SAN DIEGO, June 20, 2011 /PRNewswire/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that the
Company will present data for its two first-in-class diabetes
drugs, BYETTA® (exenatide) injection and SYMLIN® (pramlintide
acetate) injection, and its investigational diabetes drug
candidates BYDUREON™ (exenatide extended-release for injectable
suspension) and exenatide once monthly at the 71st Scientific
Sessions of the American Diabetes Association (ADA) being held in
San Diego, CA from June 24 to June 28. The Company will also host an
investor presentation and webcast on Sunday,
June 26 at 7:30 PM
PT/10:30 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
introduce data through two oral presentations and 17 posters at the
meeting. The data presented will demonstrate significant progress
and new insights concerning the scientific basis and clinical
utility of BYETTA, BYDUREON and SYMLIN. Additional information will
be presented during a corporate symposium focused on making
clinical decisions in the ever-changing environment of incretin
therapies.
"We look forward to providing updates that further demonstrate
the compelling safety and efficacy profiles of Amylin's approved
therapies, BYETTA and SYMLIN, and our investigational candidate,
BYDUREON," said Daniel M. Bradbury,
president and chief executive officer of Amylin Pharmaceuticals,
Inc. "As one of the foremost gatherings of the diabetes community,
we anticipate that the presentations and discussions at this year's
ADA Scientific Sessions will showcase innovative research and
treatment approaches that have the potential to transform the way
diabetes is treated and improve the lives of the millions of people
living with this chronic disease."
Amylin will post insights throughout the conference on its newly
launched corporate blog, "Building Blocks"
(www.amylinbuildingblocks.com). Building on the success of last
year's Amylin ADA Online Summit, the blog will feature perspectives
from Amylin leadership and global experts on key issues facing the
diabetes community, and the latest innovations that could shape the
future of diabetes care. New entries will be posted throughout the
conference, and will continue on a regular basis after the
conference concludes.
Key Amylin Abstracts Being Presented at ADA
- Oral: "DURATION-3: Efficacy of Exenatide Once Weekly (EQW) and
Insulin Glargine QD (IG) After 84 Weeks in Patients with Type 2
Diabetes (T2D)" will be presented by Michaela Diamant, M.D. on Monday, June 27 at 9:00 AM
PT.
- Oral: "Efficacy and Safety of Exenatide Once Weekly Versus
Metformin, Pioglitazone, and Sitagliptin Used as Monotherapy in
Drug-naïve Patients with Type 2 Diabetes (DUR-4)" will be presented
by David Russell-Jones, M.D. on
Monday, June 27 at 9:45 AM PT.
- Late Breaking Poster: "Safety and Efficacy of Once-Monthly
Exenatide Over 20 Weeks in Patients with Type 2 Diabetes" will be
presented by Leigh MacConell, Ph.D.
during a poster session on Sunday, June
26 from 12:00 – 2:00 PM
PT.
- Poster: "Exenatide Once Weekly Did Not Affect Corrected QT
Interval in Patients with Type 2 Diabetes" will be presented by
Philip Sager, M.D. during a poster
session on Saturday, June 25 from
11:30 AM – 1:30 PM PT.
- Poster: "Exenatide Once Weekly: Sustained Improvement in
Glycemic Control and Weight Loss Through 3 Years" will be presented
by Leigh MacConell, Ph.D. during a
poster session on Saturday, June 25
from 11:30 AM – 1:30 PM PT.
- Poster: "Efficacy and Safety of Exenatide Once Weekly Across
Background Therapies: A Pooled Analysis of DURATION Studies" will
be presented by James Malone, M.D.
during a poster session on Saturday, June
25 from 11:30 AM –
1:30 PM PT.
- Poster: "The Risk of Heart Failure Among Patients Receiving
Exenatide Versus Other Glucose-Lowering Medications for Type 2
Diabetes: A Matched Retrospective Cohort Analysis of the GE
Healthcare Electronic Medical Record Database" will be presented by
Jennie Best, Ph.D. during a poster
session on Saturday, June 25 from
11:30 AM – 1:30 PM PT.
- Poster: "Weight Change in Placebo- and Exenatide (BID)-Treated
Subjects with Type 2 Diabetes on Insulin Glargine: Effects of Sex,
Diabetes Duration, Baseline A1C, and Insulin Dose" will be
presented by John Buse, M.D. during
a poster session on Saturday, June 25
from 11:30 AM – 1:30 PM PT.
- Poster: "Effects of Pramlintide in Patients with T2DM Using
Larger Doses of Insulin – A Tertile Analysis Based on Daily Insulin
Dose" will be presented by Kathrin
Herrmann, Ph.D. during a poster session on Saturday, June 25 from 11:30 AM – 1:30 PM
PT.
- Poster: "Efficacy and Safety of Adjunctive Subcutaneous
Injections of Pramlintide in Patients with Type 1 Diabetes Using
Insulin Pumps" will be presented by Kathrin
Herrmann, Ph.D. during a poster session on Saturday, June 25 from 11:30 AM – 1:30 PM
PT.
