The deal is dependent on the acceptance of the new drug application that Axiron has lodged with the US FDA, which is currently under regulatory review as a treatment for testosterone deficiency in men, a condition known as hypogonadism
“Axiron has the potential to be the first testosterone solution to be applied via an underarm applicator, for patients who have testosterone deficiency,” said Bryce Carmine, president of Eli Lilly’s Bio-Medicines division.
Deal will see underarm testosterone treatment go global
If the licensing deal is confirmed, the agreement will give Eli Lilly the rights to market the product in the 143 countries the company already has distribution agreements in, including Australia, North America and the main EU markets.
The deal represents the biggest amount ever to be brokered by an Australian biotech company, and is estimated at a total of AUS 335m (€224m), which represents a payment of AUS 53m in cash, together with a further AUS 87m if the FDA grants a license and AUS 195m for further commercialization goals.
Although the technology is being licensed as a drug and is set to be marketed in the men’s health category, the fact that the delivery is topical is significant, suggesting there could be future applications for over-the-counter products in certain markets.
Treatment for a range of low testosterone symptoms
Axiron recommends a dosing level of 2 per cent and says the product can be used to treat a range of symptoms associated with low testosterone in males, including erectile dysfunction.
Indeed, the product fits well with Eli Lilly’s existing brand portfolio, as it already holds the licensing rights to Cialis, a leading erectile dysfunction therapy with estimated global sales of $1.6bn ($1.16bn) in 2009.
The global testosterone treatment market is currently estimated at $1.04bn, and besides erectile dysfunction therapies target fatigue, depression, reduced muscle strength and lower bone density.
Testosterone and skin care
In recent years a number of products have already been launched in the personal care category targeting testosterone as a means of treating signs of skin ageing, including the Didier Rase skin care range, which was launched three years ago.
It is formulated with a testosterone-boosting ingredient Phyto-androzyme, a magnolia plant extract that targets the depletion of a combination of major processes in the male skin ageing process: Sex Hormone Binding Globulin (SHBG), 5-Alpha-reductase and Aromatase.
Researchers involved in the project claim that the ingredient works through enzymatic inhibition as well as acting as a decoy for the depletion of SHBG, which in turn helps normalize the amount of bio-available testosterone available to the skin cells.