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
neurohormone secreted by fat cells that plays a fundamental role in
the regulation of energy metabolism and body weight. To date, more
than 1,200 overweight or obese individuals have received
metreleptin in clinical trials, several of which were 16 weeks or
longer in duration.
About Amylin Pharmaceuticals, Inc.
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. 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; 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; the clinical trial mentioned in this press
release may not be restarted; our clinical studies may not be
predictive or achieve intended results; our product candidates,
including pramlintide/metreleptin for the treatment of obesity and
metreleptin to treat diabetes and/or hypertriglyceridemia in
patients with lipodystrophy, may not receive regulatory approval;
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.
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.; Takeda Pharmaceutical
Company Limited