Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes plc
(Nasdaq: ALKS) today announced results from the long-term extension
of the DURATION-1 study, which showed that BYDUREON™ (exenatide
extended-release for injectable suspension), the first and only
once-weekly treatment for type 2 diabetes, was associated with
clinically significant and sustained improvements in glycemic
control during four years of treatment in adults with type 2
diabetes.
In the study, being presented at the 72nd Scientific Sessions of
the American Diabetes Association in Philadelphia, patients
completing four years of BYDUREON treatment experienced clinically
significant improvements in A1C (1.7 percentage points) and fasting
plasma glucose (-37 mg/dL) from baseline. A1C is a measure of
average blood sugar over three months. Although BYDUREON is not
indicated for weight loss, patients treated with BYDUREON also lost
an average of 5.5 pounds from baseline.
“In this study, patients treated with just one dose per week of
BYDUREON for four years experienced sustained improvement in
glycemic control and showed reductions in certain cardiometabolic
measures. The tolerability of BYDUREON also improved over time with
long-term treatment,” said Christian Weyer, M.D., senior vice
president, research and development, Amylin Pharmaceuticals. “The
durability of treatment effectiveness and tolerability of BYDUREON
are critically important in managing the chronic and progressive
condition of type 2 diabetes.”
Patients treated with BYDUREON also experienced statistically
significant reductions in certain cardiovascular risk markers,
including systolic blood pressure (-1.6 mmHg), total cholesterol
(-10.9 mg/dL), LDL cholesterol (-8.0 mg/dL) and triglycerides (-13
percent). No unexpected safety findings were observed with
long-term BYDUREON therapy, and incidence of mild nausea, the most
common adverse event during the controlled portion of the study,
decreased over time (27 percent weeks 1-30; 1.6 percent weeks
180-212).
Study Details DURATION-1 compared the efficacy of
once-weekly BYDUREON against twice-daily BYETTA® (exenatide)
injection in a 30-week, randomized, open-label study. Following the
controlled portion of the study, 258 of the 295 intent-to-treat
patients (87 percent) entered the extension study. A total of 68
percent of patients (n=176) completed four years of treatment, 55
percent of whom achieved the ADA-recommended A1C target of less
than 7 percent. Primary endpoints were change from baseline to year
four in A1C, and long-term safety and tolerability.
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’
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) 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. 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 2 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 Amylin Pharmaceuticals Amylin 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.
About Alkermes plc Alkermes plc is a fully integrated,
global biopharmaceutical company that applies its scientific
expertise and proprietary technologies to develop innovative
medicines that improve patient outcomes. The company has a
diversified portfolio of more than 20 commercial drug products and
a substantial clinical pipeline of product candidates that address
central nervous system (CNS) disorders such as addiction,
schizophrenia and depression. Headquartered in Dublin, Ireland,
Alkermes plc has an R&D center in Waltham, Mass., and
manufacturing facilities in Athlone, Ireland; Gainesville, Ga.; and
Wilmington, Ohio. For more information, please visit Alkermes’
website at www.alkermes.com.
Forward-Looking Statement This press release contains
forward-looking statements about Amylin and Alkermes. Actual
results could differ materially from those discussed or implied in
this press release due to a number of risks and uncertainties,
including the risk that BYETTA and/or BYDUREON and the revenues
generated from these products may be affected by competition;
unexpected new data; safety and technical issues; clinical trials
not being completed in a timely manner, not confirming previous
results, not being predictive of real-world use or not achieving
the intended clinical endpoints; label expansion requests or New
Drug Application filings not being submitted and/or accepted in a
timely manner or receiving regulatory approval; the commercial
launch of BYDUREON in the U.S. not being successful; or
manufacturing and supply issues. The potential for BYETTA and/or
BYDUREON may also be affected by government and commercial
reimbursement and pricing decisions, the pace of market acceptance
or scientific, regulatory and other issues and risks inherent in
the development and commercialization of pharmaceutical products.
These and additional risks and uncertainties are described more
fully in Amylin’s and Alkermes’ SEC filings including their
Quarterly Reports on Form 10-Q and Annual Reports on Form 10-K.
Amylin and Alkermes undertake no duty to update these
forward-looking statements.
BYETTA is a registered trademark and BYDUREON is a trademark of
Amylin Pharmaceuticals, Inc. All other marks are the marks of their
respective owners.
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