The studies compared blood levels of testosterone in healthy volunteers. The aim of the first study was to compare two different formulations of Testosterone MD Lotion®, and the aim of the second study was to compare two different application sites.
The results of the first study showed that both formulations provided similar blood levels, providing options for continued development of either formulation. In the second study, there was a significant difference in absorption between the two different application sites, providing important information for the design of the remaining clinical studies in men.
In both studies, the lotion was well tolerated, with no application site reactions noted, and no serious adverse events recorded. Full details of the studies are presented in Appendix 1.
Acrux's development of Testosterone MD Lotion® is continuing, with further studies to commence shortly to confirm the doses required to maintain testosterone blood levels in the target range for effective treatment.
Acrux CEO and Managing Director, Dr Igor Gonda said: "We believe our fast drying, no-touch metered dose lotion has significant competitive advantage over the existing products in this growing market. The remaining trials suit our expertise and require moderate investment, so in line with our financial plans we intend to complete them ourselves before choosing the best option for sales and marketing".
The remaining development programme:
The three remaining clinical studies will involve measuring the amount of drug delivered to the bloodstream ("pharmacokinetics"), following advice from the US Food and Drug Administration (FDA). This means that the programme is more straightforward and has lower risk and lower cost than a traditional clinical study programme. Acrux plans to complete all remaining development, using its own expertise and experience in pharmacokinetic studies. A New Drug Application is targeted for mid-2008 to obtain FDA approval to market the product in the USA. The next clinical study will commence later this year. This study will assess testosterone blood levels in male volunteers after multiple doses of Testosterone MD-Lotion®, with completion of the study planned for early 2006.
The target market:
It is estimated that four to five million men suffer from low testosterone (hypogonadism) in the USA alone, with this figure predicted to increase in future years. Global sales in the year to January 2005 of products to treat hypogonadism were US $415 million, representing an increase of 12% over the previous year (IMS Health, IMS Midas, MAT, Jan 2005).
Contacts:
Igor Gonda, CEO & Managing Director
Tel: 61-3-8379-0100
Geoff Harrison
RADAR Investor Relations
Tel: 61-2-8256-3333
About Acrux
www.acrux.com.au
Acrux is a specialty pharmaceutical company, developing and commercialising a range of patented, patient-preferred healthcare products for global markets, using its innovative technology to administer drugs through the skin.
Acrux's product pipeline includes treatments of hormonal deficiencies, pain and central nervous system disorders, as well as a contraceptive.
19 human clinical trials have been completed with 7 different drug products and the lead product, EvamistTM (Estradiol MDTS®), is currently in a phase 3 clinical trial in the USA.
Acrux has licensed USA rights for EvamistTM (Estradiol MDTS®) and Testosterone MDTS® to VIVUS and AUS/NZ distribution rights for Testosterone MDTS® and Fentanyl MDTS® to CSL Limited. Acrux has also licensed its technology to Eli Lilly for veterinary healthcare products, to Napa Biosciences for certain dermatology products and to Connetics for anti-psoriatics and local anaesthetics.