Amylin Pharmaceuticals to Present Promising Data From Diabetes and Obesity Programs at ADA 2008
June 02 2008 - 6:04PM
PR Newswire (US)
SAN DIEGO, June 2 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (NASDAQ:AMLN) today announced that the company will present
new data for its FDA-approved diabetes drugs, BYETTA(R) (exenatide)
injection and SYMLIN(R) (pramlintide acetate) injection, and its
pipeline diabetes and obesity drug candidates at the American
Diabetes Association's 68th Annual Scientific Sessions (ADA) being
held in San Francisco, CA from June 6 to 10. The company will also
host an investor presentation on Sunday, June 8, at 7:45 PM PT
(10:45 PM ET) that will be available by webcast. ADA is one of the
largest scientific meetings for endocrinologists and other health
care professionals involved in diabetes research and the delivery
of diabetes care. Amylin will be introducing data through over 20
posters and eight oral presentations at the meeting. The data will
demonstrate significant progress in key research and clinical
programs that include studies of BYETTA, SYMLIN, and Amylin's early
and late-stage pipeline candidates. Additional information will be
presented during two symposia focused on the multi-hormonal
approach to the treatment of diabetes and obesity, and the role of
incretin-based therapies in type 2 diabetes. "We are excited to
demonstrate advancement in our diabetes and obesity pipeline
programs at this year's ADA, particularly with updated data related
to the once-weekly formulation of exenatide and the combination
therapy program for obesity," said Daniel M. Bradbury, President
and Chief Executive Officer, Amylin Pharmaceuticals, Inc. "At
Amylin, we continually strive toward our mission of Challenging
Science and Changing Lives. By challenging science we question
conventional thinking, and open the door for truly innovative
approaches for developing novel, life-changing therapies. This
unique approach, paired with our deep expertise in peptide hormones
and broad experience in diabetes markets, has allowed us to
continue developing important medicines with life-changing
therapeutic potential for patients." KEY AMYLIN ABSTRACTS BEING
PRESENTED AT ADA Diabetes 1. Oral Late Breaker: "Exenatide Once
Weekly Elicits Sustained Glycemic Control and Weight Loss Over 52
Weeks" will be presented by John B. Buse, M.D., Ph.D., on Monday,
June 9 at 5:50 PM PT (8:50 PM ET). 2. Oral: "Exenatide Once Weekly
Results in Significantly Greater Improvements in Glycemic Control
Compared to Exenatide Twice Daily in Patients with Type 2 Diabetes"
will be presented by Daniel Drucker, M.D. on Saturday, June 7 at
9:00 AM PT (12:00 PM ET). 3. Poster: "Exenatide Monotherapy
Improves Glycemic Control and is Well Tolerated Over 24 Weeks in
Drug-Naive Patients with Type 2 Diabetes" will be presented by
Robert Brodows, M.D. during a poster session on Sunday, June 8 from
12:00 - 2:00 PM PT (3:00 - 5:00 PM ET). 4. Oral Late Breaker:
"Pramlintide or Mealtime Insulin Added to Basal Insulin Treatment
in Patients with Type 2 Diabetes" will be presented by Matthew
Riddle, M.D. on Monday, June 9 at 4:30 PM PT (7:30 PM ET). Obesity
1. Poster: "Enhanced Weight Loss Following Pramlintide/Metreleptin
Combination Treatment in Obese Subjects: Clinical Evidence for
Restoration of Leptin Responsiveness by Amylin Agonism" will be
presented by Christian Weyer, M.D. during a poster session on
Monday, June 9 from 12:00 - 2:00 PM PT (3:00 - 5:00 PM ET). 2.
Oral: "Enhanced Weight Loss Following Co-Administration of
Pramlintide with Sibutramine or Phentermine in Obese Subjects" will
be presented by Louis Aronne, M.D. on Saturday, June 7 at 5:00 PM
PT (8:00 PM ET). 3. Oral: "Triple Peptide Administration of Amylin,
Leptin and PYY (3-36) in Diet-Induced Obese Rats: Magnitude and
Mechanism of Weight Loss" will be presented by James Trevaskis,
M.D. on Sunday, June 8 at 3:15 PM PT (6:15 PM ET). A full list of
all Amylin abstracts being presented at ADA is available at:
http://scientificsessions.diabetes.org/. FEATURED SYMPOSIA 1.
