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

To: John F Beule who wrote (637)	12/1/1998 9:24:00 AM
From: jopawa	Read Replies (1) \| Respond to of 2539

More articles for today's FDA meeting. John Tuesday December 1 2:19 AM ET FDA Advisers Take A Look At New ''Super Aspirin'' By Maggie Fox, Health and Science Correspondent SILVER SPRING, Md. (Reuters) - The first of new class of painkillers known as COX-2 inhibitors goes up for consideration Tuesday by doctors who advise the U.S. Food and Drug Administration. If approved, Celebrex, known generically as celecoxib, could become a blockbuster drug with sales of more than $1 billion a year in the United States alone, analysts said. The drug offers promise as a treatment, such as for arthritis pain, that would be as effective as aspirin and other analgesics but without their painful and potentially fatal side-effects such as ulcers and stomach bleeding. Monsanto Co. (NYSE:MTC - news)'s G.D. Searle drug unit, which makes Celebrex, says several trials have shown it does work as well as current painkillers without the drawbacks. But the FDA advisers have been cautious about such claims, and rival drugmakers plan to tell the committee that the action of COX-2 inhibitors may not be as simple as has been believed. COX-2 inhibitors are meant to be 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. There are two versions -- COX-1 and COX-2. NSAIDS work against both kinds. 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. Makers of the COX-2 inhibitors say it is produced mostly in response to trauma, and drugs that affect only COX-2 should be more safe and effective than NSAIDS. COX-2 is responsible for inflammation, while COX-1 helps in blood clotting. COX-2 is elevated in most colon cancer cells, something that has made scientists look to it as a potential cancer treatment. Tuesday, however, the question is whether COX-2 inhibitors should be approved for use in treating arthritis. Of 13 million Americans who take traditional drugs to treat arthritis pain, 100,000 are hospitalized each year from complications such as ulcers, bleeding and small internal perforations. An estimated 8,000 to 10,000 die. Searle says 16,500 people die in the United States alone from the complications of NSAIDS. So demand is high for a safer painkiller. But last March the FDA advisory panel said it was not convinced the COX-2 inhibitors were indeed safer and better and recommended more tests. It said the makers should, for instance, do an endoscopic exam of volunteers, using a tiny camera to examine their stomach lining. Searle did just that. It says celecoxib was tested in more than 14,000 people worldwide. One 12-week trial of 1,149 rheumatoid arthritis patients showed that celecoxib in doses of 100 mg, 200 mg and 400 mg twice a day worked as well as the NSAID naproxen at 500 mg twice a day in relieving joint tenderness, pain and swelling. But it caused no significant side effects. ''In (another) key multinational study, celecoxib worked as well as the widely used NSAID diclofenac, but with significantly fewer gastrointestinal complaints and a four-fold reduction in ulcers as detected by endoscopy,'' Searle said in a statement. ''The overall incidences of gastrointestinal complaints (diarrhea, abdominal pain, dyspepsia) were 33 percent higher in the diclofenac group than in the celecoxib group.'' Other trials showed Celebrex did not affect blood clotting -- something NSAIDS are known to do. In fact, aspirin is often prescribed to prevent heart attack and stroke. SmithKline Beecham and American Home Products unit Wyeth-Ayerst already sell COX-2 inhibitors that are preferential, which means they do not completely block the enzyme. They plan to argue that attacking inflammation may not be the best way to fight arthritis pain, and that COX-2 may also be important to basic cell functions. The FDA is not required to follow its committee's advice but usually does. Tuesday's decision is crucial to drug makers seeking a piece of the $5 to $12 billion market for over-the-counter and prescription NSAIDS. Pfizer, which will market Celebrex if it is approved, is hiring 1,100 extra sales people. Analysts say the drug would hit the market in the first quarter of 1999 and might sell $1 billion worth in its first year in the United States alone, double that globally.