Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) today announced that
it will present data for BYDUREON™ (exenatide extended-release for
injectable suspension), the first and only once-weekly diabetes
treatment, as well as first-in-class diabetes drugs BYETTA®
(exenatide) injection and SYMLIN® (pramlintide acetate) injection
at the 72nd Scientific Sessions of the American Diabetes
Association (ADA), June 8-12, 2012, in Philadelphia. The Company
will also host an investor presentation and webcast on Sunday, June
10 at 7:30 p.m. ET/4:30 p.m. PT.
Amylin will highlight data from 13 abstracts, offering new
insights into the clinical utility of BYDUREON, BYETTA and SYMLIN,
as well as continued research into the exenatide pipeline. BYETTA
will be featured at this year’s Joint ADA/The Lancet Symposium, and
additional information on the use of long-acting GLP-1 receptor
agonist therapy to improve efficacy, adherence and weight in
patients with type 2 diabetes will be presented during a corporate
symposium.
“Multiple presentations at this year’s meeting demonstrate the
durability of effect and long-term safety and tolerability of
BYDUREON and BYETTA, as well as provide important insights into the
effect of SYMLIN on glucose targets,” said Daniel M. Bradbury,
president and chief executive officer, Amylin Pharmaceuticals. “For
25 years, Amylin has been an innovator in diabetes treatment. These
studies further demonstrate our commitment to expanding physician
and patient choices for improving diabetes management and the lives
of the millions of people living with this chronic disease.”
Joint ADA/The Lancet SymposiumJoint ADA/The Lancet
Symposium: “Exenatide Twice a Day Versus Glimepiride for Prevention
of Glycemic Deterioration in Patients with Type 2 Diabetes with
Metformin Failure (EUREXA) – An Open-Label Randomized Controlled
Trial” will be presented by Guntram Schernthaner, M.D., on
Saturday, June 9 at 8:30 a.m. ET.
Featured Symposium“Long-Acting GLP-1 Receptor Agonist
Therapy – Improving Efficacy, Adherence, and Weight in Type 2
Diabetes.” This medical education symposium will provide healthcare
professionals information about GLP-1 based therapies as an
important option in the treatment of type 2 diabetes, restoring the
diminished incretin effect and potentially addressing the decline
in beta cell function characteristic of type 2 diabetes. The event
will be chaired by John Buse, M.D., with medical and scientific
presentations by Ralph DeFronzo, M.D., and David D’Alessio, M.D.,
on Sunday, June 10 at 5:30 a.m. ET. This symposium is supported by
an educational grant from Amylin.
Investor PresentationAmylin will also conduct a webcast
on Sunday, June 10 at 7:30 p.m. ET/4:30 p.m. PT for the investment
community that will include ADA conference highlights. 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.
Key Amylin Abstracts at ADA
1.
Late Breaking Poster: “Once-Weekly Exenatide Versus
Once or Twice Daily Insulin Detemir: Randomized, Open-Label
Clinical Trial of Efficacy and Safety in Patients with Type 2
Diabetes Inadequately Controlled With Metformin ± Sulphonylureas”
will be presented by Melanie Davies, M.D., during a poster session
on Sunday, June 10 from 12 – 2 p.m. ET.
2.
Poster: “Pharmacokinetics and Pharmacodynamics of a New Exenatide
Formulation, Exenatide Suspension” will be presented by Leigh
MacConell, Ph.D., during a poster session on Saturday, June 9 from
11:30 a.m. – 1:30 p.m. ET.
3.
Poster: “Exenatide Once Weekly Resulted in Sustained Improvement in
Glycemic Control with Weight Loss through 4 Years” will be
presented by Leigh MacConell, Ph.D., during a poster session on
Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET.
4.
Poster: “Two-Year Use of Exenatide Once Weekly in Type 2 Diabetes
Mellitus (T2DM) Patients Taking Thiazolidinedione” will be
presented by Michael Trautmann, M.D., during a poster session on
Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET.
5.
Poster: “Exenatide Once Weekly was Associated with Improved
Glycemic Control Regardless of Baseline Body Weight” will be
presented by Richard Pencek, Ph.D., during a poster session on
Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET.
6.
Poster: “Improved Diabetes Treatment Satisfaction and
Weight-Related Quality of Life for Asian Patients Treated with
Exenatide Once Weekly Versus Twice Daily” will be presented by
Marilyn Boardman, Ph.D., during a poster session on Saturday, June
9 from 11:30 a.m. – 1:30 p.m. ET.
7.
Poster and Guided Audio Poster Tour:
“Anti-diabetic Effects of Exenatide and Dapagliflozin in Diabetic
Mice” will be presented by Krystyna Tatarkiewicz, Ph.D., at a
poster session on Saturday, June 9 from 11:30 a.m. – 1:30 p.m. ET
and at a Guided Audio Poster Tour on Monday, June 11 from 12 – 1
p.m. ET.
8.
Poster: “Pramlintide-Induced Shift Towards Euglycemia Based on SMBG
Profiles in T2DM” will be presented by Kathrin Herrmann, Ph.D., at
a poster session on Saturday, June 9 from 11:30 a.m. – 1:30 p.m.
ET.
A full list of all Amylin abstracts being presented at ADA is
available at http://scientificsessions.diabetes.org.
Amylin will post insights from the conference on its corporate
blog, “Building Blocks” at www.amylinbuildingblocks.com. 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.
