Exenatide Once Weekly Provided Sustained Improvements in Glycemic Control With Weight Loss Over Two Years: DURATION-1 Interim Lo
June 07 2009 - 9:15AM
PR Newswire (US)
Improvements in Systolic Blood Pressure and Triglycerides Also
Observed NEW ORLEANS, June 7 /PRNewswire-FirstCall/ -- Amylin
Pharmaceuticals, Inc. (NASDAQ:AMLN), Eli Lilly and Company
(NYSE:LLY), and Alkermes, Inc. (NASDAQ: ALKS) today announced
long-term, interim results from the DURATION-1 study that showed
sustained glucose control with weight loss, as well as improvements
in systolic blood pressure and triglycerides, through two years of
treatment with exenatide once weekly, an investigational therapy
for type 2 diabetes. These findings were presented at the 69th
Annual Scientific Sessions of the American Diabetes Association
(ADA) in New Orleans. A New Drug Application (NDA) for exenatide
once weekly was recently submitted to the U.S. Food and Drug
Administration. In the controlled portion of the open-label study,
patients received exenatide once weekly or BYETTA(R) (exenatide)
injection for 30 weeks, followed by 74 weeks of treatment with
exenatide once weekly for all patients during an open-ended
assessment period. Significant reductions in A1C of 1.7 percent and
fasting plasma glucose (FPG) of 40 mg/dL were maintained after two
years of treatment. Sixty-five percent of patients achieved an A1C
of 7 percent or less. A1C of less than 7 percent is the target for
good glucose control as recommended by the ADA. Body weight was
significantly reduced, with patients losing an average of 5.8
pounds. Serum lipid profiles were significantly improved, and there
was a significant reduction in systolic blood pressure (SBP).
"These two-year DURATION-1 data showed that maintenance of steady
state concentrations of exenatide may result in sustained
improvements in glycemic control, with potential weight loss," said
Orville G. Kolterman, M.D., senior vice president of research and
development at Amylin. "In DURATION-1, exenatide once weekly has
been shown to provide superior glycemic control, with weight loss,
compared to BYETTA. If approved, this therapy could fill an
important unmet need for treating patients with type 2 diabetes
with just one dose per week." Study Design and Findings The study
enrolled 295 patients, with nearly 75 percent completing the two
years of treatment. Baseline characteristics for these patients
were: A1C 8.2+/-1.0%, FPG 168+/-43 mg/dL, body weight 223+/-41
pounds, BMI 34.8+/-4.8 kg/m squared, diabetes duration 7.1+/-5.3
years. Significant improvements in both A1C [-1.7+/-0.1%] and FPG
[-40+/-3 mg/dL] were maintained after two years of treatment, body
weight was significantly reduced [-5.8+/-1.2 pounds], serum lipid
profiles were significantly improved [total cholesterol -8.6+/-2.8
mg/dL; LDL cholesterol -4.5+/-2.2 mg/dL; triglycerides -15+/-3
percent], and there was a significant reduction in SBP [-3.0+/-1.0
mmHg for all participants and -9.4+/-1.5 mmHg for those with
abnormal baselines]. Safety Profile Nausea was the most common
event during the 30-week treatment period and decreased over time,
occurring in 12 percent of patients during the 74-week assessment
period when all patients were receiving exenatide once weekly. No
severe hypoglycemia was observed. The safety profile of patients
treated in this study was consistent with the previously reported
profiles of BYETTA and exenatide once weekly. About Diabetes
Diabetes affects more than 23 million people in the United States
and an estimated 246 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 United States
and results in 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 support that weight loss (even a modest amount)
supports patients in their efforts to achieve and sustain glycemic
control.(vi,vii) About BYETTA(R) (exenatide) injection BYETTA is
the first and only FDA-approved incretin mimetic 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 approved by the FDA for use by people with type 2
diabetes who are unsuccessful at controlling their blood sugar
levels. BYETTA is an add-on therapy for people currently using
metformin, a sulfonylurea, or a thiazolidinedione. BYETTA provides
sustained A1C control and low incidence of hypoglycemia when used
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. For full prescribing information, visit
