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.

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.

28 Jun 2010

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Amylin Pharmaceuticals, Inc. and Eli Lilly and Company today announced results from the first double-blind, placebo-controlled clinical study to evaluate BYETTA (exenatide) injection added to Lantus (insulin glargine), which showed patients with type 2 diabetes achieved glucose targets without weight gain or increasing their risk of hypoglycemia. These findings were presented at the 70th Annual Scientific Sessions of the American Diabetes Association in Orlando, Fla.

28 Jun 2010

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Ipsen a global biopharmaceutical group, today announced that its partner Roche disclosed results of five Phase III 24-week studies for taspoglutide for type 2 diabetes at the American Diabetes Association's (ADA) 70th Annual Scientific Sessions. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

28 Jun 2010

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

Amylin Pharmaceuticals, Inc. today announced that the Company will present data for its FDA-approved diabetes drugs, BYETTA (exenatide) injection and SYMLIN (pramlintide acetate) injection, and its investigational diabetes drug candidate BYDUREON (exenatide extended-release for injectable suspension) at the American Diabetes Association's 70th Annual Scientific Sessions being held in Orlando, FL from June 25 to June 29.

18 Jun 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced results from DURATION-4, the fourth in a series of studies designed to test the superiority of BYDUREON (exenatide extended-release for injectable suspension), an investigational type 2 diabetes therapy, as compared to other type 2 diabetes medications.

18 Jun 2010

Roche implements risk mitigation plan in taspoglutide Phase III programme

Ipsen, a global biopharmaceutical group, today announced that its partner Roche today announced the implementation of a risk mitigation plan in the taspoglutide Phase III programme. Taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence, originating from Ipsen's research is developed by Roche. This compound is similar to the natural hormone GLP-1 which has a key role in blood sugar regulation.

18 Jun 2010

Health Canada approves Victoza for treatment of adults with type 2 diabetes

Diabetes is growing at an alarming rate in Canada, with an estimated 3.7 million people expected to be diagnosed by 2020. It is a progressive disease that, if not properly monitored and managed over time, will lead to serious long term complications. Canadians now have a novel treatment available to help them maintain optimal blood glucose levels. Health Canada has approved Victoza (liraglutide), the first GLP-1 analogue, for once-daily administration for the treatment of adults with type 2 diabetes to improve glycemic control in combination with metformin or metformin and a sulfonylurea.

27 May 2010

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the U.S. Food and Drug Administration (FDA) has classified the BYDUREON™ (exenatide for extended-release injectable suspension) complete response as a Class 2 resubmission and assigned a new Prescription Drug User Fee Act (PDUFA) action date of October 22, 2010.

6 May 2010

Roche announces results of phase III T-emerge 3 study of taspoglutide in diabetics

Ipsen, a global biopharmaceutical group, today announced that its partner Roche has disclosed results of the phase III T-emerge 3 study in patients with diabetes with taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence. Taspoglutide originating from Ipsen's research is developed by Roche.

29 Apr 2010

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced that the companies have submitted their reply to a complete response letter issued last month by the U.S. Food and Drug Administration (FDA) after review of the New Drug Application (NDA) submission for BYDUREON™ (exenatide for extended-release injectable suspension).

23 Apr 2010

Amylin Pharmaceuticals announces $174.1M total revenue for first-quarter 2010

Amylin Pharmaceuticals, Inc. today reported financial results for the quarter ended March 31, 2010. The Company reported total revenue of $174.1 million for the quarter ended March 31, 2010, which includes net product sales of $172.3 million. Non-GAAP operating loss was $3.8 million for the quarter ended March 31, 2010, compared to $19.9 million for the same period in 2009.

19 Apr 2010

Biotech reports record financial results for 2010 first quarter

Biotech racked up impressive gains for both the month of March and the first quarter of 2010. The Burrill Biotech Select Index posted a 3.7 percent jump in value in March and an 8 percent overall gain for Q1 '10.

2 Apr 2010

Exenatide News and Research

FDA issues complete response letter for BYDUREON NDA

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

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

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

SynCo Bio Partners extends collaboration with Versartis

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

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

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

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

First placebo-controlled clinical study results of BYETTA injection with Lantus presented at ADA 2010

Roche reports results of 5 taspoglutide Phase III studies for type 2 diabetes at 70th ADA

Data on BYETTA and SYMLIN injections, BYDUREON drug candidate to be presented at ADA 2010

DURATION-4 study tests superiority of BYDUREON as compared to other type 2 diabetes medications

Roche implements risk mitigation plan in taspoglutide Phase III programme

Health Canada approves Victoza for treatment of adults with type 2 diabetes

FDA assigns BYDUREON new PDUFA action date of October 22, 2010

Roche announces results of phase III T-emerge 3 study of taspoglutide in diabetics

Amylin, Eli Lilly and Alkermes reply to FDA complete response letter for BYDUREON NDA

Amylin Pharmaceuticals announces $174.1M total revenue for first-quarter 2010

Biotech reports record financial results for 2010 first quarter

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