New Drug Application for Exenatide Once Weekly Accepted for Review by FDA
July 07 2009 - 4:05PM
PR Newswire (US)
SAN DIEGO, INDIANAPOLIS and CAMBRIDGE, Mass., July 7
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc.,
(NASDAQ:AMLN), Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc.
(NASDAQ:ALKS) today announced that the New Drug Application (NDA)
for exenatide once weekly has been accepted for review by the U.S.
Food and Drug Administration (FDA). Exenatide once weekly is an
investigational sustained release medication for type 2 diabetes
that is injected subcutaneously and administered only once a week.
Exenatide is the active ingredient in BYETTA(R) (exenatide)
injection, which is currently available in the U.S. and in many
countries worldwide for people with type 2 diabetes who are unable
to achieve good glycemic control with common oral therapies.
"Acceptance of the NDA submission for exenatide once weekly is an
important milestone both in the exenatide development program and
in the treatment of type 2 diabetes," said Orville G. Kolterman,
M.D., senior vice president of research and development at Amylin
Pharmaceuticals. "If approved, this therapy could fill an important
unmet need for treating patients with type 2 diabetes with just one
dose per week." About Diabetes Diabetes affects more than 23
million people in the U.S. 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 U.S. 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 indicate 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 and/or the approval
of exenatide once weekly and 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 not being completed in a timely
manner, not confirming previous results, or not achieving the
intended clinical endpoints; label expansion requests or NDA
filings 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.;
Eli Lilly and Company; Alkermes, 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.byetta.com/ http://www.amylin.com/
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