New 'Roll-On' Male Testosterone Lotion

Main Category: Men's health
Also Included In: Endocrinology;  Clinical Trials / Drug Trials
Article Date: 18 Jul 2007 - 7:00 PDT

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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 has 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 centers 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 aging 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™.

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Article adapted by Medical News Today from original press release.
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A separate announcement filed with ASX, available on http://www.acrux.com.au/, contains full details of the Phase 2 trial results.

About Acrux

* Acrux is an Australian drug delivery company, developing and commercialising a range of patient-preferred, patented pharmaceutical products for global markets, using its innovative technology to administer drugs through the skin.

* Fast-drying, invisible sprays or liquids provide a delivery platform with low or no skin irritation, superior cosmetic acceptability and simple, accurate and flexible dosing. The technology platform is covered by broad and well differentiated, issued patents.

Acrux's products in clinical development include:

Estradiol MDTS™ (EvaMist™ in the USA) to treat menopause symptoms

Testosterone MDTS™ to treat decreased libido in women

Testosterone MD-Lotion™ to treat testosterone deficiency in men

Nestorone™ MDTS™ contraceptive spray for women

Fentanyl MDTS™ to treat chronic pain

* Acrux has licensed worldwide rights to its technology for selected contraceptives and for an undisclosed proprietary drug to ORGANON, USA rights for Estradiol MDTS™ to KV Pharmaceutical and for Testosterone MDTS™ to VIVUS, and AUS/NZ distribution rights for Estradiol MDTS™ to Aspen Pharmacare and for Testosterone MDTS™ and Fentanyl MDTS™ to CSL Limited. Acrux has also licensed its technology to Eli Lilly and Company for veterinary healthcare products.

Source: Richard Treagus
Research Australia