Neuren Pharmaceuticals is breaking new ground for the biotechnology industry as the first Kiwi company to undertake US Food and Drug Administration approved phase 3 human drug trials.
The Auckland-based firm has launched the New Zealand part of its phase 3 trial of Glypromate - a drug for
preventing brain damage after cardiac surgery.
NZBio chief executive Brian Ward said licences had been let for other locally developed molecules, and they had reached phase 3 trials, but Neuren was the first company to retain ownership of a drug, developmental work and run thetrial itself.
"It's a real milestone [for the sector]," he said.
"I think it's a reflection of the industry evolving ... increasing its capabilities and it's also a reflection of the quality of the research base here."
Local companies were increasingly able to attract international investment, allowing them to retain the development of their drugs.
There was a substantial uplift in value in progressing from phase 2 to phase 3 trials, Ward said.
The phase 3 trial of Glypromate - the last round of testing - wasfor effectiveness and safety andwould involve about 600 patients in New Zealand, the US and Australia.
Nearly one million cardiac surgery procedures were performed globally each year, including about 800,000 coronary artery bypass grafts and 200,000 valve repairs or replacements using cardiopulmonary bypass.
About 70 per cent of patients of cardiopulmonary bypass experienced a cognitive decline, with half still suffering impairment three months later, Neuren said.
Chief executive David Clarke said the US part of the trial began in May with recruitment now under way for 200 patients in New Zealand.
Neuren was expecting the FDA to ask for two phase 3 trials, costing A$25 million ($29.8 million). Glypromate could be marketable by 2010-11, although on average only half the drugs that started phase 3 trials proved successful. Neuren's shares closed up A1c yesterday at A29c.
Glypromate
* Drug for preventing brain damage after cardiac surgery.
* Global market worth about US$1 billion.
* Could be ready for market by 2010.
