ACR Acrux Limited

Acrux (ASX: ACR): -- Phase 2 trial under US IND starting in October 2006 -- US Market research shows strong patient preference for Acrux lotion over current marketed therapies -- Patent pending will cover convenient and discreet application to the armpit until 2026 -- Current global market US$600 million, and growing Acrux (ASX: ACR), the Australia-based drug delivery company today reported that it will start a Phase 2 clinical trial in the USA following the recent acceptance of an Investigational New Drug Application (IND) for Testosterone MD-Lotion(R) by the US Food and Drug Administration (FDA). The aim of the trial, in forty men with testosterone deficiency, is to demonstrate that once daily use of the quick-drying lotion maintains testosterone levels within the normal range. Results of the trial are expected to be available in the second quarter of 2007. If successful, a Phase 3 registration trial approved by the FDA will then be required before a US marketing application is submitted to the FDA in the second half of 2008. Acrux recently commissioned market research in the USA amongst both patients and prescribers that use current testosterone replacement products, including gels and injections. The results showed a strong preference by the patients for daily application of Acrux's metered dose lotion (MD-Lotion(R)) over the existing products. The Acrux product will apply a precise dose of quick-drying lotion to the armpit once daily, via a convenient and ergonomic "no-touch" applicator. The leading gels are applied by hand to larger areas of the torso, take longer to dry and patients are advised to wear protective clothing after application to reduce the risk of transferring testosterone to others. The market research further highlighted that the men considered Acrux's lotion would form part of a normal grooming routine and it could be discreetly applied in public, much like a deodorant. Acrux has an international patent pending, which covers the application to the armpit of a number of drugs, including testosterone, combined with a skin penetration enhancer and a volatile liquid. Once granted, the patent will provide protection against competing products until at least 2026 in all major markets. Worldwide sales of testosterone replacement therapies for men in 2005 were US$628 million, to which the leading gel contributed $338 million. The market is growing at approximately 9% in the USA and at a faster rate in Europe. Acrux CEO Richard Treagus commented "We have a unique proposition with this product. Strong patient preference and patent protection give us a real advantage in a large, growing market and we are now well placed to seek commercialisation deals." About testosterone deficiency Testosterone deficiency in men (hypogonadism) is associated with a number of symptoms including lethargy, depression, reduced libido and decrease in muscle mass and bone density. It is estimated that 20% of the US male population over 50 suffer from testosterone deficiency. Approximately 10% of hypogonadal men currently receive testosterone replacement therapy. This is expected to grow with increasing patient and physician awareness. About the Phase 2 clinical trial The trial, to be conducted in several locations in the USA, is a randomised, open label, two way crossover study in up to forty men with testosterone levels below the normal range. The primary endpoint is measurement of the level of testosterone in the blood and other pharmacokinetic parameters after daily application to the armpit of two different doses of Testosterone MD-Lotion(R) for 7 days. About Acrux www.acrux.com.au -0- *T -- 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(R) (Evamist(TM) in USA) to treat menopause symptoms -- Testosterone MDTS(R) to treat decreased libido in women -- Nestorone(R) MDTS(R) contraceptive spray for women -- Fentanyl UDTS(TM) to treat chronic pain -- Testosterone MD-Lotion(R) to treat testosterone deficiency in men -- Acrux has licensed USA rights for Estradiol MDTS(R) and Testosterone MDTS(R) to VIVUS Inc. and AUS/NZ distribution rights for Testosterone MDTS(R) and Fentanyl UDTS(TM) to CSL Limited. Acrux has also licensed its technology to Eli Lilly and Company for veterinary healthcare products. *T