Guest guest Posted March 20, 2002 Report Share Posted March 20, 2002 Merck Delays Key Arthritis Drug March 15, 2002 WHITEHOUSE STATION, N.J., March 15 (Reuters) - U.S. drugmaker Merck & Co. Inc. <MRK> on Friday said it withdrew the original marketing application with U.S. regulators for its arthritis drug Arcoxia, but plans to submit a new application seeking wider use for the medicine. Merck also said it is comfortable with earnings per share estimates in a range of 69 cents to 72 cents for the first quarter, and reaffirmed flat earnings growth forecasts for 2002. For 2003, Merck sees double-digit earnings per share growth. Arcoxia is a follow-up to Merck's hot- selling arthritis drug, Vioxx, which also works by selectively blocking the COX-2 enzyme that has been linked to inflammation. The company last year asked U.S. regulators to approve the new drug for rheumatoid arthritis, osteoarthritis and pain. The drugmaker said in a statement that it plans to submit an expanded New Drug Application for Arcoxia to the U.S. Food and Drug Administration " in order to include new efficacy data that will better position the product to compete successfully in the coxib class, where there already are three entrants. " Merck is submitting the additional efficacy data to support a new indication for ankylosing spondylitis, which is a chronic, inflammatory disorder primarily involving the spine. © Reuters 2002. All rights reserved. Republication or redistribution of Reuters content, including by caching, framing or similar means, is expressly prohibited without the prior written consent of Reuters. Reuters and the Reuters sphere logo are registered trademarks and trademarks of the Reuters group of companies around the world. Quote Link to comment Share on other sites More sharing options...
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