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Lilly, Amylin, Alkermes Diabetes Drug Moves Ahead In EU

DOW JONES NEWSWIRES An injectable diabetes drug being developed by Eli Lilly & Co. (LLY), Amylin Pharmaceuticals Inc. (AMLN) and Alkermes Inc. (ALKS) received a positive opinion from European Union regulators for the treatment of Type 2 diabetes when used in combination with oral therapies. The news sent shares of Amylin up 20% to $13.50 in recent premarket trading. Shares of Alkermes and Lilly closed Thursday at $13.41 and $35.75, respectively. Neither was active premarket. The opinion is a step toward approval, which requires a decision from the European Commission, which could take up to three months. The drug taken weekly, called Bydureon, also was submitted to the U.S. Food and Drug Administration in 2009. The FDA requested further data late last year and the companies plan to respond by the second half of this year. Bydureon last month suffered a setback as it failed to prove as effective as a once daily treatment. In a study it failed to reduce blood-sugar levels as well as Victoza, made by Novo Nordisk A/S (NVO, NOVO-B.KO). Bydureon is a long-acting version of Byetta, a twice daily drug from Lilly and Amylin that was approved in 2005 and has been losing market share to Victoza's introduction last year. -By Tess Stynes, Dow Jones Newswires; 212-416-2481; Tess.Stynes@dowjones.com

Stock News for Alkermes (ALKS)
DateTimeHeadline
05/31/201209:19:14US HOT STOCK FUTURES: HOT STOCKS TO WATCH
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
07/28/201109:30:07Amylin, Eli Lilly And Alkermes Submit Reply To FDA On Bydureon
07/27/201105:30:27CORRECT: Elan Confirms Outlook As Quarterly Net Loss Narrows
07/18/201115:19:27Alkermes Sees Sales Growth After Merger With Elan Drug Tech
07/12/201110:09:05Elan To Close Pennsylvania Site Ahead Of Unit Sale To Alkermes
06/24/201119:46:35Amylin, MannKind Shares Rise On Diabetes Data Releases
06/21/201107:02:05Lilly, Amylin, Alkermes Diabetes Drug Gets EU Approval
05/09/201104:46:15Elan Sells EDT Unit To Alkermes To Generate Cash, Cut Debt
05/09/201103:15:50Alkermes, Elan Drug Technologies To Merge In $960 Million Transaction
04/15/201110:23:33Amylin: Treatment For Metabolic Disorder Shows Promise
04/15/201108:02:24Lilly, Amylin, Alkermes Diabetes Drug Moves Ahead In EU
04/11/201112:27:13EARNINGS PREVIEW: US Drug Makers' 1Q To Benefit From Higher Prices
03/03/201110:25:36CORRECT: Lilly, Amylin, Alkermes Diabetes Treatment Misses Primary...
03/03/201109:01:49Lilly, Amylin, Alkermes Diabetes Treatment Misses Primary Endpoints
11/03/201008:09:48Amylin CEO: Company Can Withstand Diabetes-Drug Setback
10/29/201011:59:20Vivus Sees Pathway To 2011 Approval For Rejected Diet Drug
10/20/201020:02:08Eli Lilly Type-1 Diabetes Drug Fails Trial Efficacy Endpoint

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