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

Posted on: Saturday, 11 June 2005, 00:00 CDT

SAN DIEGO, June 10 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc., and Eli Lilly and Company today announced results from a study indicating that BYETTA(TM) (exenatide) injection showed sustained improvements in blood sugar control and progressive weight reduction through a year and a half of therapy for people with type 2 diabetes failing to achieve acceptable blood sugar control on metformin and/or a sulfonylurea, two common oral diabetes medications. The data also show improvements in markers associated with cardiovascular risk factors, including lipids and blood pressure. Additional data was presented showing sustained improvements in blood sugar control and progressive weight reduction in patients who had completed two years of BYETTA therapy. The findings were presented at the American Diabetes Association's (ADA) 65th Scientific Sessions in San Diego, California.

BYETTA (pronounced bye-A-tuh), the trade name for exenatide, is the first in a new class of medicines known as incretin mimetics, and was approved by the Food and Drug Administration on April 28, 2005 for the treatment of type 2 diabetes.

"Findings from these long-term data demonstrate that BYETTA has unique benefits for patients with type 2 diabetes who had previously struggled to manage the disease effectively," said David Kendall, MD, Chief of Clinical Services and Medical Director at the International Diabetes Center in Minneapolis, and a principal investigator for BYETTA clinical studies.

Key Findings

Close to 90 percent of patients completing 30 weeks of therapy in the BYETTA pivotal studies elected to continue in an open-label extension where all patients received 10 micrograms of BYETTA twice a day. Data collected over 82 weeks among 265 patients demonstrated that long-term administration of BYETTA in combination with metformin, a sulfonylurea or both, results in sustained reductions in blood sugar and progressive reductions in weight. Patients demonstrated an average reduction of 1.2 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 8.3 percent. These same patients also demonstrated reductions in body weight, with an average weight reduction of 4.6 kilograms or 10.1 pounds. The benefits associated with weight reduction are particularly significant given that many therapies for type 2 diabetes cause weight gain.

In addition to improvements in glucose control and weight, administration of BYETTA for 82 weeks resulted in clinically meaningful improvements in cardiovascular risk factors. 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.

Two-Year Data Shows Sustained Effect

To evaluate the durability of effect of BYETTA at the highest dose tested, the subset of patients who had received 10 micrograms of BYETTA for two years was also examined. In the 146 patients who completed two years of treatment on 10 micrograms in combination with metformin and/or a sulfonylurea, the average reduction in A1C from baseline was 1.2 percent with average reductions in body weight of 5.5 kilograms or 12.1 pounds.

About BYETTA

BYETTA 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) BYETTA was approved by the FDA for use by people 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. Byetta is currently available in pharmacies. For full Prescribing Information, visit http://www.byetta.com/.

Safety and Tolerability Information

Adverse events associated with BYETTA are generally mild to moderate in intensity. In clinical trials, the most frequently reported adverse event was mild-to-moderate, dose-dependent nausea. With continued therapy, the frequency and severity of nausea decreased over time in most patients.

Patients receiving BYETTA in combination with a sulfonylurea may be at a higher risk of hypoglycemia, or low blood sugar. To reduce this risk, lowering the sulfonylurea dosage may be considered. When patients begin taking BYETTA, the symptoms, treatment, and conditions that predispose development of hypoglycemia should be explained to them, and the patient's usual instructions for hypoglycemia management should be reviewed and reinforced.

Patients should also be advised that treatment with BYETTA may lead to a reduction in appetite, food intake, and/or body weight, and that there is no need to modify the dosing regimen due to such effects.

BYETTA is not a substitute for insulin in insulin-requiring patients. BYETTA should not be used in patients with type 1 diabetes. Use of BYETTA is not recommended in patients with end-stage renal disease or severe renal impairment, or in patients with severe gastrointestinal disease. BYETTA should be used with caution in patients receiving oral medications that require rapid gastrointestinal absorption.

For complete safety profile and other important prescribing considerations, visit http://www.byetta.com/.

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. BYETTA is the first FDA-approved agent of this new class of medications.

About Diabetes

Diabetes affects an estimated 194 million adults worldwide(2) and more than 18 million in the United States.(3) Approximately 90 to 95 percent of those affected 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) Diabetes is the fifth leading cause of death by disease in the United States(4) and costs approximately $132 billion per year in direct and indirect medical expenses. Type 2 diabetes usually occurs in adults over the age of 40, but is increasingly common in younger people.(3)

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of diabetes patients do not achieve target hemoglobin A1C levels (less than 7 percent according to ADA guidelines(5)) with their current treatment regimen.(6)

About Amylin and Lilly

Amylin Pharmaceuticals is a biopharmaceutical company committed to improving lives through the discovery, development and commercialization of innovative medicines. Further information on Amylin Pharmaceuticals, its marketed products, and its pipeline in metabolism 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 health care 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, Ind., 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 future clinical trials may not replicate previous trial results; risks that BYETTA may not prove to be an important new therapeutic option or may be affected by unexpected new data or technical issues. The potential for BYETTA 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.

P-LLY

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.

(6) Harris MI, Eastman RC, Cowie CC, Flegal KM, Eberhardt MS. Racial and ethnic differences in glycemic control of adults with type 2 diabetes. Diabetes Care. 1999;22:403-408.

(Logo: http://www.newscom.com/cgi-bin/prnh/20040122/LILLYAMYLINLOGO )

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Eli Lilly and Company; Amylin Pharmaceuticals, Inc.

CONTACT: Jamaison Schuler of Lilly, +1-317-655-2111, cell:+1-317-457-2113; Eric Shearin of Amylin, +1-858-552-2200 x7177, cell:+1-858-699-5514

Source: PRNewswire-FirstCall

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