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Eli Lilly and Company

BYETTA(R) Study Showed Sustained Blood Glucose Control Over Three Years in People with Type 2 Diabetes

Chicago (ots/PRNewswire)

-- BYETTA offers added benefits of progressive weight loss in an
analysis of the longest extension study to date --
Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and
Company (NYSE: LLY) today announced three-year, open-label study
results that showed treatment with BYETTA(R) (exenatide) injection
was associated with sustained blood sugar control and progressive
weight loss in people with type 2 diabetes. These findings were
presented at the 67th Annual Scientific Sessions of the American
Diabetes Association (ADA) in Chicago.
In this open-label extension study, 217 people with type 2
diabetes not achieving adequate blood sugar control on oral
medication alone (metformin and/or sulphonylurea) completed treatment
with exenatide (10 mcg) in addition to their oral medication(s) for
three years. Study participants treated with exenatide and oral
medication(s) showed sustained reductions in blood sugar as measured
by HbA1c, a test that measures average blood sugar levels over
approximately three months, and fasting blood glucose levels (-1.0
+/- 0.1 percent and 1.3 +/- 0.2 mmol/L [-23.5 +/- 3.8 mg/dL],
respectively).(1) After three years of exenatide treatment, 46
percent of study participants achieved the American Diabetes
Association's recommended HbA1c target of 7 percent and 30 percent of
participants achieved an HbA1c of 6.5 percent.(2) Weight loss from
baseline was progressive, with participants losing on average 5.3 +/-
0.40 kg (11.68 +/- 0.88 lbs) at three years. In addition, one in four
patients lost an average of 13.0 kg (28.66 lbs).
Pancreatic beta cells (beta-cells) are responsible for producing
insulin, a hormone that helps the body convert glucose (blood sugar)
into energy.(3) Type 2 diabetes develops when the pancreas does not
produce enough insulin for the body to adequately regulate blood
sugar levels, or the body is unable to use the insulin efficiently.
In this study, exenatide treatment was assessed for improvements in
pancreatic beta-cell function in a subset of 92 study participants
with evaluable data. HOMA-B (Homeostasis Model Assessment), a measure
of pancreatic beta-cell function, improved by 17 percent from
baseline over three years.
"Type 2 diabetes is associated with impaired insulin production in
the pancreas that progressively deteriorates over time," said John
Buse, Chief of the Division of General Medicine and Clinical
Epidemiology at the University of North Carolina School of Medicine
in Chapel Hill, NC. "These study findings suggests that long-term
exenatide treatment helps people with type 2 diabetes achieve
sustained control of their blood sugar levels."
Exenatide was generally well-tolerated in this study, and the side
effects were consistent with those seen in previous studies. In
clinical trials and post-approval adverse event reports, the most
common side effect is nausea, most of which was mild to moderate,
affecting approximately half of patients and usually decreases over
time.
About BYETTA(R) (exenatide) injection
BYETTA is the first in a class of drugs for the treatment of type
2 diabetes called incretin mimetics. 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 in the European Union as adjunctive
therapy to improve blood sugar control in patients with type 2
diabetes who have not achieved adequate glycaemic control on
maximally tolerated doses of metformin and/or a sulphonylurea, two
common oral diabetes medications. BYETTA provides sustained HbA1c
control, low incidence of hypoglycaemia when used with metformin and
progressive weight loss.
Important Safety Information for BYETTA(R) (exenatide) injection
In clinical studies, the most common side effects were
hypoglycaemia (low blood sugar) when taken with a sulphonylurea,
nausea (feeling sick), vomiting and diarrhea. For the full list of
all side effects reported with BYETTA, see the Package Leaflet.
BYETTA should not be used in people who may be hypersensitive
(allergic) to exenatide or any of the other ingredients.
About Diabetes
Diabetes affects an estimated 246 million adults worldwide and
more than 48 million in Europe.(4,5) Approximately 90 to 95 percent
of those affected by type 2 diabetes, a condition characterized by
failure of the pancreatic beta cells to adequately respond to the
increased demands for insulin that occur as a result of
obesity-related insulin resistance.(6) Type 2 diabetes usually occurs
in adults over the age of 40, but is increasingly common in younger
people.(5) 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).(7) The calculated estimates of the costs of diabetes care
in Europe amount to 42.8 billion International Dollars per year.(8)
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.
Amylin's research and development activities leverage the company's
expertise in metabolism to develop potential therapies to treat
diabetes and obesity. Amylin is located in San Diego, California with
over 1,700 employees nationwide. For more information about Amylin,
visit 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 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, 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 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, technical issues, clinical trials not confirming previous
results or 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 and Lilly's most recently filed
United States Securities and Exchange Commission documents such as
their Quarterly Reports on Form 10-Q. Amylin and Lilly undertake no
duty to update these forward-looking statements.
P-LLY
REFERENCES
1 American Diabetes Association's Diabetes Dictionary. Available
at: http://www.diabetes.org/diabetesdictionary.jsp?pageID=1&exitDicti
onaryTo=. Accessed June 8, 2007.
2 American Diabetes Association. "Standards of Medical Care for
Diabetes - 2007. Diabetes Care: 30 (Supplement 1), January 2007.
3 American Diabetes Association's Diabetes Dictionary. Available
at: http://www.diabetes.org/diabetesdictionary.jsp?pageID=2&exitDicti
onaryTo=. Accessed June 8, 2007.
4 The International Diabetes Federation Diabetes Atlas. Available
at: http://www.idf.org/home/index.cfm?unode=3B96906B-C026-2FD3-87B73F
80BC22682A. Accessed June 14, 2007.
5 The International Diabetes Federation, Prevalence / All
diabetes. Available at
http://www.eatlas.idf.org/Prevalence/All_diabetes/.
6 Turner RC, Cull CA, Frighi V, Holman RR. Glycemic control with
diet, sulfonylurea, metformin, or insulin in patients with type 2
diabetes mellitus: progressive requirement for multiple therapies
(UKPDS 49). JAMA. 1999; 281 (21):2005-2012.
7 The International Diabetes Federation, Complications. Available
at http://www.eatlas.idf.org/Complications/
8 The International Diabetes Federation, Diabetes Atlas, Second
edition. The Economic Impact of Diabetes. 2003: 186.
(Logo:
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO )

Contact:

Derin Denham, Eli Lilly and Company, +1-317-277-6749 office, or
+1-317-370-1435 cell, or Alice Bahner Izzo, Amylin Pharmaceuticals,
Inc., +1-858-642-7272 office, or +1-858-232-9072 cell; Photo:
http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO , AP
Archive: http://photoarchive.ap.org , PRN Photo Desk,
photodesk@prnewswire.com

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