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
issued a complete response letter regarding the New Drug
Application (NDA) for BYDUREON™ (exenatide for extended-release
injectable suspension).
In the complete response letter there are no requests for new
pre-clinical or clinical trials. Requests raised in the
letter primarily relate to the finalization of the
product labeling with accompanying Risk Evaluation and
Mitigation Strategy (REMS) and clarification of existing
manufacturing processes.
The complete response letter does not contain requests related
to the December 2009 observations from the FDA’s pre-approval
inspection at the Ohio manufacturing facility. All of those
observations have been addressed.
“This is a significant step forward in our ability to bring this
important therapy to patients,” said Orville G. Kolterman, M.D.,
senior vice president of research and development, Amylin
Pharmaceuticals. “We have a clear path forward and are working
diligently to submit our response to the FDA in the next few
weeks.”
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 accepted by
the FDA in July 2009. It is based on data from the DURATION
clinical trial program, as well as more than seven years of
clinical experience with BYETTA.
Amylin to Host Investor Conference Call
Amylin will host a conference call to discuss the complete
response letter for BYDUREON on Monday, March 15 at 8:30 a.m.
ET/5:30 a.m. PT. Daniel M. Bradbury, president and chief executive
officer, Amylin Pharmaceuticals, will lead the call.
The call will be webcast live through Amylin's corporate Web
site and a recording will be made available following the close of
the call. To access the webcast, please log on to www.amylin.com
approximately 15 minutes prior to the call to register, download
and install any necessary audio software. For those without access
to the Internet, the live call may be accessed by phone by calling
(800) 291-9234 (U.S./Canada) or (617) 614-3923 (international),
conference access code 12781062. A replay of the call will also be
available by phone beginning approximately two hours after the
close of the call and can be accessed at (888) 286-8010
(U.S./Canada) or (617) 801-6888 (international), conference access
code 34108583.
About Diabetes
Diabetes affects more than 24 million people in the U.S. and an
estimated 285 million adults worldwide.1,2 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.3
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.4 In addition, 85
percent of type 2 diabetes patients are overweight and 55 percent
are considered obese.5 Data indicate that weight loss (even a
modest amount) supports patients in their efforts to achieve and
sustain glycemic control.6,7
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
companies' response to the complete response letter may not be
submitted in a timely manner and/or the information provided in
such a response 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.
i The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed March 12, 2010.
ii Diabetes Statistics. American Diabetes Association. Available
at http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed March 12, 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 March 12, 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.
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