Eli Lilly has announced an exclusive worldwide licence agreement with Acrux for the potential commercialisation of the company’s experimental underarm testosterone solution Axiron.

A New Drug Application for Axiron is under regulatory review by the US Food and Drug Administration (FDA) for the treatment of testosterone deficiency (hypogonadism) in men.

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

Acrux will also be eligible for $87m on the issuance of marketing authorisation by the FDA, and up to $195m in potential commercialisation milestones, as well as royalty payments on potential future sales.

Testosterone deficiency is estimated to affect 39% of men over 45 years of age and is associated with a number of clinical problems.