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

To: John F Beule who wrote (627)	11/30/1998 8:47:00 AM
From: jopawa	Respond to of 2539

Monday November 30 12:18 AM ET FDA Advisers To Consider First Of New Pain Drugs By Alicia Ault WASHINGTON (Reuters) - A drug for treatment of arthritis pain, the first of a widely anticipated group of new pain-relieving drugs, goes before a Food and Drug Administration (FDA) advisory panel this week. The drug, Celebrex, made by Monsanto Co. (NYSE:MTC - news) unit G.D. Searle, is in a class of drugs known as COX-2 inhibitors that should be better suited for long-term use because they do not attack the stomach lining like other nonsteroidal anti-inflammatories (NSAIDS) such as aspirin, ibuprofen or naproxen. An estimated 16 million Americans suffer from osteoarthritis, the degenerative disease of the joints that affects virtually everyone over the age of 75. At the advisory meeting Tuesday, Celebrex might also be recommended for the early stages of rheumatoid arthritis, an autoimmune disease in which the body attacks its own joint tissues that affects about 1 percent of the population. The FDA is not bound by the advice of its advisory committees but usually follows their recommendations. The market for such drugs looks huge as the population ages. ''I think $3 (billion) to $4 billion a year is almost a given,'' independent drug industry analyst Hemant Shah told Reuters. Merck and Co. Inc. has submitted a similar drug called Vioxx for FDA approval. Searle plans to co-market Celebrex with Pfizer Inc. (NYSE:PFE - news) COX-2 drugs hold the potential to curb hospitalizations and deaths in people at highest risk for gastrointestinal problems, Lee Simon, a rheumatologist and professor of medicine at Harvard Medical School, said. Complications such as ulcers and stomach perforations cause 7,000 to 20,000 deaths a year, according to Stanford University researchers. Sold by prescription and over the counter, NSAIDS are taken by at least 13 million Americans for arthritis. ''These new drugs are a light-year development forward from a safety point of view,'' Simon, who has been an investigator for several Celebrex studies, added. Simon said COX-2s will also be important for patients who need to have surgery. Often they have to stop taking traditional anti-inflammatory drugs up to two weeks prior or just after surgery because they can cause bleeding. COX-2 inhibitors affect cyclooxygenase-2, an enzyme made by the body in response to pain or trauma. When COX-2 is released, it triggers the production of prostaglandin hormones that cause swelling and inflammation. The drugs do not block COX-2 release, but do reduce the amount of prostaglandin being made. But detailed clinical data on Celebrex has not yet been published, and some researchers still have concerns about COX-2 drugs. ''I will predict these won't be safer in patients with intrinsic kidney disease,'' Harvard's Simon said. At an FDA meeting on COX-2 drugs in March, FDA advisers said they wanted more data on the drugs' effects on the kidney, and also on bone, fertility, and mental performance. But drug industry analysts think Celebrex is destined for approval. ''The downside is going to be price,'' Hambrecht & Quist analyst Alex Zisson said. With treatment expected to cost $2-$4 a day, Zisson thinks first year sales may hit $300-400 million, but final estimates will depend on whether health insurers decide on strict limits for who gets the new drugs, according to Zisson. The FDA advisers will also have a say in which patients will best benefit. ''This shouldn't be used for a headache, this should be used in patients on long-term therapy for arthritis,'' Simon said.

To: John F Beule who wrote (627)	11/30/1998 8:50:00 AM
From: jopawa	Respond to of 2539

Several links. biz.yahoo.com biz.yahoo.com biz.yahoo.com All three concerning the DeKalb/Monsanto tango. John

To: John F Beule who wrote (627)	11/30/1998 9:27:00 AM
From: bob wallace	Respond to of 2539

John Thanks for posting this - Bob Wallace

To: John F Beule who wrote (627)	12/1/1998 9:14:00 AM
From: John F Beule	Read Replies (1) \| Respond to of 2539

Well, here's to hoping the FDA agrees with all us longs! I really don't believe yesterday's price is reflectant on potential approval, I believe it has seen recent strength due to the fact that mgmt is boldly moving ahead on their way to wanting to become a premier player in the life/sciences field. With the massive shares outstanding tho, if Celebrex is approved, we will see maybe 10% on the upside, maybe more due to the recent offering to "new" shareholders at $40. Analysts will upgrade to protect their clients. I see downside being greater (maybe 20%) due to the fact that MTC needs to pay off debt, and analysts are looking at this approval as MTC's gravy train to get them where they need to be financially. I wonder who has more at risk, PZE or MTC in todays decision? fingers are crossed....