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US meeting on HIV drug gives Avexa shares a boost
  From: The Australian
March 29, 2011
AVEXA shares shot up by more than 52 per cent after the biotech minnow announced it had held a productive meeting with the US Food & Drug Administration to discuss pushing ahead with phase-three trials of its anti-HIV drug, apricitabine (ATC).
Shares gained 2.1c to close at 6.1c yesterday. But the Melbourne company would go ahead with the trials only if it found a suitable partner to take on the costs and risks, interim chief executive Jonathan Coates said.
He declined to say how much the trials would cost or how long they would take. "The meeting with the FDA has provided a clear and expeditious regulatory pathway for ATC, which is a significant milestone for Avexa and its shareholders," Mr Coates said.
ATC was developed for HIV patients who have built up resistance to multi-drug therapy.
Avexa, which started in 2004, has had a chequered history and over the years has raised more than $155 million, including $24m last year, to conduct clinical trials.
Last year, under the previous management, the board decided its anti-HIV drug was not commercially viable.
But a new board and management team believed otherwise, Mr Coates said. So it held meetings with the US FDA to work out a less complicated regulatory pathway to pursue phase-three trials of the drug.
"Our shareholders felt that the clinical trials should continue and the ATC drug be given one more chance," Mr Coates said.
One of the company's major shareholders is Singapore's Apphia Investments, which has a 17 per cent stake.
Avexa Reaches Agreement with FDA
Melbourne-based biotechnology company Avexa Ltd says it has reached an agreement with the US drug regulator over the company's anti-HIV drug apricitabine (ATC).
Avexa said it met with the US Food and Drug Administration (FDA) and came to an agreement which meant the remaining "regulatory pathway to final approval" for ATC had been agreed.
"Most importantly, the FDA has recognised and given credit for the significant amount of previous ATC clinical studies conducted by Avexa, in particular the latest ATC study AVX-301," the company said in a statement on Monday.
"As a consequence, the remaining regulatory requirements for an ATC approval are considerably less complicated and less extensive than previously assumed and less than that required for other recently approved drugs."
Avexa shares shot up 2.1 cents, or 52.5 per cent, to 6.1 cents on Monday.
Initially, apricitabine will be developed for HIV patients who have built up resistance to multi-drug therapy.
The company says it has shown shown "great potential" as a therapy in the fight against multi-drug resistant HIV.
It said the meeting with the FDA was "a significant milestone" for Avexa and its shareholders.
"We can now plan the next regulatory steps for the programme with confidence and secure the commercialisation of this very valuable anti-HIV drug," Avexa's chief executive Jonathan Coates said.
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