Amylin and Lilly partner to develop new pen device for diabetes therapy

This 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 two companies said.

The companies will share the capital and development costs of the pen, including the initial capital investment of approximately $216 million over the next few years. Amylin and Lilly have agreed that the cost of the initial capital 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 US, and for manufacturing unlabeled and unpackaged pens for the markets outside the US. Lilly will be responsible for labeling and final packaging of the pen product to support sales outside of the US. Amylin and Lilly will share sales and marketing rights in the US, while Lilly will be responsible for sales and marketing outside of the US.

Exenatide once weekly is an investigational diabetes therapy that is injected subcutaneously once a week and is currently in Phase III development. Exenatide is also the active ingredient in twice daily Byetta (exenatide) injection, currently available in the US and in many countries worldwide for people with type 2 diabetes who are unable to achieve good glycemic control with common oral therapies.

Separately, the companies have initiated a Phase I/II 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 initial findings are expected by the end of 2009.