Navigation Links
Amylin and Takeda Voluntarily Suspend Clinical Activities in Obesity Trial
Date:3/16/2011

SAN DIEGO and OSAKA, Japan, March 16, 2011 /PRNewswire/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Takeda Pharmaceutical Company Limited (TSE: 4502) 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.

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.; Takeda Pharmaceutical Company Limited
Copyright©2010 PR Newswire.
All rights reserved

Related medicine technology :

1. Amylin Pharmaceuticals to Present at the Barclays Capital 2011 Global Healthcare Conference
2. Amylin Pharmaceuticals to Present at the 2011 ISI Annual Conference
3. Amylin Pharmaceuticals Reports 2010 Financial Results
4. Amylin Pharmaceuticals to Webcast Year-End Financial Results
5. Amylin Pharmaceuticals to Present at the 29th Annual J.P. Morgan Healthcare Conference
6. Amylin Submits Clinical and Nonclinical Sections of Rolling Biologics License Application for Metreleptin to Treat Rare Forms of Lipodystrophy
7. Amylin Pharmaceuticals Reports Third Quarter Financial Results
8. Amylin Pharmaceuticals to Present at the 2010 Credit Suisse Healthcare Conference
9. Amylin, Lilly and Alkermes Announce Receipt of Complete Response Letter from FDA for BYDUREON™
10. Amylin Pharmaceuticals to Webcast Third Quarter Results
11. Amylin Pharmaceuticals to Present at the Wedbush Life Sciences Conference 2010
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:1/23/2017)... The American Pharmacists Association (APhA) is excited ... Medically Underserved Areas Enhancement Act (H.R. 592) ... was previously introduced in the 114 th session ... through pharmacists and their patient care services. ... (R-KY), G.K. Butterfield (D-NC), Tom ...
(Date:1/23/2017)... ALBANY, New York , January 23, 2017 ... Non-Invasive Prenatal Testing Market was valued at US$0.53 bn ... by expanding at a strong 17.50% CAGR between 2014 and 2022. ... - Global Industry Analysis, Size, Volume, Share, Growth, Trends and Forecast ... ...
(Date:1/23/2017)... PALMA, Spain , January 23, ... a clinical-stage biopharmaceutical company focused on treatments for ... has been enrolled in the Phase IIb "CaLIPSO ... the treatment of cardiovascular calcification (CVC) in end-stage-renal-disease ... ESRD patients, in the last stage of chronic ...
Breaking Medicine Technology:
(Date:1/22/2017)... ... , ... "Photo Cloud allows FCPX users to add favorited photos to any ... said Christina Austin - CEO of Pixel Film Studios. , To begin, select ... Presets include scenes with one, three, four or five focus points. There are five ...
(Date:1/21/2017)... ... ... Caronlab Australia, an Australian company known for health and beauty products such ... where it benefited from outstanding meetings with major retail buyers. , Caron Labs has ... this trade show, the company had the chance to demonstrate its products and provide ...
(Date:1/21/2017)... ... ... perfect set of tools for video editors that want to create the illusion of rack ... of Pixel Film Studios. , Video editors using ProDOF can add realistic depth of ... from one area into the next. ProDOF comes with 0.5 second, 1.0 second, 1.5 ...
(Date:1/21/2017)... ... January 21, 2017 , ... Phytocéane invites you to ... the rest of the world with ZANZIBAR SHOWER GEL. Inspired by the beauty of ... Virgin Coconut Oil and moisturizing vegetal coral to create this gentle, crystal-clear shower gel ...
(Date:1/21/2017)... Rosa, CA (PRWEB) , ... January 21, 2017 ... ... announce that Redwood Family Dermatology has recently joined their multi-specialty medical ... a full range of cosmetic services. , “We’re excited to add this excellent ...
Breaking Medicine News(10 mins):