2nd UPDATE:Amgen: Denosumab 'Superior' In Head-To-Head Trial
Monday May 19th, 2008 / 22h53
(Includes detail on when Amgen plans to seek regulatory approval in the second paragraph.) DOW JONES NEWSWIRES Amgen Inc. (AMGN) said its denosumab osteoporosis drug came out ahead in a head-to-head study pitting it against rival drug alendronate, produced by Merck & Co. (MRK) under the brand name Fosamax. Denosumab is considered the most promising product in the biotech giant's pipeline, and the results sent shares up after-hours. An Amgen spokeswoman said the company will have all the information to file with the Food and Drug Administration by the end of the year. The company said the one-year double-blind Phase III trial, which included 504 post-menopausal women with low bone mass, "demonstrated superior results for all the primary and secondary endpoints." Amgen said the study found that women treated with denosumab had about 80% better bone mineral density gains than those treated with alendronate. Amgen said side effects, including infection, were evenly spread between the two drugs. In February, the company announced favorable results from another Phase III study showing that twice-yearly injections of denosumab increased bone mineral density. Last month, Amgen said its first-quarter net income rose 2.3%, as cost cuts offset dropping revenue. Amgen shares closed at $42.34 on Monday. Shares recently traded at $43.26. -By Andrew Edwards, Dow Jones Newswires; 201-938-5973; andrew.edwards@dowjones.com
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