Amylin Pharmaceuticals to Present Novel Data on Promising Obesity Pipeline at 2008 Annual Scientific Meeting of The Obesity Soci
October 01 2008 - 4:05PM
PR Newswire (US)
Data support the therapeutic potential of Amylin's integrated
neurohormonal approach to obesity pharmacotherapy SAN DIEGO, Oct. 1
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.
(NASDAQ:AMLN) today announced that new data for its pipeline
obesity candidates will be presented at the 2008 Annual Scientific
Meeting of The Obesity Society in Phoenix October 3-7. The Obesity
Society's annual meeting is one of the largest and most
comprehensive scientific conferences in the field of obesity.
Amylin will present scientific data through 11 oral and poster
presentations, showcasing progress in the company's obesity
pipeline. In addition to Amylin's lead clinical-stage programs in
obesity, pramlintide/metreleptin and AC2307, new findings will also
be presented on various preclinical programs, including a new
Y-family mimetic and Amylin's peptide hybrid (phybrid) platform.
Additional information will be presented during two
corporate-sponsored symposia focused on the emerging peptide
hormone approach to the treatment of obesity and the new science
and therapeutic research that shows promise to reduce the risk of
cardiovascular disease associated with obesity and type 2 diabetes.
"We are excited to present our latest work on the obesity front at
this year's Obesity Society meeting, and will be sharing compelling
data that demonstrates how our programs have the potential to
provide significant weight loss that can be sustained over time,"
said Daniel Bradbury, president and chief executive officer at
Amylin Pharmaceuticals, Inc. "Our unique neurohormonal approach to
obesity, and our deep expertise in peptide hormones, enables us to
develop drugs that may help regulate how many calories we eat, burn
and store as fat by mimicking the effects of naturally occurring
hormones. Amylin's approach has the potential to achieve
significant weight loss with a reduced risk for side effects that
are often seen with other obesity treatments." KEY AMYLIN
ACTIVITIES AT THE OBESITY SOCIETY MEETING 1. Invited symposium
presentation: "Therapeutic Potential of Leptin in General Obesity:
A New, Integrated Neurohormonal Approach" will be presented by
Christian Weyer, MD, Vice President, Corporate Development for
Diabetes and Obesity at Amylin Pharmaceuticals, Inc., as part of a
symposium entitled "Leptin: From Bench to Bedside" on Sunday,
October 5 from 3:45-5:30 p.m. PT (6:45 p.m. ET). This symposium is
part of the conference's core scientific program. 2. Oral 64-OR:
"Enhanced weight loss following pramlintide/metreleptin combination
treatment in overweight and obese subjects is accompanied by
improved control of eating" will be presented by Steve Smith, MD,
Sunday, October 5 at 11:45 a.m. PT (2:45 p.m. ET). 3. Poster 323-P:
"Safety of 360 ug pramlintide BID treatment for up to 2 years" will
be presented by Nicole Kesty, PhD, Saturday, October 4 at 5 p.m. PT
(8 p.m. ET). 4. Poster 592-P: "Changes in weight and binge eating
scale scores in obese subjects treated with pramlintide as
monotherapy and in combination with oral weight loss agents" will
be presented by Fulton Velez, MD, Sunday, October 5 at 5:30 p.m. PT
(8:30 p.m. ET). 5. Poster 205-P: "Effects of amylin/leptin lead-in
on the weight-reducing effects of amylin and/or leptin in
diet-induced obese (DIO) rats" will be presented by Chunli Lei,
Saturday, October 4 at 5 p.m. PT (8 p.m. ET). 6. Poster 651-P:
"AC2307, an amylin mimetic, reduced 24-h food intake in obese
subjects without changing subjective perceptions of hunger and
fullness" will be presented by Nico Pannacciulli, MD, PhD, Sunday,
October 5 at 5:30 p.m. PT (8:30 p.m. ET). 7. Poster 489-P: "Central
activation and weight-lowering actions of AC164209, a peptide
hybrid linking a glucagon-like peptide-1 (GLP-1) receptor agonist
and an amylin mimetic" will be presented by Christine Mack, PhD,
Sunday, October 5 at 5:30 p.m. PT (8:30 p.m. ET). 8.
Corporate-sponsored symposium: "Emerging Peptide Hormone Therapies
for the Treatment of Obesity: Mechanisms of Action, Clinical Safety
and Efficacy." This medical educational symposium will help
healthcare providers understand the peptide hormone approach to the
treatment of obesity. The event will be chaired by George A. Bray,
MD, MACP, Saturday, October 4 at 7:15 p.m. PT (10:15 p.m. ET). This
symposium is supported by an unrestricted educational grant from
Amylin Pharmaceuticals. 9. Corporate-sponsored symposium: "Reducing
CVD Risk: Emerging Science and Therapeutic Options in the
Management of Obesity and Type 2 Diabetes." This medical education
symposium will help healthcare providers understand new science and
therapeutic options to reducing cardiovascular disease risk in the
treatment of obesity and type 2 diabetes. The event will be chaired
by Robert H. Eckel, MD, Monday, October 6 at 5:45 p.m. PT (8:45
p.m. ET). This symposium is supported by an unrestricted
educational grant from Amylin Pharmaceuticals and Eli Lilly and
Company. A full list of all Amylin abstracts being presented at the
2008 Obesity Society meeting is available at:
http://www.obesity.org/annualmeeting08/OS_Phoenix08_Final_Program.pdf
. About Obesity Obesity is a chronic disease that affects millions
of people and is linked to increased health risk of several medical
conditions including type 2 diabetes, high blood pressure, heart
disease, stroke, osteoarthritis, sleep disorders and several types
of cancers. According to The Obesity Society, obesity is the second
leading cause of preventable death in the United States. The total
direct and indirect cost attributed to overweight and obesity
health issues exceeds $100 billion in the United States each year.
