ACRUX LIMITED — Capital/Financing Update 2007

Nov 12, 2007

ACRUX (ACR) - ASX ANNOUNCEMENT

13 NOVEMBER 2007

ACRUX REPORTS POSITIVE CLINICAL TRIAL RESULTS AND PROGRESS ON TESTOSTERONE MD-LOTION[®] PHASE 3 DEVELOPMENT

Acrux (ASX: ACR), the Australia-based drug delivery company, today provided an update on its global Phase 3 development programme for Testosterone MDLotion[®] , including the successful completion of its supplementary clinical trial assessing key in-use attributes of the product, such as interaction with deodorants and anti-perspirants.

Acrux CEO Richard Treagus commented “I am pleased to report that we are on track against the budget and timelines that we presented following positive Phase 2 trial results in July 2007. We have now also confirmed that Testosterone MD-Lotion[®] can be used with deodorants and anti-perspirants, further enhancing its commercial value.”

Successful completion of supplementary clinical trial

In a recently completed clinical trial conducted in Canada in 96 healthy volunteers, Acrux assessed the following attributes at various different time points, by measuring the amount of testosterone in blood samples:

1. the interaction of Testosterone MD-Lotion[®] with anti-perspirants and deodorants

2. the impact of washing the armpit following application of Testosterone MD-Lotion[®]

3. the degree of patient-to-person transfer following application of Testosterone MDLotion[®]

The first attribute was a key commercial consideration and the second and third attributes are routinely required by regulatory authorities for the registration and labelling of transdermal pharmaceutical products.

The results of the trial demonstrated that commonly marketed deodorants and antiperspirants did not interfere with the absorption of Testosterone MD-Lotion[®] from the armpit, regardless of whether they were applied before, or afterwards. This provides further confirmation that Testosterone MD-Lotion[®] can readily become part of a normal daily grooming routine for men and will provide a significant improvement over the currently available testosterone treatments.

Both the washing and transfer effects were broadly in line with experience from other Acrux products, and will offer comparative labelling to existing transdermal testosterone products.

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Update on Phase 3 development program

The balance of the Testosterone MD-Lotion[®] development programme is progressing well and is on track with respect to the previously stated budget and timelines. Marketing applications to regulatory authorities in the key markets are planned for the second half of 2009.

Acrux is in the process of finalising the appointment of a leading international clinical research organisation to manage the multi-centre Phase 3 clinical trial, which is scheduled to commence in the second quarter of 2008. The trial will require the recruitment of 150 hypogonadal men in the USA, Europe and Australia, who will receive daily treatment with Testosterone MD-Lotion[®] for a 3 month period.

Work is also advancing towards the finalisation of the unique armpit applicator utilising the expertise of an internationally recognised design and development business. A specialist medical products manufacturer based in Sydney has been appointed to produce the applicators for the Phase III clinical trial and to develop the commercial manufacturing process. In addition, selection of the commercial finished product contract manufacturer is well underway, with technology transfer and scale up activities scheduled to commence in early 2008. Acrux strengthened its skills in the manufacturing area in September 2007 with the appointment of an experienced Director of Technical Operations & Product Development.

Contact

Richard Treagus, CEO & Managing Director Tel: +613 8379 0100 Mobile: +61 417 520 509 e-mail: richard.treagus@acrux.com.au

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About Acrux’s Testosterone MD-Lotion®

Testosterone MD-Lotion[®] is indicated for the treatment of hypogonadism (testosterone deficiency) in men and involves supplementing endogenous testosterone through the application of a precise dose of quick-drying lotion to the armpit once daily, via a convenient and ergonomic “no-touch” applicator.

Market research in the USA amongst both patients and prescribers that use current testosterone replacement products, including gels and injections, showed a strong preference by the patients for daily application of Acrux’s lotion over the existing products. The leading gel is currently applied each day as a 5 gram dose by hand to the shoulders, upper arms and/or abdomen. It takes longer to dry, is sticky and messy to apply and presents a large surface area with which others must avoid contact. In contrast, the market research highlighted that the men considered Acrux’s lotion would form part of a normal grooming routine and it could be discreetly applied, 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. Testosterone MD-Lotion® is already covered until 2017 by Acrux’s granted patents.

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 over 20% of the US male population over 50 suffer from testosterone deficiency, with the incidence increasing with age. Approximately 10% of hypogonadal men currently receive testosterone replacement therapy. This is expected to grow with increasing patient and physician awareness. Ex-manufacturer sales of testosterone replacement therapies for men in 2006 in the USA alone were more than US$500 million, growing at 14% per annum, to which the leading gel contributed US$377 million. Sales in the key European markets of Germany, UK, France, Italy, Spain and Sweden are currently growing at 20% per annum.

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About Acrux:

www.acrux.com.au

• 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 has one product, Estradiol MDTS[®] (EvaMist™) to treat menopause symptoms, approved by the US FDA and has the following products in clinical development:

• Testosterone MDTS[®] to treat decreased libido in women

• Testosterone MD-Lotion[®] to treat testosterone deficiency in men

• Nestorone[®] MDTS[®] contraceptive sprays for women

• An undisclosed companion animal health product

• Fentanyl MDTS[®] to treat chronic pain

• Nicotine MDTS[®] for smoking cessation

• 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.

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