Thursday, April 30, 2009

How soon before Amylin and Lilly merge?

Amylin and Lilly will work together to develop and market a new delivery device for Byetta (exenatide), a treatment for type 2 diabetes.

Under the agreement, the two companies will cooperate on the development, manufacture and marketing of a pen device that patients can use to administer the drug on a once-weekly basis.

The pre-filled device will replace the syringe and vial used in clinical trials for the drug.

Lilly will provide 60 percent of the $216 million to develop the device, and Amylin will contribute 40 percent, according to a news release. Amylin will develop and manufacture the final pen product in the U.S. and manufacture unlabeled and unpackaged pans for non-U.S. markets. Amylin and Lilly will share U.S. sales and marketing rights, and Lilly will handle sales and marketing outside the U.S.

The companies also said they have begun a phase 1/2 clinical trial on an exenatide once-weekly suspension. The trial, using healthy volunteers and patients with type 2 diabetes, will examine the effectiveness, tolerability and safety of the formulation. It will begin in April and is expected to be completed by year-end.

San Diego-based Amylin (NASDAQ: AMLN) announced in May 2007 that it was expanding a previously announced facility on Trade Port Drive in West Chester to manufacture the long-acting release formulation of exenatide, marketed under the brand name Byetta. Amylin has cooperated with Indianapolis-based Lilly (NYSE: LLY) on the development of the drug.
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