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Eli Lilly and Company

Long-Term Data on Exenatide Show Sustained Improvements in Glucose Control and Progressive Weight Reduction in People With Type 2 Diabetes

Athens, Greece (ots/PRNewswire)

- Improvements in cardiovascular risk factors were also observed
Eli Lilly and Company (NYSE: LLY) and Amylin Pharmaceuticals,
Inc., (Nasdaq: AMLN) today presented results from a study indicating
that the investigational compound exenatide showed sustained
improvements in blood sugar control and progressive weight reduction
through two years of therapy for people with type 2 diabetes failing
to achieve acceptable blood sugar control on metformin and/or a
sulfonylurea, two commonly-used oral diabetes medications.
Additional data were presented showing improvements in markers
associated with cardiovascular risk factors, including lipids and
blood pressure through a year-and-a-half of treatment. The findings
were presented at the 41st annual meeting of the European Association
for the Study of Diabetes in Athens, Greece.
Exenatide is the first in a new class of medicines known as
incretin mimetics and was approved for use in the United States by
the U.S. Food and Drug Administration on 28 April 2005 for the
treatment of type 2 diabetes. The U.S. is the first country in the
world that has received regulatory approval for exenatide.
"Findings from these long-term data demonstrate that exenatide may
have unique benefits for patients with type 2 diabetes who had
previously struggled to manage the disease effectively," said Prof.
Francesco Giorgino, M.D., Chief, Division of Endocrinology and
Metabolic Diseases, University Hospital, and Professor of
Endocrinology and Metabolism, University of Bari, Italy, who
presented the data in a press briefing at EASD. "The benefits
associated with weight reduction are particularly significant given
that many therapies for type 2 diabetes cause weight gain."
Key Findings
Nearly 90 percent of patients completing 30 weeks of therapy in
the exenatide pivotal studies elected to continue in an open-label
extension where all patients received 10 micrograms of exenatide
twice a day. Data collected over two years among 195 patients
demonstrated that long-term administration of exenatide in
combination with metformin, a sulfonylurea or both, results in
sustained reductions in blood sugar and progressive reductions in
weight.
Patients in the study (who received 10 micrograms of exenatide
twice daily) demonstrated an average reduction from baseline of 1.1
percent in A1C levels, a measure reflecting a person's average blood
sugar over a three-month period. The average starting A1C for these
patients was 8.2 percent. These same patients also demonstrated
reductions in body weight, with an average weight reduction of 5.5
kilograms (11.4 pounds).
In addition to improvements in glucose control and weight,
administration of exenatide for 82 weeks resulted in clinically
meaningful improvements in cardiovascular risk factors in a group of
265 patients. These included clinically positive changes associated
with HDL cholesterol, triglycerides, and blood pressure.
In general, improvements in cardiovascular risk factors appeared
greatest in patients who experienced the greatest weight reduction.
Side effects, which were predominantly gastrointestinal in nature,
were consistent with those observed in patients during the
placebo-controlled trials. No new safety signals were observed.
About exenatide
Exenatide is the first in a new class of drugs for the treatment
of type 2 diabetes called incretin mimetics and exhibits many of the
same effects as the human incretin hormone glucagon-like peptide-1
(GLP-1). GLP-1, secreted in response to food intake, has multiple
effects on the stomach, liver, pancreas and brain that work in
concert to regulate blood sugar.(1) Exenatide was approved by the
U.S. FDA for use by people in the United States with type 2 diabetes
who are unsuccessful at controlling their blood sugar levels despite
using the commonly prescribed oral medications metformin, a
sulfonylurea or both. The U.S. is the first country in the world that
has received regulatory approval for exenatide. It is not approved
for use in Europe. Lilly anticipates submissions for regulatory
review in other countries in the near future.
About Incretin Mimetics
Incretin mimetics is a new class of therapeutics for use in the
fight against type 2 diabetes. An incretin mimetic works to mimic the
antidiabetic or glucose-lowering actions of naturally occurring human
hormones called incretins. These actions include stimulating the
body's ability to produce insulin in response to elevated levels of
blood sugar, inhibiting the release of a hormone called glucagon
following meals, slowing the rate at which nutrients are absorbed
into the bloodstream and reducing food intake. Exenatide is the first
U.S. FDA-approved agent of this new class of medications.
About Diabetes
Diabetes affects an estimated 194 million adults worldwide(2) and
around 48.4 million in Europe.(2) Of those affected approximately 85
to 95 percent have type 2 diabetes, a condition where the body does
not produce enough insulin and/or the cells in the body do not
respond normally to insulin.(3) Type 2 diabetes usually occurs in
adults over the age of 40, but is increasingly common in younger
people.(3) In virtually every developed society, diabetes is ranked
among the leading causes of blindness, renal failure and lower limb
amputation, as well as death through its effects on cardiovascular
disease (70-80 percent of people with diabetes die of cardiovascular
disease)(4). The calculated estimates of the costs of diabetes care
in Europe amount to 42.8 million International Dollars per year.(5)
About Lilly and Amylin
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 health care
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 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, Ind., Lilly provides
answers -- through medicines and information -- for some of the
world's most urgent medical needs.
P-LLY
Amylin Pharmaceuticals is a biopharmaceutical company committed to
improving lives through the discovery, development and
commercialization of innovative medicines.
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 future clinical trials may
not replicate previous trial results; risks that exenatide may not
prove to be an important new therapeutic option, additional
indications for exenatide may not be received, or exenatide may be
affected by unexpected new data or technical issues. The potential
for exenatide may also be affected by government and commercial
reimbursement and pricing decisions, the pace of market acceptance
and any issues related to manufacturing and supply. These and
additional risks and uncertainties are described more fully in Amylin
and Lilly's most recently filed SEC documents such as their Annual
Reports on Form 10-K. Amylin and Lilly undertake no duty to update
these forward-looking statements.
REFERENCES
(1) Kolterman O, Buse J, Fineman M, Gaines E, Heintz S, Bicsak T,
Taylor K, Kim D, Aisporna M, Wang Y, Baron A. Synthetic exendin-4
(exenatide) significantly reduces postprandial and fasting glucose in
subjects with type 2 diabetes. Journal of Clinical Endocrinology &
Metabolism. 2003; 88(7):3082-3089.
(2) The International Diabetes Federation Diabetes Atlas.
Available at:
http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F80BC22682A.
Accessed April 12, 2005.
(3) Centers for Disease Control and Prevention, National Diabetes
Fact Sheet. Available at:
http://www.cdc.gov/diabetes/pubs/pdf/ndfs_2003.pdf.
(4) Kochanek KD, Murphy SL, Anderson RN, Scott C. Deaths: Final
data for 2002. National vital statistics reports; vol 53 no 5.
Hyattsville, Maryland: National Center for Health Statistics. 2004.
(5) American Diabetes Association. Standards of medical care in
diabetes. Diabetes Care 2005;28:S4-36S.
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Contact:

Scott MacGregor of Eli Lilly and Company, +1-317-651-1494, or mobile:
+1-317-332-5557 /Photo:
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