Last night (and I doubt coincidentally) two promising therapies for MS released positive data. Novartis’s fingolimod (FTY720) in a Phase II study extension showed 68-73% of patients with multiple sclerosis remained relapse-free after three years of treatment and that 89% of patients free from active brain lesions - the injury caused by MS - three years after starting treatment. These results are simply breathtaking. Most, if not all, MS therapies are IV or SC administration, while fingolimod is dosed orally. This, in addition to the better efficacy, will be a huge plus for the Novartis drug. Of course, you don’t get something for nothing, and the press release manages not to mention the bradycardia or the leukopenia but those are small prices to pay for such a debilitating disease. Novartis expects to file an NDA in 2009. The 800lb gorilla in the MS market is the INF blocker Avonex from Biogen. The next shot on goal from the company was the integrin blocker Tysabri, though much more efficacious than Avonex, has been mostly sidelined due to increased incidence of progressive multifocal leukoencephalopathy (PML) - a fatal viral infection due to immune suppression. Biogen, I can only assume in response to Novartis’s positive data, released long term data showing no cases of PML in 26,000 patients since the FDA allowed Tysabri back on the market in a limited and controlled manner in 2006. The bottom line and take away message should be better therapies for MS are on the horizon and after all, that is why most of us got in to this business in the first place.
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Eben is a highly caffeinated business development associate at a small, cash sensitive pharmaceutical company somewhere in Massachusetts. He enjoys cliche-less banter, compartmentalization, non-equilibrium thermodynamics and NPV analysis. Agree or disagree with what he's posted? He encourages comments.
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