The new drug application for Axiron is currently under regulatory review by the FDA for the treatment of testosterone deficiency (hypogonadism) in men.

As per the terms of the agreement, Lilly is expected to receive exclusive worldwide rights to commercialise Axiron. In exchange for these rights, Acrux will receive an upfront payment of $50m plus $3m on the transfer of manufacturing assets.

Additionally, Acrux is further eligible for $87m upon the issuance of marketing authorisation by the FDA, and up to $195m in potential commercialisation milestones, as well as royalty payments on future global sales if Axiron is successfully commercialised. As a result of this transaction, Lilly expects to incur a charge to earnings in the first quarter of 2010 of approximately $.03 per share.

Bryce Carmine, president of bio-medicines at Lilly, said: "The addition of Axiron reinforces Lilly's commitment to men's health and, if approved, could provide a new treatment option for men suffering from low testosterone.

"Lilly hopes to leverage our experience in men's health to advance both the science and clinical outcomes for men with low testosterone. Some of the needs of patients in approaching therapy include the need for a convenient way to administer therapy over a small and discreet area of the body. Axiron has the potential to be the first testosterone solution to be applied via an underarm applicator, for patients who have testosterone deficiency. We look forward to working with Acrux and the FDA during the regulatory review process."

Richard Treagus, CEO of Acrux, said: "We are delighted to build on our established relationship with Lilly and collaborate on the potential worldwide commercialisation of Axiron."

Source：web of PBR