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Additional information

Additional	Information
Market:	ASX
Sector:	Pharma & Biotech
Epic:	ASX:ACR
News:	Latest news
Web Site:	Acrux Limited
Other Articles:	02-10-200916-07-200923-02-2009

Clinical trial results positive for Acrux's contraceptive spray

Acrux (ASX:ACR) today announced positive results from the latest clinical trials of Nestorone® MDTS®, its unique contraceptive skin spray.  The spray is designed to be a better choice for women using hormonal contraceptive pills or patches. The global contraceptive market was worth US$7.2 billion in 2007 and by 2012 is estimated to have grown by 45%. 3 out of 4 contraceptive pills and the only approved contraceptive patch, contain both a progestin and ethinyl estradiol (an estrogen).

Nestorone®, which cannot be taken orally, is a fourth-generation progestin contraceptive that has no androgenic hormonal effects, and a good safety profile. MDTS® is a small, hand-held, easy-to-use spray that is designed to provide an easy and convenient means to deliver a preset dose of a therapeutic drug via the skin.

Acrux’s trials in Australia with 40 women tested a number of its skin spray formulations, applied to the forearm once a day over 14 days. The formulations contained the proprietary new generation progestin Nestorone®, combined with either ethinyl estradiol or estradiol as the estrogen. The amount of each of these hormones in the blood was measured once a day and every 4 hours on day 14. Importantly, these were the first trials to test the performance of daily sprays over an extended period. In earlier trials Acrux has tested only single doses of Nestorone® MDTS® formulations.

Formulations containing Nestorone® and ethinyl estradiol successfully delivered therapeutic amounts of both hormones across the skin into the blood. All spray formulations were well tolerated, with no serious adverse events recorded.

Next commercialisation steps

The next step in the development of the contraceptive spray is expected to be a Phase 2 dose-ranging clinical trial before conducting Phase 3 global registration trials. Through its alliance with Orion Corporation, Acrux will have the capability to provide commercial manufacture and supply of Nestorone® MDTS®. Following these latest clinical trial results, Acrux will now engage a commercial partner to undertake the remaining clinical trials.

“These multi-dose, steady-state results are very exciting and represent the first extended trial of our unique combination contraceptive sprays”, commented Acrux CEO Richard Treagus. “The results with Nestorone®, together with our formulation work on other contraceptive progestins, now place Acrux in a strong position to make commercial progress in this very large market” he added.

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.

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:

- Testosterone MD-Lotion® 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 had $25.4 million in cash at end of  December quarter of 2008.

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