25 to 0! Now That's a Ringing Endorsement

It wasn't perfect, but yesterday's Food and Drug Administration advisory panel went about as good as Novartis (NYSE: NVS  ) could have hoped for.

The committee was reviewing Novartis' Gilenia, the first potential oral multiple sclerosis drug in a sea of drugs from Bayer, Merck KGaA, Pfizer (NYSE: PFE  ) , Teva Pharmaceutical (Nasdaq: TEVA  ) , Biogen Idec (Nasdaq: BIIB  ) , and Elan (NYSE: ELN  ) that all have to be injected or infused. Gilenia clearly works -- the panel voted 25 to 0 recommending approval of the drug -- but the question was whether side effects would get in the way.

The panel voted 21-3 supporting Gilenia's use as a first-line treatment. Given its advantage of avoiding needles, being relegated to a second-class citizen would have been costly. Novartis also escaped a costly delay when the panel voted that the company doesn't need to test a lower dose of the drug before approval. It'd still like to see the data, just not before the drug is on the market.

About the only thing that hurt Novartis was the panel's vote recommending that the first dose be administered inside a doctor's office because of potential heart issues. The panel also recommended that patients receive routine lung function tests because the drug has been linked to decreased lung function. Both will be a constant reminder to doctors about the potential side effects of the drug.

The advisory committee only makes recommendations, but given the overwhelming support, I'd be really surprised if the FDA doesn't approve Gilenia in September.

How well Gilenia will sell once it's approved is less certain, though some analysts are expecting blockbuster status; that is, more than $1 billion in sales per year. Given its safety profile, doctors may be cautious about its adoption until they have some real-life experience with the drug. A slow start could be bad news for Novartis because Merck KGaA, sanofi-aventis (NYSE: SNY  ) and Biogen all have oral multiple sclerosis drugs in their pipelines.

Squandering its lead is not what the doctor ordered.