Amylin Pharmaceuticals, Inc. (AMLN) and Takeda Pharmaceutical Co. Ltd. (TKDG.DE) Voluntarily Suspend Clinical Activities in Obesity Trial
SAN DIEGO and OSAKA, Japan, March 16, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq:AMLN - News) and Takeda Pharmaceutical Company Limited (TSE:4502.to - News) today announced that they have suspended clinical activities in an ongoing Phase 2 study examining the safety and effectiveness of the investigational combination therapy pramlintide/metreleptin for the treatment of obesity. The clinical study was voluntarily halted to investigate a new antibody-related laboratory finding with metreleptin treatment in two patients who participated in a previously completed clinical study of obesity.
"The safety of patients in our clinical programs is of paramount concern to the companies. We have taken this precaution so that we can thoroughly investigate this finding," said Orville Kolterman, M.D., senior vice president and chief medical officer of Amylin Pharmaceuticals. "Together with our partner, Takeda, we are committed to working closely with clinical investigators, regulators and outside experts to determine the best path forward."
Independent of the partnership agreement with Takeda, Amylin confirmed that today's announcement does not affect Amylin's lipodystrophy development program investigating the use of metreleptin to treat diabetes and/or hypertriglyceridemia (high levels of triglycerides in the bloodstream) in patients with rare forms of lipodystrophy.
About Pramlintide/Metreleptin Combination Treatment
Pramlintide acetate is a synthetic analog of the natural hormone amylin, a neurohormone secreted by the pancreas that is known to play a role in the regulation of appetite, food intake and postprandial glucose concentrations. To date, approximately 8,000 individuals have received pramlintide in clinical trials, including more than 950 in obesity studies. Metreleptin (methionyl recombinant leptin; r-metHuLeptin) is an analog of human leptin, a neurohormone secreted by fat cells that plays a fundamental role in the regulation of energy metabolism and body weight. To date, more than 1,200 overweight or obese individuals have received metreleptin in clinical trials, several of which were 16 weeks or longer in duration.
About Amylin Pharmaceuticals, Inc.
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.
About Takeda Pharmaceutical Company Limited
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.
Forward-Looking Statements Related to Amylin
This press release contains forward-looking statements about Amylin which involve risks and uncertainties. The actual results for Amylin could differ materially from those discussed due to a number of risks and uncertainties, including that the Company's obesity co-development and commercialization collaboration with Takeda will not achieve the results we expect; unexpected new data, safety and/or technical issues; our clinical trials may not start when planned, be completed in a timely manner and/or confirm previous results; the clinical trial mentioned in this press release may not be restarted; our clinical studies may not be predictive or achieve intended results; our product candidates, including pramlintide/metreleptin for the treatment of obesity and metreleptin to treat diabetes and/or hypertriglyceridemia in patients with lipodystrophy, may not receive regulatory approval; and inherent scientific, regulatory and other risks associated in the drug development and commercialization process. These and additional risks and uncertainties are described more fully in Amylin's most recently filed SEC documents, including its Annual Report on Form 10-K. Amylin undertakes no duty to update these forward-looking statements.
Forward-Looking Statements Related to Takeda
This press release contains forward-looking statements. Forward-looking statements include statements regarding Takeda's plans, outlook, strategies, results for the future, and other statements that are not descriptions of historical facts. Forward-looking statements may be identified by the use of forward-looking words such as "may," "believe," "will," "expect," "project," "estimate," "should," "anticipate," "plan," "assume," "continue," "seek," "pro forma," "potential," "target," "forecast," "guidance," "outlook" or "intend" or other similar words or expressions of the negative thereof. Forward-looking statements are based on estimates and assumptions made by management that are believed to be reasonable, though they are inherently uncertain and difficult to predict. Investors are cautioned not to unduly rely on such forward-looking statements.
Forward-looking statements involve risks and uncertainties that could cause actual results or experience to differ materially from that expressed or implied by the forward-looking statements. Some of these risks and uncertainties include, but are not limited to, (1) the economic circumstances surrounding Takeda's business, including general economic conditions in Japan, the United States and worldwide; (2) competitive pressures and developments; (3) applicable laws and regulations; (4) the success or failure of product development programs; (5) actions of regulatory authorities and the timing thereof; (6) changes in exchange rates; (7) claims or concerns regarding the safety or efficacy of marketed products or product candidates in development; and (8) integration activities with acquired companies.
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