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Amgen: Key Bone-Drug Study Meets Goal; Data Coming In Sep |
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| Friday July 25th, 2008 / 22h18 |
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By Thomas Gryta Of DOW JONES NEWSWIRES NEW YORK -(Dow Jones)- Amgen Inc. (AMGN) reported the success of a massive pivotal trial of its bone drug Denosumab in reducing fractures in post-menopausal osteoporosis patients, but didn't give highly anticipated key data.
The three-year study of 7,800 patients met its primary endpoint of reducing vertebral fractures, as well as its secondary goal of cutting non-vertebral fractures. Notably, the study showed that side effects experienced by patients using the drug were similar to those of patients who took a placebo.
"We are encouraged by the magnitude and consistency of the treatment effect and pleased with the safety results," said Amgen's Roger Perlmutter, executive vice president of research and development, in a statement.
Shares of Amgen jumped 10% to $59.75 on the news in after-hours trading, from Friday's closing price of $53.92.
Though the study was successful, a largely expected outcome on Wall Street, specific data weren't release. The company hopes to present the information at a meeting of the American Society of Bone and Mineral Research in September.
The data related to the study are vital, because Denosumab will attempt to enter a crowded osteoporosis market that already includes a popular and cheap generic version of Merck & Co.'s (MRK) Fosamax.
If the data show the clear superiority of Denosumab over its rivals, sales could reach $3 billion, according to industry observers.
That Denosumab reduces factures is important, but the degree of that reduction will dictate where the drug stands in comparison to competitors.
To get widespread use, Denosumab needs to perform better than bisphosphonates, the class of drugs that includes Fosamax, which have been shown to generally reduce vertebral fractures by 50% versus placebo - a closely watched benchmark.
-By Thomas Gryta, Dow Jones Newswires; 201-938-2053; thomas.gryta@dowjones.com
Click here to go to Dow Jones NewsPlus, a web front page of today's most important business and market news, analysis and commentary: http://www.djnewsplus.com/al?rnd=momliFUbkLkO9OuIQJjF%2Bw%3D%3D. You can use this link on the day this article is published and the following day.
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| Friday July 25th, 2008 / 22h18 |
Source : Dowjones Business News |
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