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AMGEN (AMGN)
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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; [email protected]

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Financials ($)
Sales 2017 22 886 M
EBIT 2017 11 755 M
Net income 2017 8 326 M
Finance 2017 6 819 M
Yield 2017 2,65%
P/E ratio 2017 15,10
P/E ratio 2018 15,04
EV / Sales 2017 5,09x
EV / Sales 2018 4,90x
Capitalization 123 B
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Mean consensus OUTPERFORM
Number of Analysts 26
Average target price 191 $
Spread / Average Target 12%
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Managers
NameTitle
Robert A. Bradway Chairman & Chief Executive Officer
Esteban Santos Executive Vice President-Operations
David W. Meline Executive VP, Chief Financial & Accounting Officer
Sean E. Harper Executive Vice President-Research & Development
Paul R. Eisenberg Chief Medical Officer & Senior VP-Global Medical
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