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The companies said that there are no plans to pull the drug off the market and its current monitoring program for cases of a rare but sometimes fatal brain disorder is adequate.
The disclosure of two new cases of the rare viral infection called progressive multifocal leukoencephalopathy reignited already simmering concerns about the drug's sales potential. It was pulled from the market in 2005 after being linked to the rare brain disease but was reintroduced under restricted sales conditions in mid-2006.
Biogen said that the risks associated with the drug are clearly labeled and all patients are not only notified but have to sign a waiver acknowledging the risks. PML almost always occurs in people with a severe immune deficiency, as is the case with most patients taking Tysabri. Multiple sclerosis is an autoimmune disorder that results in physical and neurological damage.
The company said that there are about 32,000 patients on Tysabri worldwide, with 17,800 in the U.S.
Both new cases came out of European, with the first patient having been on Tysabri for 17 months. Another, who is still hospitalized, had been on Tysabri for 14 months. The company said it can count about 6,600 patients on the drug for about 18 months now, reinforcing its stance that the treatment is worth the risk.
Shares of Biogen plunged $19.75, or 28.3 percent, to $50.01, after hitting their lowest point in more than a year at $49.84 earlier in the session. Shares of Elan sank $10.12, or 50.5 percent, to $9.93 after hitting $9.55, their lowest point in nearly three years.
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