8/5/2011 6:34:13 AM
OSAKA, Japan, Aug. 5, 2011 -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) today announced that they are discontinuing development of pramlintide/metreleptin, an investigational combination therapy for the treatment of obesity that comprises pramlintide, an analog of the natural hormone amylin, and metreleptin, an analog of the natural hormone leptin. The joint decision was based on a commercial reassessment of the pramlintide/metreleptin program, which had been in Phase 2 development as a twice-a-day injection formulation. The commercial assessment took into account a revised development plan as well as evolving dynamics within the obesity therapeutic area. The companies will continue to evaluate other assets as potential candidates for the treatment of obesity and related indications under the terms of their existing collaboration agreement.
"The interplay of hormonal signals, such as amylin and leptin, plays a crucial role in the regulation of body weight," said Christian Weyer, M.D., Senior Vice President, Research and Development at Amylin Pharmaceuticals. "Advances in peptide engineering and delivery may help us leverage this biology to develop a therapy with less frequent dosing. With our partner, Takeda, we look forward to continuing to explore new options for the obesity market."
"As the prevalence of obesity continues to rise in the U.S., it is important to develop innovative weight loss therapies for patients with this condition," said David Recker, M.D., Senior Vice President, Clinical Science, Takeda Global Research & Development Center, Inc.
While the pramlintide/metreleptin development program has been discontinued, Amylin and Takeda will continue to investigate the previously announced antibody-related laboratory finding with metreleptin treatment in patients who participated in a previously completed clinical study of obesity.
Neither Amylin nor Takeda expect to revise the latest financial guidance for their respective 2011 fiscal years in connection with the discontinuation of this program.
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, and has a commercial manufacturing facility in Ohio. 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, or we may not identify any obesity product candidates for future development; 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; our clinical studies may not be predictive or achieve intended results; our product candidates, including any product candidates we decide to develop with Takeda for the treatment of obesity, may not receive regulatory approval; any financial guidance we provide may differ from our actual future financial results; 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 about Takeda. 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. The forward-looking statements contained in this press release speak only as of the date of this press release, and Takeda undertakes no obligation to revise or update any forward-looking statements to reflect new information, future events or circumstances after the date of the forward-looking statement. If Takeda does update or correct one or more of these statements, investors and others should not conclude that Takeda will make additional updates or corrections.
SOURCE Amylin Pharmaceuticals, Inc.