Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and
Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today
announced results from an analysis of the DURATION-1 study that
showed the investigational type 2 diabetes medication BYDUREON™
(exenatide extended-release for injectable suspension) was not
associated with clinically relevant QT prolongation in patients
with type 2 diabetes. These findings will be presented in a poster
session at the 71st Scientific Sessions of the American Diabetes
Association in San Diego on Saturday, June 25 from 11:30 a.m. to
1:30 p.m. PDT.
The QT interval represents the amount of time the heart’s
electrical system takes to repolarize, or recharge, after each
beat.1 Drugs that substantially prolong the QT interval have been
associated with cardiac arrhythmias.
This analysis used data from the DURATION-1 study to evaluate
changes in the QT interval associated with BYDUREON, correcting for
heart rate with Fridericia’s formula (QTcF). The change in QTcF
from baseline was small and clinically insignificant at 14 weeks
(1.7 milliseconds) and 30 weeks (3.0 milliseconds). There was no
correlation between change in QTcF and exenatide blood plasma
concentrations or renal status.
“These results suggest BYDUREON does not produce clinically
relevant QT prolongation,” said Christian Weyer, M.D., senior vice
president, research and development, Amylin Pharmaceuticals. “To
further characterize the QT-related safety of BYDUREON, we are
currently conducting a thorough QT study according to guidelines
set by the FDA. We believe that BYDUREON could be an important
treatment option for patients with type 2 diabetes, and we continue
to focus our efforts on making this once-weekly therapy available
to patients and healthcare providers in the U.S.”
BYDUREON received marketing authorization in the European Union
earlier this month. In the U.S., the FDA issued a complete response
letter for the BYDUREON New Drug Application in late 2010. The
companies plan to submit a response, including results of the
thorough QT (tQT) study, in the second half of 2011. The tQT study
uses intravenous exenatide to achieve plasma exenatide
concentrations expected with BYDUREON, including the concentrations
expected in patients with renal impairment.
BYDUREON is the proposed brand name for exenatide
extended-release for injectable suspension. It is an
investigational 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 more than 70
countries worldwide to improve glycemic control in adults with type
2 diabetes.
Analysis Design
This analysis included 148 patients with type 2 diabetes from
the BYDUREON arm of DURATION-1, a phase 3, randomized, open-label,
comparator-controlled trial. Electrocardiogram (ECG) recordings
were performed at baseline; once steady-state plasma exenatide
concentrations had been achieved following at least 14 weeks of
treatment; and in a subset of patients at 30 weeks of treatment or
sooner if the patient left the study early. Board-certified
cardiologists who were blinded to treatment assignment performed
analyses (interpretations) of all ECG tracings.
About Diabetes
Diabetes affects nearly 26 million people in the U.S. and an
estimated 285 million adults worldwide.2,3 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.4
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.5 In addition, 85
percent of type 2 diabetes patients are overweight and 55 percent
are considered obese.6 Data indicate that weight loss (even a
modest amount) supports patients in their efforts to achieve and
sustain glycemic control.7,8
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 the
analysis mentioned in this press release may not be predictive;
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
QT study mentioned in this press release may not produce the
results we expect; 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 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.
1 Long QT Syndrome. Heart Rhythm Society. Available at
http://www.hrsonline.org/PatientInfo/HeartRhythmDisorders/IDisorders/index.cfm.
Accessed June 17, 2011.
2 Diabetes Statistics. American Diabetes Association. Available
at http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed June 17, 2011.
3 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.
4 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.
5 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.
6 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.
7 Nutrition Recommendations and Interventions for Diabetes: a
position statement of the American Diabetes Association. Diabetes
Care 2008; 31 Suppl 1; S61-78.
8 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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