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To: John F Beule who wrote (740)	12/9/1998 2:53:00 PM
From: Anthony Wong	Respond to of 2539

Merck 'Optimistic' About Quick Regulatory Review of Vioxx Bloomberg News December 9, 1998, 2:13 p.m. ET Merck 'Optimistic' About Quick Regulatory Review of Vioxx Whitehouse Station, New Jersey, Dec. 9 (Bloomberg) -- Merck & Co., the world's biggest drugmaker, said it is optimistic about the changes of getting quick regulatory review of its experimental painkiller Vioxx. Merck also disclosed for the first time that Vioxx is statistically no more likely to cause stomach ulcers than a placebo, or sugar pill. That finding is important because Vioxx is likely to be prescribed for long-term use in patients suffering from arthritis, who risk developing ulcers when they use existing painkillers. Merck shares rose 11/16 to 159 3/8. Merck told analysts that after three months, 7.3 percent of patients on placebo had ulcers, compared to 4.7 percent of those who received a 25 milligram daily dose of Vioxx and 8.1 percent of those who received 50 milligrams. By comparison, 28.5 percent of those treated with the painkiller ibuprofen developed ulcers. Merck presented the research on Vioxx at its analyst meeting in Whitehouse Station, New Jersey. Edward Scolnick, president of Merck's research laboratories, also said he was ''optimistic'' that the U.S. Food and Drug Administration would grant Merck expedited review of Vioxx. Merck submitted its U.S. Food and Drug Administration application for Vioxx in November. Merck is looking to Vioxx to offset the expected loss of patent by 2001 on four drugs with combined 1997 sales of $3.5 billion. Rival Monsanto Co.'s Celebrex is expected to be the first of a new class of painkillers, the Cox-2 drugs. These appear to treat pain and swelling without the side effects of existing painkillers, which can cause stomach bleeding. Vioxx and Celebrex are each expected to have annual sales of more than $1 billion. If Merck wins accelerated review of Vioxx, it could be introduced about six months after Celebrex. If not, it could follow by about a year. --Kerry Dooley in Whitehouse Station through the Washington news.com

To: John F Beule who wrote (740)	12/9/1998 4:24:00 PM
From: Anthony Wong	Read Replies (1) \| Respond to of 2539

NDA for Vioxx submitted to FDA on Nov. 23..around 6 months behind Celebrex, even if Vioxx is given priority review. Excerpt from Merck's new release: The company also revealed new data on VIOXX™ (rofecoxib) -- its once- daily, anti-inflammatory COX-2-specific inhibitor for the treatment of the signs and symptoms of osteoarthritis and the relief of pain -- and confirmed it had submitted a New Drug Application to the U.S. Food and Drug Administration on November 23. Merck expects to have filed similar regulatory applications worldwide by the end of the year. News Release - New Products to Drive Revenue and Earnings Growth, Merck Tells Analysts; New Data Released on Investigational Medicine for Osteoarthritis and Pain biz.yahoo.com