David Clarke, chief executive of Neuren Pharmaceuticals, says the battle has not been won yet. Photo / Richard Robinson
Auckland-based Neuren Pharmaceuticals has become the first Australasian biotechnology firm to win US approval for phase 3 trials of a human drug - placing it first in the race for a global market worth more than $1 billion a year.
The US Food and Drug Administration has given
Neuren the go-ahead for phase 3 human trials of the drug Glypromate for prevention of brain damage after cardiac surgery.
Tom Duthy, analyst at Sydney-based stockbroker Taylor Collison, said the trial approval reflected a monumental effort by Neuren.
"[It's a] very, very positive day for Neuren and puts them well and truly at the forefront of Australasian biotechnology," Duthy said.
"It's absolutely imperative because what it allows them to do now is ... conduct the clinical trial under the auspices of the US FDA and essentially half of their market ... is in the US."
Phase 3 trials are the last testing round - evaluating effectiveness and safety in a wide sample of human patients - after which the drug can be approved for commercial release.
Neuren's shares shot up A4.5c yesterday to A53.5c on news of the progress.
However, sounding a note of caution Neuren chief executive David Clarke said a rule of thumb suggested drugs that reached phase 3 still had only a 50:50 chance of success.
If the trial was successful the FDA could request another complete phase 3 trial with the drug potentially reaching the market in 2010.
More than 400,000 patients in the US have coronary artery bypass graft surgery each year, showing a loss of brain function in up to 70 per cent at discharge and more than one-third of patients after three months.
Clarke said other companies were striving to develop drugs for the same treatment but none were as advanced as Neuren.
The prize was to be first to reach a global market that Clarke said was worth about US$1 billion ($1.45 billion) a year.
"If this trial's successful it will put not only Neuren on the map it'll put New Zealand biotech on the map," Clarke said.
Animal studies had shown the drug could significantly reduce brain damage while phase 2 safety and tolerability trials showed no drug-related adverse events.
