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Biotech / Medical : Genentech (NYSE:DNA) formerly known as (NYSE:GNE)

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To: tnsaf who wrote (216)	2/20/2009 8:23:32 AM
From: nigel bates	Read Replies (1) of 250

FDA issues warning for Genentech drug Raptiva Silicon Valley / San Jose Business Journal - by Ron Leuty 20th Feb At least two patients using the Genentech Inc. psoriasis drug Raptiva have died from a rare brain infection progressive multifocal leukoencephalopathy, or PML, the Food and Drug Administration said. The FDA’s public health advisory on Raptiva comes four months after the agency revised labeling for the drug that called attention to the risk of infections like PML. At that time, South San Francisco-based Genentech (NYSE:DNA) was told to develop a strategy to ensure that patients receive risk information about Raptiva. European regulators recommended suspending Raptiva sales, the news agency Bloomberg reported. Merck KGaA of Germany sells Raptiva outside the United States. PML is a rare, progressive neurologic disease caused by a virus that affects the central nervous system. It typically occurs in people whose immune systems have been severely weakened. There is no known treatment. Raptiva, or efalizumab, works by affecting T-cells in the immune system. The effects also decrease the function of the immune system and increase susceptibility to infections. Raptiva sales last year totaled $108 million, only 1 percent of Genentech’s total U.S. product sales of $9.5 billion. Three of four reported PML cases have been confirmed. Two of the patients with confirmed PML and one patient with possible PML died. All were 47 to 73 years old, were treated with Raptiva continuously for more than three years and were not receive other immune system-suppressing treatments while taking the drug. “The FDA is reviewing this latest information,” the agency said on its web site. “The agency will take appropriate steps to ensure that the risks of Raptiva do not outweigh its benefits, that patients prescribed Raptiva are clearly informed of the signs and symptoms of PML, and that health-care professionals carefully monitor patients for the possible development of PML.” Raptiva was approved in October 2003 to treat chronic moderate to severe plaque psoriasis. Raptiva treated 2,764 patients at the time of its approval — but only 218 for more than one year — and there were no cases of PML at the time of its approval. The label warning last fall came after one case was reported. The FDA said long, continuous use of Raptiva may increase the risk of PML.

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