Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and
Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) today
announced top-line results from DURATION-6, a head-to-head study
designed to compare weekly BYDUREON™ (exenatide extended-release
for injectable suspension), an investigational type 2 diabetes
therapy, to daily Victoza® (liraglutide (rDNA origin) injection).
Both drugs are members of the class of type 2 diabetes medications
known as glucagon-like peptide-1 (GLP-1) receptor agonists.
This open-label 26-week, multicenter clinical study compared
BYDUREON (2 mg weekly) to Victoza administered at the maximum
approved dose of 1.8 mg daily. The study was designed to measure
A1C, an assessment of average blood sugar, and to evaluate safety
and tolerability.
Results showed that patients receiving BYDUREON experienced a
reduction in A1C of 1.3 percentage points from baseline, compared
to a reduction of 1.5 percentage points for Victoza. BYDUREON did
not meet the pre-specified primary endpoint of non-inferiority to
Victoza.
More than 85 percent of patients in both treatment arms
completed the study. Gastrointestinal adverse events occurred more
frequently among Victoza patients (nausea reported among 20 percent
of patients, vomiting 11 percent, diarrhea 13 percent) compared
with BYDUREON patients (nausea 9 percent, vomiting 4 percent,
diarrhea 6 percent). Injection site nodule occurred more frequently
among BYDUREON users (10 percent) compared with Victoza users (1
percent). There were no major hypoglycemia events in either
treatment group.
Further evaluation of this data set is underway and, when
complete, the companies plan to submit the full study results for
publication.
“While this study did not meet its primary endpoint, these
results reinforce the important role of GLP-1 receptor agonists in
the treatment of type 2 diabetes,” said Gwen Krivi, M.D., vice
president, product development, Lilly Diabetes. “This is the sixth
DURATION study showing once-weekly BYDUREON had a significant A1C
reduction from baseline. If approved, BYDUREON could provide
millions of patients a once-weekly treatment option.”
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 more than 70
countries worldwide to improve glycemic control in adults with type
2 diabetes.
The New Drug Application for BYDUREON was submitted to the U.S.
Food and Drug Administration (FDA) in 2009. The FDA issued a
complete response letter and requested further data in October
2010. The companies plan to submit a response in the second half of
2011.
Study Design
DURATION-6 is the sixth in a series of studies comparing
BYDUREON to other type 2 diabetes medications. The 26-week,
head-to-head, open-label, superiority study enrolled approximately
900 patients in 19 countries outside the U.S. with type 2 diabetes
who were not achieving adequate A1C control with diet and exercise
in conjunction with metformin, a sulfonylurea, metformin plus a
sulfonylurea or metformin plus Actos® (pioglitazone HCI). Patients
had an average type 2 diabetes diagnosis of more than eight years.
The patients were randomized to receive subcutaneous injection of
either BYDUREON (2 mg, once per week) (n=461) or Victoza (forced
titration to 1.8 mg, once per day) (n=451). 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 safety and tolerability.
About Diabetes
Diabetes affects nearly 26 million people in the U.S. and an
estimated 285 million adults worldwide.1,2 Approximately 90-95
percent of those affected have type 2 diabetes. Diabetes costs
approximately $174 billion per year in direct and indirect medical
expenses.3
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.4 In addition, 85
percent of type 2 diabetes patients are overweight and 55 percent
are considered obese.5 Data indicate that weight loss (even a
modest amount) supports patients in their efforts to achieve and
sustain glycemic control.6,7
About BYETTA® (exenatide) injection
BYETTA was the first 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 has been used by more than 1.5 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 agency.
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, pulmonary 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 and/or the European Commission 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 future
revenues from BYDUREON, if approved, and/or BYETTA (exenatide for
injection) may be affected by competition; unexpected new data;
safety and technical issues; clinical trials, including the
clinical trial mentioned in this press release, 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., and Medisorb® is a registered
trademark of Alkermes, Inc. All other marks are the marks of
their respective owners.
1 Diabetes Statistics. American Diabetes Association. Available
at: http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed March 2, 2011.
2 The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed March 2, 2011.
3 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 March 2,2011.
4 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.
5 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.
6 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.
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