Once-Weekly Exenatide Showed Statistical Superiority in Glucose Control Compared to BYETTA in Head-to-Head Study

- Both Groups Experienced Significant Weight Loss - - New Drug Application Filing Planned by the End of the First Half of 2009 - SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Oct. 31 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: ...

Benefit of exenatide has not yet been proven

Since May 2007, a new drug has been available for the treatment of patients with diabetes mellitus type 2 in Germany: exenatide (trade name: Byetta), which is marketed by the manufacturer Eli Lilly. This drug was developed for patients who cannot sufficiently control their blood glucose levels wit...

Lilly Reports Solid Second-Quarter 2009 Results, Raises EPS Guidance

...., and Alkermes, Inc. submitted a New Drug Application (NDA) to the FDA for exenatide once weekly. exenatide once weekly is an investigational sustained release medication for type 2 d...

Amylin Pharmaceuticals Reports Second Quarter Financial Results

...ate a more efficient global cost structure for the exenatide franchise and restructured our sales force to more... decreased spending associated with the BYETTA and exenatide once weekly development programs. Selling... primarily reflects lower development expenses for exenatide once weekly and BYETTA, and reduced expenses for t...

Diabetes Drug Byetta May Aid Weight Loss in Obese Patients

... THURSDAY, June 11 (HealthDay News) -- exenatide (Byetta), a drug normally used to treat diabetes, ...o diabetes. One group received 10 micrograms of exenatide twice a day, while the other received a placebo. B...e study authors. After six months, those taking exenatide lost three times more weight than those taking the...

New Diabetes Drug Shows Promise in Trial

...natural hormone, researchers say MONDAY, June 8 (HealthDay News) -- An experimental diabetes drug called liraglutide appears to outperform exenatide (Byetta), the only currently approved drug in its class, a study funded by liraglutide's maker, Novo Nordisk, shows. Liraglutide is a laboratory-ma...

Two-Year Data Show Investigational Drug Liraglutide More Effective at Lowering Blood Sugar Than Glimepiride

...ion in Diabetes) The LEAD(TM) program comprises five randomized, controlled, double-blinded studies plus one open-label head-to-head study against exenatide and involved more than 4,000 patients with type 2 diabetes in 40 countries. About Liraglutide Once-daily liraglutide is the first human Gluc...

Amylin Pharmaceuticals to Present Compelling Efficacy and Safety Data From Diabetes Programs at ADA 2009

...n, and its investigational diabetes drug candidate exenatide once weekly at the American Diabetes Association's... in key research and clinical programs for BYETTA, exenatide once weekly and SYMLIN. Additional information wil...ht compelling efficacy and safety data for BYETTA, exenatide once weekly and SYMLIN. The data presented at ADA ...

Amylin Announces Preliminary Results of Annual Meeting of Stockholders

...ders, especially through the anticipated launch of exenatide once weekly, our investigational therapy that has ...ertainties, including risks that BYETTA, SYMLIN or exenatide once weekly may be affected by competition, unexpe...or sNDAs for label expansion requests, such as the exenatide once weekly NDA mentioned in this press release, m...

Amylin Advises All Shareholders to Vote Their Blue Proxy Card Today

...hey benefit from the value creation opportunity of exenatide once weekly, the Company's investigational therapy...ertainties, including risks that BYETTA, SYMLIN or exenatide once weekly may be affected by competition, unexpe...or sNDAs for label expansion requests, such as the exenatide once weekly NDA mentioned in this press release, m...

Exenatide in Medical Technology

Meta-Analysis of Clinical Data Showed No Increased Risk of Cardiovascular Events Associated With Exenatide Use: Data Presented at ADA 2009

Cardiovascular Safety and Potential Benefits of Exenatide to be Prospectively Assessed in Large Outcomes Trial NEW ORLEANS, June 8 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ) and Eli Lilly and Company (NYSE: LLY ) today announced results from a meta-analysis of ...

Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly

Companies Committed to Investing in New Product Presentations for Patients SAN DIEGO and INDIANAPOLIS, April 29 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ) and Eli Lilly and Company (NYSE: LLY ) today announced that the companies have agreed in principle to the ...

Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback

SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE, Mass., Dec. 11 /PRNewswire/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ) and Alkermes, Inc. (Nasdaq: ALKS ) today announced that the U.S. Food and Drug Administration (FDA) recently indicated that the ongoing ext...

After One Year, Type 2 Diabetes Patients Taking Exenatide Once Weekly Sustained Improvements in Glycemic Control and Weight; DURATION-1 Presented at ADA 2008

Phase 3 Once Weekly Investigational Diabetes Therapy Also Improved Glucose Control in Patients Switching from Exenatide Taken Twice a Day SAN FRANCISCO, June 9 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ), and Alkermes, Inc. (N...

Type 2 Diabetes Patients Taking Exenatide Once Weekly, a Phase 3 Investigational Diabetes Therapy, Showed Improvements in Glycemic Control, Weight

DURATION-1 Data Presented at the 68th Annual Scientific Sessions of the American Diabetes Association SAN FRANCISCO, June 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ), and Alkermes, Inc. (Nasdaq: ALKS ) anno...

One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function

-- When compared to insulin glargine, exenatide offered added benefits of weight loss and improved beta-cell function when used with metformin -- AMSTERDAM, Netherlands, Sept. 21 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ) and Eli Lilly and Company (NYSE: LLY ) to...

One Year Study of Exenatide Treatment Showed Improved Beta-Cell Function

-- When compared to insulin glargine, exenatide offered added benefits of weight loss and improved beta-cell function when used with metformin -- AMSTERDAM, Netherlands, Sept. 21 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ) and Eli Lilly and Company (NYSE: LLY ) to...

