over by Sanofi in 2011 for $20.1 billion in a transaction centered on the acquisition of Lemtrada.