More TYSABRI MS Woes, Sort Of (BIIB, ELN, ACOR)

October 23, 2009 · Filed Under Uncategorized 

Biogen Idec Inc. (NASDAQ: BIIB) is feeling the pain of regulatory review this morning.  And Elan Corp. plc (NYSE: ELN) is feeling it even worse.  The reason these are under pressure this Friday is because a European panel has begun a review of Biogen’s controversial yet effect multiple sclerosis drug TYSABRI.  The review is over higher rates of PML brain infections (progressive multifocal leukoencephalopathy) than had been disclosed.

The European Medicines Agency’s Committee for Medicinal Products for Human Use showed some 23 PML cases since the launch of TYSABRI.  Previous data showed that there were 13 cases since TYSABRI came back on the market in 2006 after the company voluntarily removed it to study the PML data.   The European panel will discuss additional measures, if needed, to ensure a safe use of the drug and how to measure risks.

Biogen Idec is already in U.S. talks with the FDA over the TYSABRI label.  Most recent data showed more than 46,000 people were taking TYSABRI, and over 13,000 patients had been taking TYSABRI for more than two years and were classified under long-term use.

It is impossible to pre-judge this situation, but personal discussions have given a personal belief here that the reason people keep taking TYSABRI is because many think it is the best MS drug on the market.  As far as a 1 in a thousand risk, that is a very low incident ratio compared to other drugs that treat other diseases and many are willing to take that risk.

Biogen Idec is down 5.7% at $44.50 and Elan is down almost 17% at $5.35.  Acorda Therapeutics, Inc. (NASDAQ: ACOR) has been noted this week as having an MS drug candidate pending under priority review date and that has been extended out to January 2010 by the FDA.

JON C. OGG
OCTOBER 23, 2009

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