Avexa closer to EMA approval for ATC

Shares in Avexa Limited (ASX:AVX) surged in value by 31% after the company revealed it had taken another step towards European approval for its anti-HIV drug, apricitabine (ATC).

The Melbourne-based company said the European Medicines Agency (EMA) had given a positive reception to the company's phase III development roadmap for the drug.

Avexa CEO Jonathan Coates said the company was recently invited to attend a working party to further discuss this development with the regulatory body.

He said the EMA's response to date has been similar to that provided by the FDA related the company's US application.

The FDA granted fast-track status to the drug in 2009. In November 2010, the company revealed it had booked meetings with the FDA to discuss clinical development opportunities for ATC, and by the following March both parties had agreed on the way forward to receiving regulatory approval.

“This means that an expedited pathway for approval of ATC has now been clarified with both the FDA and EMA,” he said, noting that the US and the EU are the world's two largest HIV markets.

“Importantly, regulatory authorities in many other countries typically follow the requirements of one or both of these two key authorities,” he added.

Apricitabine is a nucleoside reverse transcriptase inhibitor for the treatment of drug-resistant HIV. It was originally developed by BioChem Pharma but later sold to Shire Pharmaceuticals, which then sold the rights to develop the drug to Avexa.

Avexa (ASX:AVX) shares grew 31.03% in Thursday's trading to $0.038, the highest daily price at market close since early December 2011.