MELBOURNE, Australia—Eli Lilly and Co. and Acrux announced today thatthey have entered into an exclusive worldwide license agreement for thepotential commercialization of Acrux's experimental underarm testosteronesolution (proposed trade name Axiron).The deal is said to be worth up to $335 million to Lilly.
The new drug application for Axironis currently under regulatory review by the U.S. Food and Drug Administration(FDA) for the treatment of testosterone deficiency (hypogonadism) in men.
"The addition of Axiron reinforces Lilly'scommitment to men's health and, if approved, could provide a new treatmentoption for men suffering from low testosterone," said Bryce Carmine,president of Lilly's Bio-Medicines. "Lilly hopes to leverage ourexperience in men's health to advance both the science and clinical outcomesfor men with low testosterone. Some of the needs of patients in approachingtherapy include the need for a convenient way to administer therapy over asmall and discreet area of the body. Axiron has the potential to be the firsttestosterone solution to be applied via an underarm applicator, for patientswho have testosterone deficiency. We look forward to working with Acrux and theFDA during the regulatory review process."
Testosterone deficiency in men (hypogonadism) isassociated with a number of clinical problems. It has been estimated that up to39 percent of men over 45 years of age may have testosterone levels below the normalhealthy range. However, in the majority of men this remains undiagnosed,with approximately 10 percent of those with the condition receiving treatment. Reportedly, global sales of testosterone therapies have grown tomore than $1 billion per year, with sales of testosterone gels in the United States comprising$700 million.
Acrux is an Australian drug delivery company,developing and commercializing a range of patented pharmaceutical products forglobal markets, using its technology to administer drugs through theskin.