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Biotech / Medical : Monsanto Co. -- Ignore unavailable to you. Want to Upgrade?

To: LFQ who wrote (687)	12/2/1998 8:10:00 AM
From: John F Beule	Respond to of 2539

The bottom line: ""But even if Celebrex isn't as good or better than other painkillers, experts theorized it still would sell if proved safer. So Searle gave 4,700 patients endoscopies -- snaking a tube into their stomachs to see if ulcers were forming even before patients experienced symptoms. Some 25 percent to 40 percent of patients taking ibuprofen or naproxen showed these mini-ulcers, vs. 5 percent to 10 percent of Celebrex patients. " Going long...

To: LFQ who wrote (687)	12/2/1998 8:50:00 AM
From: Henry Niman	Respond to of 2539

Today's WSJ is reporting that the advisory committee voted NOT to classify Celebrex as a new class of drugs. Details linked to the COX-2 Inhibitor table on the New Therapeutics page at webf2179.ntx.net (the domain name transfer to this site is propagating through the internet and the new site should be accessable with biocognizance.com within 24 hours).

To: LFQ who wrote (687)	12/2/1998 1:21:00 PM
From: Anthony Wong	Respond to of 2539

LFQ & Curtis, thanks for your clarification...most helpful.<eom> Anthony

To: LFQ who wrote (687)	12/2/1998 1:51:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 2539

St. Louis Post-Dispatch: Monsanto arthritis drug gets approval of FDA panel Wednesday, December 2, 1998 By Yuki Noguchi Post-Dispatch Washington Bureau SILVER SPRING, Md. -- A federal advisory panel unanimously recommended approval Tuesday for Celebrex, the drug Monsanto Co. has developed for treatment of osteoarthritis and rheumatoid arthritis. For 40 million arthritis sufferers, one in six Americans, the advent of Celebrex and similar drugs may mean an option to the anti-inflammatory drugs now commonly used for arthritis that often bring side effects like ulcers and stomach bleeding. Analysts predict the drug, from Monsanto subsidiary G.D. Searle & Co., will be on the market early next year, and may generate annual sales of $1 billion. The advisory panel to the Food and Drug Administration gave Searle virtually everything it sought for the drug, to be sold by prescription only: * The panel accepted Searle's claim that Celebrex, taken once a day, is effective for the treatment of osteoarthritis. * The panel recommended that the FDA allow Searle to modify the warning label the agency now requires for nonsteroidal anti-inflammatory drugs. Searle's clinical studies show fewer gastrointestinal side effects from Celebrex than from such anti-inflammatory drugs now on the market, such as naproxen. * The panel hasn't approved Searle's request to market Celebrex for "general management of acute pain." That would have vastly increased its sales. The advisory committee's decisions are not binding, but the FDA usually follows its actions, especially when its conclusion is unanimous. The FDA will make a final determination by the end of the year. "We're pretty satisfied with the outcome of the day," said Phil Needleman, Searle's co-president. He said the panel's support marks "the beginning of an era of smart drugs." Sergio Traversa, an analyst for Mehta Partners, an investment research firm in New York, said Monsanto "got almost everything they were asking for." Searle's announcement that Celebrex is effective as a once-a-day drug makes it comparable with a rival medication, Vioxx, which Merck & Co is developing. Merck applied for FDA review last week, but Vioxx will not reach the market at least until next fall, Traversa said. Then it will have to combat Celebrex, which will be marketed jointly by Searle and Pfizer Inc., he said. "The key point" is what kind of labeling Celebrex will finally get, and whether it will be able to market itself as a general painkiller, Traversa said. Critics on the panel said such a label would, in effect, approve the drug for use against headaches, menstrual cramps and other symptoms for which Searle has not conducted clinical tests for effectiveness. Sidney Wolfe, head of Public Citizen's Health Research Group, said there isn't yet enough evidence to allow Celebrex on the market without the standard warning label. "Purported new classes of drugs such as Celebrex offer not only new mechanisms of action, but also new mechanisms of potential toxicity and the possibility of a new spectrum of adverse events," he said. But members of the panel agreed that the studies on Celebrex showed a low incidence of severe gastrointestinal side effects compared with other nonsteroidal anti-inflammatory drugs. Panel members called for a "conservative," modified warning label that details Searle's clinical findings. Searle's clinical tests of over 13,000 patients showed that the incidence of ulcers and stomach bleeding was about 0.2 percent, compared with almost 4 percent for most NSAIDs. "It would be great" to get approval for the general labeling, said Monsanto spokeswoman Scarlett Foster. "But it will do nothing to slow this drug down." The FDA and Searle officials will discuss other matters, such as Celebrex's effects on the kidneys, and the direction of other clinical tests. The panel said further tests would be needed to determine the long-term effects of the use of Celebrex. Monsanto had announced earlier that the results of clinical studies showing that Celebrex does not interfere with methoxtrate and warfarin, two drugs often prescribed to arthritis patients. Copyright (c) 1998, St. Louis Post-Dispatch stlnet.com