Successful Completion of Study Comparing Exenatide to Insulin Glargine Results in Milestone Payment from Lilly to Amylin
Patients on Exenatide Experienced Similar Glucose Control Compared to Patients on Insulin Glargine, With Associated Weight Loss
SAN DIEGO, and INDIANAPOLIS, July 26 /PRNewswire-FirstCall/ -- Amylin Pharmaceuticals, Inc. (Nasdaq: AMLN) and Eli Lilly and Company (NYSE:LLY) announced today results from a six-month study that compared exenatide and insulin glargine in people with type 2 diabetes failing to achieve acceptable glycemic control with common oral therapies. Patients in both groups achieved similar degrees of glycemic control in the study. In addition, patients on exenatide lost weight, compared to those on insulin glargine, who gained weight. As a result of the completion and analysis of this study, Lilly will pay Amylin a development milestone payment of $5 million.
The focus of the study was to compare exenatide -- the first drug candidate in a new class of drugs called incretin mimetics in development for the treatment of type 2 diabetes -- with insulin glargine, a human insulin analog, in patients who have failed to control their diabetes on a combination of sulfonylurea and metformin. More than 500 subjects were randomized to receive either a variable dose of insulin glargine at bedtime, or a fixed dose of exenatide twice daily just before breakfast and dinner in addition to their current oral therapies. The primary objective of the study was to achieve comparable glycemic response between the two groups, as evaluated by a change in A1C levels from baseline. Additional endpoints of the study included effects on weight, incidence of hypoglycemia, safety and tolerability.
Results demonstrate that both exenatide and insulin glargine achieved similar A1C reductions, with endpoint A1Cs of 7.2 percent for both groups at the end of the study. Subjects on exenatide lost an average of 5 pounds, while those on glargine gained an average of 3 pounds. Overall, the incidence of mild-to-moderate hypoglycemia was similar in both groups. There were four subjects in each treatment group that required the assistance of another person to provide oral treatment for hypoglycemia. None of these patients required medical assistance. Adverse events related to exenatide were similar to those seen in previous clinical trials. The most common adverse event reported was mild to moderate nausea, which occurred most frequently early in the study.
Exenatide is the first in a new class of drugs being investigated for the treatment of type 2 diabetes called incretin mimetics, and exhibits many of the same effects as the human incretin hormone GLP-1. Exenatide, like GLP-1, has effects on multiple organs that work in concert to improve blood sugar. A New Drug Application for exenatide was submitted to the Food and Drug Administration (FDA) for regulatory approval in June 2004.
About Amylin and Lilly
Amylin Pharmaceuticals is committed to improving the lives of people with diabetes and other metabolic diseases through the discovery, development and commercialization of innovative, cost-effective medicines. Further information on Amylin Pharmaceuticals and its pipeline in metabolism is available at http://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 http://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 results referred to in this release or that exenatide will receive regulatory approvals or prove to be commercially successful. 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 for the fiscal year ended December 31, 2003 under the heading "Risk Factors Related to Our Business" their subsequently filed Quarterly Reports on Form 10-Q, and Amylin's recently filed Form S-3.