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Biogen, Elan Crash For Pulling MS Drug After Patient Death; Biogen Off 43%, Elan 70%; Bombshell about Tysabri is just the latest black eye for FDA's safety record.(A)
Byline: MARILYN ALVA
Biogen Idec and Elan withdrew their promising new multiple sclerosis drug on Monday, the industry's latest major withdrawal for safety concerns, sending shares of both companies crashing.
After one patient died and another developed life-threatening side effects, Biogen and Elan voluntarily pulled their potential blockbuster Tysabri and halted further trials.
Shares of Biogen crashed 43% while Elan plunged 70%.
Though the decision was voluntary, Biogen said it was made in "full collaboration" with the Food and Drug Administration.
Two patients had developed serious side effects, one a confirmed case and the other a suspected case of progressive multifocal leukoencephalopathy, an often-fatal disease of the central nervous system.
"Before today, it looked like an outstanding drug with a great clinical profile," said David Steinberg, analyst with Deutsche Bank Securities. "It was a major shock."
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