Biogen Reports No New PML Cases In Weekly Tysabri Update
Tysabri, sold with Ireland's Elan Corp. (ELN), was pulled from the market for 18 months because of a suspected link to progressive multifocal leukoencephalopathy, or PML.
Since the July 2006 relaunch, Biogen has reported 10 confirmed cases - including one in each of the past three updates - and one death. The cases since the relaunch have frustrated Biogen's aim of making Tysabri into a blockbuster drug.
Biogen plans to post a case update every Friday afternoon until July 24, the third anniversary of relaunch, by which time it expects the risk/benefit profile to be clearer.
News of the 10th case last week pressured Biogen shares this week. The stock fell 10% over the four trading days, closing at $45. Elan shares also fell earlier in the week but ended 3.3% higher to $7.60, thanks to an agreement Thursday with Johnson & Johnson (JNJ).
Tysabri was pulled from the U.S. market in 2005 after three initial PML cases, including two deaths. After holding hearings to weigh Tysabri's risks and benefits, the Food and Drug Administration allowed it to be reintroduced in 2006, under monitoring rules and a prohibition on using it in combination with other MS drugs. The system was aimed at reducing PML incidence.
-By George Stahl, Dow Jones Newswires; 212-416-2182; george.stahl@dowjones.com
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Publié le 03 Juillet 2009 Copyright © 2009 Dowjones
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