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.
SOURCE Amylin Pharmaceuticals, Inc.
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Related links:
http://www.amylin.com
CONTACT:
Alice Izzo of Amylin Pharmaceuticals,
+1-858-642-7272, Cell, +1-858-232-9072, alice.izzo@amylin.com; or
Rachel Martin of Edelman, +1-323-202-1031, Cell, +1-323-373-5556,
rachel.martin@edelman.com, for Amylin Pharmaceuticals
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