INDIANAPOLIS, SAN DIEGO and WALTHAM, Mass., June
21, 2011 /PRNewswire/ -- Eli Lilly and Company (NYSE: LLY),
together with Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and
Alkermes, Inc. (Nasdaq: ALKS), announced today that the European
Commission has granted marketing authorization to BYDUREON™
(exenatide 2 mg powder and solvent for prolonged release suspension
for injection).
BYDUREON, a glucagon-like peptide-1 (GLP-1) receptor agonist, is
the first once-weekly treatment for type 2 diabetes. It delivers
glycemic control in a single weekly dose and is indicated for the
treatment of type 2 diabetes in adult patients in combination with
metformin, a sulfonylurea, a thiazolidinedione, metformin plus a
sulfonylurea or metformin plus a thiazolidinedione.
"As the global impact of diabetes continues to expand, so does
the need for innovative medicines to help people living with
diabetes successfully fit treatment into their lives," said
Enrique Conterno, president, Lilly
Diabetes. "BYDUREON is the first and only once-weekly treatment for
type 2 diabetes and has demonstrated powerful efficacy in multiple
clinical trials."
The EU Marketing Authorization of BYDUREON is based on review of
the submission package, including data from studies in the DURATION
clinical program in which exenatide resulted in improvements in
glycemic control with just one dose per week. In the data
submitted, BYDUREON showed statistically significant improvements
in glycemic control based on reduction of A1C (a measure of average
blood sugar over three months) between 1.5 and 1.9 percent after
six months. Although BYDUREON was not studied as a weight-loss
product, most patients taking BYDUREON lost weight. Further, the
BYDUREON submission builds upon six years of market experience with
BYETTA® (exenatide) injection, the twice-daily form of exenatide
that is available in more than 70 countries worldwide. The most
common side effect with BYDUREON in clinical trials was
mild-to-moderate nausea, which affected approximately 20 percent of
patients and decreased over time in most patients. Other common
side effects were vomiting, diarrhea and constipation.
In the U.S., the New Drug Application for BYDUREON (exenatide
extended-release for injectable suspension) was submitted to the
U.S. Food and Drug Administration (FDA) in 2009. The FDA issued a
complete response letter and requested further data in late 2010.
The companies plan to submit a response in the second half of 2011.
BYDUREON is the proposed trade name.
BYDUREON is delivered using a biodegradable microsphere
technology developed by Alkermes. The medicine offers a continuous
release of exenatide with just one weekly dose.
About Diabetes
Diabetes affects an estimated 285 million adults worldwide and
nearly 26 million people in the U.S.(1),(2) Approximately
90-95 percent of those affected have type 2 diabetes. Diabetes
costs exceed $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 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 postmarketing 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 was approved in the EU in
June 2011 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.
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 as soon as anticipated or at all;
the companies' response to the FDA's complete response letter may
not be submitted in a timely manner and/or the information provided
in such 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 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.
P-LLY
(1) Diabetes Statistics. American Diabetes Association.
Available at
http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed June 14, 2011.
(2) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-live-diabetes-2010.
Accessed June 14, 2011.
(3) 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 June 14, 2011.
(4) 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.
(5) 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.
(6) Nutrition Recommendations and Interventions for Diabetes: a
position statement of the American Diabetes Association.
Diabetes Care 2008; 31 Suppl 1; S61-78.
(7) 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 Pharmaceuticals, Inc.