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SEC Opens Tysabri Investigation

This article was originally published in The Pink Sheet Daily

Executive Summary

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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Biogen Idec Expects Tysabri-Related Charges Up To $100 Mil. In 2005

First quarter charges related to the withdrawn multiple sclerosis therapy totaled $36 mil.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.

Tysabri Withdrawal Prompts Biogen Idec To Suspend Financial Guidance

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.

Tysabri Could Return In Fall; Marketing Suspended By Biogen Idec And Elan

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.

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