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TOUGH ROAD AHEAD FOR AVEXA’S APRICITABINE

March 12th 2010 01:40
Biotech Daily

Friday February 5, 2010

Daily news on ASX-listed biotechnology companies

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MARC SINATRA’S BIOGUIDE BRIEF: AVEXA

Avexa announced the results of its truncated phase III trial of apricitabine in HIV patients with nucleoside reverse transcriptase inhibitor resistance yesterday (BD: Feb 4, 2010).

While it seems clear that apricitabine (ATC) works, the main issue is that it wasn’t shown to work significantly better than lamivudine (3TC) in terms of the primary outcome measure of HIV viral load suppression at 24 weeks.

The issue for Avexa is finding a partner willing to commit the tens of millions of dollars it is likely to take to bring apricitabine to market when it has, at best, modest benefits over 3TC.

Compounding the difficulty of the task facing Avexa is that 3TC will go off patent in the US and Europe very soon and generic versions of the drug are ready to hit the market. Consequently, if apricitabine were to make it to market it will be competing not only with an exceedingly well established drug, but one that is almost certain to become as cheap as chips.

What worries me most, however, is that I haven’t, as yet, found any truly significant evidence from Avexa’s phase IIb trial of ATC versus 3TC to suggest overwhelmingly that ATC would out-perform 3TC in the phase III trial.

This makes Avexa’s phase III trial more of long kick to a large pack, rather than a stab pass to a full-forward metres in the clear.

Avexa has to put on a brave face despite its phase III trial results if it is to have any chance of finding a partner for ATC, but they will need to be able to put a flawless business case together to justify throwing any more money at the compound.

Avexa fell one cent or 6.9 percent to 13.5 cents with 4.7 million shares traded.

Marc Sinatra
Analyst


email Marc here

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