Multiple sclerosis drug Tysabri is arguably the most important drug to both Biogen Idec
Tysabri is at a crossroads, an intersection that investors should be watching very closely. So far, though, the drug has taken the high road.
You'll recall that Tysabri was pulled off the market after reports of progressive multifocal leukoencephalopathy, or PML. The FDA decided the drug's benefit justified the risk of PML, and Biogen and Elan were allowed to resume selling the drug. Since then, especially after more cases of PML were reported, the duo has been working on a way to stratify the risk to make patients more comfortable taking the drug.
Earlier this year, the FDA approved Quest Diagnostics'
With the new diagnostic available for most of the quarter, more than 1,900 net new patients went on therapy. More importantly, Biogen characterized discontinuation rates as "stable quarter over quarter." Since 50% to 60% of patients have the JC virus present, you could imagine they'd jump ship. Some certainly will, although it doesn't look like a major issue at this point.
Interestingly, the number of newly diagnosed patients who have never been treated for multiple sclerosis increased from a low-single-digit percentage to the high single digits this quarter, probably because doctors can be more certain that the virus isn't present to produce PML. Moving earlier into the disease progression to compete with Bayer's Betaseron, Teva Pharmaceuticals'
High road indeed.
Looking for more high-tech stock ideas? Check out the Fool's free report, "3 Hidden Winners of the iPhone, iPad, and Android Revolution," where you'll find three companies quietly cashing in on the booming smartphone and tablet PC markets. Get your free copy.