University of Western Australia Secures Approval For its First Drug

A technology project originally developed by researchers at The University of Western Australia has secured approval from the United States Food and Drug Administration for its first drug.
The FDA has approved Zorvolex™, a non-steroidal anti-inflammatory drug to treat mild-to-moderate acute pain in adults.  Zorvolex™ was developed by iCeutica Inc, a UWA spin-out, in collaboration with its US partner, Iroko Pharmaceuticals LLC.
In 2011, private equity investors associated with Iroko Pharmaceuticals purchased iCeutica, which develops new drugs using the technology now known as SoluMatrix Fine Particle Technology™.  SoluMatrix™ technology creates submicron-sized particles of drugs which dissolve much more quickly than conventional drugs, which means faster action of pain drugs, lower doses and fewer side effects.
UWA’s Office of Industry and Innovation, – the technology transfer arm of the University – provided proof-of-concept funding support for the project in 2004 through its early seed funding program called Pathfinder and also negotiated a licensing and option deal.  In 2005, with the formation of iCeutica, the University obtained a shareholding in exchange for its intellectual property.
US-based iCeutica CEO and UWA graduate Matt Callahan said the approval was an important step in the company’s development.
“It represents a unique experience for most life sciences companies, taking a product from an idea all the way through approval and now on to launch,” Mr Callahan said. “It is very satisfying to carry it all the way through – you don't get that opportunity often in life – and as an Australian biotech, it very rarely happens.  All credit to the great team at iCeutica (past and present) and our partner Iroko.”
Dr Andy Sierakowski, Director UWA’s Office of Industry and Innovation, said “this project demonstrates two key points of technology transfer – the importance of pre-seed funding like Pathfinder in a university environment and the time required for a biotechnology-related invention to make it to marketplace use.”