ACRUX LIMITED — Capital/Financing Update 2009

Sep 2, 2009

ACRUX (ACR) - ASX ANNOUNCEMENT

3 SEPTEMBER 2009

ACRUX TO PROCEED WITH AXIRON[™] NEW DRUG APPLICATION FOLLOWING MEETING WITH FDA

Highlights:

• Pre-NDA meeting held with the FDA

• FDA agrees that Acrux may proceed to submit a New Drug Application (NDA) for AXIRON[™]

• Acrux targeting submission of NDA by end of 2009

• AXIRON Phase 3 trial results to be released in week beginning 28 September 2009

• Strong interest received from potential marketing partners, with formal partnering discussions scheduled to commence in October 2009

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Melbourne, 3 September 2009: Acrux (ASX: ACR) today confirmed its plans to submit a New Drug Application (NDA) for AXIRON[™] in the United States following a pre-NDA meeting with the US Food and Drug Administration (FDA) in Washington, DC. The FDA has agreed that Acrux may proceed to file the application, which Acrux is targeting for the end of 2009.

In July 2009, Acrux announced the completion on schedule of its pivotal Phase 3 openlabel trial of AXIRON and today confirmed that results of the trial will be released in the week beginning 28 September 2009. The primary endpoint of the trial, which involved 4 months of treatment with AXIRON, is the proportion of patients with average blood levels of testosterone within the normal range. The trial will be successful in the event that more than 75% of patients have testosterone levels within the normal range following treatment with AXIRON.

The safety extension study is also complete. This comprised 52 patients who received an additional 2 months of treatment, which was specifically undertaken to monitor skin safety following 6 months of continuous use.

Acrux has already received strong interest from a number of potential marketing partners for AXIRON. Following release of the Phase 3 trial results, formal partnering discussions with interested parties will commence in October 2009.

If approved by the FDA, 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.

Last year Acrux published results from market research conducted in both patients and physicians in the USA, in which 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. Importantly, 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.

“We are very pleased with the outcome of the meeting with the FDA and look forward to submitting the marketing application for AXIRON”, said Dr Richard Treagus, CEO and Managing Director of Acrux. “In the meantime, we anticipate strong interest in the formal partnering process that will commence next month following release of the Phase 3 results”, he said.

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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 abdomen, 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 contact with the application site or from residue left on the hands following application . AXIRON[™] is a faster-drying 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.

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.

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• 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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