Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN), Eli Lilly and
Company (NYSE: LLY) and Alkermes, Inc. (Nasdaq: ALKS) will unveil
data from more than 20 studies at the 45th Annual Meeting of the
European Association for the Study of Diabetes (EASD) in Vienna,
Austria, taking place from Sept. 29 to Oct. 2. The companies will
present the latest research findings on BYETTA® (exenatide)
injection and exenatide once weekly. The EASD annual meeting, which
brings together more than 14,000 delegates, is the most important
platform in Europe for professional exchange in the diabetes
field.
“The presentations at EASD continue to reinforce the efficacy
and safety of BYETTA and the promise of exenatide once weekly as a
potential new treatment option for patients with type 2 diabetes,”
stated Orville G. Kolterman, M.D., senior vice president of
research and development, Amylin Pharmaceuticals. “EASD is a venue
where researchers and clinical practitioners from around the world
gather to discuss new developments in diabetes care. We look
forward to participating in this exchange of ideas by presenting
compelling data on the exenatide molecule.”
Key exenatide abstracts for EASD 2009 include:
Clinical Trial Data
- Poster: Presentation #729,
Sept. 30, 1:45-2:45 p.m. CEST“Effects of Exenatide plus
Rosiglitazone on Measures of Beta Cell Function and Insulin
Sensitivity in Subjects with Type 2 Diabetes Previously Treated
With Metformin” will be presented by Leonard Glass, M.D.
- Poster: Presentation #730,
Sept. 30, 1:45-2:45 p.m. CEST“Exenatide Once Weekly Treatment
Elicits Sustained Glycaemic Control and Weight Loss Over 2 Years”
will be presented by Michael Trautmann, M.D.
- Poster: Presentation #739,
Oct. 1, 12:45-1:45 p.m. CEST“DURATION-2: Exenatide Once Weekly
Demonstrated Superior Glycemic Control and Weight Reduction
Compared to Sitagliptin or Pioglitazone After 26 Weeks of
Treatment” will be presented by Carol Wysham, M.D.
- Poster: Presentation #795,
Oct. 1, 12:45-1:45 p.m. CEST“Changes in Adipokines in Type 2
Diabetic Patients Treated with Exenatide versus Glimepiride on
Metformin Background – Results of a Prospective, Randomized
Controlled Study Over 9 Months” will be presented by Baptist
Gallwitz, M.D.
Safety Assessments
- Oral: Presentation #6, Sept.
30, 12:15-12:30 p.m. CEST“Incidence of Acute Pancreatitis in
Exenatide Initiators Compared to Other Antidiabetic Drug
Initiators: A Retrospective, Cohort Study” will be presented by
Gary Bloomgren, M.D.
- Poster: Presentation #758,
Oct. 2, 12:45-1:45 p.m. CEST“Exenatide Once Weekly Improved
Cardiometabolic Risk Factors in Subjects with Type 2 Diabetes
During One Year of Treatment” will be presented by Richard
Bergenstal, M.D.
- Poster: Presentation #759,
Oct. 2, 12:45-1:45 p.m. CEST“Cardiovascular Safety of Exenatide
BID: An Integrated-Analysis from Long-Term Controlled Clinical
Trials in Subjects with Type 2 Diabetes” will be presented by Larry
Shen, Ph.D.
- Poster: Presentation #768,
Oct. 2, 1:45-2:45 p.m. CEST“Safety and Tolerability of
Exenatide BID in Patients With Type 2 Diabetes: Integrated Analysis
of 3854 Patients From 11 Comparator Controlled Clinical Trials”
will be presented by Matthew Wintle, M.D.
