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Biotech / Medical : PFE (Pfizer) How high will it go? -- Ignore unavailable to you. Want to Upgrade?

To: marc ultra who wrote (712)	3/25/1998 6:37:00 PM
From: Brian Malloy	Respond to of 9523

Current NSAID work as COXI and COXII inhibitors COX II is primarily expressed in inflammatory states while COX I is basically always expressed. Pfizer's new drug as well as Merck's new drug specifically target the COXII receptor. Thus the drug will be found in higher concentrations in locations with inflammation (as with arthritis in a joint) rather than in the nonspecific mucosal lining. Thus the nasty little GI problems are dispensed with and the patient gets better pain relief. The market for the COXII class inhibitors from what I have read is pegged in excess of 1B. It will be a huge money maker and just in time to help the Boomers <ggg>

To: marc ultra who wrote (712)	3/25/1998 8:37:00 PM
From: Dave	Respond to of 9523

COX-2's are definitely the way to go in patients at risk for NSAID-related gastropathy and renal side effects. Unfortunately there may be a delay in bringing these products to market. See the following press release off of yahoo today. Tuesday March 24, 8:25 pm Eastern Time FDA suggests more study of new arthritis drugs By Alicia Ault GAITHERSBURG, Md., March 24 (Reuters) - More tests are needed to ensure that a new class of painkillers known as COX-2 inhibitors are safer or better than existing drugs, advisers to the U.S. Food and Drug Administration said on Tuesday. COX-2 inhibitors are an advance on drugs such as aspirin and ibuprofen, which belong to a class known as non-steroidal anti-inflammatory drugs (NSAIDS). NSAIDS work against an enzyme known as cyclooxygenase, COX for short, which triggers pain and inflammation. But there are two versions of COX -- COX-1 and COX-2. NSAIDS work against both kinds. Recent research has shown that COX-1 is present in all tissues and is important in a variety of functions. Suppressing its production may lead to the stomach damage caused by NSAIDS. COX-2 seems to be produced mostly in response to trauma, and drugs that affect only COX-2 should be more safe and effective than NSAIDS. But the panel of experts from across the country who advise the FDA on such matters said they were not convinced. Monsanto unit Searle (MTC - news) and Merck & Co. (MRK - news) are expected to seek FDA approval for their COX-2 inhibitors later this year. The panelists said COX-2 studies should be compared to a placebo -- a dummy pill -- and to at least one active drug in treating rheumatoid and osteoarthritis. Trials should also include endoscopic tests -- sticking a tiny camera into the stomach -- to look for ulcers, and should study potential kidney, bone and reproductive toxicity. The committee's suggestions are crucial to drug makers seeking to get a piece of the $5 billion market for over-the-counter and prescription NSAIDS. Better safety would provide an edge. Of 13 million Americans who take the drugs to treat arthritis pain, 100,000 are hospitalized each year from complications caused by the drugs, such as ulcers, bleeding, and small perforations, and 8,000 to 10,000 die. The panel recommendations could delay Searle and Merck, which have already completed most of the work on pivotal studies of their drugs, Celebra (celecoxib) and Vioxx (MK-966). Michael Weintraub, director of the FDA's anti-inflammatory drugs division, said COX-2 makers ''are going to have to pay attention to the things the committee is recommending.'' And he added, drug makers will have to provide firm evidence of safety. SmithKline Beecham (quote from Yahoo! UK & Ireland: SB.L) and American Home Products unit Wyeth-Ayerst (AHP - news) already sell COX-2 inhibitors that are ''preferential,'' that is they don't completely block the enzyme. Robert Palmer, SmithKline rheumatology director, said that made its drug, Relafen (nabumetone) safer. But the FDA has not allowed either company to claim a safety edge. And on Mar. 13, the agency sent a letter to SmithKline warning the drug maker it was falsely claiming superiority in its Relafen promotions. -------------------------------------------------------------------------------- More Quotes and News: American Home Products Corp (NYSE:AHP - news) Merck & Co Inc (NYSE:MRK - news) Monsanto Co (NYSE:MTC - news) Related News Categories: health