Amylin Pharmaceuticals Expands Clinical Program In Obesity
25 Oct 2006
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced an extensive program of clinical trials which will assess the safety and efficacy of multiple neurohormones used in combination to treat obesity.
This integrated approach to obesity therapy is based on extensive clinical experience with the analog of the human hormone, amylin, called pramlintide, and preclinical data combining neurohormones. Results presented today from a Phase 2 extension study demonstrate that patients completing 52 weeks of pramlintide therapy experienced a 7-8% mean body weight reduction (depending upon dose) compared to a 1% reduction in patients receiving placebo. Also, preclinical data were presented revealing novel, additive and synergistic weight loss effects when amylin is used in combination with other neurohormones.
Four of the clinical studies will be conducted using pramlintide in combination with:
-- Leptin
-- PYY 3-36
-- Leptin with PYY 3-36
Approved oral anti-obesity agents
The fifth clinical study will evaluate an amylin mimetic designed to have enhanced anti-obesity properties. An Investigational New Drug application was recently submitted to the Food and Drug Administration for this drug candidate.
"Amylin's research is focused on novel peptide hormones and their potential to treat a wide range of complex diseases," said Ginger L. Graham, Chief Executive Officer of Amylin Pharmaceuticals. "This approach has been applied successfully to diabetes with the introduction of BYETTA and SYMLIN. Today we announced a new clinical research program, which applies this scientific strategy to address the global epidemic of obesity."
A replay of Amylin's R&D Breakfast is accessible through the company's website, located at
http://www.amylin.com.
About Amylin
Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Amylin has developed and gained approval for two first-in-class medicines for diabetes, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R) (exenatide) injection. Amylin's research and development activities leverage the company's expertise in metabolism to develop potential therapies to treat diabetes, obesity and cardiovascular disease. Amylin is located in San Diego, California with over 1400 employees nationwide. Further information on Amylin Pharmaceuticals is available at
http://www.amylin.com.
This press release contains forward-looking statements about Amylin, which involve risks and uncertainties. The Company's actual results could differ materially from those discussed due to a number of risks and uncertainties, including that our clinical trials may not start when planned and/or confirm previous results; our preclinical studies may not be predictive; our product candidates may not receive regulatory approval; and inherent scientific, regulatory and other risks in the drug development and commercialization process. These and additional risks and uncertainties are described more fully in the Company's most recently filed SEC documents, including its Form 10-Q. Amylin undertakes no duty to update these forward-looking statements.
Amylin Pharmaceuticals, Inc
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