Amylin Pharmaceuticals and Eli Lilly have entered, in principle, into a joint supply agreement for an exenatide once weekly pen device. The companies also have initiated a phase 1/2 clinical study to examine a new exenatide once weekly suspension formulation.
Exenatide once weekly is an investigational diabetes therapy that is injected subcutaneously once a week and is currently in phase 3 development. Exenatide is also the active ingredient in the twice daily Byetta (exenatide) injection, currently available in the U.S. and in other countries for people with type 2 diabetes who are unable to achieve good glycemic control with common oral therapies.
The San Diego-based Amylin and the Indianapolis-based Lilly have agreed to cooperate in the development, manufacturing and marketing of exenatide once weekly in a dual-chamber cartridge pen configuration. The design will enable patients to mix and administer exenatide once weekly from a pre-filled pen device, instead of the syringe and vial currently used in clinical trials.
The companies said they will share the capital and development costs of the pen, including the initial capital investment of approximately $216 million, over the next few years. They have agreed that the cost of the initial capital investment will be allocated 60 percent to Lilly and 40 percent 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. Amylin and Lilly will share sales and marketing rights in the U.S., while Lilly will be responsible for sales and marketing outside of the U.S.
The companies also have initiated a phase 1/2 clinical trial designed to evaluate the pharmacokinetics, tolerability and safety of this new exenatide once weekly formulation in both healthy volunteers and people with type 2 diabetes. The study will also evaluate efficacy in the type 2 diabetes patients. The trial began this month and initial findings are expected by the end of 2009.