Lilly acquires rights to testosterone treatment

Lilly have entered into a worldwide licensing agreement with Australian-based Acrux for Axiron, an experimental under-arm testosterone applicator.

The treatment is for men suffering with hypogonadism (testosterone deficiency) and is currently filed with the FDA awaiting regulatory review.

The deal gives Lilly exclusive worldwide rights to commercialise Axiron, and in exchange Acrux will receive an upfront payment of $50 million plus $3 million on the transfer of manufacturing assets.

Acrux will be eligible for $87 million upon FDA approval, and up to $195 million in potential milestones, as well as royalty payments on future global sales.

Data from IMS Health shows that global sales of testosterone therapies have grown to more than $1 billion per year, with sales of testosterone gels in the US comprising $700 million.

“The addition of Axiron reinforces Lilly’s commitment to men’s health and, if approved, could provide a new treatment option for men suffering low testosterone levels,” said Bryce Carmine, president of Lilly’s Bio-medicines.

Carmine continued: "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 under-arm applicator, for patients who have testosterone deficiency. We look forward to working with Acrux and the FDA during the regulatory review process."

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

Treagus added: "Through Lilly's considerable global resources and leadership position in the field of men's health, Acrux now has the opportunity to achieve the full commercial potential of Axiron."

Hypogonadism is associated with a number of clinical problems - it has been estimated that up to 39% of men over 45 years of age may have testosterone levels below the normal healthy range. However, in the majority of men this remains undiagnosed, with approximately 10% of those with the condition receiving treatment.