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Sixth Tysabri patient has brain disease

Biogen Idec has announced that another patient with MS taking Tysabri has developed a potentially deadly brain infection since the drug was reintroduced to the market in July 2006

Biogen Idec has announced that another patient with multiple sclerosis (MS) taking Tysabri (natalizumab) has developed a potentially deadly brain infection since the drug was reintroduced to the market in July 2006.

The patient was confirmed as having progressive multifocal leukoencephalopathy (PML) on April 15, and had been taking Tysabri for 31 months, according to a report on Cambridge-based Biogen Idec's website.

Biogen Idec has said that it does not plan to announce each new case of PML, except as a weekly update on its website. Even so, the confirmation occurred the day before Biogen's first-quarter earnings conference call and some analysts question why the company did not mention it.

Biogen Idec and marketing partner Elan Corp pulled Tysabri from the market in 2005 after three patients, two of whom died, developed PML. The Food and Drug Administration (FDA) allowed sales to resume in July 2006 after deciding that benefits for slowing MS relapses outweighed the risk. There were no reported infections for about two years after the drug's reintroduction.

According to Biogen Idec, as of the end of March around 40,000 patients worldwide were on Tysabri and about 56,000 patients have used the drug. The likelihood of getting PML from Tysabri is about 1 in 1,000 according to the drug's label.

Since the news was announced, Biogen Idec's shares have since fallen 4.3 per cent compared to a decline of 2.4 per cent in the American Stock Exchange Biotech Index.

21st April 2009

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