CORRECTED - UPDATE 3-Genentech withdraws Raptiva from U.S. market

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Wed Apr 8, 2009 7:46pm EDT

(Corrects to say that Xoma is paid a royalty on sales of Raptiva)

LOS ANGELES, April 8 (Reuters) - Genentech Inc, which was acquired by Roche Holding AG (ROG.VX) last month, announced on Wednesday a phased voluntary withdrawal of psoriasis drug Raptiva from the U.S. market due to its link to a brain infection.

Raptiva has recently been associated with an increased risk of progressive multifocal leukoencephalopathy (PML), a rare and usually fatal disease of the central nervous system.

Sales of the drug, for which a royalty is paid to Xoma Ltd (XOMA.O), totaled $108 million in the United States last year.

Roche said it expects to record a $125 million charge for the withdrawal, but its 2009 targets would not be affected.

Authorities in Europe, where Raptiva is sold by Merck KGaA (MRCG.DE), recommended in February that the drug be suspended in light of the PML risk.

The European Commission is expected to follow that advice.

There have been three cases of diagnosed PML in patients receiving Raptiva, two of which were fatal, and a fourth patient who developed progressive neurologic symptoms and died of unknown causes.

Raptiva is approved for the treatment of chronic moderate-to-severe plaque psoriasis in adults 18 years or older who are candidates for systemic therapy or light therapy.

PML has also become an issue for patients treated with multiple sclerosis drug Tysabri, which is sold by Biogen Idec Inc (BIIB.O) and Elan Corp Plc (ELN.I).

Tysabri, which had 2008 sales of $813 million, was withdrawn from the market in 2005, but reintroduced in July 2006 with stricter safety warnings as patients with the degenerative disease were willing to assume the risk given the drug's clear benefits over other treatments.

Five cases of PML have emerged in patients taking the MS drug since last July and one patient has died.

Genentech said that, effective immediately, physicians should not issue prescriptions for Raptiva for any new patients and should promptly contact patients currently receiving the drug to assess the most appropriate treatment alternatives.

The company said Raptiva will not be available after June 8 and estimated that around 2,000 U.S. patients may be receiving the drug for chronic plaque psoriasis. (Reporting by Deena Beasley; editing by Matthew Lewis and Andre Grenon)

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