SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., April
22, 2010 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals,
Inc. (Nasdaq: AMLN), Eli Lilly and Company (NYSE: LLY) and
Alkermes, Inc. (Nasdaq: ALKS) today announced that the companies
have submitted their reply to a complete response letter issued
last month by the U.S. Food and Drug Administration (FDA) after
review of the New Drug Application (NDA) submission for BYDUREON™
(exenatide for extended-release injectable suspension). In
accordance with its guidelines, the FDA is expected to classify the
complete response as a Class 1 or Class 2 resubmission, and also
provide the companies with an updated Prescription Drug User Fee
Act (PDUFA) target action date within the next two weeks.
The companies' reply addresses requests from the FDA primarily
related to finalization of the product labeling with accompanying
Risk Evaluation and Mitigation Strategy (REMS) and clarification of
existing manufacturing processes.
The FDA's complete response letter did not request new
pre-clinical or clinical trials, nor did it contain requests
related to the December 2009
observations from the FDA's pre-approval inspection at the
Ohio manufacturing facility. All
of these observations have been addressed.
"The companies have worked diligently and quickly over the last
few weeks to submit a complete response and are confident we
addressed the requests that were outlined by the FDA," said
Orville G. Kolterman, M.D., senior
vice president of research and development, Amylin Pharmaceuticals.
"We are committed to making BYDUREON available to patients as soon
as possible and will continue to work closely with the agency
toward our goal."
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 approximately 60 countries worldwide to improve
glycemic control in adults with type 2 diabetes. BYDUREON and
BYETTA belong to the glucagon-like peptide-1 (GLP-1) receptor
agonist class of medications.
The NDA for BYDUREON was submitted in May
2009 and was based on data from the DURATION clinical trial
program, as well as more than seven years of clinical experience
with BYETTA. The NDA was accepted by the FDA in July 2009. The agency issued a complete response
letter to the companies in March
2010.
About Diabetes
Diabetes affects more than 24 million people in the U.S. and an
estimated 285 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 costs
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® (exenatide) injection
BYETTA is the first FDA-approved GLP-1 receptor agonist 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 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
recommended to be taken with insulin. BYETTA is not for people with
type 1 diabetes or people with diabetic ketoacidosis.
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 April 2005 and has been used by more than one
million patients since its introduction. See important safety
information below. Additional information about BYETTA is 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
(http://pi.lilly.com/us/byetta-pi.pdf) and Medication
Guide
(http://pi.lilly.com/us/byetta-ppi.pdf).
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 agencies.
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, 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 Waltham, Massachusetts, 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 in a timely manner or at all; the
information provided in the companies' response to the FDA's
complete response letter may not satisfy the FDA; 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, such as the NDA filing for
BYDUREON mentioned in this press release, not receiving regulatory
approval; the commercial launch of BYDUREON, if approved, 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.
P-LLY
(i) The International Diabetes Federation
Diabetes Atlas. Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed April 4, 2010.
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(ii) Diabetes Statistics. American Diabetes
Association. Available at
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed April 4, 2010.
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(iii) 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 April 4, 2010.
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(iv) 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.
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(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.
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(vi) Nutrition Recommendations and
Interventions for Diabetes: a position statement of the American
Diabetes Association. Diabetes Care. 2007;30 Suppl
1:S48-65.
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(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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SOURCE Amylin; Lilly; Alkermes