A full list of all Amylin abstracts being presented at ADA is
available at: http://scientificsessions.diabetes.org.
Featured Symposium
"Incretin Therapy in Type 2 Diabetes Applied: Navigating and
Making Choices in an Ever-Changing Environment." This medical
education symposium will educate healthcare professionals about the
differential effects within the incretin mimetic class, and when to
use incretin mimetics to improve patient health outcomes. The event
will be chaired by John Buse, M.D.,
with medical and scientific presentations by Dr. Ralph DeFronzo, M.D. and Dr. Steven Kahn, M.B., Ch.B., on Saturday, June 25 at 6:00
AM PT. This symposium is supported by an educational grant
from Amylin Pharmaceuticals and Lilly USA, LLC.
Investor Presentation
Amylin will also conduct a webcast on Sunday, June 26 at 7:30 PM
PT/10:30 PM ET for the
investment community to review information presented at ADA. The
presentation will be webcast live through the "Investors" section
of Amylin's corporate website at www.amylin.com, and a recording
will be made available on the website following the event. To
access the live webcast, please log on to Amylin's website
approximately 15 minutes prior to the presentation to register,
download, and install any necessary audio software.
About SYMLIN® (pramlintide acetate) Injection
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, beta cells in the
pancreas that make both insulin and amylin are either damaged or
destroyed, resulting in reduced secretion of both insulin and
amylin after meals. Amylin deficiency can make it harder to control
glucose levels after meals; therefore, using SYMLIN helps patients
to spend more time in their normal glycemic range.
The SymlinPen® (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®120 features fixed dosing to deliver
60 or 120 micrograms of SYMLIN per dose. The SymlinPen®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 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.
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 BYETTA® (exenatide) Injection
BYETTA was the first glucagon-like peptide-1 (GLP-1) receptor
agonist to be approved by the FDA for the treatment of type 2
diabetes. BYETTA exhibits many of the same effects as the human
incretin hormone 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 an injectable prescription medicine that may improve
blood sugar (glucose) control in adults with type 2 diabetes
mellitus, when used with a diet and exercise program. BYETTA is not
insulin and should not be taken instead of insulin. BYETTA is not
currently recommended to be taken with insulin. BYETTA is not for
people with type 1 diabetes or people with diabetic ketoacidosis.
BYETTA has not been studied in people who have pancreatitis.
BYETTA provides sustained A1C control and low incidence of
hypoglycemia when used alone or in combination with metformin or a
thiazolidinedione, with potential weight loss (BYETTA is not a
weight-loss product). BYETTA was approved in the U.S. in
April 2005 and in Europe in November
2006 and has been used by more than 1.8 million patients
since its introduction. See important safety information below.
Additional information about BYETTA is available at
www.byetta.com.
Important Safety Information for BYETTA® (exenatide)
Injection
Based on postmarketing data BYETTA has been associated with
acute pancreatitis, including fatal and non-fatal hemorrhagic or
necrotizing pancreatitis. Patients should be observed for signs and
symptoms of pancreatitis after initiation or dose escalation of
BYETTA. The risk for getting low blood sugar is higher if BYETTA is
taken with another medicine that can cause low blood sugar, such as
a sulfonylurea. BYETTA should not be used in people who have severe
kidney problems and should be used with caution in people who have
had a kidney transplant. Patients should talk with their healthcare
provider if they have severe problems with their stomach, such as
delayed emptying of the stomach (gastroparesis) or problems with
digesting food. Antibodies may develop with use of BYETTA. Patients
who develop high titers to exenatide could have worsening or
failure to achieve adequate glycemic control. Consider alternative
therapy if this occurs. Severe allergic reactions can happen with
BYETTA. There have been no clinical studies establishing conclusive
evidence of macrovascular risk reduction with BYETTA or any other
antidiabetic drug.
The most common side effects with BYETTA include nausea,
vomiting, diarrhea, dizziness, headache, feeling jittery, and acid
stomach. Nausea most commonly happens when first starting BYETTA,
but may become less over time.
These are not all 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 additional important safety information about BYETTA,
please see the full Prescribing Information
(www.byetta.com/pi) and Medication Guide
(www.byetta.com/mg).
About Amylin Pharmaceuticals
Amylin Pharmaceuticals is a biopharmaceutical company dedicated
to improving lives of patients through the discovery, development,
and commercialization of innovative medicines. Amylin has developed
and gained approval for two first-in-class medicines for diabetes,
SYMLIN® (pramlintide acetate) injection and BYETTA® (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
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 BYDUREON 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,
confirm previous results, achieve intended clinical end-points
and/or be predictive of real world use; risks that our preclinical
studies may not be predictive; risks that our product candidates,
including BYDUREON and/or exenatide once monthly, 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.
SOURCE Amylin Pharmaceuticals, Inc.