To: twt who wrote (828 ) 1/5/1999 8:34:00 AM From: jopawa Read Replies (1) | Respond to of 2539
This does indeed give MTC a head start on MRK. The only big potential problem is if MRK gets no GI labeling instructions. Otherwise it is what we expected, a battle between the giants, PFE v. MRK. John Monday January 4, 4:47 pm Eastern Time Monsanto to start shipping Celebrex within 10 days (Adds details in paragraphs 5-8, 10, 13, byline; updates stock price) By Emily Kaiser CHICAGO, Jan 4 (Reuters) - Monsanto Co. (NYSE:MTC - news) said Monday it would begin shipping its newly approved arthritis drug Celebrex to pharmacies within 10 days, making it the first to market a new line of drugs that are designed to treat arthritis pain without potentially deadly side effects. Celebrex, which received U.S. Food and Drug Administration approval last Thursday for the treatment of rheumatoid and osteoarthritis, will cost patients on average about $2.42 a day, comparable with other treatments currently available, Monsanto said in a teleconference monitored in Chicago. ''We believe that Celebrex will be the biggest single innovation in the broad treatment of arthritis symptoms since the widespread adoption by doctors of prescription agents known as non-steroidal anti-inflammatory drugs, or NSAIDS, more than decades ago,'' said Richard De Schutter, vice chairman of St. Louis-based Monsanto and chief executive of Monsanto's Searle pharmaceutical unit. Celebrex is the first in a new class of drugs known as COX-2 inhibitors. They are designed to work as well as other analgesics such as aspirin, ibuprofen and naproxen, but without side effects such as ulcers and gastrointestinal bleeding. The drugs block an enzyme known as cycloozygenase, or 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 suppressing COX-1 may lead to the stomach damage caused by NSAIDS. Monsanto, which makes a diversified line of agricultural, nutrition and pharmaceutical products, said more than 100,000 Americans are hospitalized each year from such stomach damage, and as many as 16,500 die. Even so, the FDA has been not convinced that Celebrex is easier on the stomach than aspirin and other drugs. The FDA said last Thursday that additional studies of ''many thousands of patients'' would be needed to see whether Celebrex actually causes fewer serious gastrointestinal complications than other NSAIDS. Until such studies are done, Celebrex will carry a label advising patients taking the drug to be alert for ulcers and bleeding than can occur with or without warning. Monsanto said it was confident it will get approval for a labeling change as more patients take the drug and their results are tabulated and presented to the FDA. While Monsanto's drug is the first to obtain FDA approval, other companies are working on similar products. Merck & Co. (NYSE:MRK - news), the largest U.S. pharmaceutical company, is seeking FDA approval for its pain and osteoarthritis drug Vioxx. SmithKline Beecham Plc (quote from Yahoo! UK & Ireland: SB.L) and American Home Products Corp.'s (NYSE:AHP - news) Wyeth-Ayerst unit make COX-2 inhibitors that are preferential, meaning they do not completely block the enzyme. Analysts have said the market for Celebrex is huge, with potential sales of $1 billion in the first year in the United States alone, which has more than 16 million rheumatoid and osteoarthritis sufferers. Monsanto and co-marketer Pfizer Inc. (NYSE:PFE - news) will begin shipping Celebrex to wholesalers and pharmacies within 10 days. By mid-February, the drug should be available in virtually all retail pharmacies, Monsanto said. Monsanto said it would fill prescriptions free of cost for indigent patients without health insurance through a Searle foundation that has donated more than $100 million of its products to date. Shares of Monsanto closed up 44 cents at $47.94 on the New York Stock Exchange trading.