SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., June
15, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and
Alkermes, Inc. (Nasdaq: ALKS) today announced results from
DURATION-4, the fourth in a series of studies designed to test the
superiority of BYDUREON™ (exenatide extended-release for injectable
suspension), an investigational type 2 diabetes therapy, as
compared to other type 2 diabetes medications.
This 26-week clinical study compared BYDUREON monotherapy to
Januvia® (sitagliptin), Actos® (pioglitazone HCI) or metformin,
three oral type 2 diabetes medications commonly prescribed early in
the treatment of type 2 diabetes. Study participants were not
achieving adequate A1C control using diet and exercise, and were
not on any diabetes therapy when they entered the study. A1C is a
measure of average blood sugar over three months. After 26 weeks of
treatment, patients randomized to BYDUREON experienced
a reduction in A1C of 1.5 percentage points from baseline,
which was significantly greater than the reduction of 1.2
percentage points for Januvia. Patients randomized to metformin
experienced a reduction in A1C of 1.5 percentage points, and
patients receiving Actos experienced a reduction of 1.6 percentage
points. Patients receiving BYDUREON, Actos and metformin treatment
achieved an average A1C of less than 7 percent by study end.
Treatment with BYDUREON produced an average weight loss of 4.5
pounds, which was statistically significantly greater than the
average 1.7 pounds patients lost with Januvia and the average 3.3
pounds patients gained with Actos. Patients receiving metformin
experienced an average weight loss of 4.4 pounds.
"The majority of patients in this study reached an optimal A1C
goal of less than seven percent, which is the glucose control
target recommended by the American Diabetes Association," said
Orville G. Kolterman, M.D., senior
vice president, chief medical officer, Amylin Pharmaceuticals.
"DURATION-4 reinforced that continued presence of exenatide helped
these recently diagnosed patients to achieve glycemic control. The
combination of efficacy, tolerability, and once weekly dosing in
this monotherapy setting further supports the potential role
BYDUREON can play in helping patients and physicians manage type 2
diabetes."
More than 80 percent of patients in all treatment arms completed
the study. There were no major hypoglycemia events in any treatment
group. The most frequently reported adverse events among BYDUREON
users were nausea (withdrawal rate less than 1 percent) and
diarrhea; metformin, diarrhea and headache; Actos, upper
respiratory tract infection, headache, hypertension and peripheral
edema; and Januvia, upper respiratory tract infection and
headache.
BYDUREON (pronounced by-DUR-ee-on) is the proposed brand name
for exenatide once weekly. It is an investigational,
extended-release medication for type 2 diabetes designed to deliver
continuous therapeutic levels of exenatide in a single weekly dose.
BYDUREON 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 approximately 60 countries worldwide to improve
glycemic control in adults with type 2 diabetes. BYDUREON and
BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor
agonist class of medications.
Study Design
The 26-week, double-blind, randomized, four-arm parallel study
enrolled 820 patients who were not achieving adequate A1C control
on diet and exercise. Patients had an average type 2 diabetes
diagnosis of two to three years. The patients were randomized as
follows: BYDUREON (2 mg, once per week) (n=248); metformin (dose
escalated up to 2,500 mg/day) (n=246); Actos (dose escalated up to
45 mg/day) (n=163); and Januvia (100 mg/day) (n=163). The primary
endpoint was reduction in A1C, while secondary endpoints included
change in body weight along with other parameters of glucose
control, cardiovascular health and patient-reported outcomes.
The companies plan to present the full data set at a major
medical meeting and submit the data for publication.
About Diabetes
Diabetes affects more than 24 million people in the U.S. and an
estimated 285 million adults worldwide.(i,ii) Approximately 90-95
percent of those affected have type 2 diabetes. Diabetes is the
fifth leading cause of death by disease in the U.S. and costs
approximately $174 billion per year
in direct and indirect medical expenses.(iii)
According to the Centers for Disease Control and Prevention's
National Health and Nutrition Examination Survey, approximately 60
percent of people with diabetes do not achieve their target blood
sugar levels with their current treatment regimen.(iv) In addition,
85 percent of type 2 diabetes patients are overweight and 55
percent are considered obese.(v) Data indicate that weight loss
(even a modest amount) supports patients in their efforts to
achieve and sustain glycemic control.(vi,vii)
About BYETTA® (exenatide) injection
BYETTA is the first FDA-approved GLP-1 receptor agonist 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 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
recommended to be taken with insulin. BYETTA is not for people with
type 1 diabetes or people with diabetic ketoacidosis.