The Lancet Publishes Direct Comparison Study Between Liraglutide and Exenatide

NEW ORLEANS, June 8 /PRNewswire/ -- Today, The Lancet published online the results of the Novo Nordisk (NVO) LEAD(TM) 6 study, a direct comparison between two products in a new class of diabetes treatments, the GLP-1 receptor agonists. Results show that patients treated with liraglutide had a...

Exenatide Once Weekly Provided Superior Glucose Control Compared to Lantus(R) in Head-to-Head DURATION-3 Study

...om a study comparing subjects randomized to either exenatide once weekly or Lantus((R)) (insulin glargine). Patients randomized to exenatide once weekly experienced a statistically superior r...nt. At the end of the study, patients treated with exenatide once weekly achieved a mean A1C of 6.8 percent com...

Research: Popular Diabetes Medications Associated with Increase in Bone Fractures

...indings Contradict Pancreatitis Risk from Incretin Mimetics New research suggests that the medications known as incretin mimetics -- which include exenatide and sitagliptin -- do not increase the risk of pancreatitis in patients with diabetes, contradicting previous case reports concerning the drug class t...

Exenatide in Biological News

New once-a-week treatment for type 2 diabetes developed by Mount Sinai researcher

...ts can receive once a week." The new treatment, exenatide once weekly is the first in a new class of long-ac...port compared outcomes for patients self-injecting exenatide once weekly against results from the conventional ...e currently available version of the drug known as exenatide (Byetta). In an international multicentre 6-mo...

Exenatide in Biological Technology

New Drug Application for Exenatide Once Weekly Accepted for Review by FDA

SAN DIEGO, INDIANAPOLIS and CAMBRIDGE, Mass., July 7 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., (Nasdaq: AMLN ), Eli Lilly and Company (NYSE: LLY ) and Alkermes, Inc. (Nasdaq: ALKS ) today announced that the New Drug Application (NDA) for exenatide once weekly has been accepte...

Lilly and Amylin Enter Into Supply Agreement for Exenatide Once Weekly

Lilly to Pay Amylin $125 Million and Extend $165 Million Line of Credit to Amylin SAN DIEGO and INDIANAPOLIS, Oct. 21 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN ) and Eli Lilly and Company (NYSE: LLY ) today announced they have entered...

New Data From Head-to-Head Phase 3 Trial Demonstrate That Liraglutide is More Effective Than Exenatide in Treatment of Type 2 Diabetes

MONTREAL, Oct. 17 /PRNewswire-FirstCall/ -- Today, at the Canadian Diabetes Association Congress, physicians will get a first-time look at more detailed results from a phase 3b clinical study (LEAD(TM) 6) comparing the investigational new drug liraglutide to exenatide. The study showed that li...

Intarcia Therapeutics, Inc. Presents ITCA 650 Phase 1b Study Results as a Late-Breaker at the American Diabetes Association 69th Scientific Sessions

... DUROS(R) continuous delivery of exenatide produces impressive reductions in fasting plasma g...effective and patient-friendly approach to deliver exenatide therapy for the treatment of type 2 diabetes," sai...ients receive the benefits of an optimized dose of exenatide immediately upon initiation of treatment, and it c...

Amylin Announces Preliminary Tabulation of Annual Meeting Results

...specially through the anticipated launch of exenatide once weekly, our investigational therapy that has ...ertainties, including risks that BYETTA, SYMLIN or exenatide once weekly may be affected by competition, unexpe...ay also affect the potential for BYETTA, SYMLIN or exenatide once weekly. These and additional risks and uncert...

Intarcia Therapeutics, Inc. Announces Acceptance of ITCA 650 Phase 1b Study for Late-Breaker Presentation at the American Diabetes Association 69th Scientific Sessions

...l study evaluating DUROS(R) continuous delivery of exenatide for the treatment of type 2 diabetes HAYWARD,...y of ITCA 650: Continuous Subcutaneous Delivery of exenatide via DUROS(R) Device Lowers Fasting and Postprandia...rable tolerability of DUROS continuous delivery of exenatide on the lower doses, patients have been enrolled to...

Amylin Responds to Eastbourne Letter

...o achieve a highly successful commercialization of exenatide once weekly and maximize shareholder value. I...ket position with the highly anticipated launch of exenatide once weekly in 2010. exenatide once weekly will be the first once-a-week treatmen...

Amylin Comments on RiskMetrics Report

...y submission of the New Drug Application (NDA) for exenatide once weekly to U.S. Food and Drug Administration (...ertainties, including risks that BYETTA, SYMLIN or exenatide once weekly may be affected by competition, unexpe...or sNDAs for label expansion requests, such as the exenatide once weekly NDA mentioned in this letter, may not ...

Exenatide Once Weekly New Drug Application Submitted to FDA for Type 2 Diabetes

...ay announced that a New Drug Application (NDA) for exenatide once weekly has been submitted to the U.S. Food and Drug Administration (FDA). exenatide once weekly is an investigational sustained releas... subcutaneously and administered only once a week. exenatide is the active ingredient in BYETTA(R) (exenatide) ...

Amylin Pharmaceuticals Announces a New Sales Approach to Better Target the Diabetes Market

...rts to improve the efficiency and effectiveness of exenatide alliance operations with partner Eli Lilly and Com...ill be coordinated and aligned with the continuing exenatide sales efforts of Lilly. Amylin's resulting field s...sition the companies for the anticipated launch of exenatide once weekly. "This new, more focused approach...