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Biotech / Medical : GUMM - Eliminate the Common Cold -- Ignore unavailable to you. Want to Upgrade?

To: Mike M who wrote (4115)	3/19/2002 10:15:50 PM
From: Mike M	Respond to of 5582

VPHM...Panel rejection without the company spin: *Cold drug not ready for approval, US panel says* By Lisa Richwine GAITHERSBURG, Md., March 19 (Reuters) - A drug that treats the common cold by attacking its cause, rather than just symptoms, suffered a setback Tuesday as U.S. advisers unanimously said regulators should not approve the medicine. Picovir, a pill made by ViroPharma Inc <VPHM.O> and co-developed with Aventis SA <AVEP.PA> <AVE.N>, is the first medicine to strike viruses responsible for more than half of the 1 billion colds that afflict Americans each year. Over-the-counter remedies only mask symptoms such as coughing and a runny nose. Saying they were not yet assured of Picovir's safety, members of a U.S. Food and Drug Administration (FDA) advisory committee urged the agency to reject ViroPharma's application to sell the drug in the United States. The FDA usually follows its panels' advice. Panel members said Picovir produced a modest benefit in some patients. In clinical trials, patients' colds cleared up about a day faster on average than with a placebo. Members said they were not convinced, however, that the drug was safe enough to treat an illness that usually is just a nuisance and not life-threatening. "I have not seen adequate (data) from my point of view to conclude this drug is safe as we anticipate it will be used," said Dr. Brian Wong, a panel member. ViroPharma executives said they would meet with FDA officials to discuss what further information the company needs to convince regulators to clear the drug. Mark McKinlay, a ViroPharma vice president, said studies underway may be able to answer many questions the panel raised. "This drug is not dead," McKinlay told reporters after the panel vote. One analyst said the panel's rejection and list of concerns put Picovir at least a year away from getting on the market. "Ultimately, is the drug approvable? Yes, but you have to establish (with the FDA) how many hoops do you have to jump through," said Mark Augustine, an industry analyst for U.S. Bancorp Piper Jaffray. On safety, panel members worried that the drug may stimulate development of resistant cold germs. They also were concerned that Picovir may stop oral contraceptives from working, creating a risk of unintended pregnancies, or reduce the effectiveness of other medicines. Patients need to start taking Picovir within 24 hours after symptoms start. Treatment lasts five days, and the drug must be taken with food three times a day. If approved, Picovir would be available by prescription only. The drug did not help smokers. Picovir targets picornaviruses, the viruses that cause more than half of all colds, and up to 80 percent in the peak spring and fall seasons. Doctors have no quick way to test which colds are caused by picornaviruses to identify who may benefit from Picovir. Picovir works by sliding into a pocket on the surface of picornaviruses. By occupying the pocket, Picovir prevents the virus from copying itself and infecting healthy cells. "The development of the first antiviral drug to treat the predominant cause of the common cold is a landmark development in the history of anti-infectives," Dr. Ellen Cooper, a ViroPharma vice president, told the FDA panel. ViroPharma is based in Exton, Pennsylvania. Trading in ViroPharma shares was halted on Tuesday. They last closed at $13.41 on March 18. 17:50 03-19-02