Acrux has received an $87 million milestone payment from Eli Lilly as a result of FDA’s clearance of the topical testosterone replacement therapy, Axiron®. Sanction covers the use of Axron in men wtih conditions associated with a deficiency or absence of endogenous testoeterone.
The regulatory package included Phase III trial data demonstrating that 84% of men with low testosterone who completed the study achieved average serum testosterone concentrations within the normal range when treated using Axiron once daily. The drug’s safety and efficacy in males under the age of 18 years has not been established, Acrux points out.
Lilly negotiated exclusvie, worldwide rights to commercialize Axiron, paying $50 million up front in March. The firm will pay Acrux another $3 million on the transfer of manufacturing assets plus up to another $195 million in commercial milestones. Lilly is responsible for obtaining marketing approval for Axiron in territories outside the U.S. Acrux estimates global annual sales of testosterone therapies are approximately $1.2 billion, of which sales in the U.S. comprise $1 billion, with the market currently growing at 20% per annum.
Axiron is an alcohol-based testosterone formulation administered to the armpit using a metered-dose applicator. The firms claim the treatment is the first topical testosterone solution to have been approved for underarm application.
The firm’s first product to receive FDA approval, Evamist™ (Ellavie™ outside the U.S.), is used to treat menopause symptoms and is marketed by U.S. licensee, KV Pharmaceutical, and other distributors in additional approved territories.
Acrux’ clinical pipeline includes Luramist™, which is in Phase II development for the treatment of decreased libido in women along with its Nesterone® MDTS® contraceptive and Nicotine MDTS smoking cessation products, which are in Phase I/II development.
Luramist is a testosterone spray for treating hypoactive sexual desire disorder in women. In April Acrux announced that it had successfully regained U.S. rights to the product from Vivus and is now exploring regulatory and partnering options for further development.