Wednesday, October 07, 2009

1st oral treatment for MS submitted for FDA approval by Merck KGaA

Germany's Merck KGaA filed for approval of its multiple sclerosis pill cladribine in the US in a bid to bring the first oral treatment against the debilitating disease to market.

The drugs-to-chemicals hybrid said last week that it submitted a New Drug Application with the FDA, two months after regulatory filing in Europe.

As reported by Reuters, the move follows a pivotal Phase III clinical trial, which in January showed that cladribine reduced the number of relapses per year in patients with some forms of MS by 58 percent compared with a placebo.

In a best-case scenario, the pill would come to the U.S. market in the second quarter of 2010, and European market launch would ideally be in the last quarter of 2010, said Elmar Schnee, the head of Merck's drugs unit, earlier this month.

The filing helps the German drugmaker make headway over Swiss rival Novartis, which is planning to seek U.S. and European approval for an MS pill known as FTY720 at the end of this year.

According to some analysts, cladribine and FTY720 are expected to take a sizable chunk of the $8.6 billion market for MS treatments, currently dominated by injectables from Teva, Biogen Idec, Bayer, and Merck KGaA itself.

(At Stinson Brand Innovation, we work with the Merck Chemicals group to support its global biosciences marketing and sales strategy for the brands Calbiochem, Novabiochem, and Novagen. These life science research products are used worldwide in university laboratories, as well as in pharmaceutical and biotech industries.)

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