avx roadshow press

Avexa talks strategy
Amanda Ellis
Thursday, 23 December 2010

FORMER HIV drug developer Avexa is keeping mum about whether it has applied for orphan drug designation for apricitabine (ATC) in the US, but has revealed it has spoken to a handful of large pharmaceutical companies about the asset since July

The company is planning a meeting with US Food and Drug Administration next year to discuss the value of ATC.

Avexa chief executive Jonathan Coates told BTN the company was focused on building up shareholder value and had worked hard since July.

?ATC is progressing to regulatory meeting in early 2011,? he said.

Coates said a recent highlight for Avexa was an independent expert?s review, which found real potential in its portfolio.

In May the company suffered a large drop in share price after it closed that drug?s development program and made staff redundant.

?We are progressing to FDA with ATC and that will help us position and partner,? he predicted.

When asked by BTN whether Avexa would return to clinical investigation of ATC after that meeting, Coates indicated the company would only return to the program with a partner.

?We will not undertake clinical trials on our own after FDA,? he said.

?Even after we have gained a good go-decision from them, that what we have put to them shows that ATC could be clinically trialled in a different way.

?We would only do that if we can obtain a suitable and appropriate partner.?

Coates acknowledged that evaluating whether to apply for orphan drug status was one option for a company who was evaluating a new clinical approach to a drug.

However, when asked by BTN whether Avexa had applied for orphan drug status for ATC, he said it would be confidential for him to comment.

Avexa recently abandoned its hepatitis C virus assets on the expert?s advice, out-licensed its antibacterial assets to Valevia, became an Allied Medical investor and out-licensed its integrase program to a Shanhai organic chemistry institute.

The company has taken up a recommendation from the expert to work for twelve months on its integrase program to enhance its value, Coates said.

By mid-afternoon today Avexa?s shares sat at yesterday?s 3.9c close on the exchange of 230,432 shares.