Part 2
Although mild nausea was the most frequent adverse event, it was transient and fewer than 3 percent of patients receiving exenatide discontinued as a result of nausea. Antibody formation observed in this study was consistent with previous exenatide data reported to date. The data do not suggest a relationship between antibody formation and the sustained effect of exenatide on A1C.
About Exenatide
Exenatide is being investigated for its potential to address important unmet medical needs of many people with type 2 diabetes. Clinical trials suggest that exenatide treatment decreases blood glucose toward target levels and is associated with weight loss. The effects on glucose control seen with exenatide treatment are likely due to several actions that are similar to those of the naturally occurring incretin hormone glucagon-like peptide-1 (GLP-1). These actions are stimulation of the body's ability to produce insulin in response to elevated levels of blood glucose, inhibition of the release of glucagon following meals and slowing the rate at which nutrients are delivered for absorption into the bloodstream(1). In animal studies exenatide administration resulted in increased beta-cell mass(2). Beta-cells are the insulin-producing cells in the pancreas which fail as type 2 diabetes progresses.
Diabetes -- The Need for New Treatments
Diabetes affects an estimated 194 million adults worldwide(3) and more than 18.2 million in the United States(4). Approximately 90-95 percent of those affected have type 2 diabetes, in which either the body does not produce enough insulin and/or the cells in the body do not respond normally to the insulin. According to the US Center for Disease Control's National Health and Examination Survey, 57 percent of diabetes patients do not achieve target A1C levels with their current treatment regimen and approximately 41 percent have A1Cs above 8 percent. According to the ADA, patients with A1Cs above target are more likely to develop diabetes-related complications, such as kidney disease, blindness and heart disease(5).
About Amylin and Lilly
Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic disorders through the discovery, development and commercialization of innovative, cost-effective medicines. Further information on Amylin Pharmaceuticals and its pipeline in metabolism is available at www.amylin.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 www.lilly.com.
This press release contains forward-looking statements, which involve risks and uncertainties. Actual results could differ materially from those forward-looking statements discussed in this press release. There can be no assurance that current or future clinical trials will confirm the preliminary results referred to in this release, that a new drug application will be filed for exenatide on a timely basis, or that exenatide will receive regulatory approvals or prove to be commercially successful. Additional risks and uncertainties are described more fully in both Lilly's and Amylin's most recently filed SEC documents, such as their Annual Reports on Form 10-K for the fiscal year ended December 31, 2002 under the heading "Risk Factors," and their Quarterly Reports on Form 10-Q.
(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) Xu G, Stoffers DA, Habener JF, Bonner-Weir S. Exendin-4 stimulates both b-cell replication and neogenesis, resulting in increased b-cell mass and improved glucose tolerance in diabetic rats. Diabetes 1999; 48:2270-2276
(3) The International Diabetes Federation Diabetes Atlas. Available at: idf.org 87B73F80BC22682A. Accessed August 6, 2003.
(4) American Diabetes Association. Available at: diabetes.org. Accessed November 20, 2003.
(5) Saaddine JB, Engelgau MM, Beckles GL, Gregg EW, Thompson TJ, Narayan KM. A diabetes report card for the United States: Quality of care in the 1990s. Ann Intern Med. 2002; 136:565-574.
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