Plans for Exenatide Once Weekly NDA Submission by End of First Half of 2009 Reaffirmed Following FDA Feedback
December 11 2008 - 6:30AM
PR Newswire (US)
Companies Intend To Use Ongoing Study To Meet Manufacturing
Comparability Requirements SAN DIEGO, INDIANAPOLIS, and CAMBRIDGE,
Mass., Dec. 11 /PRNewswire/ -- Amylin Pharmaceuticals, Inc.,
(NASDAQ:AMLN), Eli Lilly and Company (NYSE: LLY) and Alkermes, Inc.
(NASDAQ:ALKS) today announced that the U.S. Food and Drug
Administration (FDA) recently indicated that the ongoing extension
of the DURATION-1 study is appropriate to use as the basis for
demonstrating comparability between intermediate-scale clinical
trial material made in Alkermes' manufacturing facility, and
commercial-scale drug product made at Amylin's manufacturing
facility. "Following feedback from FDA, we now have an appropriate
pathway to demonstrate manufacturing comparability of exenatide
once weekly. This is a very important step for the submission of
exenatide once weekly," said Orville G. Kolterman, M.D., senior
vice president, research and development at Amylin Pharmaceuticals.
"We remain confident that our NDA submission is on track to be
completed by the end of the first half of 2009." Final acceptance
of the comparability data is dependent upon DURATION-1 study
extension results that are expected in early 2009. DURATION Program
Update The overall DURATION clinical program, designed to
demonstrate superiority of exenatide once weekly as compared to
other medications in the treatment of type 2 diabetes, remains on
track. The companies recently initiated DURATION-4, the fourth
planned DURATION study. The DURATION-4 study examines exenatide
once weekly as a monotherapy treatment compared to either
metformin, a thiazolidinedione (TZD) or a dipeptidyl peptidase-4
(DPP-4) inhibitor. The double-blind study is expected to include
approximately 800 patients and complete in 2010. "We are confident
that the strategy of the DURATION program will yield powerful data
to support a strong launch for exenatide once weekly," said James
Malone, M.D., global exenatide medical director, Eli Lilly and
Company. "We believe the program will demonstrate the value of
exenatide once weekly to physicians, patients and payers."
DURATION-3 completed enrollment in the fourth quarter. This
approximately 450 patient, open-label, superiority study compares
exenatide once weekly with insulin glargine on a background of oral
agent therapy. Results are expected in the third quarter of 2009.
DURATION-2 completed enrollment in the third quarter of 2008. This
500 patient, double-blind, superiority study compares exenatide
once weekly with TZD and a DPP-4 inhibitor on a background of
metformin therapy. Results are expected in the second quarter of
2009. DURATION is an acronym for the overall exenatide once weekly
clinical program. It stands for "Diabetes therapy Utilization:
Researching changes in A1C, weight and other factors Through
Intervention with exenatide ONce weekly." Exenatide once weekly
uses a proprietary technology for long-acting medications developed
by Alkermes. The technology encapsulates active medication into
polymer-based microspheres that are injected into the body where
they degrade slowly, gradually releasing the drug in a controlled
manner to provide continuous therapeutic exenatide levels in
plasma. About Diabetes Diabetes affects more than 23 million 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 costs approximately $132 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, low incidence of hypoglycemia when used with
metformin or a thiazolidinedione, and progressive weight loss.
BYETTA was approved in April 2005 and has been used by
approximately 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 first-in-class and
best-in-class 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. 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
exenatide once weekly and the revenues generated from BYETTA may be
affected by competition; unexpected new data; safety and technical
issues; clinical trials, including the clinical trials 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; pre-clinical trials not
predicting future results; label expansion requests or NDA filings,
including the NDA filing mentioned in this press release, not being
submitted 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) The
International Diabetes Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed June 2, 2008. (ii) "All About Diabetes." American Diabetes
Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed June 8, 2008.
(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 June 8, 2008. (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. 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. (Logo:
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http://www.newscom.com/cgi-bin/prnh/20060610/AMYLINLOGO
http://photoarchive.ap.org/ DATASOURCE: Eli Lilly and Company
CONTACT: Alice Izzo of Amylin, +1-858-642-7272, or cell,
+1-858-232-9072, ; or Kindra Strupp of Lilly, +1-317-277-5170 or
cell, +1-317-554-9577, ; or Rebecca Peterson of Alkermes,
+1-617-583-6378, or cell, +1-617-899-2447, Web site:
http://www.byetta.com/
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