http://www.byetta.com/. Important Safety Information for BYETTA
BYETTA improves glucose (blood sugar) control in adults with type 2
diabetes. It is used with metformin, a sulfonylurea, or a
thiazolidinedione. BYETTA is not a substitute for insulin in
patients whose diabetes requires insulin treatment. BYETTA is not
recommended for use in patients with severe problems digesting food
or those who have severe disease of the stomach or kidney. When
BYETTA is used with a medicine that contains a sulfonylurea,
hypoglycemia (low blood sugar) is a possible side effect. To reduce
this possibility, the dose of sulfonylurea medicine may need to be
reduced while using BYETTA. Other common side effects with BYETTA
include nausea, vomiting, diarrhea, dizziness, headache, feeling
jittery and acid stomach. Nausea is the most common side effect
when first starting BYETTA, but decreases over time in most
patients. If patients experience the following severe and
persistent symptoms (alone or in combination): abdominal pain,
nausea, vomiting, or diarrhea, they should talk to their healthcare
provider because these symptoms could be signs of serious medical
conditions. BYETTA may reduce appetite, the amount of food eaten,
and body weight. No changes in dose are needed for these side
effects. These are not all of 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 full prescribing
information, visit http://www.byetta.com/. About Amylin, Lilly and
Alkermes Amylin, Lilly, and Alkermes are working together to
develop exenatide once weekly, a subcutaneous injection of
exenatide for the treatment of type 2 diabetes based on Alkermes'
proprietary technology for long-acting medications. Exenatide once
weekly is not currently approved by any regulatory agencies. Amylin
Pharmaceuticals is a biopharmaceutical company committed to
improving lives 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, pulmonary and oral products for the
treatment of prevalent, chronic diseases, such as central nervous
system disorders, addiction and diabetes. Headquartered in
Cambridge, Massachusetts, Alkermes has research facilities in
Massachusetts and a commercial manufacturing facility in Ohio. This
press release contains forward-looking statements about Amylin,
Lilly and Alkermes and the investigational drug, exenatide once
weekly. 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, exenatide once
weekly, and/or the revenues generated from BYETTA and/or exenatide
once weekly may be affected by competition; unexpected new data;
safety and technical issues; pre-clinical trial results; clinical
trials, including the clinical trial mentioned in this press
release, not being completed in a timely manner, not confirming
previous results, or not achieving the intended clinical endpoints;
the DURATION-1 study extension results potentially not being
accepted to support comparability; label expansion requests or NDA
filings, including the NDA filing mentioned in this press release,
not being submitted and/or accepted in a timely manner; regulatory
approval being delayed or not received; or manufacturing and supply
issues. The potential for BYETTA and/or exenatide once weekly 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. P-LLY
(i) "All About Diabetes." American Diabetes Association. Available
at: http://www.diabetes.org/about-diabetes.jsp. Accessed March 28,
2009. (ii) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed March 28, 2009. (iii) "Direct and Indirect Costs of
Diabetes in the United States." American Diabetes Association.
Available at:
http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp.
Accessed March 28, 2009. (iv) Saydah SH, Fradkin J and Cowie CC.
"Poor control of risk factors for vascular disease among adults
with previously diagnosed diabetes." JAMA: 291(3), January 21,
2004. (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. DATASOURCE: Amylin Pharmaceuticals, Inc.
CONTACT: Anne Erickson of Amylin Pharmaceuticals, Inc.,
+1-858-754-4443, Cell, +1-858-349-3195, ; or Kindra Strupp of Eli
Lilly and Company, +1-317-277-5170, Cell, +1-317-554-9577, ; or
Rebecca Peterson of Alkermes, Inc., +1-617-583-6378, Cell,
+1-617-899-2447, Web Site: http://www.amylin.com/
http:/www.BYETTA.com
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