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To: Anthony Wong who wrote (1036)	11/12/1998 5:31:00 PM
From: Anthony Wong	Respond to of 1722

Monsanto Touts Safety Benefits Of Arthritis Drug Celebrex November 12, 1998 3:43 PM NEW YORK -(Dow Jones)- A leading scientist with Monsanto Co.'s G.D. Searle pharmaceutical division said Thursday that late-stage studies of its arthritis pain drug Celebrex show it "does not cause ulcers." That statement, by G. Steven Geis, Searle's vice president of clinical research, is the company's strongest statement yet on the drug, known generically as celecoxib. Geis and other Searle scientists are scheduled to present the latest clinical data on Celebrex Thursday at the American College of Rheumatology meeting in San Diego. Summarizing the various studies so far on the drug, Geis said, "We have demonstrated efficacy in osteoarthritis and rheumatoid arthritis. The individual studies continue to confirm that adverse events are relatively low." Celebrex belongs to a class of drugs called COX-2 inhibitors. They are intended to help thousands of patients avoid the dangerous, sometimes fatal, bleeding ulcers associated with existing arthritis-pain drugs, known as nonsteroidal anti-inflammatory drugs. If approved by the Food and Drug Administration, Celebrex will be competing with less expensive NSAIDs and rival COX-2 drugs. One such drug in the class is Merck & Co.'s Vioxx. Hemant K. Shah, a drug-industry analyst, has estimated that the market for this new class of drugs could reach $3 billion annually by 2001. Some rheumatologists are concerned that Celebrex and related drugs may prove toxic to the kidneys, but Geis said this hasn't occurred so far. "We don't see any cause for concern," Geis said. There have been, he said, "no weight gain or blood-pressure changes. But it is something that has to be watched." Especially impressive so far, said Geis, is the fact that "the incidence of ulcers with celecoxib is similar to placebo." That fact has been confirmed, he said, with endoscopic data - devices snaked down through the esophagus that enable doctors to see ulcers or confirm that they aren't there. The Phase III tests show no ulcers related to Celebrex, he said, even at "super-therapeutic doses" more than double what patients actually will need to take. In one study, for instance, the incidence of gastroduodenal ulcers was 4% in the Celebrex group and 15% in the group taking an older NSAID called Voltaren. In that study lasting over six months, 655 rheumatoid arthritis patients were randomized to take Celebrex or Voltaren, and their conditions were verified with endoscopic exams. Despite the impressive safety data, its isn't yet clear how managed-care comanies plan to pay for the drugs. The COX-2 drugs are expected to cost several dollars a pill, and insurers might want patients to start off on less expensive, older drugs before moving to the newer ones. However, its very difficult to pinpoint which patients may wind up in a hospital because of a bleeding ulcer caused by the older medication. Copyright (c) 1998 Dow Jones & Company, Inc. All Rights Reserved. smartmoney.com

To: Anthony Wong who wrote (1036)	11/12/1998 5:38:00 PM
From: Anthony Wong	Read Replies (2) \| Respond to of 1722

11/12 15:43 New arthritis drug avoids usual side effects -study By Mark Egan LOS ANGELES, Nov. 12 (Reuters) - The makers of a new anti-inflammatory drug said Thursday its treatment was as effective in treating arthritis as popular drugs like Advil and aspirin while avoiding side effects like ulcers and bleeding. Monsanto Co.'s <MTC.N> G.D. Searle drug unit said trials of its drug Celebrex, known generically as celecoxib, revealed it was equally effective in treating both the most common and severe forms of arthritis while avoiding the common side effects of traditional treatments. Earlier this week, Monsanto rival Merck & Co. <MRK.N> announced results from trials of a similar drug that can provide arthritis relief without the side effects of traditional medications. Monsanto said its phase III trials, usually the last step before seeking regulatory approval for a drug, showed Celebrex was as effective as the popular drug naproxen in treating osteoarthritis and as effective as diclofenac in treating rheumatoid arthritis. The trials also revealed patients taking the traditional drugs were much more likely to suffer from stomach or intestinal ulcers and bleeding than patients taking Celebrex. Osteoarthritis is the most common form of arthritis affecting about 20 million Americans. It is caused by the wearing down of cartilage in the joints and often results in patients needing hip or knee replacement surgery. Rheumatoid arthritis, the most severe form of the disease, affects about 2.5 million Americans and can cripple its victims. "I am thrilled. I've been in this area of research for about 15 years and we have constantly worked on the issue of how can we get drugs to treat arthritis with a safety profile that keeps the patient from harm," Searle vice president of clinical research Dr. Steven Geis told Reuters. "Now we have found out that (Celebrex) is that answer. It has all the advantages of (traditional drugs) but doesn't have that gastrointestinal toxicity," he said. In a 1,000 patient trial, which compared Celebrex with naproxen, patients were tested before the study began to ensure they had no ulcers. At the end of the 12-week trial patients were again tested for ulcers. Among those taking the traditional drug naproxen 26 percent had ulcers compared to just 4 percent for those taking either Celebrex or a placebo. "This test shows Celebrex had a much superior safety profile compared to naproxen," Geis said. Celebrex is is part of a new class of drugs knows as Cox-2 inhibitors. The drug fights pain and inflammation by blocking the so-called Cox-2 enzyme. Commonly available drugs like naproxen, diclofenac, Motrin, Advil and aspirin also inhibit the Cox-2 enzyme, but often cause ulcers and other gastrointestinal side effects by also blocking the Cox-1 enzyme which protects the stomach lining. Doctors estimate that about 76,000 people are admitted to hospitals annually as a result of side effects from anti-inflammatory drugs with about 7,600 deaths each year attributed to the drugs. Researchers claim those problems could be largely eradicated with the use of Cox-2 inhibitors. Results of the trials were presented at the American College of Rheumatology's annual meeting in San Diego. Merck released similar findings on its Cox-2 inhibitor drug, Vioxx, earlier in the week at the San Diego meeting. The two drugs are both expected to be approved by regulators some time in the new year. Searle had originally planned to market its drug under the name Celebra but recently changed the brand name to Celebrex to avoid possible confusion with another unrelated drug. moneynet.com@NEWS-P2&Index=1&HeadlineURL=../News/NewsHeadlines.asp&DISABLE_FORM=&NAVSVC=News\Company