Amylin Pharmaceuticals and Eli Lilly Provide Context for FDA Alert for BYETTA
August 26 2008 - 5:46PM
PR Newswire (US)
SAN DIEGO and INDIANAPOLIS, Aug. 26 /PRNewswire-FirstCall/ --
Amylin Pharmaceuticals, Inc. (NASDAQ:AMLN) and Eli Lilly and
Company (NYSE:LLY) in a conference call today provided context and
additional information regarding the August 18, 2008 U.S. Food and
Drug Administration (FDA) update to a prior alert for BYETTA(R)
(exenatide) injection referencing pancreatitis. The companies were
aware of the pancreatitis cases referenced in the alert, as well as
others, and previously reported these cases to the FDA. The
complete conference call replay will be available through Amylin's
and Lilly's corporate websites after the call. Since 2006, the U.S.
prescribing information for BYETTA has included information about
pancreatitis. A recent study has also shown that patients with type
2 diabetes were at nearly three times the risk of developing
pancreatitis than those without diabetes.(1) While a definite
causal relationship between BYETTA and pancreatitis has not been
proved, to better understand the suspected relationship, Amylin and
Lilly continue to pursue a comprehensive drug safety program that
includes extensive internal and external review of individual
cases, and clinical and epidemiologic studies. "At Amylin and
Lilly, patient safety is our foremost concern. We are committed to
continuing to work closely with the FDA to ensure that physicians
and patients are provided with accurate information about any
potential risks associated with the use of our products," said
Orville G. Kolterman, Senior Vice President, Research and
Development at Amylin. "It is important to understand that
pancreatitis, an inflammatory condition of the pancreas, is a rare
event. Further, the characteristics and complications of the
pancreatitis cases in patients on BYETTA are consistent with
pancreatitis in the general population. We believe BYETTA continues
to have a positive benefit-risk profile for patients with type 2
diabetes." About BYETTA(R) (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, low incidence of hypoglycemia when used with
metformin or a thiazolidinedione, and progressive weight loss.
BYETTA was approved in April 2005 and has been used by
approximately one million patients since its introduction. For full
prescribing information, visit http://www.byetta.com/. About
Diabetes Diabetes affects more than 21 million in the United States
and an estimated 246 million adults worldwide.(2,3) Approximately
90-95 percent of those affected have type 2 diabetes. Diabetes is
the fifth leading cause of death by disease in the United States
and costs approximately $132 billion per year in direct and
indirect medical expenses.(4) 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.(5) In addition, 85 percent of type 2 diabetes
patients are overweight and 55 percent are considered obese.(6)
Data support that weight loss (even a modest amount) supports
patients in their efforts to achieve and sustain glycemic
control.(7,8) Important Safety Information for BYETTA BYETTA
improves glucose (blood sugar) control in adults with type 2
diabetes. It is used with metformin, a sulfonylurea, or a
thiazolidinedione. 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 http://www.byetta.com/. About Amylin and Lilly
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(R) (pramlintide acetate) injection and BYETTA(R) (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 with over 2,000 employees nationwide. Further
information about 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. For more information about Lilly's
current diabetes products visit, http://www.lillydiabetes.com/.
Lilly, a leading innovation-driven corporation, is developing a
growing portfolio of first-in-class and best-in-class
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. Additional
information about Lilly is available at http://www.lilly.com/. This
press release contains forward-looking statements about Amylin and
Lilly. 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 the revenues
generated from BYETTA may be affected by competition; unexpected
new data; safety and technical issues; clinical trials not
confirming previous results; pre-clinical trials not predicting
future results; label expansion requests not being submitted in a
timely manner or receiving regulatory approval; or manufacturing
and supply issues. The potential for BYETTA 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 commercialization of
pharmaceutical products. These and additional risks and
uncertainties are described more fully in Amylin's and Lilly's most
recently filed SEC including their Quarterly Reports on Form 10-Q
and Annual Reports on Form 10-K. Amylin and Lilly undertake no duty
to update these forward-looking statements. 1. Noel R, Braun D,
Patterson R, Bloomgren G. Increased risk of acute pancreatitis
observed in patients with type 2 diabetes. 24th International
Conference on Pharmacoepidemiology and Therapeutic Risk Management.
Copenhagen, Denmark. International Society for
Pharmacoepidemiology: 2008. 2. The International Diabetes
Federation Diabetes Atlas. Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed June 2, 2008. 3. "All About Diabetes." American Diabetes
Association. Available at:
http://www.diabetes.org/about-diabetes.jsp. Accessed June 6, 2008.
4. "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 June 6, 2008. 5. 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. 6.
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.
7. Nutrition Recommendations and Interventions for Diabetes: a
position statement of the American Diabetes Association. Diabetes
Care. 2007;30 Suppl 1:S48-65. 8. 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.
DATASOURCE: Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
CONTACT: Alice Izzo of Amylin, office, +1-858-642-7272, or cell,
+1-858-232-9072; or Kindra Strupp of Lilly, office,
+1-317-277-5170, or cell, +1-317-554-9577 Web site:
http://www.amylin.com/ http://www.lilly.com/ http://www.byetta.com/
http://www.lillydiabetes.com/
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