24 September 2010

A Blockbuster in Due Time

No surprise here. Novartis' (NYSE: NVS) oral multiple sclerosis drug Gilenya received Food and Drug Administration approval as expected yesterday.
OK, perhaps there was one surprise: The drug's name changed from Gilenia to Gilenya. But that shouldn't come as too big of a surprise since the spelling with a y is what Novartis is using in Russia, where it's already approved.
While an approval was widely expected after a unanimous positive recommendation from an FDA advisory panel, sales of Gilenya are still a big mystery.
Gilenya is the first oral drug used to slow down relapses in multiple sclerosis patients. The other drugs from Bayer, Merck KGaA, Pfizer (NYSE: PFE), Teva Pharmaceutical (Nasdaq: TEVA), Biogen Idec, and Elan (NYSE: ELN) have to be injected or infused.
Acorda Therapeutics' (Nasdaq: ACOR) Ampyra is taken orally, but it's designed to help multiple sclerosis patients walk, not slow down the disease's progression.
My fellow Fool Jordan DiPietro is excited about Gilenya. His mom has multiple sclerosis, and they've been looking forward to the availability of the drug for a while.
I'm a little more reserved. Doctors will prescribe Gilenya for sure. There are patients who aren't taking medication simply because of their disdain for needles. But I have a hard time seeing a mass exodus from the proven drugs toward one that has only been tested on a limited number of patients. Gilenya exhibited side effects in the clinical trials, and doctors will likely want to get real life experience -- in the aforementioned trypanophobiacs -- before prescribing Gilenya to the masses.
There's also the issue of competing oral drugs coming down the pipeline. Merck KGaA has one currently up for FDA review, and Biogen, Teva, and sanofi-aventis (NYSE: SNY) are also working on oral drugs. Depending on how the efficacy and safety profiles look for those drugs, Gilenya could end up peaking earlier than expected as more oral drugs make it to market. That could end up being the biggest surprise of all.

**Published in "The Motley Fool"

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