"Multi-Hormonal Treatment Approaches and the Diabetes-Obesity
Continuum." Building upon the success of last year's symposium,
this medical education symposium will help healthcare providers
understand the potential of multi-hormonal treatment approaches for
diabetes and obesity. The event will be chaired by Carol Hatch
Wysham, M.D., FACP, FACE on Saturday, June 7 at 6:00 AM PT (9:00 AM
ET). This symposium is supported by an unrestricted educational
grant from Amylin Pharmaceuticals. 2. "Transformation of the Type 2
Diabetes Algorithm: The Incretin Effect." This medical education
symposium will help healthcare providers understand the role of
incretin-based therapies in relation to type 2 diabetes. The event
will be chaired by Ralph DeFronzo, M.D. on Sunday, June 8 at 6:00
AM PT (9:00 AM ET). This symposium is supported by an unrestricted
educational grant from Amylin Pharmaceuticals and Eli Lilly and
Company. INVESTOR PRESENTATION Amylin will also conduct a webcast
for investors to review the information presented at ADA on Sunday,
June 8 at 7:45 PM PT (10:45 PM ET). The live presentation will be
webcast, and a recording will be made available following the
event. The webcast and recording will be accessible through
Amylin's corporate Web site, located at http://www.amylin.com/. To
access the live webcast, please log on to Amylin's site
approximately 15 minutes prior to the presentation to register and
download any necessary audio software. About SYMLIN Taken at
mealtime, SYMLIN is the first and only amylin mimetic for use in
patients with diabetes treated with mealtime insulin. SYMLIN is a
synthetic analog of human amylin, a naturally occurring hormone
that is made in the beta cells of the pancreas, the same cells that
make insulin. In patients with type 2 diabetes who use insulin, and
in patients with type 1 diabetes, those cells in the pancreas are
either damaged or destroyed, resulting in reduced secretion of both
insulin and amylin after meals. The use of SYMLIN contributes to
glucose control after meals. SymlinPen(R) (pramlintide acetate)
pen-injector devices offer convenient pre-filled SYMLIN
administration with simple, fixed dosing to improve mealtime
glucose control. SymlinPen(R) 120 features fixed dosing to deliver
60 or 120 micrograms of SYMLIN per dose. SymlinPen(R) 60 features
fixed dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per
dose. Healthcare professionals and people with diabetes may obtain
more information, including the complete Prescribing Information
and the Medication Guide, at http://www.symlin.com/. Important
Safety Information for SYMLIN 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. 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
BYETTA BYETTA is the first and only FDA-approved incretin mimetic
for the treatment of type 2 diabetes. BYETTA exhibits many of the
same effects as the human incretin hormone glucagon like peptide-1
(GLP-1). GLP-1 improves blood sugar after food intake through
multiple effects that work in concert on the stomach, liver,
pancreas and brain. BYETTA is approved by the FDA for use by people
with type 2 diabetes who are unsuccessful at controlling their
blood sugar levels. BYETTA is an add-on therapy for people
currently using metformin, a sulfonylurea, or a thiazolidinedione.
BYETTA provides sustained A1C control, low incidence of
hypoglycemia when used with metformin or a thiazolidinedione, and
progressive weight loss. BYETTA was approved in April 2005 and has
been used by approximately one million patients since its
introduction. For full prescribing information, visit
http://www.byetta.com/. Important Safety Information for BYETTA
BYETTA improves glucose (blood sugar) control in adults with type 2
diabetes. It is used with metformin, a sulfonylurea, or a
thiazolidinedione. BYETTA is not a substitute for insulin in
patients whose diabetes requires insulin treatment. BYETTA is not
recommended for use in patients with severe problems digesting food
or those who have severe disease of the stomach or kidney. When
BYETTA is used with a medicine that contains a sulfonylurea,
hypoglycemia (low blood sugar) is a possible side effect. To reduce
this possibility, the dose of sulfonylurea medicine may need to be
reduced while using BYETTA. Other common side effects with BYETTA
include nausea, vomiting, diarrhea, dizziness, headache, feeling
jittery, and acid stomach. Nausea is most common when first
starting BYETTA, but decreases over time in most patients. If
patients experience the following severe and persistent symptoms
(alone or in combination): abdominal pain, nausea, vomiting, or
diarrhea, they should talk to their healthcare provider because
these symptoms could be signs of serious medical conditions. BYETTA
may reduce appetite, the amount of food eaten, and body weight. No
changes in dose are needed for these side effects. These are not
all of the side effects from use of BYETTA. A healthcare provider
should be consulted about any side effect that is bothersome or
does not go away. For full prescribing information, visit
http://www.byetta.com/. 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 for diabetes,
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: media, Alice Izzo
of Amylin, +1-858-642-7272, cell, +1-858-232-9072, ; or Rachel
Martin of Edelman, +1-323-202-1031, cell, +1-323-373-5556, ; or
investors, Michael York of Amylin, +1-858-458-8602, cell,
+1-858-349-8118, Web site: http://www.amylin.com/
http://www.byetta.com/ http://scientificsessions.diabetes.org/
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