Other than the cash strapped slant its a good...

Other than the cash strapped slant its a good summary.

INTERVIEW-Cash-short Avexa aims to line up HIV drug partners

Published: 14 Oct 2009 22:10:41 PST
* Expects late-stage trial result early in Q1 2010

* Research talks progress with Johnson & Johnson's Tibotec

* Sees big pharma focusing more on early stage collaborations

* Shares fall 2.6 percent after touching 13-month high

MELBOURNE, Oct 15 - Australian biotech firm Avexa Ltd is cash-strapped and eager to line up a partner for its HIV drug, a new generation of treatment in a late stage trial, aiming to get it to market by mid-2011 at the earliest.

Avexa's shares shot up this week after a research house reiterated a buy recommendation on the stock, 10 days after Avexa said it was closing its trial of apricitabine (ATC) against HIV at 24 weeks, about six months earlier than planned.

Avexa Chief Executive Julian Chick told Reuters in an interview that closing its late-stage trial on ATC early meant potential partners would get to see results of the study about six months earlier than planned and would help it find the fastest way to get the drug to market.

Near term, however, the key juncture for the company and its investors comes in November, when it is hoping to line up a research and licensing agreement with Johnson & Johnson's Tibotec arm for a new class of HIV drug.

Chick said big pharmaceutical companies reviewing their licensing portfolios are currently more focused on teaming up on early stage research than late stage trials, as it involves less of a funding commitment.

"So we are seeing some deals being done, particularly early stage deals, but late stage products not so much, unless it's a replacement for a programme that's failed or about to come off patent," he said.

Tibotec has a six-month exclusivity agreement to review Avexa's pipeline of integrase inhibitors, a new class of HIV drug like Merck & Co Inc's Isentress.

"The interaction has been very positive from both sides to date," Chick said.

Bank of America/Merrill Lynch analysts estimate Isentress will reap $1 billion in sales next year.

Avexa shares fell 2.6 percent to A$0.185 on Thursday, valuing it at A$126 million, after touching a 13-month high.

FAST-TRACK GOAL

Chick declined to say which companies or how many Avexa was talking to about developing its drug ATC, a new generation of anti-HIV nucleoside reverse transcriptase inhibitor (NRTI), which has won fast track status with the FDA.

The big names in HIV drugs include GlaxoSmithKline, Pfizer, Gilead Sciences, Bristol-Myers Squibb, Tibotec, and Merck, about to be taken over by Schering-Plough.

Avexa will be releasing data from an earlier trial this quarter, tracking how effective ATC has been over nearly three years on patients resistant to other drugs.

Then results from the 24-week Phase III trial will be released early in the first quarter of 2010, after which the company would talk to regulators and decide whether it needs to raise more money, Chick said.

"Our interactions historically with the regulatory authorities have indicated that they like the programme - they would like to see it approved," he said.

Avexa had just under A$19 million ($18 million) in hand at the end of June following an equity raising.

Analysts believe the regulator's decision to allow the trial to be stopped early was a good sign.

"From a partner's perspective, we believe the possibility that ATC may require a smaller clinical trial programme and the potential for accelerated approval should be seen as favourable," RBS Morgans analyst Tanya Solomon said in a research note.

Under fast-track status, when a company files for approval of a drug it is reviewed within six months.

At best, if the FDA does not require any further Phase III trials, the company could file for at least a limited approval early in the second half of 2010, with approval in 2011.

Chick dismissed criticism that ATC might have limited applications because some drug companies were moving away from NRTI's in their cocktails of HIV drugs, saying ATC was less toxic and had fewer side effects from interacting with other drugs than earlier NRTI's. ($1=1.085 Australian Dollar) (Editing by Valerie Lee) (

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Source: Reuters