SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., July
28, 2011 /PRNewswire/ -- 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 in
October 2010 by the U.S. Food and
Drug Administration (FDA) regarding BYDUREON™ (exenatide
extended-release for injectable suspension), an investigational
medication for type 2 diabetes. The companies expect to receive an
updated Prescription Drug User Fee Act (PDUFA) action date from the
FDA within the next two weeks. Since the reply included additional
data, it will likely be categorized as a Class 2 resubmission
requiring up to six months for review.
The reply submission includes results from the recently
completed thorough QT (tQT) study, which showed that exenatide, at
and above therapeutic levels, did not prolong the corrected QT
interval in healthy individuals as defined by the FDA's published
guidance. The reply also contains results from the DURATION-5
study, which compared the commercial formulation of BYDUREON to
BYETTA® (exenatide) injection. Additionally, it includes an update
of safety information from studies ongoing or completed since the
last submission, as is standard practice in a complete response
scenario.
"We worked expeditiously to complete the requested tQT study and
consulted with the FDA throughout the process," said Christian Weyer, M.D., senior vice president,
research and development, Amylin Pharmaceuticals. "We are confident
that the study results and our detailed submission have addressed
the requirements outlined by the FDA, and we remain committed to
making BYDUREON available to patients in the U.S. as soon as
possible."
BYDUREON is the proposed brand name for exenatide
extended-release for injectable suspension. It is an
investigational 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 more than 70
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 New Drug Application (NDA) for BYDUREON was submitted in
May 2009. It is based on safety and
efficacy data from the DURATION clinical trial program and the
BYETTA NDA, as well as post-marketing experience with BYETTA. The
FDA issued complete response letters to the companies in
March 2010 and October 2010.
BYDUREON received marketing authorization in the European Union
in June 2011. It is available in the
U.K. and will launch in other major European countries as soon as
possible.
About Diabetes
Diabetes affects nearly 26 million people in the U.S. and an
estimated 347 million adults worldwide.(i)(ii) Approximately
90-95 percent of those affected have type 2 diabetes. In the U.S.,
diabetes costs more than $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 was the first glucagon-like peptide-1 (GLP-1) receptor
agonist to be approved by the FDA for the treatment of type 2
diabetes. BYETTA exhibits many of the same effects as the human
incretin hormone 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
currently recommended to be taken with insulin. BYETTA is not for
people with type 1 diabetes or people with diabetic ketoacidosis.
BYETTA has not been studied in people who have pancreatitis.
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 the U.S. in
April 2005 and in Europe in November
2006 and has been used by more than 1.8 million patients
since its introduction. See important safety information below.
Additional information about BYETTA is available 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. Patients should be observed for signs and
symptoms of pancreatitis after initiation or dose escalation of
BYETTA. 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. Antibodies may develop with use of BYETTA. Patients
who develop high titers to exenatide could have worsening or
failure to achieve adequate glycemic control. Consider alternative
therapy if this occurs. Severe allergic reactions can happen with
BYETTA. There have been no clinical studies establishing conclusive
evidence of macrovascular risk reduction with BYETTA or any other
antidiabetic drug.
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
(www.byetta.com/pi) and Medication Guide
(www.byetta.com/mg).
About Amylin, Lilly and Alkermes
Amylin and Lilly partnered to develop and market BYDUREON, which
is based on proprietary technology for long-acting medications
developed by Alkermes, Inc. BYDUREON is approved in the EU and is
under regulatory review in the U.S.
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 and has a commercial manufacturing facility in
Ohio.
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, 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, Mass., 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 or royalties 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 in the U.S.,
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.
P-LLY
(i) Diabetes Statistics. American Diabetes Association.
Available at:
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed July 19, 2011.
(ii) Danaei G, et al. National, regional, and global trends in
fasting plasma glucose and diabetes prevalence since 1980:
systematic analysis of health examination surveys and
epidemiological studies with 370 country-years and 2.7 million
participants. Lancet.
2011;DOI:10.1016/S0140-6736(11)60679-X.
(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 July 19, 2011.
(iv) Saydah SH, Fradkin J, 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. 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.
SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company;
Alkermes, Inc.