SAN DIEGO, INDIANAPOLIS and WALTHAM, Mass., May 6,
2010 /PRNewswire-FirstCall/ -- 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) has classified the BYDUREON™ (exenatide for
extended-release injectable suspension) complete response as a
Class 2 resubmission and assigned a new Prescription Drug User Fee
Act (PDUFA) action date of October 22,
2010.
"If approved, BYDUREON will be the first once-weekly treatment
for type 2 diabetes, and we are committed to making this important
therapeutic option available to patients as soon as possible," said
Orville G. Kolterman, M.D., senior
vice president of research and development, Amylin Pharmaceuticals.
"We will continue to work closely with the agency through this
final stage of the review process."
The new drug application (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® (exenatide) injection.
The agency issued a complete response letter to the companies in
March 2010 and the companies
responded to that letter in April
2010.
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, 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.
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 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
companies' response to the 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 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 May 3, 2010.
(ii) Diabetes Statistics. American Diabetes Association.
Available at
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed May 3, 2010.
(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 May 3, 2010.
(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.
(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.
SOURCE Amylin Pharmaceuticals, Inc.