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

To: chirodoc who wrote (697)	12/2/1998 6:25:00 PM
From: John F Beule	Read Replies (3) \| Respond to of 2539

After the issuance of bonds by MTC this week we should see some upward revisions and upward movement. It's good timing, having this bond offering this week, 1: market is in high flux, makes for fast sales of "safer" investments; 2: Celebrex WILL contribute to bottom-line to show increased cash flow to pay off debt, and that's what Moody's et al are interested in when issuing these bonds, this equals fast sales also. I read in an earlier post that MTC's Searle unit was up 26% YOY? Wow, that news got buried in all the talk of Celebrex. The fundementals of MTC are quickly becoming FANTASTIC! Going long.... John

To: chirodoc who wrote (697)	12/2/1998 6:35:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 2539

Washington Post article: washingtonpost.com FDA Panel Backs First of 'Super Aspirins' for Arthritis Inflammation By Justin Gillis Washington Post Staff Writer Wednesday, December 2, 1998; Page A06 An expert panel recommended yesterday that the Food and Drug administration approve a new drug for people suffering from arthritis, the first of a long-awaited class of "super aspirins" that may be useful for many kinds of pain and inflammation. By unanimous vote, the committee of doctors and other experts recommended that the FDA approve the drug, called celecoxib, for sale by prescription for the treatment of osteoarthritis and rheumatoid arthritis, diseases that afflict millions of Americans. But the committee tempered its recommendation by urging that the drug carry some of the same warnings about potential side effects as older inflammatory drugs, including the possibility of damage to the lining of the stomach and small intestine. And the panel declined to endorse use of the drug for acute pain of the sort that follows having a tooth pulled. Several panel members said more studies were needed on the drug's effectiveness for that purpose. The FDA is not required to follow the recommendations of its advisory panels, but usually does and is expected to do so in this case, approving the drug initially for arthritis. The drug would be sold under the brand name Celebrex, according to officials at G.D. Searle & Co., a Monsanto Co. subsidiary that developed the drug. Similar compounds are under development at drug companies around the world. Celebrex targets an enzyme called cyclooxygenase, or COX, which is present in many types of inflammations. So do older drugs like aspirin, Advil and various prescription products. However, in recent years scientists have realized that COX is found in the body in two slightly different forms, dubbed COX-1 and COX-2. Their precise roles are still being studied, but the evidence suggests that COX-1 is more involved in the body's "housekeeping" functions, such as protecting the lining of the digestive tract, while COX-2 is more involved in the pain and inflammation associated with ailments such as arthritis. Older anti-inflammatory drugs work by reducing both forms of COX. Companies are rushing to bring to market highly selective "COX-2 inhibitors" like Celebrex, on the theory that they will be safer. About 100,000 Americans are hospitalized every year for bleeding ulcers and other digestive complications caused by anti-inflammatory medicines. From 10,000 to 20,000 people die each year from taking these drugs. Searle presented studies yesterday showing that the drug was clearly effective at reducing arthritis symptoms such as chronic pain. And Celebrex appeared to have a lower incidence of damage to the digestive tract caused by many common medicines used for pain and arthritis. Searle argued that serious intestinal complications with its drug were close to the "background rate" for people not taking any anti-inflammatory drug. This position has been reflected in many popular accounts of the "super aspirins," which have been portrayed as having no side effects. "It certainly is the impression many people hold," said Robert H. Palmer, group director for rheumatology at SmithKline Beecham, a Searle competitor. But the claim of no side effects was disputed yesterday, with Palmer and other critics arguing that it remains to be seen exactly how serious stomach and intestinal problems will be for those on Celebrex. The FDA panel adopted a middle ground, urging the agency to warn doctors about the potential for serious side effects while alerting them to the Searle studies suggesting the drug is relatively safe. Eventually, panel members said, wide use of the drug should clarify the safety issue. Studies have also shown that Celebrex can cause many of the same rare side effects, such as kidney problems, as other anti-inflammatory drugs. Research is underway to clarify whether and how to use the drug in other conditions. Preliminary evidence is that COX-2 inhibitors may, for instance, be useful in slowing or preventing the onset of Alzheimer's disease and colon cancer. The fate of Celebrex has been closely watched on Wall Street, as millions of people may eventually take COX-2 inhibitors. Shares of Monsanto closed at $43.50, down $1.8125. © Copyright 1998 The Washington Post Company

To: chirodoc who wrote (697)	12/2/1998 9:49:00 PM
From: Anthony Wong	Respond to of 2539

INSIDE THE INDUSTRY - CELEBREX: ARTHRITIS DRUG SCORES FDA ADVISORY PANEL OK 12/02/98 American Health Line A hotly anticipated new osteoarthritis and rheumatoid arthritis drug is on the verge of Food and Drug Administration approval after a positive recommendation yesterday from an advisory panel. The expert panel unanimously approved celecoxib, to be marketed by Monsanto Co.'s G.D. Searle & Co. as Celebrex, the first in a potentially revolutionary new class of painkillers known as COX-2 inhibitors. The Washington Post reports that the panel "tempered its recommendation by urging that the drug carry some of the same warnings about potential side effects" as older painkillers (Gillis, 12/2). Known as COX-1 inhibitors or non-steroidal anti-inflammatory drugs, this class included drugs such as ibuprofen, which can cause stomach lining perforation and bleeding. (Winiarski, USA Today, 12/2). The Post reports that Celebrex was specifically designed to bypass those side effects, which cause 100,000 hospitalizations and up to 20,000 deaths annually (12/2). USA Today reports that "[w]hile FDA scientists acknowledge Celebrex seemed to have fewer gastrointestinal side effects, the FDA must still decide whether the label should warn of possible gastrointestinal problems until further studies can prove otherwise" (12/2). The Post reports the panel "adopted a middle ground, urging the agency to warn doctors about the potential for serious side effects while alerting them to the Searle studies suggesting the drug is relatively safe" (12/2). SHOW ME THE MONEY Wall Street industry analysts were paying exceptionally close attention to yesterday's panel meeting, as the approval of Celebrex -- to be co-marketed by Pfizer Inc. -- is expected to usher in $1 billion in sales of the drug by 2000 and $2 billion by 2001. The Chicago Tribune reports that "one in six Americans will be able to take advantage" of the drug. It will be a highly anticipated and overdue win for Searle, which "hasn't had a drug come through its own pipeline since Monsanto bought the company in 1985," according to J.P. Morgan analyst Donald Carson. However, managed care plans are expected to closely monitor the prescription of the expensive drug, projected to cost $2 to $4 per day. Hambrech & Quist analyst Alex Zisson said, "Managed care companies will reimburse it, but they will try to be very strict that those patients are taking it for chronic therapy. One thing HMOs are worrying about is getting a $4 prescription for Celebrex rather than a 20-cent prescription for ibuprofen" (Japsen, 12/2). Bloomberg/New York Times reports that "Monsanto told the panel that research showed its drug could work when taken once a day," potentially erasing an advantage for Merck & Co., which had touted its COX-2 inhibitor, Vioxx, as a once-a- day drug. Vioxx is several months from FDA approval (12/2). Celebrex could be approved as early as January (USA Today, 12/2). The above is re-posted from BigKNY3's post at PFE thread: Message 6657883