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.

Patients switching to Victoza experience further reductions in A1c and weight loss

Diabetes Care published online the results of the Novo Nordisk LEAD™ 6 extension study, which evaluated the efficacy and safety of switching from exenatide, which is taken twice a day, to once-daily Victoza®. Results show that when added to oral antidiabetes drugs, patients who switched from exenatide to Victoza experienced further reductions in A1c and weight loss.

31 Mar 2010

QRxPharma initiates Phase 1 trial for evaluating PK profiles of morphine, oxycodone CR formulations

QRxPharma announced today initiation of the Company's first Phase 1 trial to evaluate the pharmacokinetic (PK) profiles of experimental controlled-release (CR) morphine and oxycodone formulations that will be incorporated into MoxDuo®CR. MoxDuo®CR contains a fixed 3:2 morphine:oxycodone combination and is intended to be dosed twice daily in patients experiencing chronic pain, an approximately US$7 billion dollar market worldwide.

31 Mar 2010

NDA for BYDUREON: FDA issues complete response letter

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

15 Mar 2010

FDA sets new PDUFA action date for exenatide once weekly NDA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today confirmed that the U.S. Food and Drug Administration (FDA) has set a new Prescription Drug User Fee Act (PDUFA) action date of March 12 for its review of the exenatide once weekly new drug application (NDA).

25 Feb 2010

Amylin Pharmaceuticals and Takeda Pharmaceutical to advance pramlintide/metreleptin combination therapy development

Amylin Pharmaceuticals, Inc. and Takeda Pharmaceutical Company Limited announced today that the companies have selected the combination treatment of pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin, for advancement toward Phase 3 development. The decision to advance the program followed encouraging results from a 52-week blinded, placebo-controlled Phase 2 extension study. The pramlintide/metreleptin combination met the key target criteria of sustained and robust weight loss.

23 Feb 2010

Roche discloses results of two of eight taspoglutide T-emerge phase III studies in diabetes patients

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed headline results of the fourth and fifth of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first once weekly glucagon-like peptide-1 (GLP-1) analogue based on a human sequence.

17 Dec 2009

Positive results from study comparing exenatide once weekly to BYETTA

Amylin Pharmaceuticals, Inc., Eli Lilly and Company and Alkermes, Inc. today announced positive results from a head-to-head study comparing exenatide once weekly, an investigational diabetes therapy, to BYETTA® (exenatide) injection taken twice daily, in patients with type 2 diabetes.

15 Dec 2009

Eli Lilly provides financial guidance for 2010

At its annual meeting today with the investment community, Eli Lilly and Company highlighted how its innovation-based strategy will enable it to better serve patients and compete effectively in a challenging health care environment. The company also detailed the progress being made in its labs and across its five new business units on an expanding pipeline of innovative molecules and marketed medicines, and provided investors with the company's financial guidance for 2010.

10 Dec 2009

Roche announces results of phase III taspoglutide study in diabetes patients

Ipsen, an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed the results of the second and third of eight T-emerge phase III studies in patients with diabetes for taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s research and developed by Roche.

2 Dec 2009

US Patent & Trademark Office allows patent application for NOD technology

NOD Pharmaceuticals Inc. announced the US Patent & Trademark Office (PTO) has allowed the patent application for its nano-particle oral delivery or NOD technology.

25 Nov 2009

Shanghai Biolaxy receives IND approval for insulin formulation to treat diabetes

Shanghai Biolaxy announced the Chinese State Food & Drug Administration (SFDA) has approved the investigational new drug application (IND) for its oral insulin project (Nodlin), an innovative insulin formulation to treat diabetes. This IND approval allows Biolaxy to initiate its first phase I clinical study.

24 Nov 2009

FDA update on BYETTA injection: Amylin Pharmaceuticals and Eli Lilly respond

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company today issued the following statement in response to the U.S. Food and Drug Administration (FDA) update on BYETTA® (exenatide) injection.

3 Nov 2009

FDA updates Byetta prescribing information following reports of kidney problems

The U.S. Food and Drug Administration today acted on new safety information about possible kidney function problems, including kidney failure, in patients taking Byetta (exenatide), a drug used to treat Type 2 diabetes.

3 Nov 2009

Amylin and Takeda to develop and commercialize pharmaceutical products for obesity

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) announced today that they have entered into a worldwide exclusive license, development and commercialization agreement to co-develop and commercialize pharmaceutical products for the treatment of obesity and related indications.

2 Nov 2009

FDA approves an expanded indication for BYETTA injection

Amylin Pharmaceuticals, Inc., and Eli Lilly and Company (NYSE: LLY) today announced that the U.S. Food and Drug Administration (FDA) has approved an expanded indication for BYETTA® (exenatide) injection. BYETTA is now approved for use as a stand-alone medication (monotherapy) along with diet and exercise to improve glycemic control in adults with type 2 diabetes.

31 Oct 2009

Roche discloses the results of first Phase III clinical study using Taspoglutide

Ipsen (Paris:IPN), an innovation-driven global specialty pharmaceutical group, today announced that its partner Roche has disclosed the results of a first phase III clinical study using Taspoglutide, the first human once weekly glucagon-like peptide-1 (GLP-1) analogue originating from Ipsen’s Research.

29 Oct 2009

Liraglutide drug causes less nausea and hypoglycaemia compared to exenatide

New data on patient treatment satisfaction from the LEAD(TM) 6 trial presented on the 22nd October at the 20th World Diabetes Congress (International Diabetes Federation) shows that patients have higher overall treatment satisfaction with liraglutide than they do with exenatide.

23 Oct 2009

Amylin Pharmaceuticals to present new data from its obesity program at Obesity 2009

Amylin Pharmaceuticals, Inc. today announced that new data from its obesity program will be presented at Obesity 2009, the 27th Annual Scientific Meeting of The Obesity Society, to be held in Washington, D.C. October 24-28. Phase 2 data from the pramlintide/metreleptin combination treatment clinical program will be the subject of a late-breaking oral presentation.

20 Oct 2009

Intarcia's ITCA 650 phase 2 study in type 2 diabetes begins patient enrollment

Intarcia Therapeutics, Inc. today announced the start of enrollment for a phase 2 study comparing its proprietary drug candidate ITCA 650 (DUROS continuous delivery of exenatide) with Byetta, an FDA-approved twice-daily injection form of exenatide.

17 Sep 2009

Amylin and Biocon collaborate to develop a peptide therapeutic for treating diabetes

Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Biocon, Limited (NSE: BIOCON) announced today that they have entered into an exclusive agreement to jointly develop, commercialize and manufacture a novel peptide therapeutic for the potential treatment of diabetes. Amylin and Biocon will collaborate to develop the therapeutic potential of the compound and share development costs. Research will center on Amylin's "phybrid" technology.

11 Sep 2009