Wednesday, March 2, 2011

EMD Serono's MS oral drug rejected by FDA

By Julie M. Donnelly, Boston Business Journal

The U.S. Food and Drug Administration has rejected EMD Serono’s oral drug candidate to treat multiple sclerosis.

The bad news for Rockland-based EMD Serono is good news for its competitor, Weston-based Biogen Idec, which produces two blockbuster MS infusion treatments but does not yet have an oral pill on the market.

Merck KGaA, the German parent company of EMD Serono, announced Wednesday that the company received a “complete response” letter from the FDA for the potential treatment. Company executives said the letter noted that while there was substantial evidence of the effectiveness of the drug candidate, the safety data on the drug was insufficient. The FDA asked for either additional analyses or additional studies to clarify the risks and overall risk-benefit profile of the poetential drug.

The company said it would ask for a meeting with the FDA to determine the next steps.

“Our commitment to transform the way people living with MS approach their therapy options remains steadfast,” EMD Serono CEO Fereydoun Firouz said in a statement. “We look forward to working with the FDA to address the safety issues in its letter and will continue to move toward identifying a potential path that provides patients and physicians the opportunity to have access to Cladribine Tablets in the treatment of MS.”

EMD Serono has remaining ongoing trials that are studying the safety and efficacy of the drug, and more data is expected by the end of the year. EMD Serono’s drug is already approved in Australia and Russia, where it is called Movectro.

Swiss drug maker Novartis AG is the only company with an FDA approved oral drug to treat multiple sclerosis. Novartis’ drug, Gilenya, was approved in September 2010. Biogen Idec also an MS pill in late-stage development, and results from two Phase 3 trials are expected by the end of the year.