Acrux's US partner completes enrolment for phase III trial

Melbourne-based Acrux's (ASX:ACR) US partner Vivus (NASDAQ:VVUS) has completed enrolment for its phase III clinical study of Acrux's estradiol transdermal spray product Evamist for the treatment of menopausal symptoms.

The phase III trial is a multi-centre, randomised, double-blind placebo controlled study to evaluate the safety and efficacy of Evamist.

Over 400 patients were enrolled at 43 centres throughout the USA.

The primary endpoint is a reduction in frequency and severity of moderate to severe vasomotor symptoms, including hot flushes, associated with menopause at weeks 4 and 12 of the study.

When asked when the study will be completed, Acrux's CFO Jon Pilcher said that: "Vivus haven't given an exact time-frame, but the treatment period is 12 weeks, so I guess you could add three months onto the end of enrolment, which means early in the new year."

The study was initiated in December 2004 under a special protocol assessment (SPA) with the FDA. The SPA is a formal agreement that designates the agreed upon terms and conditions under which Vivus will conduct and analyse data from the phase III trial.

"The fact that it's under a special protocol assessment means that there's very little risk in this whole project. Not only have we got a product in phase III, but it's one in which virtually all the technological risk is now gone," said Pilcher.

Vivus expects that the New Drug Application (NDA) for Evamist will be submitted to the US Food and Drug Association (FDA) in mid 2006 and Acrux will receive two milestone payments worth US$4 million, one payment upon filing and the other on approval of the NDA.

"We haven't disclosed how much is on each but it's $4 million in total," said Pilcher. "Obviously we get royalties on the sales once it hits the market. We also have access to the phase III data to use for Australia and New Zealand, and we're free to license to anyone else in the world."

Vivus has rights to the US market for Evamist, however, Acrux retains the rights for the rest of the world.

Pilcher said that Acrux is "banking" on FDA approval for Evamist taking up to a year enabling the product to be on the US market by mid 2007.

"It's our first product that's going to be on the market," said Pilcher. "Because it's a platform technology the first product getting out there will be commercial validation of the whole technology, so we think that partners and patients are going to be much keener for our products once the first one's out there."