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

To: Anthony Wong who wrote (7825)	6/9/1999 1:42:00 PM
From: The Ox	Read Replies (1) \| Respond to of 9523

Searle/Pfizer Challenge Merck Data Comparing Celebrex(TM) and Vioxx; Study of Competing COX-2 is Without Scientific Merit Inequivalent Dose Comparison Results in Erroneous Conclusions CHICAGO, June 9 /PRNewswire/ -- G. D. Searle & Co. and Pfizer Inc today refuted claims by Merck & Co. about the pain-relieving benefits of Merck's COX-2 inhibitor because conclusions were drawn from a poorly designed study. Searle and Pfizer, which co-promote Celebrex(TM) (celecoxib capsules), asserted that Merck's conclusions were erroneous because the company used inequivalent doses when comparing Celebrex with Merck's Vioxx (rofecoxib). Limited data on the Merck study, a single-dose study in acute dental pain, was made available during a medical meeting in Scotland this week. The Merck study compared the lowest recommended dose for Celebrex (200 mg per day) with the highest possible dose of Vioxx (50 mg per day). Searle and Pfizer believe these data are misleading because the maximum recommended daily dose of Celebrex in the United States is 400 mg. "A more appropriately designed comparator trial requires the use of equivalent effective doses of both agents," said Searle Co-President and Monsanto Chief Scientist Philip Needleman, Ph.D. "The reported Merck trial did not meet that scientific criterion." The 50 mg dose of Vioxx is not approved for use in the United Kingdom, where the data were released. Prescribing information in the United States indicates that the 50 mg dose of Vioxx carries a higher incidence of gastrointestinal, renal and cardiovascular side effects compared to the lower 25 mg dose. Further, according to the approved prescribing information in the United Kingdom, patients should not receive more than a 25 mg dose of Vioxx per day because "the risks of (experiencing) gastrointestinal symptoms, edema or hypertension are increased." Dr. Needleman noted surprise that the information was released in the UK, where neither product is approved for post-surgical dental pain, which is the subject of the comparator trial. Celebrex is approved in the United States for the treatment of the signs and symptoms associated with osteoarthritis and adult rheumatoid arthritis. It is not currently licensed for sale in the European Union. Searle, a global leader in arthritis products and educational programs, is the pharmaceutical sector of Monsanto Company (NYSE: MTC). Searle develops, produces and markets prescription pharmaceuticals, including major products to treat arthritis, cardiovascular disease, cancer and its complications and insomnia, and to promote women's health. For more information on Searle, access searlehealthnet.com. As a life sciences company, Monsanto is committed to finding solutions to the growing global needs for food and health by sharing common forms of science and technology among agriculture, nutrition and health. In 1998, Monsanto reported sales of $8.6 billion and invested approximately $1 billion in research and development. Pfizer Inc (NYSE: PFE) is a research-based, global pharmaceutical company that discovers, develops, manufactures and markets innovative medicines for humans and animals. The company reported revenues of more than $13.5 billion in 1998 and spent more than $2.2 billion on research and development. In 1999, Pfizer celebrates its 150th anniversary. For more information on Pfizer, access pfizer.com. SOURCE G.D. Searle & Co. and Pfizer Inc CO: G.D. Searle & Co.; Pfizer Inc ST: Illinois IN: MTC SU: 06/09/99 12:54 EDT prnewswire.com