SEC Opens Tysabri Investigation
This article was originally published in The Pink Sheet Daily
The Securities & Exchange Commission has opened an investigation into the marketing suspension of Biogen Idec/Elan's multiple sclerosis therapy Tysabri (natalizumab)
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First quarter charges related to the withdrawn multiple sclerosis therapy totaled $36 mil. Inventory charges are expected in the second quarter as the company completes the natalizumab production cycle; idle capacity charges totaling $20 mil.-$30 mil. are likely in the latter half of the year.
Company plans to issue revised guidance in May after warning investors not to rely on previous financial forecasts. Announcement coincides with news that a third diagnosis of PML was discovered in a clinical trial for Tysabri.
One fatal, confirmed case of progressive multifocal leukoencephalopathy and one suspected case prompt withdrawal of multiple sclerosis product; risk/benefit ratio needs to be reestablished, companies say. Return to market would not be unprecedented, but Tysabri’s withdrawal sharpens focus on FDA's drug safety oversight.