Amylin Pharmaceuticals to Present Compelling Efficacy and Safety Data From Diabetes Programs at ADA 2009
May 29 2009 - 8:00AM
PR Newswire (US)
SAN DIEGO, May 29 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (NASDAQ:AMLN) today announced that the company will present
data for its FDA-approved diabetes drugs, BYETTA(R) (exenatide)
injection and SYMLIN(R) (pramlintide acetate) injection, and its
investigational diabetes drug candidate exenatide once weekly at
the American Diabetes Association's (ADA's) 69th Annual Scientific
Sessions being held in New Orleans from June 5 to 9. The company
will also host an investor presentation and webcast on Sunday, June
7, at 7:45 PM CT (8:45 PM ET). The annual meeting of the ADA is one
of the largest scientific meetings for endocrinologists and other
health care professionals involved in diabetes research and
diabetes care. Amylin will be introducing data through 16 posters
and five oral presentations at the meeting. The data being
presented will demonstrate significant progress in key research and
clinical programs for BYETTA, exenatide once weekly and SYMLIN.
Additional information will be presented during two
corporate-sponsored symposia focused on the potential of peptide
therapy treatment approaches for type 2 diabetes, and the role of
incretin-based therapies in relation to type 2 diabetes.
"Presentations at ADA will highlight compelling efficacy and safety
data for BYETTA, exenatide once weekly and SYMLIN. The data
presented at ADA will further demonstrate Amylin's progress in
bringing life-changing therapies to market," said Daniel M.
Bradbury, president and chief executive officer of Amylin
Pharmaceuticals, Inc. "We look forward to this year's ADA and are
pleased to have the opportunity to contribute to a body of work
that is focused on improving the lives of people living with
diabetes." KEY AMYLIN ABSTRACTS BEING PRESENTED AT ADA 1. Oral:
"Exenatide Once Weekly Treatment Elicits Sustained Glycemic Control
and Weight Loss Over 2 Years" will be presented by Ken Wilhelm,
M.D. on Sunday, June 7 at 8:15 AM CT (9:15 AM ET). 2. Oral:
"Exenatide Once Weekly Improved Cardiometabolic Risk Factors in
Subjects with Type 2 Diabetes During One Year of Treatment" will be
presented by Richard Bergenstal, M.D. on Sunday, June 7 at 9:45 AM
CT (10:45 AM ET). 3. Oral: "Cardiovascular Safety of Exenatide BID:
An Integrated-Analysis from Long-Term Controlled Clinical Trials in
Subjects with Type 2 Diabetes" will be presented by Larry Shen,
Ph.D. on Monday, June 8 at 6:15 PM CT (7:15 PM ET). 4. Oral:
"Incidence of Acute Pancreatitis in Exenatide Initiators Compared
to Other Antidiabetic Drug Initiators: A Retrospective, Cohort
Study" will be presented by Gary Bloomgren, M.D. on Sunday, June 7
at 8:00 AM CT (9:00 AM ET). 5. Oral: "Comparison of Mealtime
Pramlintide, Insulin or a Combination of Both, When Added to Basal
Insulin Treatment in Patients with Type 2 Diabetes" will be
presented by Dennis Karounos, M.D. on Saturday, June 6 at 5:30 PM
CT (6:30 PM ET). 6. Poster Late Breaker: "DURATION-2: Exenatide
Once Weekly Demonstrated Superior Glycemic Control and Weight
Reduction Compared to Sitagliptin or Pioglitazone after 26 Weeks of
Treatment" will be presented by Richard Bergenstal, M.D., during a
poster session on Saturday, June 6 from 11:30 AM - 1:30 PM CT
(12:30 - 2:30 PM ET). 7. Poster: "Safety and Tolerability of
Exenatide BID in Patients With Type 2 Diabetes: Integrated Analysis
of 3854 Patients From 11 Comparator Controlled Clinical Trials"
will be presented by Simon Bruce, M.D. during a poster session on
Saturday, June 6 from 11:30 AM - 1:30 PM CT (12:30 - 2:30 PM ET).
8. Poster: "Clinical and Patient Reported Outcomes in Adults with
Type 2 Diabetes on Basal Insulin Randomized to Addition of Mealtime
Pramlintide or Rapid-Acting Insulin" will be presented by Mark
Peyrot, Ph.D. during a poster session on Saturday, June 6 from
11:30 AM - 1:30 PM CT (12:30 - 2:30 PM ET). A full list of all
Amylin abstracts being presented at ADA is available at:
http://scientificsessions.diabetes.org/ FEATURED SYMPOSIA 1.
"Effective Use of Peptide Therapies for Optimal Glucose and Weight
Control in Type 2 Diabetes." This medical education symposium will
help healthcare providers understand the potential of peptide
therapy treatment approaches for diabetes. The event will be
chaired by David Kendall, M.D., on Saturday, June 6 at 6:00 AM CT
(7:00 AM ET). This symposium is supported by an unrestricted
educational grant from Amylin Pharmaceuticals. 2. "The Clinical
Relevance of Today's Incretin Therapies in the Context of the
Current Algorithm." 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 7 at 6:00 AM CT (7:00 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 the
investment community to review information that will be presented
at ADA. The presentation is on Sunday, June 7 at 7:45 PM CT (8:45
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. The SymlinPen(R)
(pramlintide acetate) pen-injector is an easy way for patients to
use SYMLIN and offers convenient pre-filled SYMLIN administration
with simple, dial-up dosing to improve mealtime glucose control.
The SymlinPen(R) 120 features fixed dosing to deliver 60 or 120
micrograms of SYMLIN per dose. The SymlinPen(R) 60 features fixed
dosing to deliver 15, 30, 45, or 60 micrograms of SYMLIN per dose.
Healthcare professionals and patients 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(R) (exenatide)
injection 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 and low incidence of
hypoglycemia when used with metformin or a thiazolidinedione, with
potential weight loss. BYETTA is not a weight loss product. BYETTA
was approved in April 2005 and has been used by more than 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
the most common side effect 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. 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 herein due to a number
of risks and uncertainties, including risks that BYETTA, SYMLIN or
exenatide once weekly may be affected by competition, unexpected
new data, technical or safety issues, or manufacturing and supply
issues; risks that our clinical trials may not start when planned
and/or confirm previous results; risks that our preclinical studies
may not be predictive; risks that our product candidates may not
receive regulatory approval; 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: Anne Erickson of Amylin Pharmaceuticals, Inc.,
+1-858-754-4443, cell, +1-858-349-3195, ; or Rachel Martin of
Edelman, +1-323-202-1031, cell, +1-323-373-5556, , for Amylin
Pharmaceuticals, Inc. Web Site: http://www.amylin.com/
https://www.symlin.com/ http://www.byetta.com/
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