Promising Phase III data clears Acrux's path to the FDA

Australia's Acrux has lived up to analysts' expectations, reporting that its late-stage trial of a new testosterone spray proved promising, which clears the way to an FDA application later this year.

Acrux's share price has tripled this year as investors' hopes were raised by the experimental Axiron program. More than a third of all men over the age of 45 suffer from low testosterone levels, a condition that can result not only in a low sex drive but also osteoporosis as well as memory loss. The market for testosterone treatments is about a billion dollars a year, but it's dominated by testosterone gels that are often considered messy by the men who use them.

Axirone, on the other hand, is a spray that effectively returned testosterone back to normal levels in 84 percent of the men who used it in the trial. "We believe this will generate significant revenue for our company from 2010 onwards," said Acrux CEO Richard Treagus.

"In terms of the proportion of responders to testosterone replacement using Axiron, the pharmacokinetic parameters and the response from this multi-center clinical trial, the results are very exciting and precisely what we had hoped to see," commented lead investigator Professor Christina Wang, MD.

- check out the press release
- read the article from Bloomberg

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