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Eli Lilly Type-1 Diabetes Drug Fails Trial Efficacy Endpoint

DOW JONES NEWSWIRES Eli Lilly & Co. (LLY) and its partner in licensing diabetes-drug candidate teplizumab said the treatment failed to reach the main efficacy goal a late-stage study. As a results, Lilly and MacroGenics Inc. suspended further enrollment and dosing of patients in two other ongoing clinical trials of the treatment effect in type-1 diabetes. Teplizumab, which the companies license from PDL BioPharma Inc. (PDLI), was being tested to treat newly diagnosed type-1 diabetes, the less-common type of the disease. The treatment was meant to slow its progression. Gwen Krivi, a Lilly executive in diabetes product development, called the drug's failure to reach the primary endpoint "obviously disappointing. She said the two companies will be considering all options for teplizumab. Under the licensing arrangement, Lilly agreed to pay PDL BioPharma fees during testing of teplizumab and would pay royalties on sales if the drug is approved. The trial results follow other another disappointment for Lilly on a diabetes drug-candidate earlier this week. The Food and Drug Administration held off on approving the company's long-acting version of diabetes drug Byetta, requesting more testing and data analysis. Eli Lilly is developing the drug with Amylin Pharmaceuticals Inc. and Alkermes Inc. (ALKS). The approval was widely expected. Lilly shares were down 0.2% at $35.95 in after-hours trading, while PDL closed the regular session Wednesday up 2.2% at $5.59 and wasn't active after the close. -By Joan E. Solsman, Dow Jones Newswires; 212-416-2291; joan.solsman@dowjones.com

Stock News for Alkermes (ALKS)
DateTimeHeadline
02/11/201610:59:05Schedule 13g<br /> (sc 13g/a)
02/10/201617:18:39Statement of Changes in Beneficial Ownership (4)
02/10/201610:39:01Amended Statement of Ownership (sc 13g/a)
02/10/201610:17:35Amended Statement of Ownership (sc 13g/a)
02/10/201607:00:00Alkermes Announces Initiation of Second Phase 3 Study of ALKS...
02/04/201617:14:58Statement of Changes in Beneficial Ownership (4)
02/03/201615:21:28Schedule 13g<br /> (sc 13g/a)
02/02/201616:00:00Alkermes’ Corporate Presentation to be Webcast at Two Upcoming C...
01/25/201607:00:00Alkermes Announces Initiation of Phase 1 Clinical Study of New...
01/21/201613:05:00SHAREHOLDER ALERT: Levi & Korsinsky, LLP Announces an Investigation...
01/21/201609:10:00Alkermes Reports Disappointing Trial Results For Depression Drug
01/21/201607:02:49Current Report Filing (8-k)
01/21/201607:00:00Alkermes Announces Topline Results of FORWARD-3 and FORWARD-4...
01/11/201612:10:02Confidential Treatment Order (ct Order)
01/05/201616:00:00Alkermes’ Corporate Presentation to be Webcast at the 34th A...
01/04/201618:47:56Statement of Changes in Beneficial Ownership (4)
01/04/201618:45:40Statement of Changes in Beneficial Ownership (4)
12/28/201517:06:42Statement of Changes in Beneficial Ownership (4)
12/23/201517:23:36Statement of Changes in Beneficial Ownership (4)
12/16/201507:00:00Alkermes Announces Achievement of Milestones for CNS Medicines...

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