Navigation Links
Amylin and Takeda Announce Decision to Advance Development of Pramlintide/Metreleptin Combination Treatment for Obesity

SAN DIEGO and OSAKA, Japan, Feb. 22, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) 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.

"There is an enormous unmet need to help reduce the individual and economic burden of obesity," said Christian Weyer, M.D., vice president, medical development at Amylin Pharmaceuticals. "Through our global co-development and commercialization agreement with Takeda, we are committed to developing innovative therapies to help the millions of people who need better solutions to manage obesity. Today's announcement is an important step forward in helping us make good on that commitment."

"We are pleased with the results of the Phase 2 extension study for the pramlintide/metreleptin combination therapy," said Nancy Joseph-Ridge, M.D., general manager of Takeda's Pharmaceutical Development Division. "This potential new therapy continues to build on our commitment to the management of obesity."

In this extension of a 28-week Phase 2 dose-ranging study, patients who continued treatment with pramlintide/metreleptin for a total of 52 weeks demonstrated sustained weight loss, whereas those continuing on placebo regained almost all of their weight. Consistent with results at 28 weeks, the most robust efficacy was seen in patients with a body mass index (BMI) less than 35 kg/m2.

The combination therapy appeared to be generally well tolerated through 52 weeks, with nausea and injection site adverse events observed as the most common side effects on initiation of pramlintide or metreleptin in combination treatment. Following initiation of therapy, these adverse events occurred at a reduced rate over time in patients continuing combination therapy.

Results from the 28-week portion of this Phase 2 study have been previously reported. Patients who completed the 28-week study had the option to enroll in an extension protocol that assessed longer-term safety and efficacy of various dose combinations of pramlintide and metreleptin to a total of 52 weeks. Approximately 275 patients (75% of those eligible) chose to continue in the extension.

Data from this study may be presented in a future medical forum.

Davalintide Status Update

Amylin has also completed a Phase 2 study of davalintide, a second-generation analog of amylin, for the treatment of obesity. In this study, the weight loss efficacy and tolerability profile of davalintide was not improved over pramlintide, and was inferior to that of the pramlintide/metreleptin combination. Based on this information, Amylin and Takeda, as part of their co-development and commercialization agreement, have decided to halt further development of davalintide at this time.

About Obesity

Obesity is a chronic disease that affects over 400 million people worldwide and is linked to increased health risk of several medical conditions. According to The Obesity Society, obesity is the second leading cause of preventable death in the United States. The total direct and indirect cost attributed to overweight and obesity health issues exceeds $140 billion in the United States each year. Obesity is also rapidly becoming a major health problem in industrialized nations and many developing countries.

About Amylin Pharmaceuticals

Amylin Pharmaceuticals is a biopharmaceutical company dedicated to improving lives of patients through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide) injection. Amylin's research and development activities leverage the Company's expertise in metabolism to develop potential therapies to treat diabetes and obesity. Amylin is headquartered in San Diego, California. Further information on Amylin Pharmaceuticals is available at

About Takeda

Located in Osaka, Japan, Takeda is a research-based global company with its main focus on pharmaceuticals. As the largest pharmaceutical company in Japan and one of the global leaders of the industry, Takeda is committed to striving toward better health for individuals and progress in medicine. Additional information about Takeda is available through its corporate website,

Forward-Looking Statements

This press release contains forward-looking statements about Takeda and Amylin, which involve risks and uncertainties. The actual results for each company could differ materially from those discussed due to a number of risks and uncertainties, including that the companies' obesity co-development and commercialization collaboration will not achieve the results we expect; our clinical trials may not start when planned, be completed in a timely manner and/or confirm previous results; our clinical studies may not be predictive; our product candidates, including pramlintide/metreleptin, may not receive regulatory approval; and inherent scientific, regulatory and other risks in the drug development and commercialization process.

With respect to Amylin, these and additional risks and uncertainties are described more fully in Amylin's most recently filed SEC documents, including its Form 10-Q. Amylin undertakes no duty to update these forward-looking statements.

