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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 neur
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SOURCE Amylin Pharmaceuticals, Inc.; Takeda Pharmaceutical Company Limited
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