Overview

The combination of potency and the glucose dependent mechanism of action inherent in exenatide makes it well suited to development of a sustained release formulation. The goal of the exenatide once weekly program is to develop a sustained release, subcutaneous injection of exenatide.

This development program is jointly managed by Amylin, Lilly, and Alkermes. The program utilizes Alkermes’ patented, FDA approved and proprietary Medisorb® injectable sustained release drug delivery technology.

Amylin is leveraging its science to continually advance diabetes care and to deliver new treatments for obesity and other diseases. The company’s lead development program is a potentially breakthrough medicine—exenatide once weekly—for type 2 diabetes.

Clinical trials

In October 2000, the feasibility stage of the development work was successfully completed and additional preclinical work was initiated to support exenatide once weekly human clinical trials. Phase 1 data released in 2001 demonstrated a sustained release of exenatide for over 30 days with no significant adverse effects.

Exenatide once weekly completed a Phase 2, single-dose study which demonstrated a sustained release of exenatide with no dose limiting side effects. A Phase 2 multi-dose study was started in early 2005 using a once-a-week formulation.

Enrollment was completed in 1Q07 for a 30-week, open-label, randomized study of approximately 300 subjects comparing exenatide once weekly versus BYETTA® twice daily. Study results showed that exenatide once weekly demonstrated powerful glucose efficacy, complemented by striking weight loss - the best ever observed in a diabetes pivotal study.

About Diabetes

Diabetes affects more than 20 million in the United States and an estimated 246 million adults worldwide. Approximately 90-95 percent of those affected have type 2 diabetes. Diabetes is the fifth leading cause of death by disease in the United States and costs approximately $132 billion per year in direct and indirect medical expenses.

According to the Centers for Disease Control and Prevention's National Health and Nutrition Examination Survey, approximately 60 percent of people with diabetes do not achieve their target blood sugar levels with their current treatment regimen.