SAN DIEGO, Aug. 4, 2011 /PRNewswire/ -- OSAKA, Japan, Aug. 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.
About Amylin Pharmaceuticals
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, and has a
commercial manufacturing facility in Ohio. 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, or we may not
identify any obesity product candidates for future development;
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; our clinical studies may not be
predictive or achieve intended results; our product candidates,
including any product candidates we decide to develop with Takeda
for the treatment of obesity, may not receive regulatory approval;
any financial guidance we provide may differ from our actual future
financial results; 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 about
Takeda. 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.