Merck KGaA races to regulators with oral MS drug

Racing to beat Novartis to the world's biggest drug markets with a new oral therapy for multiple sclerosis, Merck KGaA has filed for regulatory approval of cladribine in Europe and plans to file in the U.S. later this quarter.

The application brings Merck "closer to the possibility of providing an oral short-course treatment to patients with multiple sclerosis," Executive Vice President Roberto Gradnik said in a statement. Last spring researchers reported that cladribine cut the risk of relapse in half, though some patients also experienced a depletion of white blood cells needed to protect them from infections. The therapy works by blunting the human immune system.

Analysts say that cladribine is likely to achieve blockbuster status, with a billion dollars in annual sales. "A market entry in Europe beginning of 2010 seems feasible, as should be the case for the U.S.," wrote analysts for DZ Bank AG.

- read the report from Bloomberg

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