US Pharmaceutical major Eli Lilly and Company (Lilly) has entered into an exclusive global licensing pact with Australian drug maker Acrux for its experimental testosterone Axiron which is under review by the US Food and Drug Administration (FDA) for the treatment of testosterone deficiency in men.
Testosterone is a steroid hormone which plays a key role in the development of male reproductive tissues and also essential for general health and prevention of osteoporosis. Up to 39 per cent of men over 45 years are estimated to have testosterone deficiency, also known as hypogonadism.
The agreement provides Lilly for the exclusive worldwide rights to commersialise Axiron. Acrux will be paid $50 million upfront plus $3 million on transfer of manufacturing assets. Further, Acrux will receive $87 million upon issuance of marketing authorisation by FDA, and up to $195 million based on commercialisation, a joint statement issued on Monday said.
The total value of the deal works out to $335 million. In addition, Acrux will be entitled for royalty payments on successful commercialisation of the new product.
Melbourne-based Acrux develops and commercialises a range of patented pharmaceutical products for global markets using its innovating technology to administer drugs through the skin.
Axiron solution is applied to the armpit which is a discreet and convenient application site, using a special applicator that avoids direct hand contact with the drug. The fast drying properties, novel application site, and 'no touch' features mean that, if approved, Axiron may potentially represent an attractive new option for patients compared to existing gel products.