Protemix aims to take NZ bio to market

Prof Garth Cooper, CEO of Auckland biopharmaceutical company Protemix Corp, aims to make his company the first New Zealand biotech to take a discovered compound all the way to market.

Cooper has done it once already. As a PhD researcher at Oxford University in 1986-87, the Kiwi biochemist-medico discovered a hormone, amylin, that when co-administered with insulin, markedly reduces the unpleasant side-effects of chronic insulin therapy in diabetics.

He founded Amylin Pharmaceuticals to commercialise an amylin homologue, Pramlintide. When he migrated to California in 1988, the company went with him.

Today Amylin is capitalised at US$4 billion, and growing. It recently submitted Pramlintide to the US Food and Drug Administration for registration.

Cooper returned to New Zealand in 1993 to take up a professorship at the University of Auckland -- but also with the intention of creating a major biotech company to provide a focal point for local and international investment in New Zealand's emerging biotechnology industry. "I knew it would be a harder road, but I conducted a series of commercial experiments that led me to conclude New Zealand was a viable place to have a crack at it," he says.

"My experience in the industry, and having a network of top people around me, would ameliorate the less positive aspects of the environment."

Cooper's confidence in his ability to do an encore was in plain view in his choice of a name for the company he established to discover and commercialise new endocrine therapeutics: Endocore.

In the late 1990s Cooper began working with diabetes clinician Dr John Baker, who had founded his own company, Glycox. They merged their companies to form Protemix.

Cooper and Baker have demonstrated a rare knack for finding significant molecules -- at last count, Protemix had seven compounds in its therapeutic pipeline.

One, an orally active molecule called Laszarin, has been shown in pre-clinical animal models and Phase II human clinical trials to restore hearts damaged by chronic diabetes.

"Laszarin breaks the link between high blood glucose and heart disease. Type 2 diabetics tend to develop an enlarged heart, or cardiomegaly," Cooper says. "Six months of Laszarin therapy significantly reduces heart mass, and it has been shown to recondition the heart ventricles in animal studies."

Cooper says the US Food and Drug Administration has determined that Laszarin fulfils a major, unmet therapeutic need, and has accorded it fast-track approval.

Protemix is currently undertaking an Australasian Phase IIb trial. Four of the nine sites for the P2B trials will be conducted in Australian hospitals, with Monash University heart expert Prof Henry Krum as co-lead investigator. With its fast-track status, Laszarin could be in clinical use within four years. Cooper believes it is a potential blockbuster drug, with the potential for annual sales of US$750 million.

Protemix recently received an NZ$18 million capital injection from a consortium of New Zealand private investors, headed by Birnie Capital Partners. In addition, the New Zealand government has just underwritten the Laszarin project with a $2 million investment.

NZ milestone

NZ Science Minister Peter Hodgson last week hailed the Protemix deal as "a milestone in the development of a New Zealand biopharmaceutical industry".

Hodgson gave Protemix a big wrap, saying it would help New Zealand to retain and recruit the pool of scientists, business people and scientific entrepreneurs it needs to participate in the global biopharmaceutical market.

"Its presence in New Zealand will inevitably attract more interest from overseas investors and give confidence to other biotech players that there is a commitment to help them take their discoveries through to commercialisation."

Another lead compound is about to go into Phase II clinical trials -- a new peptide compound that shows promise of reversing insulin resistance in non-insulin dependent diabetes, a disorder that is rife in Western nations because of the obesity epidemic.

Cooper's Protemix team, working with Prof Ted Kragen's diabetes research group at Sydney's Garvan Institute, identified a major mechanism that underpins insulin resistance in type 2 diabetes.

Protemix is in the process of lodging international patents on a new peptide molecule that exploits the mechanism to reverse insulin resistance. The rising incidence of overweight and obesity in Western nations is causing an epidemic of type 2 diabetes.

The compound will soon go into Phase II clinical trials in volunteers.

Cooper's team has developed another compound that reverses steatohepatosis and hepatitis in livers damaged by chronic alcoholism or obesity.

The compound, which recently featured on the cover of the Journal of Clinical Investigation, is based on the hormone adiponectin. It reduces liver inflammation, and the fatty deposits that impair liver function.

"The underlying theme in all this is that Protemix is identifying the toxic principles that mediate major metabolic disorders like heart disease, diabetes and liver disease," Cooper says.

"We've learned how to tap into body's ability to regenerate itself. The body has innate powers of self-regeneration that are much greater than previously recognised. Basically, we're switching on these natural regeneration mechanisms."