Eli Lilly and Company (NYSE: LLY), together with Amylin
Pharmaceuticals, Inc. (Nasdaq: AMLN) and Alkermes, Inc. (Nasdaq:
ALKS), announced today that the Committee for Medicinal Products
for Human Use (CHMP) of the European Medicines Agency (EMA) has
issued a positive opinion recommending approval of exenatide 2 mg
powder and solvent for prolonged release suspension for injection
(proposed trade name BYDUREON™) in the European Union for
the treatment of type 2 diabetes in combination with certain oral
therapies. This application to the European regulatory authorities
is for use of BYDUREON as a once-weekly 2 mg dose to improve
glycemic control in adults who have not achieved adequate glycemic
control on maximally tolerated doses of these oral therapies. If
approved, BYDUREON would be the first once-weekly type 2 diabetes
treatment.
The CHMP’s positive opinion is now referred for final action by
the European Commission, which has the authority to approve
medicines for the European Union. The Commission usually makes a
decision on CHMP recommendations within two to three months.
“The CHMP’s positive opinion is a pivotal step toward marketing
authorization for BYDUREON in Europe. If approved, BYDUREON will
offer patients the benefits of a GLP-1 receptor agonist in a
once-weekly injection,” said Enrique Conterno, president, Lilly
Diabetes. “We remain deeply committed to advancing the treatment of
diabetes through innovative treatment options and solutions that
meet the specific needs of millions of people living with
diabetes.”
The positive opinion was reached after CHMP 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 more than five 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.
The companies are seeking approval of BYDUREON as a once-weekly
2 mg dose for the treatment of type 2 diabetes in combination with
metformin, a sulfonylurea, a thiazolidinedione, metformin plus a
sulfonylurea or metformin plus a thiazolidinedione.
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 belongs to the class of glucagon-like peptide-1 (GLP-1)
receptor agonists.
With just one weekly dose, a continuous release of exenatide is
delivered using Medisorb®, a biodegradable microsphere technology
developed by Alkermes.
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
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 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, 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.
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 and/or the European Commission 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., and Medisorb® is a registered
trademark of Alkermes, Inc.
1 Diabetes Statistics. American Diabetes Association. Available
at http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed April 4, 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 April 4, 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 April 4, 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. 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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