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Biotech investors eye FDA closely It's not just because the drug is critical to the future of the Cambridge based company, whose only other product on the market, multiple sclerosis drug Avonex, faces new competition from another drug approved by the FDA in March. It's because the whole industry, battered by recent FDA setbacks that have clobbered biotech stocks, is looking for a winner. "For Biogen specifically, this is one of the next drivers for growth for the company, so (the attention is) understandable," said Ron Renaud, an associate director at Bear Stearns. "I think for the overall biotech environment, the importance is in the fact that investors just want to start getting comfortable that the FDA is approving products, or has the potential to approve products, given that most of the recent FDA actions have been setbacks." On Wednesday, there was mixed response after the FDA posted an analysis that showed Amevive had some effectiveness treating psoriasis but also described two "serious adverse events" from patients who took the drug in clinical trials. Investors initially bid Biogen shares down nearly 6 percent after the analysis was posted, but the stock recovered and closed down $1.12, or 3 percent, at $40.36 on the Nasdaq Stock Market. "You need to have a flawless efficacy kind of review with a little more muted safety language than I saw," said SunTrust analyst Dr. Martin Auster. "Overall that makes me incrementally bearish." The close attention on such a hearing is somewhat unusual. The FDA advisory panel may not even make a recommendation, and if it does, it would not bind the agency. Renaud said earlier Wednesday that investors already had built worries the drug may not be approved into Biogen's stock price, which has fallen from more than $60 a share late last year. Biogen downplayed the meeting. "Biogen believes that Amevive is an approvable drug that has value, but we also see this as a continued step in the process of review and approval for the FDA," spokeswoman Kathleen O'Donnell said. She declined to comment on the report posted by FDA staff. Some think Amevive may become the latest high profile drug development setback. In March, the FDA rejected an allergy drug made by Marlboro based Sepracor, cutting the company's stock value in half in a day. Shares of Emisphere Technologies Inc. also lost half their value earlier this month after the company stopped development of heparin, a blood thinning drug. Dendreon Corp., Cubist Pharmaceuticals Inc. and Inspire Pharmaceuticals Inc. also have had setbacks recently. Most famously, the FDA last year refused to accept ImClone Systems' application for its cancer drug, Erbitux, saying clinical data were inadequate. Those and other scares have overshadowed some successes and helped drive the American Stock Exchange Biotechnology Index down about 20 percent from its peak this year. "You go to a good restaurant and you tell four people, you go to a bad restaurant you tell 11," says Dr. Mark Monane, biotech equity analyst at Needham and Co. in New York. Some analysts think the FDA is becoming more cautious; others insist the FDA is applying the same standards but that profit pressed drug developers are more aggressively pushing products before they're ready. The FDA is also seeing new kinds of drugs: fewer products that mimic others in an attempt to steal market share, and more of the novel, advanced drugs that tackle more complex problems but are also less well understood, experts say. "Novel is promising, but novel is also uncertain and unknown, and therefore by definition riskier," says Dr. Joseph Zammit Lucia, president of Cambridge Pharma Consultancy. About 4.5 million people nationwide suffer from the psoriasis, according to a study released earlier this month by the National Psoriasis Foundation, with 1.5 million suffering severe effects. It occurs when immune system cells send faulty signals causing skin cells to regenerate too quickly and build up into red, scaly patches. Many current treatments can have dangerous side effects. Biogen says Amevive, which inhibits the activation of the misfiring immune system cells, showed no side effects in clinical trials. And it hopes the drug could be useful in other autoimmune disorders, including rheumatoid arthritis, Crohn's disease and multiple sclerosis. A number of competitors, including Genentech, are also working on treatments for the disease. Genentech's Xanelim has completed the last stage of human trials required before seeking FDA approval.

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