Acrux pushes forward

In the four months since it listed on the ASX, Melbourne-based Acrux (ASX: ACR) has had a busy time of it. This week the company announced successful completion of its Phase I study for a transdermal spray to deliver pain drug Fentanyl to treat severe chronic pain. CEO Igor Gonda is confident that this outcome gives the company an attractive commercial opportunity.

"We've done everything we promised in our IPO and more," Gonda told Australian Biotechnology News recently.

"We're hitting our timelines on all products."

"Our plans on the remaining development and commercialisation strategy will advance after discussions with the US Food and Drug Administration (FDA) on the path to approval for the US market," he said.

The product is already the subject of a distribution agreement with CSL in Australia and New Zealand, and Acrux is seeking appropriate commercial partners in the US and European markets.

And the company has a lot of products in its portfolio with five products currently in clinical development, and more coming up.

At the top of the list of achievements is December's announcement that US partner Vivus has commenced its Phase III clinical trial for the treatment of menopausal symptoms with Acrux's estradiol transdermal spray product Evamist. The 400-500 patient trial, which is fully funded by Vivus, is expected to wrap up in the second half of 2005, and Vivus is likely to file for approval in 2006.

Assisting the process is the FDA, which recently completed a Special Protocol Assessment on the trial, which means that if the trial hits its endpoints, it can form the basis of the New Drug Application, streamlining the process of approval.

Acrux stands to gain considerably from its agreement with Vivus -- a milestone payment of US$1 million is due by June 29 this year, and another $4 million will be forthcoming once the NDA has been filed.

The other product covered by Acrux's agreement with Vivus -- the testosterone transdermal spray for treatment of female sexual dysfunction -- is also moving along. The company received a US$125,000 milestone payment after Vivus completed its Phase IIb trial in October, and the Phase III trial is expected to commence in the first half of this year, once discussions with the FDA on the protocol have been completed. In addition, the product has been licensed to CSL for marketing and distribution in Australia and New Zealand -- Vivus's rights for both products are for North America only, leaving Acrux plenty of room to come to agreements with other partners.

But in addition to its two Phase III projects, the company has plenty of earlier stage clinical projects to keep it busy. A phase I trial for a testosterone lotion incorporating Acrux's proprietary enhancers for use in men was completed last year and the company is working out its strategy for going forward.

"We plan to take this product through clinical trials on our own," Gonda said.

And a Phase I study of a contraceptive spray based on the fourth generation progestin Nestorone, in collaboration with the non-profit reproductive research organisation The Population Council, is also underway.

Waiting in the wings is an incontinence drug -- a transdermal spray of oxybutynin -- which is likely to commence clinical trials in the coming months. It's one of a variety of niche areas the company hopes to target.

"We'll be making some decisions on niche product areas this year, which areas would be best for us to develop," Gonda said. "The selection process is very different -- you look at the value of the market for yourself. But you can often negotiate much better terms than for a blockbuster drug."