To: Harry Ehrlich who wrote (33 ) 8/24/1998 5:47:00 PM From: Rob C. Respond to of 67
Reason for the pop.... By Kathy Fieweger CHICAGO, Aug. 24 (Reuters) - A new and gentler arthritis pain reliever -- potentially the hottest drug of 1999 -- may hit pharmacies in six to nine months, after the Food and Drug administration said it will review the drug on a priority basis. News that the FDA had granted priority review status to the drug, called Celebra, sent shares of co-developers Monsanto Co. and Pfizer Inc. soaring on the New York Stock Exchange in heavy volume, although Pfizer later turned lower. The initial launch for Celebra should take place in the first quarter of 1999, analysts said, pegging the estimated market for pain and inflammation drugs at about $12 billion. Celebra could sell well over $1 billion annually in the United States, analysts said, potentially reaching nearly double that worldwide. When a drug gets priority status, the FDA will review it within six months, versus the usual 12. Priority status is also reserved for drugs that may make major advances in healthcare. "This is a breakthrough drug," Donaldson, Lufkin and Jenrette analyst William Young said. "Everybody knows it." Celebra, or celecoxib, is the first of a new class of so-called COX-2 inhibitors, which block an enzyme called cyclooxygenase that causes pain and inflammation. Unlike other arthritis remedies, Celebra is touted to have fewer side effects, particularly stomach problems like ulcers and bleeding often caused by non-steroidal anti-inflammatory drugs (NSAIDS). NSAIDS -- including ibuprofen and aspirin -- block COX-2, but they also inhibit COX-1, a related enzyme that protects the lining of the stomach. David Saks, senior drug analyst at Gruntal and Co., said the COX-2 drugs could be in 1999 what Viagra is proving to be this year. About 40 million people suffer from arthritis in the United States, Saks said, adding that the number will only grow as the baby boomer population ages and faces deteriorating health. "The aging of boomers worldwide guarantees demand for this product," he said. G.D. Searle & Co., Monsanto's pharmaceutical unit based in northern Illinois, and New York's Pfizer will develop and sell Celebra in all areas of the world except Japan. Terms of the deal are confidential, although Pfizer has already paid Searle some money. The first use for which Celebra is being reviewed is to treat osteoarthritis and rheumatoid arthritis and for pain management. But the drug could eventually have much wider uses, particularly to treat Alzheimer's disease and colon cancer. According to a research report by Gruntal and Co., Celebra is already in phase II clinical trails for those uses. Edward Jones analyst William Fiala said the FDA's granting the priority status lends credence to the idea that good results from Celebra are already unfolding. Other analysts agreed. "The company (Monsanto) has done very well in preliminary testing," Argus Research analyst James Kelleher said. "There may be many, many applications." Merck and Co. Inc. also has a COX-2 inhibitor in the pipeline, as does privately held German company Boehringer-Mannheim GmbH, but analysts said Celebra is clearly in the lead, time-wise. Merck's Vioxx and Celebra are currently involved in a complex patent dispute that analysts said shows no sign of being resolved as yet. Monsanto shares were up $4.3125 at $61.8125 and Pfizer's were down 68 cents at $105.37. Shares of American Home Products , which is merging with Monsanto, also rose $4.375 to a 52-week high of $57.3125. REUTERS Rtr 16:48 08-24-98 Copyright 1998, Reuters News Service