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.
SOURCE Amylin Pharmaceuticals, Inc.; Eli Lilly and Company
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Related links:
http://www.amylin.com
http://www.lilly.com http://www.BYETTA.com
http://www.lillydiabetes.com
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
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