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Amylin, Eli Lilly And Alkermes Submit Reply To FDA On Bydureon

DOW JONES NEWSWIRES Three partners on diabetes drug Bydureon--Amylin Pharmaceuticals Inc. (AMLN), Eli Lilly & Co. (LLY) and Alkermes Inc. (ALKS)--submitted a response to the U.S. Food and Drug Administration that includes additional data indicating the drug didn't slow heart rates. The FDA requested further testing for the drug last year. Bydureon's success is key to the future of Amylin, which hasn't reported a profit since going public in 1992. The drug also would be a positive development for Lilly, which is seeking new drugs to offset looming generic competition to its top products. European regulators approved the treatment last month. The companies' reply includes results from a recently completed survey that shows that exenatide--the drug's nontrade name--at and above therapeutic levels didn't prolong corrected heart intervals in healthy individuals. It also includes an update of safety information from ongoing or completed studies since the companies' last response. "We are confident that the study results and our detailed submission have addressed the requirements outlined by the FDA, and we remain committed to making Bydureon available to patients in the U.S. as soon as possible," said Christian Weyer, senior vice president, research and development, for Amylin. The companies said they expect to receive an updated Prescription Drug User Fee Act action date from the FDA in two weeks. The companies said their resubmission could take up to six months for review. Amylin shares, down 37% over the past 12 months, closed at $11.96 on Wednesday and were inactive premarket. Lilly shares, up 6.5% over the past 12 months, fell 0.7% in premarket trading to $37.72. Alkermes shares, up 34% over the past 12 months, closed at $17.55 and were inactive premarket. -By Nathalie Tadena, Dow Jones Newswires; 212-416-3287; nathalie.tadena@dowjones.com

Stock News for Amylin Pharmaceuticals (AMLN)
DateTimeHeadline
08/09/201208:24:09AstraZeneca: Bristol-Myers Squibb Completes Purchase of Amylin
08/02/201212:30:06Bristol-Myers Executive Charged With Insider Trading
08/02/201212:17:26U.S. Charges Bristol-Myers Executive With Insider Trading
08/02/201211:07:11Bristol-Myers Pension Executive Robert Ramnarine Arrested for...
07/26/201210:24:24Evercore 2nd-Quarter Profit Climbs 19% On Higher Investment Banking...
07/25/201208:20:16Bristol-Myers Profit Falls 28%
07/25/201208:00:01Bristol-Myers 2nd-Quarter Profit Falls 28% on Drug-Patent Expirations
07/02/201211:53:36Bristol Sees Commercial Muscle Accelerating Sales of Bydureon
06/29/201223:36:26Bristol-Myers to Buy Amylin Pharmaceuticals for $5.3 Billion
06/10/201220:35:15Novo Nordisk's Victoza More Efficient Than Peers In New Study
06/09/201208:30:11Sanofi's Lantus Cuts Blood Sugar More Than Merck's Januvia in...
06/05/201209:10:47Amylin is Said To Draw First-Round Bids of Up to $29/Share -Bloomberg
04/25/201214:53:05Icahn: Suit Against Amylin Dropped After Talks With CEO
04/19/201213:53:31FDA Is Asked To Remove Novo Nordisk Diabetes Drug From Market
04/09/201213:08:09Icahn Files Lawsuit Against Amylin To Force Nomination Extension
03/28/201210:08:30Amylin Has Rejected $3.5 Billion Buyout Bid By Bristol-Myers...
03/23/201209:08:11Amylin: EU Approves Diabetes Treatment Byetta With Basal Insulin
01/30/201217:42:15US Stocks Edge Lower As Europe's Debt Flashpoints Weigh
01/30/201208:02:33US Stock Futures Lower On Renewed Worries Over Greece
01/27/201216:12:26FDA Approves Amylin's Bydureon Diabetes Drug After Delays

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