About BYDUREON™ (exenatide extended-release for injectable
suspension)BYDUREON is the first and only once-weekly medicine
to be approved by the U.S. Food and Drug Administration (FDA) for
the treatment of type 2 diabetes. It is a once-weekly formulation
of exenatide, the active ingredient in BYETTA® (exenatide)
injection, which has been available in the U.S. since June 2005 and
is used in nearly 80 countries worldwide. BYDUREON works with the
body to help make its own insulin when needed, providing continuous
glycemic control with just one dose per week. Using Alkermes plc’s
proprietary technology for long-acting medications, the
biodegradable microspheres in each dose of BYDUREON provide a
controlled release of exenatide throughout the week. BYDUREON was
approved in the U.S. in January 2012 and in Europe in June
2011.
BYDUREON is an injectable prescription medicine that may improve
blood sugar (glucose) in adults with type 2 diabetes mellitus, and
should be used along with diet and exercise. BYDUREON is not
recommended as the first medication to treat diabetes.
BYDUREON and BYETTA both contain the same active ingredient,
exenatide, and therefore should not be used together. BYDUREON is
not insulin and should not be taken instead of insulin. BYDUREON is
not for people with type 1 diabetes or people with diabetic
ketoacidosis. BYDUREON is not recommended for use in children. It
is not known if BYDUREON is safe and effective in people with a
history of pancreatitis or severe kidney problems. See important
safety information below. Additional information about BYDUREON is
available at www.BYDUREON.com.
Important Safety Information for BYDUREON™ (exenatide
extended-release for injectable suspension)
In animal studies, BYDUREON caused rats to develop tumors of
the thyroid gland. Some tumors were cancers. It is not known if
BYDUREON causes thyroid tumors or a type of thyroid cancer called
medullary thyroid cancer (MTC) in people. BYDUREON should not be
used if there is a personal or family history of MTC or Multiple
Endocrine Neoplasia syndrome type 2.
Based on post-marketing data, exenatide 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 of BYDUREON.
The risk of getting low blood sugar is higher if BYDUREON is
taken with another medicine that can cause low blood sugar, such as
a sulfonylurea. The dose of sulfonylurea may need to be lowered
while BYDUREON is used. BYDUREON should not be used in people who
have or had severe kidney problems and may cause or worsen problems
with kidney function, including kidney failure. 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 BYDUREON, which may lead to worsening or
failure to achieve adequate glycemic control. Severe allergic
reactions can happen with BYDUREON. There have been no clinical
studies establishing conclusive evidence of macrovascular risk
reduction with BYDUREON or any other antidiabetic drug.
The most common side effects with BYDUREON include nausea,
diarrhea, headache, vomiting, constipation, itching at injection
site, a small bump (nodule) at the injection site, and indigestion.
Nausea most commonly happens when first starting BYDUREON, but may
become less over time.
These are not all the side effects from use of BYDUREON. A
healthcare provider should be consulted about any side effect that
is bothersome or does not go away.
For additional important safety information about BYDUREON,
please see the full Prescribing Information
(www.BYDUREON.com/pi) and patient Medication Guide
(www.BYDUREON.com/mg).
About BYETTA® (exenatide) InjectionBYETTA
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. It can also
be used with metformin, a sulfonylurea, a thiazolidinedione or
Lantus® (insulin glargine), which is a long-acting insulin.
BYETTA is not insulin and should not be taken instead of
insulin. BYETTA should not be taken with short- and/or rapid-acting
insulin. BYETTA is not for people with type 1 diabetes or people
with diabetic ketoacidosis. BYETTA has not been studied in patients
with a history of pancreatitis. Other antidiabetic therapies should
be considered for these patients.
BYETTA provides sustained A1C control 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 post-marketing 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 of getting low blood sugar is higher if BYETTA is taken
with another medicine that can cause low blood sugar, such as a
sulfonylurea or insulin. The dose of sulfonylurea or insulin may
need to be lowered while BYETTA is used. BYETTA should not be used
in people who have severe kidney problems and may cause or worsen
problems with kidney function, including kidney failure. 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. 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, feeling jittery, dizziness, headache, acid
stomach, constipation and weakness. 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 patient Medication Guide
(www.BYETTA.com/mg).
About SYMLIN® (pramlintide acetate)
InjectionTaken at mealtime, SYMLIN is the first and only amylin
mimetic for use in patients with diabetes treated with mealtime
insulin. SYMLIN is a synthetic analogue 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 can help 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.
For additional important safety information about SYMLIN,
please see the full Prescribing Information
(http://documents.symlin.com/SYMLIN_PI.pdf) and
patient Medication Guide
(http://documents.symlin.com/SYMLIN_Medication_Guide.pdf).
Important Safety Information for SYMLIN (pramlintide acetate)
InjectionSYMLIN 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 Amylin PharmaceuticalsAmylin Pharmaceuticals is a
biopharmaceutical company dedicated to improving lives of patients
through the discovery, development and commercialization of
innovative medicines. Amylin is committed to delivering novel
therapies that transform the way diabetes and related metabolic
disorders are treated. Amylin is headquartered in San Diego, Calif.
and has a commercial manufacturing facility in Ohio. More
information about 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
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.
BYETTA, SYMLIN and SymlinPen are registered trademarks and
BYDUREON is a trademark of Amylin Pharmaceuticals, Inc. All other
marks are the marks of their respective owners.
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