ACRUX LIMITED — Capital/Financing Update 2009

Jul 15, 2009

16 JULY 2009

ACRUX (ACR) - ASX ANNOUNCEMENT

ACRUX COMPLETES PHASE 3 TRIAL OF AXIRON[™]

Highlights:

• AXIRON[™] pivotal, open-label Phase 3 trial in USA, Europe and Australia completed

• Primary objective is to demonstrate that AXIRON[™] restores average blood levels of testosterone into the normal range

• Trial results expected to be announced in September 2009

• Global sales of testosterone therapy products reached US$1 billion in the year to March 2009, growing by more than 20% in the USA

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Melbourne, 16 July 2009: Acrux (ASX: ACR) today announced the completion on schedule of its pivotal Phase 3 open-label trial of AXIRON[™] , with results expected to be announced in September 2009. All patients have finished 4 months of treatment with AXIRON[™] . The primary endpoint of the trial is the proportion of patients with average blood levels of testosterone within the normal range.

Four remaining patients are still completing a further 2 months of treatment in the extension study monitoring skin safety with 6 months of continuous use.

Acrux is targeting submission of a marketing application to the US Food and Drug Administration (FDA) in December 2009. If approved, AXIRON[™] is expected to enter the testosterone therapy market in early 2011. Based on IMS data, global sales in this market for the year to March 2009 exceeded US$1 billion for the first time, and sales in the US market grew by more than 20%. Sales of testosterone gels grew to US$0.75 billion.

The FDA recently announced that it had received reports of adverse effects in children who were inadvertently exposed to testosterone (secondary exposure) through contact with patients being treated with testosterone gels. The FDA is now requiring marketers of the gels to include a “boxed warning” in their product information, providing additional information about the risk of secondary exposure and the steps that should be taken to reduce this risk. The gels are applied by hand on to the upper torso, shoulders or arms. In contrast, AXIRON[™] is a faster-drying solution that is applied in a small volume to the armpits, using a convenient “no-touch” applicator.

Last year Acrux published results from market research conducted in both patients and physicians in the USA, in which 94% of patients who tried AXIRON[™] rated it better than the testosterone gels in its ability to reduce the risk of transference of testosterone to others. In addition, 92% of physicians surveyed who prescribe gels as first line therapy rated AXIRON[™] as very good or excellent in its ability to reduce the risk of transference to others when compared to the gels. Two thirds of patients confirmed that they would prefer AXIRON[™] to their existing gel treatment and 87% of physicians said that they would offer AXIRON[™] to their patients that currently use gels.

“The commercial value of AXIRON[™] has increased further following the FDA directive to the market-leading testosterone gels”, said Dr Richard Treagus, CEO and Managing Director of Acrux. “We anticipate announcing results from the Phase 3 trial on schedule in September and in parallel we will actively engage the FDA on the benefits of AXIRON[™] , most notably, its greatly reduced risk of secondary exposure. We are excited about the prospect of making this unique product available to patients in

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all major markets and in doing so, delivering strong financial returns back to Acrux and its investors”, he said.

The commercial manufacturing arrangements for AXIRON[™] are a key component of the FDA marketing application. In parallel with the Phase 3 trial, Acrux has completed the transfer of the manufacturing process to Orion Corporation in Europe, which will be the exclusive manufacturer of AXIRON[™] . Orion has scaled-up the process and has successfully manufactured three registration batches, formulated at commercial scale, as required for the marketing application.

About the Phase 3 trial

27 sites in the USA, the UK, Sweden, France, Germany and Australia are participating in the open-label trial, treating men with testosterone levels below the normal range. The primary objective is to demonstrate that AXIRON[™] restores average blood levels of testosterone into the normal range. The main trial treatment period is 4 months, during which blood samples are analysed to determine the level of testosterone in the blood. At least 50 men at the US sites continue treatment for 2 months to monitor skin safety with 6 months of continuous use.

About AXIRON[™] (testosterone solution) 2%

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. Estimates of men over 50 years of age having testosterone levels below the normal healthy range vary from 10% to 39%. However, in the majority of men this remains undiagnosed, with only around 5% to 10% of those with the condition receiving treatment. With a high incidence rate and low but growing treatment rates, the male testosterone deficiency market will remain an attractive commercial opportunity. AXIRON[™] has been designed to overcome the significant issues and drawbacks associated with the current gel treatments. Large volumes of gel are applied by hand and rubbed on to the upper torso, shoulders or arms. They are considered messy, sticky, slow-drying and may have an unpleasant odour to some patients. One of the biggest drawbacks is the risk of transference to other people through direct skin contact or from residue left on the hands following application . AXIRON[™] is a fasterdrying and pleasant smelling solution that is applied to the armpits once daily, using a convenient and ergonomic “no-touch” applicator designed in Australia. The armpit is a unique novel application site for transdermal drug delivery and it offers significant advantages to the patient in terms of convenience and a vastly reduced risk of transference from patient to others. A factsheet on AXIRON[™] is available for download at www.acrux.com.au.

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For more information contact:

Dr Richard Treagus, CEO Hugh Alsop, Business Development Director +61 417 520 509 +61 439 080 353 richard.treagus@acrux.com.au hugh.alsop@acrux.com.au

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, Evamist™ (brand name Ellavie™ outside the USA) to treat menopause symptoms, marketed by its licensee in the USA and has the following products in clinical development:

• AXIRON[™] to treat testosterone deficiency in men

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

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

• An undisclosed companion animal health product

• Nicotine MDTS[®] for smoking cessation

• Acrux has licensed US rights for Evamist™ to KV Pharmaceutical and has appointed distributors for Ellavie™ in Switzerland, Southern Africa, South Korea and Australia. Acrux has also licensed its technology to Eli Lilly and Company for veterinary healthcare products, US rights for Testosterone MDTS[®] to VIVUS, and has an exclusive alliance with Orion Corporation for commercial product supply.

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