Narhex hires Polish groups for drug development
Monday, 18 July, 2005
Sydney anti-viral drug developer Narhex Life Sciences (ASX:NLS) has signed separate manufacturing research agreements with two Polish organisations to reduce the cost and complexity of manufacturing its HIV protease inhibitor DG-35.
The Centre of Molecular and Macromolecular Studies (CMMS) in Poland will be paid a flat fee to convert DG-35, which is not orally bio-available, into a pro-drug, suitable for administration to humans (DG-17).
The Institute of Organic Chemistry of the Polish Academy of Sciences (IOC) will also be paid a flat fee for providing a simpler and less costly method of synthesis for DG-35, by avoiding some of the more complex steps.
By engaging these two organisations, Narhex should be able to scale-up production of DG-35 to commercial quantities, said Narhex CEO and MD John Majewski.
The company chose to engage IOC and CMMS rather than a large pharmachemical manufacturer, because it didn't want to be "locked into commitments with suppliers", said Majewski.
The manufacturer would also "end up owning the intellectual property", said Majewski. "We wanted to extend the life of our intellectual property. And we think we have a fair chance of that."
It is expected that CMMS will complete the drug conversion work by August 10. Formulation of the drug is then expected to take a month and Narhex will also be developing protocols for clinical studies applications to test the formulations. These studies will most likely be conducted in Australia and are planned for the end of September or early October, said Majewski.
"Once we've done that and we're satisfied, then we'll contract the manufacturers to manufacture the quantity of drug to run clinical studies on a larger scale," said Majewski.
The IOC is expected to complete its work in four months.
NarHex had previously signed an agreement with the giant Chinese government trading company CMC Shaanx, which will pay the costs of phase III clinical trials, and registering the drug for clinical use in China.
"Phase II and phase III clinical trials of DG-35 are intended to run in China," said Majewski.
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