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.
SOURCE Amylin Pharmaceuticals, Inc.
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Related links:
http://www.amylin.com
http://www.BYETTA.com
http://scientificsessions.diabetes.org
CONTACT:
media, Alice Izzo of Amylin, +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; or investors, Michael York of Amylin,
+1-858-458-8602, cell, +1-858-349-8118, michael.york@amylin.com
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