LOS ANGELES, July 31 (Reuters) - Biogen Idec Inc and Elan Corp Plc
notified regulators of two confirmed cases of a potentially deadly brain
disease in multiple sclerosis (MS) patients being treated with Tysabri.
The news on Thursday sent shares of Biogen down about 23 percent, while
Elan's shares fell 45 percent in New York.
Sales of the drug, marketed by both companies, were suspended in 2005
after three patients developed a brain infection known as progressive multifocal
leukoencephalopathy (PML).
Tysabri returned to the market in 2006 with warnings after the U.S. Food
and Drug Administration decided MS patients willing to accept the risks, should
be able to have access to the drug's potential benefits.
The two new PML patients, one of whom is hospitalized, are in the
European Union, the companies said.
"We've said all along, and the FDA has also stated and it's clearly
outlined in our label that we expect to see additional cases of PML," Biogen
spokeswoman Naomi Aoki said. "These are the first cases we've seen since the
reintroduction in the U.S. and approval in Europe two years ago."
She said the company believes that heightened clinical vigilance has been
the best way to monitor for PML and that heightened vigilance was critical in
identifying these cases.
Tysabri, co-marketed by Ireland's Elan and Cambridge, Massachusetts-based
Biogen, also won U.S. approval this year to treat adults with moderate to severe
Crohn's disease who have had a poor response to, or cannot take, other
therapies.
Shares of Biogen, which closed at $69.76 on Nasdaq, fell to $53.68 after
hours, while shares of Elan, which closed at $20.05 on the New York Stock
Exchange, were trading at $11.00.
(Reporting by Deena Beasley and Bill Berkrot; editing by Jeffrey Benkoe)
Keywords: BIOGEN ELAN/TYSABRI
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