Acrux to Start USA Trial of Its Unique Testosterone Lotion For Men

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
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    --  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.
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