SAN DIEGO — August 4, 2011 and
OSAKA, Japan — August 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.
