To: twt who wrote (593 ) 11/23/1998 7:29:00 PM From: Anthony Wong Respond to of 2539
11/23 18:00 Merck Submits New Drug Application for Vioxx(TM), An Investigational <MRK.N> Merck Submits New Drug Application for Vioxx(TM), An Investigational COX-2 Specific Inhibitor WEST POINT, Pa., Nov. 23 /PRNewswire/ -- Merck & Co., Inc. (NYSE: MRK) today announced it has submitted to the U.S. Food and Drug Administration (FDA) a New Drug Application for Vioxx(TM) (rofecoxib), an investigational once-daily, anti-inflammatory COX-2 specific inhibitor for the treatment of osteoarthritis and pain. COX-2 specific inhibitors are being studied to determine whether the apparent difference in how they work may result in fewer certain serious gastrointestinal side effects than nonsteroidal anti-inflammatory drugs, which are medications that are currently available for the treatment of osteoarthritis and pain. Merck's application includes results from 68 studies in nearly 10,000 patients that evaluated Vioxx for the treatment of the signs and symptoms of osteoarthritis and for the relief of pain. Within the next 60 days, the FDA will determine whether or not it will accept Merck's application as submitted. Merck expects to begin to file similar regulatory applications for Vioxx, worldwide, by the end of the year. Merck scientists have contributed to many important scientific discoveries in the treatment of pain and inflammation of arthritis over the past sixty years. Merck & Co., Inc. is a global research-driven pharmaceutical company that discovers, develops, manufactures and markets a broad range of human and animal health products, directly and through its joint ventures, and provides pharmaceutical benefit services through Merck-Medco Managed Care. Vioxx(TM) is the Merck trademark for rofecoxib. SOURCE Merck & Co., Inc. -0- 11/23/98 /CONTACT: Media, Kyra Lindemann, 215-652-6931, or Investor, Laura Jordan, 908-423-5185, both for Merck/ -- PHM051 -- 8859 11/23/98 17:30 EST prnewswire.com Copyright PR Newswire 1998. All rights reserved.moneynet.com @NEWS-P2&Index=1&HeadlineURL=../News/NewsHeadlines.asp&DISABLE_FORM=&NAVSVC=News\Company