Those cheers you heard coming from Switzerland weren't because Novartis
The German drugmaker said yesterday that the Food and Drug Administration had turned down its multiple sclerosis drug cladribine. The pill would have competed with Novartis' Gilenya, which gained FDA approval last year.
For the foreseeable future, Gilenya will remain the only oral drug on the market that slows down relapses in multiple sclerosis patients. Merck KGaA will likely have to run additional clinical trials to characterize the risk-benefit ratio for cladribine. Biogen Idec
Acorda Therapeutics
The year or more head start should help Novartis, but it's still going to be an uphill battle. In theory, the pill form should make it easier to compete against drugs that have to be injected: Teva's Copaxone, Biogen's Avonex, Bayer's Betaseron, and Rebif, which is sold by Merck KGaA and Pfizer
When it released earnings at the end of January, Novartis said it had sold $13 million worth of Gilenya in the U.S. since the drug launched in October. That's not terribly impressive, but the party is just getting started. Thankfully for Novartis shareholders, Merck KGaA didn't rain on it.
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