Log in
E-mail
Password
Remember
Forgot password ?
Become a member for free
Sign up
Sign up
Settings
Settings
Dynamic quotes 
OFFON

4-Traders Homepage  >  Equities  >  Nasdaq  >  Amgen, Inc.    AMGN

SummaryQuotesChartsNewsAnalysisCalendarCompanyFinancialsConsensusRevisions 
News SummaryMost relevantAll newsSector newsTweets 

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

share with twitter share with LinkedIn share with facebook
share via e-mail
0
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

share with twitter share with LinkedIn share with facebook
share via e-mail
0
Latest news on AMGEN, INC.
02/22 Genmab and J&J's cancer drug set for blockbuster sales this year
02/21 AMGEN : Repatha® (Evolocumab) Receives European Commission Approval For New 420 ..
02/15 AMGEN : Amgn) Shares Sold by Amp Capital Investors Ltd
02/14 AMGEN : MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS ..
02/14 AMGEN : Submits Supplemental Biologics License Application For BLINCYTO® (Blinat..
02/13 AMGEN, INC. : ex-dividend day
02/09 REGENERON PHARMACEUTICALS INC (NASDA : REGN) And Sanofi SA (ADR)(NYSE:SNY) Loses..
02/09DJAppeals Court Allows Sanofi, Regeneron to Continue Selling Cholesterol Drug
02/08 FDA APPROVES AMGEN, INC. (NASDAQ : AMGN) Drug For Treating Secondary Hyperparath..
02/08 AMGEN : FDA Approves Amgen's Parsabiv™ (Etelcalcetide), First New Treatmen..
More news
Sector news : Bio Therapeutic Drugs
02/22 Genmab and J&J's cancer drug set for blockbuster sales this year
02/21 Icahn buys Bristol-Myers shares, adding to activist pressure
02/21DJBristol-Myers Expands Board, Boosts Buybacks Amid Activist Pressure
02/16 How Sanofi lost out to J&J in $30 billion battle for Actelion
02/14 Gilead challenges GSK with strong HIV drug data
More sector news : Bio Therapeutic Drugs
News from SeekingAlpha
02/23 Can 20 Financial Ratios Measure A Company's Moat Just Like Morningstar? Updat..
02/21 420 mg single-dose monthly delivery option for Amgen's Repatha OK'd in Europe
02/21 This Biotech ETF Looks Primed To Rally Again
02/17 What Makes Amgen A Compelling Buy In 2017?
02/16 Verubecestat Halt Fails To Stop The Bace Chase
Advertisement
Financials ($)
Sales 2017 23 092 M
EBIT 2017 11 793 M
Net income 2017 8 094 M
Finance 2017 188 M
Yield 2017 2,63%
P/E ratio 2017 15,93
P/E ratio 2018 15,10
EV / Sales 2017 5,54x
EV / Sales 2018 4,92x
Capitalization 128 150 M
More Financials
Chart AMGEN, INC.
Duration : Period :
Amgen, Inc. Technical Analysis Chart | AMGN | US0311621009 | 4-Traders
Full-screen chart
Technical analysis trends AMGEN, INC.
Short TermMid-TermLong Term
TrendsBullishNeutralNeutral
Technical analysis
Income Statement Evolution
More Financials
Consensus
Sell
Buy
Mean consensus OUTPERFORM
Number of Analysts 25
Average target price 185 $
Spread / Average Target 6,4%
Consensus details
EPS Revisions
More Estimates Revisions
Managers
NameTitle
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
More about the company
Sector and Competitors
1st jan.Capitalization (M$)
AMGEN, INC.18.06%128 150
CELGENE CORPORATION3.04%92 936
GILEAD SCIENCES, INC.-3.13%91 392
REGENERON PHARMACEUTIC..0.85%38 291
ACTELION LTD22.45%28 790
VERTEX PHARMACEUTICALS..16.45%21 264
More Results