Amylin Pharmaceuticals and Lilly have agreed to the terms of a joint supply agreement for a pen device for exenatide once-weekly. The two companies have each initiated a Phase I/II clinical study for a new exenatide once-weekly suspension formulation.
Amylin and Lilly have agreed to develop, manufacture and market the drug in a dual chamber cartridge pen device. This design will enable patients to mix and administer the drug from a pre-filled pen, instead of the syringe and vial currently used in clinical trials. The companies will share the capital and development costs of the pen, including the initial investment of approximately $216 million during the next few years. The cost of the initial investment will be allocated 60% to Lilly and 40% to Amylin.
Amylin will be responsible for developing and manufacturing the final pen product for the U.S., and for manufacturing unlabeled and unpackaged pens for the markets outside the U.S. Lilly will be responsible for labeling and final packaging of the pen product to support sales outside of the U.S. The two companies will share sales and marketing rights in the U.S. and Lilly will be responsible for sales and marketing outside of the U.S.
"The agreement for an exenatide once-weekly pen device underscores our commitment to enhance the user experience for patients with type 2 diabetes," said Vince Mihalik, senior vice president, sales and marketing, and chief commercial officer at Amylin Pharmaceuticals. "While our DURATION-1 patient questionnaire results showed that the delivery system used in clinical trials was well accepted by patients, we continue to look for ways to enhance delivery and offer patients a range of choices through alternative delivery possibilities."
Exenatide once-weekly is an investigational diabetes therapy that is injected once a week and is currently in Phase III development.