Exenatide News and Research

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Exenatide (marketed as Byetta) is one of a new class of medications (incretin mimetics) approved for the treatment of diabetes mellitus type 2.

Amylin, JDRF collaborate to investigate combination therapy for type 1 diabetes treatment

The Juvenile Diabetes Research Foundation and Amylin Pharmaceuticals, Inc. announced today that they have entered into a research collaboration agreement to provide financial support for a series of clinical studies to investigate the feasibility of mixing pramlintide, an analog of the human hormone amylin, with insulin to treat type 1 diabetes.

11 May 2011

Amylin reports total revenue of $152.7 million for quarter ended March 31, 2011

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended March 31, 2011.

18 Apr 2011

Amylin's new metreleptin data in lipodystrophy to be presented at AACE meeting

Amylin Pharmaceuticals, Inc. today announced results from a new analysis of an ongoing, long-term research study of the investigational drug metreleptin, an analog of the human hormone leptin, for the treatment of lipodystrophy.

16 Apr 2011

Positive results from exenatide phase 2 study in patients with type 2 diabetes

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a phase 2 study evaluating the effects of a once-monthly injectable suspension formulation of exenatide on glycemic control in patients with type 2 diabetes.

10 Mar 2011

TransPharma completes ViaDor-GLP1 agonist Phase 1b trial for treatment of type II diabetes

TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today the successful completion of a Phase 1b trial of ViaDor-GLP1 agonist, which is being developed for the treatment of diabetes mellitus type II.

22 Feb 2011

Sanofi-aventis announces GetGoal-X Phase III study of lixisenatide against type 2 diabetes

Zealand Pharma A/S, a biopharmaceutical company dedicated to the discovery and development of innovative peptide drugs, is pleased to announce that its partner, sanofi-aventis, today announced that the GetGoal-X Phase III study of lixisenatide, a once-daily GLP-1 receptor agonist licensed from Zealand Pharma, achieved its primary endpoint of non-inferiority in HbA1c reduction from baseline, compared with exenatide twice-daily.

2 Feb 2011

Health Canada approves Eli Lilly's BYETTA for treatment of adults with type 2 diabetes

Eli Lilly Canada is pleased to announce the Health Canada approval of BYETTATM for the treatment of adults with type 2 diabetes.

18 Jan 2011

Amylin, Lilly submit BYETTA sNDA for type 2 diabetes

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced that a supplemental New Drug Application (sNDA) has been submitted to the U.S. Food and Drug Administration (FDA) for the expanded use of BYETTA® (exenatide) injection as an add-on therapy to basal insulin, with or without metformin and/or a thiazolidinedione (TZD) in conjunction with diet and exercise for adults with type 2 diabetes who are not achieving adequate glycemic control.

23 Dec 2010

Amylin submits metreleptin rolling submission BLA for treatment of rare forms of lipodystrophy

Amylin Pharmaceuticals, Inc. today announced that it has submitted the initial sections of a rolling submission for a Biologics License Application (BLA) to the U.S. Food and Drug Administration (FDA) for the use of metreleptin to treat diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in patients with rare forms of lipodystrophy.

21 Dec 2010

Study: Mixing exenatide with insulin provides better blood sugar control in type 2 diabetes patients

A new study finds that combining the newer diabetes drug exenatide with insulin provides better blood sugar control in patients with type 2 diabetes than insulin alone and helps promote weight loss.

7 Dec 2010

JDRF, Amylin collaborate to support metreleptin study for type 1 diabetes

The Juvenile Diabetes Research Foundation (JDRF) and Amylin Pharmaceuticals, Inc. announced today that they entered into a research collaboration agreement to provide financial support for a clinical proof-of-concept study to investigate the effects of metreleptin, an analog of the human hormone leptin, in patients with type 1 diabetes. Researchers at The University of Texas (UT) Southwestern Medical Center will conduct the study.

17 Nov 2010

FDA issues complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has issued a complete response letter regarding the New Drug Application (NDA) for BYDUREON™ (exenatide extended-release for injectable suspension).

21 Oct 2010

Australian reimbursement committee is set to consider Novo Nordisk's type 2 diabetes treatment

In its November meeting, the Pharmaceutical Benefits Advisory Committee (PBAC) will consider Novo Nordisk's second-to-market glucagon-like peptide-1 (GLP-1) agonist Victoza for reimbursement, which would be essential in order for the drug to compete effectively with Eli Lilly's Byetta. However, its chances of success are uncertain, considering that it took three years to get Byetta on the Pharmaceutical Benefits Scheme (PBS).

4 Oct 2010

Intarcia Therapeutics presents ITCA 650 phase 2 study results for type 2 diabetes

Intarcia Therapeutics, Inc. presented today final results of a 24-week phase 2 clinical study of ITCA 650 (DUROS continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes at the 46th Annual Meeting of the European Association for the Study of Diabetes in Stockholm, Sweden.

23 Sep 2010

TransPharma Medical completes ViaDerm-GLP1 agonist Phase 1a trial for type II diabetes

TransPharma Medical Ltd., a specialty pharmaceutical company focused on the development and commercialization of drug products utilizing a proprietary active transdermal drug delivery technology, announced today the successful completion of a Phase 1a trial of ViaDerm-GLP1 agonist which is being developed for the treatment of diabetes mellitus type II.

14 Sep 2010

SynCo Bio Partners extends collaboration with Versartis

SynCo Bio Partners today announced an extension of its successful collaboration with Versartis, Inc. following the recent initiation of a Phase 1 clinical trial in type 2 diabetes mellitus (T2DM) patients with monthly dosing of VRS-859. This news comes less than 12 months since the parties entered into a strategic partnership to manufacture Versartis' lead product VRS-859 (exenatide-XTEN).

30 Jul 2010

Amylin reports $164.4M total revenue for quarter ended June 30, 2010

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended June 30, 2010. The Company reported total revenue of $164.4 million for the quarter ended June 30, 2010, which includes net product sales of $162.5 million. Net loss, excluding a restructuring charge of $3.4 million, was $40.8 million, or $0.28 per share.

22 Jul 2010

Amylin presents improved indices of beta-cell function after three years of BYETTA(R) therapy

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from a study comparing the effect of long-term treatment with either BYETTA® (exenatide) injection or Lantus® (insulin glargine) on overall beta-cell function. (Beta cells are cells in the pancreas that produce insulin.) Three years of BYETTA therapy improved indices of beta-cell function assessed four weeks after discontinuing therapy. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association (ADA) in Orlando, Fla.

30 Jun 2010

Intarcia presents ITCA 650 Phase 2 study results at 70th ADA

Intarcia Therapeutics, Inc. presented today the results of a phase 2 clinical study of ITCA 650 (DUROS® continuous subcutaneous delivery of exenatide) for the treatment of type 2 diabetes as a late-breaker at the Annual Conference of the American Diabetes Association in Orlando, FL (June 25-29, 2010). Results of the phase 2 study demonstrated substantial reductions in HbA1c and body weight during the 12 weeks of treatment with ITCA 650 at both the 20 mcg/day and 40 mcg/day doses.

28 Jun 2010

Clinical study results show no increased risk of CV events associated with SYMLIN injection

Amylin Pharmaceuticals, Inc. today announced results from an analysis of an integrated database of clinical studies that showed no increased risk of cardiovascular events associated with SYMLIN (pramlintide acetate) injection use compared to a pooled comparator group treated with either placebo or rapid-acting insulin. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.