Phase 2 Extension Study Demonstrated Sustained Weight Loss
San Diego, CA – February, 22 and Osaka, Japan – February 23, 2010 – 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.
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 www.amylin.com.
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, www.takeda.com.
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.
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Amylin – Anne Erickson
Phone: (858) 754-4443
Cell: (858) 349-3195
Takeda (Japan) – Seizo Masuda
Takeda (USA) – Julia Ellwanger
Phone: (224) 554-7681