Obesity is also rapidly becoming a major health problem in all
industrialized nations and many developing countries. Amylin's
Approach to Obesity Research and Development Physicians and
patients seeking prescription medications for weight loss have
limited therapeutic options. New scientific advances have
established the key role of neurohormones in regulating appetite
and energy balance, as well as the importance of studying the
interaction among these hormones (within the brain) to uncover
their full therapeutic potential. Amylin scientists discovered that
combination treatment with neurohormones such as amylin and leptin
can produce additive and synergistic weight loss in animal models.
These findings formed the basis for Amylin's innovative integrated
neurohormonal approach to the development of obesity treatments.
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. Pramlintide is the active ingredient in SYMLIN(R)
(pramlintide acetate) injection, which is indicated for use by
patients with type 1 and type 2 diabetes who use mealtime insulin
and who have failed to achieve desired glucose control despite
optimal insulin therapy. Since launch, over 110,000 patients have
been treated with SYMLIN. 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. Preclinical and clinical evidence published recently in
PNAS, Proceedings of the National Academy of Sciences of the United
States of America, demonstrates that, when pramlintide and
metreleptin are administered in combination, leptin responsiveness
is at least partially restored by amylin agonism. Experiments in
diet-induced obese rats co-administrated with amylin and leptin
resulted in synergistic reductions in food intake (up to 45%) and
body weight (up to 15%), effects considerably greater than with
leptin or amylin treatment alone. Weight loss with amylin/leptin
treatment was fat- specific, and not accompanied by a reduction in
lean mass. Translational clinical research confirms that findings
in the non-clinical experiments are relevant to human obesity and
suggest that metreleptin and pramlintide may be effective partners
to pramlintide in the treatment of obesity. The most common side
effects with the pramlintide/metreleptin combination treatment were
injection site adverse events and nausea, which were mostly mild to
moderate and transient in nature. Important Safety Information for
SYMLIN(R) SYMLIN is not intended for all patients with diabetes.
SYMLIN is used with insulin and has been associated with an
increased risk of insulin-induced severe hypoglycemia, particularly
in patients with type 1 diabetes. When severe hypoglycemia
associated with SYMLIN use occurs, it is seen within three hours
following a SYMLIN injection. If severe hypoglycemia occurs while
operating a motor vehicle, heavy machinery, or while engaging in
other high- risk activities, serious injuries may occur.
Appropriate patient selection, careful patient instruction, and
insulin dose adjustments are critical elements for reducing this
risk. This information is highlighted in a boxed warning in the
SYMLIN prescribing information for healthcare professionals and in
a medication guide for patients, which will be distributed by
pharmacists. Other adverse events commonly observed with SYMLIN
when co-administered with insulin were mostly gastrointestinal in
nature, including nausea, which was the most frequently reported
adverse event. The incidence of nausea was higher at the beginning
of SYMLIN treatment and decreased with time in most patients. The
incidence and severity of nausea are reduced when SYMLIN is
gradually increased to the recommended doses. About Amylin
Pharmaceuticals Amylin Pharmaceuticals is a biopharmaceutical
company committed to improving lives through the discovery,
development and commercialization of innovative medicines. Amylin
has developed and gained approval for two first- in-class
medicines, SYMLIN(R) (pramlintide acetate) injection and BYETTA(R)
(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 with over 2,000 employees nationwide. Further
information on Amylin Pharmaceuticals is available at
http://www.amylin.com/. This press release contains forward-looking
statements about Amylin, which involve risks and uncertainties. The
Company's actual results could differ materially from those
discussed due to a number of risks and uncertainties, including
that our clinical trials may not start when planned and/or confirm
previous results; our preclinical studies may not be predictive;
our product candidates may not receive regulatory approval; and
inherent scientific, regulatory and other risks in the drug
development and commercialization process. These and additional
risks and uncertainties are described more fully in the Company's
most recently filed SEC documents, including its Form 10-Q. Amylin
undertakes no duty to update these forward-looking statements.
DATASOURCE: Amylin Pharmaceuticals, Inc. CONTACT: Alice Izzo of
Amylin Pharmaceuticals, +1-858-642-7272, Cell, +1-858-232-9072, ;
or Rachel Martin of Edelman, +1-323-202-1031, Cell,
+1-323-373-5556, , for Amylin Pharmaceuticals Web site:
http://www.amylin.com/
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