SAN DIEGO, June 24, 2011 /PRNewswire/ -- Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE:
LLY) and Alkermes, Inc. (Nasdaq: ALKS) today announced additional
results from a phase 2 study of an investigational, once-monthly
injectable suspension formulation of exenatide which showed
substantial improvements in glycemic control, including reductions
in A1C and fasting plasma glucose, with modest weight loss. These
findings will be presented in a late breaking poster session at the
71st Scientific Sessions of the American Diabetes Association on
Sunday, June 26 from 12-2 p.m. PDT.
The 121-patient study assessed the efficacy, safety and
tolerability of three different doses (5 mg, 8 mg and 11 mg) of
exenatide once monthly, a long-acting glucagon-like peptide-1
(GLP-1) receptor agonist. After 20 weeks of treatment (total of
five injections), patients receiving exenatide once monthly
experienced average improvements in A1C (a measure of average blood
sugar over three months) from baseline of 1.3 percentage points for
the 5 mg and 8 mg doses and 1.5 percentage points for the 11 mg
dose. In addition, 50 percent of those treated with the 5 mg dose,
57 percent treated with the 8 mg dose and 70 percent treated with
the 11 mg dose achieved an A1C of less than 7 percent, the
ADA-recommended target for good glucose control. Patients also lost
a modest amount of weight (0.9 pounds with the 8 mg dose and 2.4
pounds with the 5 mg and 11 mg doses), although exenatide once
monthly is not being studied as a weight-loss product. Fasting
plasma glucose was improved with all doses, with reductions of 25
mg/dL with the 5 mg dose, 30 mg/dL with the 8 mg dose and 49 mg/dL
with the 11 mg dose. The mean pharmacokinetic profile showed all
three exenatide once monthly doses resulted in steady-state
exenatide plasma levels within the known therapeutic range.
As a reference arm, the study also included patients receiving
BYDUREON™ (exenatide extended-release for injectable suspension),
another investigational form of exenatide that is dosed
once-weekly. Results for A1C, fasting glucose and weight in the
exenatide once monthly treatment arms were generally comparable to
those seen in the BYDUREON reference arm. Patients receiving
BYDUREON experienced reductions in A1C (1.5 percentage points),
fasting plasma glucose (34 mg/dL) and weight (3.1 pounds) compared
to baseline.
"Our exenatide suspension program builds upon our extensive
experience and knowledge gained throughout the development of
BYETTA and BYDUREON, and suggests promise in harnessing the
therapeutic potential of continuous GLP-1 agonism in a monthly
dose," said Christian Weyer, M.D.,
senior vice president, research and development, Amylin
Pharmaceuticals. "We are committed to expanding the treatment
options available to patients living with type 2 diabetes through
the continued investigation of additional formulations of
exenatide."
More than 90 percent of patients completed the study. The most
common adverse events within the exenatide once monthly treatment
groups were headache (17-27 percent) and nausea (17-23 percent).
Headache (30 percent) and diarrhea (27 percent) were most common
among the BYDUREON group. No major or minor hypoglycemia was
reported in the study. The duration of adverse events was generally
similar between treatment groups.
Exenatide once monthly is an investigational, extended-release
formulation of exenatide, the active ingredient in BYETTA®
(exenatide) injection, which is given twice daily. Exenatide once
monthly is based on the same microsphere technology used in
BYDUREON. BYDUREON is the proposed brand name for exenatide
extended-release for injectable suspension, an investigational
medication for type 2 diabetes designed to deliver continuous
therapeutic levels of exenatide in a single weekly dose. BYDUREON
received marketing authorization in the European Union earlier this
month.
Study Design
This phase 2, randomized, open-label, dose-ranging study
included 121 adults with type 2 diabetes (baseline A1C: 8.6 percent
for BYDUREON and 8.4-8.5 percent for exenatide once monthly) who
were not achieving adequate glucose control using diet and exercise
alone or with a stable regimen of metformin, Actos® (pioglitazone)
or both. Subjects were randomized to receive either 2 mg weekly
subcutaneous injections of BYDUREON or subcutaneous injections of
exenatide once monthly at a low (5 mg), medium (8 mg) or high (11
mg) dose administered once every four weeks for 20 weeks.
About Diabetes
Diabetes affects nearly 26 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 costs more
than $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 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, Lilly and Alkermes
Amylin and Lilly partnered to develop and market BYDUREON, which
is based on proprietary technology for long-acting medications
developed by Alkermes, Inc. BYDUREON is approved in the EU and is
under regulatory review in the U.S.
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.
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, 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, Mass., 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 as soon as anticipated or at all;
the companies' response to the FDA's complete response letter may
not be submitted in a timely manner and/or the information provided
in such response 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, including the trial mentioned in
this press release, not being completed in a timely manner, not
confirming previous results, not being replicated in future
studies, not being predictive of real world use or not achieving
the intended clinical endpoints; label expansion requests or NDA
filings not receiving regulatory approval; the commercial launch of
BYDUREON being delayed; 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 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. All other marks are the marks of their
respective owners.
P-LLY
(i) Diabetes Statistics. American Diabetes Association.
Available at:
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed June 17, 2011.
(ii) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed June 17, 2011.
(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 June 17, 2011.
(iv) Saydah SH, Fradkin J, 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. 2008;31 Suppl 1;S61-78.
(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.
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SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company;
Alkermes, Inc.