Silicon Investor (SI) -- The First Internet Community

STOCKTALK

We've detected that you're using an ad content blocking browser plug-in or feature. Ads provide a critical source of revenue to the continued operation of Silicon Investor. We ask that you disable ad blocking while on Silicon Investor in the best interests of our community. If you are not using an ad blocker but are still receiving this message, make sure your browser's tracking protection is set to the 'standard' level.

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

To: BigKNY3 who wrote (6592)	12/31/1998 7:07:00 PM
From: BigKNY3	Read Replies (1) \| Respond to of 9523

FOCUS-Monsanto arthritis drug gets FDA approval (Adds Monsanto, analysts' comments grafs 4-6, 10-15, byline) By Emily Kaiser CHICAGO, Dec 31 (Reuters) - Life sciences firm Monsanto Co. said on Thursday the U.S. Food and Drug Administration approved its drug Celebrex to treat rheumatoid arthritis and osteoarthritis, putting Monsanto first in line to begin tapping the estimated $7 billion market. 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 potentially fatal side effects. 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 arthritis sufferers. "This will be one of the most important new products for the pharmaceutical industry in 1999," said Viren Mehta, of the New York research firm Mehta Partners. "This has a potential of meeting a significant need because existing drugs offer variety, but also a common theme of potentially serious side effects," Mehta said. Analysts said the approval, while widely expected, was important for Monsanto because other drug companies have similar products in the works. Merck & Co. , the largest U.S. pharmaceutical company, is seeking FDA approval for its pain and osteoarthritis drug Vioxx. The FDA said Celebrex was found to be an effective arthritis treatment in clinical trials that included 2,100 patients with rheumatoid arthritis and 4,200 patients with osteoarthritis. Osteoarthritis is the most common form of arthritis affecting the elderly, while rheumatoid arthritis is an auto-immune disease caused when the body's immune system mistakenly turns against the joints. Both cause painful and swollen joints. The agency said studies showed patients taking Celebrex had a substantially lower risk of ulcers than those who took non-steroidal anti-inflammatory drugs (NSAIDS) such as aspirin or ibuprofen, existing treatments which can cause ulcers. However, the FDA said 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 drugs to be alert for ulceration and bleeding that can occur with or without warning, the FDA said in a statement. Richard De Schutter, vice chairman of St. Louis-based Monsanto and chief executive officer of Monsanto's Searle pharmaceutical unit, said the company hopes to obtain more favorable labeling as it continues to gather data and present findings to the FDA. Celebrex should be on the market in February, De Schutter told Reuters in a telephone interview. Monsanto will announce pricing on Monday, but said it will be comparable to other branded treatments that cost about $2.40 to $3.00 a day. De Schutter said 100,000 people are hospitalized each year with side effects such as ulcers and bleeding related to arthritis treatments, and 16,500 die from those side effects. Mehta, the research partner with Mehta Partners, said that for now, Monsanto has the edge over the competition because it will be first on the shelves with its drug. But he added that the market is big enough for Monsanto, Merck and others. "This is a $7 billion category," he said. "There is ample room for several participants." Monsanto will co-market the drug with Pfizer Inc. . Terms of the marketing agreement have not been disclosed. Shares of Monsanto were up $1.8125 at $48.00 in late New York Stock Exchange trading.