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.
Amylin Pharmaceuticals, Inc.