AVEXA, FDA AGREE ATC FOR HIV PATH
March 29th 2011 21:09
Monday March 28, 2011
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AVEXA
Avexa says “a comprehensive and highly productive meeting with the US Food and Drug Administration” has found a regulatory pathway for the anti-HIV drug apricitabine (ATC).
Avexa chief executive officer Dr Jonathan Coates told Biotech Daily that the company retained about $20 million in cash, but any new trial would primarily be funded by a partner for the drug.
“I want to find a partner for the trial, the marketing and distribution and I am not contemplating a capital raising,” Dr Coates said.
In its media release, Avexa did not say how large a new phase III trial would be or what it would cost but more than 100 patients and at least $100 million appear to be minimum requirements.
Avexa said in its media release that the FDA recognized and gave credit “for the significant amount of previous ATC clinical studies conducted by Avexa, in particular the latest ATC study AVX-301”, the last phase III trial reported in February 2010 (see below).
Avexa said that as a consequence, the remaining regulatory requirements for an ATC approval were “considerably less complicated and less extensive than previously assumed and less than that required for other recently approved drugs”.
The company said it could expect a simpler, faster regulatory path; considerable risk mitigation; lower costs; an immediate phase III trial with near term approval potential; and to be far more attractive economically to potential partners.
Avexa said apricitabine would be developed initially for multi-drug resistant HIV patients.
Avexa said ATC had shown “great potential as a therapy in the fight against multi-drug resistant HIV” and as a twice-a-day dosed drug ATC complemented new generation drugs such as Merck’s HIV integrase inhibitor Isentress, which was also twice daily.
Avexa said apricitabine was a novel nucleoside, a class of drug that was “a vital component of anti-HIV therapy” and offered an extension to existing therapies in the treatment of HIV especially for patients with limited therapeutic options.
“This is a significant milestone for Avexa and its shareholders,” Dr Coates said.
“We can now plan the next regulatory steps for the program with confidence and secure the commercialization of this very valuable anti-HIV drug,” Dr Coates said.
Last year, following the publication of 24-week phase III trial results showing a non-significant positive clinical benefit for apricitabine compared to the standard of care 3TC, Avexa dropped its ATC phase III program, chief executive officer Dr Julian Chick resigned and a board spill was requested (BD: Feb 4, 5, 15; May 10, 2010).
Avexa said last year that it would “cease any further development of … ATC following the unsuccessful conclusion of partnering discussions with global pharmaceutical companies”.
Avexa said it had shown that 34 of the 36 patients who completed the phase II ATC study maintained “undetectable viral loads up to week 144” and detailed phase III results were provided to interested parties to secure a licencing transaction, but on May 6, 2010, the last party involved in the process said it did not intend to submit a term sheet.
The company conducted a review, but the details of the review were never made public.
Avexa acquired 24 percent of Allied Medical and agreed to sell 19.9 percent of that company to Biomd. Allied Medical has a major interest in Coridon Vaccines which is developing vaccines for infectious diseases and cancers (BD: Feb 24, 2011).
Last December, chairman Joe Baini and chief executive officer Dr Jonathan Coates told Biotech Daily that Avexa would be an anti-viral focused company with two main assets, a second generation HIV integrase program and the stake in Allied Medical which controls Coridon (BD: Dec 13, 2010). Mr Baini said Avexa had licenced its anti-biotic programs to Valevia for up to $66 million with no up-front fee but significant milestone payments.
Avexa was up 2.1 cents or 52.5 percent to 6.1 cents with 147.2 million shares traded.
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