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 April 2005 and has been used by more than one
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. 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. Severe allergic
reactions can happen with BYETTA.
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, Lilly and Alkermes
Amylin, Lilly and Alkermes are working together to develop
BYDUREON, a subcutaneous injection of exenatide for the treatment
of type 2 diabetes based on Alkermes' proprietary Medisorb®
technology for long-acting medications. BYDUREON is not currently
approved by any regulatory agencies.
Amylin Pharmaceuticals is a biopharmaceutical company dedicated
to improving lives of patients through the discovery, development
and commercialization of innovative medicines. 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.
Through a long-standing commitment to diabetes care, Lilly
provides patients with breakthrough treatments that enable them to
live longer, healthier and fuller lives. Since 1923, Lilly has been
the industry leader in pioneering therapies to help healthcare
professionals improve the lives of people with diabetes, and
research continues on innovative medicines to address the unmet
needs of patients.
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of pharmaceutical products by applying the latest
research from its own worldwide laboratories and from
collaborations with eminent scientific organizations. Headquartered
in Indianapolis, Indiana, Lilly
provides answers – through medicines and information – for some of
the world's most urgent medical needs.
Alkermes, Inc. is a fully integrated biotechnology company
committed to developing innovative medicines to improve patients'
lives. Alkermes' robust pipeline includes extended-release
injectable and oral products for the treatment of prevalent,
chronic diseases, such as central nervous system disorders,
addiction and diabetes. Headquartered in Waltham, Massachusetts, Alkermes has a
research facility in Massachusetts
and a commercial manufacturing facility in Ohio.
This press release contains forward-looking statements about
Amylin, Lilly 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 BYDUREON
may not be approved by the FDA in a timely manner or at all; the
companies' response to the complete response letter may not satisfy
the FDA; the FDA may request additional information prior to
approval; BYETTA and/or the approval of 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 NDA
filings, such as the NDA filing for BYDUREON, not receiving
regulatory approval; the commercial launch of BYDUREON being
delayed; or manufacturing and supply issues. The potential for
BYETTA and/or BYDUREON, if approved, 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 including those inherent in the
collaboration with and dependence upon Amylin, Lilly and/or
Alkermes. These and additional risks and uncertainties are
described more fully in Amylin's, Lilly's and Alkermes' most recent
SEC filings including their Quarterly Reports on Form 10-Q and
Annual Reports on Form 10-K. Amylin, Lilly and Alkermes undertake
no duty to update these forward-looking statements.
BYDUREON™ and BYETTA® are trademarks of
Amylin Pharmaceuticals, Inc., and Medisorb® is
a registered trademark of Alkermes, Inc. All other marks are the
marks of their respective owners.
P-LLY
(i) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed May 28, 2010.
(ii) Diabetes Statistics. American Diabetes Association.
Available at:
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed May 28, 2010.
(iii) Direct and Indirect Costs of Diabetes in
the United States. American
Diabetes Association. Available at:
http://www.diabetes.org/how-to-help/action/resources/cost-of-diabetes.html.
Accessed May 28, 2010.
(iv) Saydah SH, Fradkin J and Cowie CC. Poor control of
risk factors for vascular disease among adults with previously
diagnosed diabetes. JAMA. 2004;291:335-42.
(v) Bays HE, Chapman RH, Grandy S. The relationship of
body mass index to diabetes mellitus, hypertension and
dyslipidaemia: comparison of data from two national surveys. Int
J Clin Pract. 2007;61:737-47.
(vi) Nutrition Recommendations and Interventions for
Diabetes: a position statement of the American Diabetes
Association. Diabetes Care. 2007;30 Suppl 1:S48-65.
(vii) Anderson JW, Kendall CW, Jenkins DJ. Importance of
weight management in type 2 diabetes: review with meta-analysis of
clinical studies. J Am Coll Nutr. 2003;22:331-9.
SOURCE Amylin Pharmaceuticals, Inc.