SOURCE Amylin Pharmaceuticals, Inc.

Back to top



SOURCE Amylin Pharmaceuticals, Inc.
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Amylin Pharmaceuticals to Webcast Year-End Financial Results
2. Amylin Highlights 2010 Corporate Priorities at J.P. Morgan Healthcare Conference
3. Amylin Pharmaceuticals to Present at the 18th Annual Credit Suisse Healthcare Conference
4. Amylin Pharmaceuticals and Eli Lilly and Company Statement on FDAs BYETTA(R) (Exenatide) Injection Update
5. Amylin Pharmaceuticals Reports Third Quarter Financial Results
6. Amylin Pharmaceuticals Highlights New Data Supporting Therapeutic Potential of Obesity Pipeline at Obesity 2009
7. Amylin and Lilly Announce Plans to Develop Pen Device for Exenatide Once Weekly
8. Amylin Pharmaceuticals to Present Novel Data on Promising Obesity Pipeline at 2008 Annual Scientific Meeting of The Obesity Society
9. Amylin Pharmaceuticals Initiates Phase 2B Dose-Ranging Clinical Study of Pramlintide/Metreleptin Combination Treatment in Obesity
10. Takeda Announces Initiation of Trial to Study the Concomitant Use of Dexlansoprazole and Other Proton Pump Inhibitors with Plavix(R) (clopidogrel bisulfate)
11. Emerging Agents from Theravance/Astellas, Johnson & Johnson/Basilea and Forest/Astrazeneca/Takeda Will Drive Modest Growth in the MRSA Drug Market Through 2018
Post Your Comments:
(Date:11/30/2015)... Nov. 30, 2015   Royal Philips (NYSE: ... the industry,s first MRI guided user interface and automatic ... patients with MR Conditional implants, such as knee and ... 2015 Radiological Society of North America Annual Meeting (RSNA) ... supports diagnostic confidence of this growing patient population. ScanWise ...
(Date:11/30/2015)... RATON, Fla. , Nov. 30, 2015   ... (the Institute) announced today that it has finalized ... device start-up company with technology developed at Florida State ... publicly-funded research, and bridges early funding gaps for companies ... and research institutions. --> ...
(Date:11/30/2015)... , Nov. 30, 2015 Baxalta ... biopharmaceutical leader dedicated to delivering transformative therapies ... medical conditions, today announced the launch and ... PEGylated], an extended circulating half-life recombinant factor ... on full-length ADVATE [Antihemophilic Factor (Recombinant)]. The ...
Breaking Medicine Technology:
(Date:11/30/2015)... ... November 30, 2015 , ... ... teams looking to maximize recovery through quality sleep. Tim DiFrancesco, training coach for ... a better night’s sleep. ChiliPad precisely regulates the surface temperature of each side ...
(Date:11/30/2015)... NJ (PRWEB) , ... November 30, 2015 , ... Dr. ... With three office locations, patients can visit Dr. Margulies to experience the best available ... to hold the title of "NJ Top Dentist"! , Orthodontics is the branch of ...
(Date:11/30/2015)... ... November 30, 2015 , ... The recently published ... Data System (NPDS) reveals that in 2014, someone called a poison center about ... million of which were human exposure cases. , The American Association of Poison ...
(Date:11/30/2015)... ... November 30, 2015 , ... The American Society for Clinical Pathology (ASCP) announced ... Day 2015. On Nov. 30, ASCP shared its “Give a minute. Get tested. Find ... and the importance of getting tested for HIV. , ASCP has asked members to ...
(Date:11/30/2015)... PITTSBURGH, PA (PRWEB) , ... November 30, 2015 , ... ... scoop often results in wasted time. Fortunately, an inventor from Chesterfield, Va., has found ... SCOOP CLIP to keep the scoop used to measure powdered contents in a canister ...
Breaking Medicine News(10 mins):