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Amgen, Inc. : Amgen : FDA Letter Rejects Expanded Use Of Xgeva For Prostate Cancer

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04/27/2012 | 01:22pm CET

Amgen Inc. (AMGN) received a complete response letter from the U.S. Food and Drug Administration rejecting the expanded use of Xgeva in men with prostate cancer that hasn't spread to the bones.

According to the drug maker, the FDA letter said the agency can't approve the supplemental biologics license application in its present form because the effect on bone metastases-free survival doesn't outweigh the risks, such as osteonecrosis of the jaw, a rare jaw-decay problem.

"We are reviewing the complete response letter and will work with FDA to determine any next steps," said Sean E. Harper, executive vice president of research and development.

Xgeva is currently approved to delay fractures and other bone injuries in patients whose cancer has already spread to the bones. It is also sold under the brand name Prolia as an osteoporosis treatment, but is administered at a lower dose. Xgeva's and Prolia's combined sales in 2011 topped $550 million.

A federal advisory panel in February rejected Amgen's proposal to expand the bone drug's use, saying it was unclear whether the results were clinically meaningful.

Amgen's study of Xgeva in men with prostate cancer that hadn't responded to previous therapies, but hadn't yet spread to the bones showed the drug prolonged median bone metastatis-free survival by 4.2 months.

Shares closed Thursday at $70.79 and were inactive premarket. The stock it up 10% so far this year.

-By Melodie Warner, Dow Jones Newswires; 212-416-2283; melodie.warner@dowjones.com

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Financials ($)
Sales 2016 22 793 M
EBIT 2016 11 081 M
Net income 2016 7 646 M
Debt 2016 2 579 M
Yield 2016 2,75%
P/E ratio 2016 14,05
P/E ratio 2017 13,33
EV / Sales 2016 4,76x
EV / Sales 2017 4,49x
Capitalization 105 927 M
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Average target price 183 $
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Robert A. Bradway Chairman & Chief Executive Officer
Esteban Santos Executive Vice President-Operations
David W. Meline Chief Financial Officer & Executive Vice President
Paul R. Eisenberg Chief Medical Officer & Senior VP-Global Medical
Frank J. Biondi Independent Director
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