INDIANAPOLIS and MELBOURNE, Australia, March 15 /PRNewswire-FirstCall/ -- Eli Lilly and Company and Acrux announced today that they have entered into an exclusive worldwide license agreement for the potential commercialization of Acrux's experimental underarm testosterone solution (proposed tradename AXIRON(TM)). The new drug application for AXIRON is 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's commitment to men's health and, if approved, could provide a new treatment option for men suffering from low testosterone," said Bryce Carmine, president of Lilly's Bio-Medicines. "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."
Testosterone deficiency in men (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(1). However, in the majority of men this remains undiagnosed, with approximately 10% of those with the condition receiving treatment(1). According to IMS data, 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.
Acrux is an Australian drug delivery company, developing and commercializing a range of patented pharmaceutical products for global markets, using its innovative technology to administer drugs through the skin. Additional information about Acrux is available at www.acrux.com.au.
CONTACT: Lilly - Mark E. Taylor, +1-317-276-5795, email@example.com;
or Acrux - Dr Richard Treagus, +61 417 520 509,
Web site: http://www.lilly.com/