Acrux delivers on male testosterone lotion

Listed Australian biotech company Acrux (ASX: ACR) has taken a significant step forward towards becoming a world leader in the simple and effective delivery of male testosterone replacement therapy, following the success of a clinical trial with its innovative testosterone under-arm lotion.

Acrux today announced the results of an 8-month clinical trial conducted in the United States, demonstrating that its Testosterone MD-Lotion® applied to the armpit of men with low testosterone was able to effectively and safely restore testosterone levels into the normal range, with no adverse side effects.

The completion of the phase 2 trial, carried out across nine different centres in the US, now paves the way for the phase 3 trial - the final step needed prior to Acrux seeking marketing approval from the US Food and Drug Administration (FDA) and other regulatory bodies in Europe and Australia.

“The Testosterone MD-Lotion® delivery mechanism is a significant advance over conventional treatments such as gels, patches and injections. The fast-drying lotion is applied directly into the patient’s armpit using a “no-touch” applicator, in much the same way as a deodorant”, said Dr Richard Treagus, CEO of Acrux.

Following the success in phase 2, Acrux has decided in the interests of maximising shareholder value that it will fund and conduct the phase 3 development of Testosterone MD-Lotion® itself rather than licensing the product to a marketing partner at this point. Acrux believes that this strategy more than doubles the value of the product. “The phase 3 development will cost us approximately $20 million, and we will raise additional funding for this project as quickly as we can”, added Treagus.

Acrux is on track to commence the phase 3 trial in the first half of 2008. Subject to successful completion of phase 3, the company will then submit a marketing application to the FDA in the second half of 2009 with product launch in the US market and beyond expected in late 2010.

The male testosterone replacement market is estimated to be worth over US$600 million and is growing at 14 per cent annually. This growth is set to continue, given the ageing of the population, the heightened awareness of the condition amongst prescribers and the availability of more patient-friendly testosterone delivery mechanisms such as Acrux’s MD-Lotion®.

Source : Research Australia