BYETTA and BYDUREON to be Featured in More Than a Dozen Study Presentations at EASD 2010
SAN DIEGO, INDIANAPOLIS, and WALTHAM, Mass., Sept. 14, 2010
/PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) , Eli Lilly and Company (NYSE:LLY) and Alkermes, Inc. (NASDAQ:ALKS) today announced that the latest
research findings on BYETTA® (exenatide) injection and the
investigational product BYDUREON(TM) (exenatide extended-release
for injectable suspension) will be presented at the 46th Annual
Meeting of the European Association for the Study of Diabetes
(EASD). The EASD annual meeting, taking place from Sept. 20-24 in
Stockholm, Sweden, brings together more than 16,000 attendees and
is an important platform in Europe for professional exchange in the
diabetes field.
"At this year's EASD, we are pleased to share data that deepen
our understanding of the safety and efficacy of BYETTA, as well as
the potential benefits of BYDUREON," stated Orville G. Kolterman,
M.D., senior vice president, chief medical officer, Amylin
Pharmaceuticals. "These studies underscore our commitment to
advancing diabetes treatment."
Key BYETTA and BYDUREON abstracts for EASD 2010 include:
-- Oral: Presentation #73, Sept. 22, 10:45 a.m.-12:15 p.m. CEST
"Exenatide Added to Insulin Glargine-Treated Patients with Type
2 Diabetes Provided Excellent Fasting and Postprandial Control
with Weight Loss and no Increased Risk of Hypoglycaemia" will be
presented by Richard Bergenstal, M.D., International Diabetes
Center, Minneapolis
-- Poster: Presentation #833, Sept. 21, 1:30-2:30 p.m. CEST
"Exenatide Added to a Thiazolidinedione with or without Metformin
Resulted in Superior Glycaemic Control Versus Placebo after 26
Weeks of Treatment" will be presented by Joanne Liutkus, M.D.,
Medicine Professional Corporation, Cambridge, Ontario, Canada
-- Poster: Presentation #836, Sept. 21, 1:30-2:30 p.m. CEST
"Meta-Analysis of the Efficacy of GLP-1R Agonists and DPP-4
Inhibitors for Treatment of Type 2 Diabetes Mellitus" will be
presented by Vanita Aroda, M.D., MedStar Research, Hyattsville,
Md.
-- Poster: Presentation #837, Sept. 21, 1:30-2:30 p.m. CEST
"Risk of Cardiovascular Events in Patients with Type 2 Diabetes
Treated with Exenatide or Other Glucose-Lowering Therapies: A
Retrospective Analysis of the LifeLink(TM) Database" will be
presented by Jennie Best, Ph.D., Amylin
-- Poster: Presentation #842, Sept. 22, 12:30-1:30 p.m. CEST
"DURATION-2: Effect of Switching to Once-Weekly Exenatide from
Maximum Daily Doses of Sitagliptin or Pioglitazone" will be
presented by Carol H. Wysham, M.D., Rockwood Clinic, Spokane,
Wash.
-- Poster: Presentation #858, Sept. 23, 12:30-1:30 p.m. CEST
"Antibodies to Exenatide did not Cross-React with Human GLP-1
or Glucagon or Alter the Efficacy or Safety of Exenatide" will
be presented by Mark Fineman, Amylin
-- Poster: Presentation #863, Sept. 23, 1:30-2:30 p.m. CEST
"Impact of Exenatide Once Weekly and Insulin Glargine on Glucose
Control and Cardiovascular Risk Factors in Subjects with Type 2
Diabetes" will be presented by Michaela Diamant, M.D., Diabetes
Centre, VU University Medical Centre, Amsterdam
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. BYETTA has been available in the U.S. since
June 2005 and is used in more than 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 an estimated 285 million adults worldwide and
more than 24 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 in the U.S.(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 1.3 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. 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 (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 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 not receiving regulatory approval; the commercial launch of
BYDUREON being delayed; or manufacturing and supply issues. The
potential for BYETTA and/or BYDUREON, if approved, 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(TM) and BYETTA® are trademarks of Amylin
Pharmaceuticals, Inc., and Medisorb® is a registered trademark
of Alkermes, Inc. All other marks are the marks of their respective
owners.
P-LLY
(1) The International Diabetes Federation Diabetes Atlas.
Available at: http://www.diabetesatlas.org/content/some-285-million-people-worldwide-will-li
ve-diabetes-2010. Accessed September 10, 2010.
(2) Diabetes Statistics. American Diabetes Association.
Available at: http://www.diabetes.org/diabetes-basics/diabetes-statistics/.
Accessed September 10, 2010.
(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 September 10, 2010.
(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 and 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. 2007;30 Suppl 1:S48-65.
(7) Anderson JW, Kendall CW and 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.
CONTACT: Alice Izzo of Amylin Pharmaceuticals, Inc.,
+1-858-642-7272,
cell, +1-858-232-9072, alice.izzo@amylin.com; or
Kindra Strupp of Lilly,
+1-317-277-5170, cell, +1-317-554-9577, kstrupp@lilly.com; or Rebecca
Peterson
of Alkermes, +1-781-609-6378, cell, +1-617-899-2447,
rebecca.peterson@alkermes.com
Web Site: http://www.amylin.com/
Posted: September 2010
