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

To: BigKNY3 who wrote (6462)	12/9/1998 11:41:00 PM
From: BigKNY3	Respond to of 9523

Dow Jones Newswires -- December 9, 1998 Merck Says Vioxx Data Supports Expected Safety Profile By Melanie Trottman WHITEHOUSE STATION, N.J. (Dow Jones)--Vioxx, Merck & Co.'s (MRK) once-daily anti-inflammatory drug currently under Food and Drug Administration review, caused a lower rate of ulcers in osteoarthritis patients than did ibuprofen, the company said. That findings was part of two six-month safety studies filed with the FDA Nov. 23 on Vioxx, a COX-2 inhibitor, to treat osteoarthritis, the most common form of arthritis, and pain. The data are particularly meaningful, Merck said, because they "fully support" the company's expected safety profile for Vioxx. The findings could also make the drug a more appealing option than existing treatments like ibuprofen, which cause gastrointestinal side effects in many patients. "Vioxx has clearly lived up to our product expectations," said Edward Scolnick, president of Merck Research Laboratories, who presented the data at Merck's annual business briefing here Wednesday. The studies evaluated Vioxx to determine whether the drug caused fewer serious gastrointestinal side effects than nonsteroidal anti-inflammatory drugs, the most commonly used therapy available to treat osteoarthritis and pain. (Ibuprofen is a nonsteroidal anti-inflammatory drug.) The side effects of nonsteroidals in arthritis patients can be severe and can even lead to death in certain cases. In the studies, which evaluated 1,427 osteoarthritis patients, the cumulative rate of ulcers for once-daily Vioxx doses was significantly less than the rate on ibuprofen dosed three times a day, Scolnick said. Vioxx was dosed once daily in 25- and 50-milligram amounts, while ibuprofen was delivered three times daily at doses of 800 milligrams each time. The rate of ulcers in patients on Vioxx was similar to the rate of those on placebo, Scolnick said. Ulcers in patients involved in the study were observed using an endoscope, a medical instrument that allows physicians to view the esophagus, stomach and a small part of the upper intestine. Endoscopies were performed at the start of the study, and at weeks six, 12 and 24. Scolnick also summarized results from two acute pain studies in which Vioxx relieved dental pain and post-orthopedic surgery pain comparable with widely used prescription nonsteroidal anti-inflammatory drugs and was superior to placebo. Merck's second COX-2 entry, a compound called MK-663, is in ongoing Phase IIb studies, Scolnick, president of Merck Research Laboratories, said. The compound is more potent than Vioxx and will begin Phase III trials in mid-1999 for osteoarthritis, rheumatoid arthritis and pain. Merck's substance P compound MK-869, first unveiled at the company's annual business briefing last year for depression and anxiety, will enter Phase III clinical trials in 1999, Scolnick said. The compound is currently in Phase IIb clinical dose ranging trials and demonstrated "excellent tolerability" compared with a selective serotonin re-uptake inhibitor from the leading class of antidepressants, Scolnick said. Scolnick also reviewed other compounds under investigation at Merck Research Labs, including Cansidas, a once-a-day intravenous antifungal compound; MK-826, a once-a-day long-acting antibiotic; VLA-4, an inhaled drug for asthma that Merck has licensed from biotechnology firm Biogen Inc. (BGEN) and an anti-cancer compound that inhibits the activity of the ras protein enzyme involved in pancreatic, colon, lung and breast cancers; and the company's human papillomavirus vaccine. Clinical data for VLA-4 will be available in 1999. Phase IIa efficacy trials are proceeding and the drug has shown good tolerability to date. Scolnick said Merck didn't file with the FDA for Vioxx in rheumatoid arthritis, the most severe form of the disease, because it was concerned with timing and couldn't conduct the safety profiles it thought necessary in time. The company does have plans, however, to at some point file for Vioxx's use to treat rheumatoid arthritis. Phase III studies of the drug for this indication will start in early 1999. Merck is also conducting an ongoing study of Vioxx for the treatment and prevention of Alzheimer's disease and will start a study in 1999 for Vioxx in the prevention of colonic polyps/cancer.