Patient-Reported Outcomes
- Poster: Abstract Presentation
#745, Oct. 1, 12:45-1:45 p.m. CEST“DURATION 2: Weight-Related
Quality of Life, Psychological Well-Being, and Satisfaction with
Exenatide Once Weekly Compared to Sitagliptin or Pioglitazone After
26 Weeks of Treatment” will be presented by Jennie Best, Ph.D.
About BYETTA® (exenatide) Injection
BYETTA is the first and only FDA-approved incretin mimetic 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 approved by the FDA for use by people
with type 2 diabetes who are unsuccessful at controlling their
blood sugar levels. BYETTA is an add-on therapy for people
currently using metformin, a sulfonylurea, or a thiazolidinedione.
BYETTA provides sustained A1C control and low incidence of
hypoglycemia when used 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 million
patients since its introduction. For full prescribing information,
visit www.BYETTA.com.
Important Safety Information for BYETTA
BYETTA is not a substitute for insulin in patients whose
diabetes requires insulin treatment. BYETTA is not recommended for
use in patients with severe problems digesting food or those who
have severe disease of the stomach or kidney.
When BYETTA is used with a medicine that contains a
sulfonylurea, hypoglycemia (low blood sugar) is a possible side
effect. To reduce this possibility, the dose of sulfonylurea
medicine may need to be reduced while using BYETTA. Other common
side effects with BYETTA include nausea, vomiting, diarrhea,
dizziness, headache, feeling jittery, and acid stomach. Nausea is
the most common side effect when first starting BYETTA, but
decreases over time in most patients.
If patients experience the following severe and
persistent symptoms (alone or in combination): abdominal
pain, nausea, vomiting, or diarrhea, they should talk to their
healthcare provider because these symptoms could be signs of
serious medical conditions. BYETTA may reduce appetite, the amount
of food eaten, and body weight. No changes in dose are needed for
these side effects. These are not all of 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 full prescribing information, visit www.BYETTA.com.
About Diabetes
Diabetes affects approximately 24 million people in the U.S. and
an estimated 246 million adults worldwide.(i,ii) Approximately
90-95 percent of affected adults have type 2 diabetes. Diabetes is
the fifth leading cause of death by disease in the U.S. and results
in approximately $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 Amylin, Lilly and Alkermes
Amylin, Lilly and Alkermes are working together to develop
exenatide once weekly, a subcutaneous injection of exenatide for
the treatment of type 2 diabetes based on Alkermes’ proprietary
technology for long-acting medications. Exenatide once weekly is
not currently approved by any regulatory agencies.
Amylin Pharmaceuticals is a biopharmaceutical company committed
to improving lives through the discovery, development and
commercialization of innovative medicines. Amylin has developed and
gained approval for two first-in-class medicines for diabetes,
SYMLIN® (pramlintide acetate) injection and BYETTA® (exenatide)
injection. 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. Further information on Amylin
Pharmaceuticals is available at http://www.amylin.com.
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 Cambridge,
Massachusetts, Alkermes has research facilities in Massachusetts
and a commercial manufacturing facility in Ohio.
This press release contains forward-looking statements about
Amylin, Lilly and Alkermes, BYETTA and the investigational drug,
exenatide once weekly. 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 BYETTA and/or
exenatide once weekly may be affected by unexpected new data;
safety and technical issues; clinical trials not being completed in
a timely manner, not confirming previous results, not being
predictive of future results, or not achieving the intended
clinical endpoints; label expansion requests not being submitted in
a timely manner; regulatory approval, including approval for
exenatide once weekly, being delayed or not being received; or
manufacturing and supply issues. The potential for BYETTA and/or
exenatide once weekly 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 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.
P-LLY
(i) "All About Diabetes." American Diabetes Association.
Available at: http://www.diabetes.org/about-diabetes.jsp. Accessed
July 13, 2009.
(ii) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed July 13, 2009.
(iii) "Direct and Indirect Costs of Diabetes in the United
States." American Diabetes Association. Available at:
http://www.diabetes.org/diabetes-statistics/cost-of-diabetes-in-us.jsp.
Accessed July 13, 2009.
(iv) Saydah SH, Fradkin J and Cowie CC. "Poor control of risk
factors for vascular disease among adults with previously diagnosed
diabetes." JAMA: 291(3), January 21, 2004.
(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.
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