Wednesday 5th November 2014
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GlycoSyn is seeking new global customers for kifunensine, a key ingredient in the manufacture of a drug for the treatment of rare genetic disorders that's worth 20 times more than gold on a per gram basis.
The drug research, development, and manufacturing unit of Callaghan Innovation is a world leader in carbohydrate chemistry and has sold more than $16 million of clinical grade kifunensine to a US based biotech company in the past seven years. It is now marketing the ingredient to other pharma to boost the export revenue that funds the business.
Kifunensine is used as an ingredient to make drugs that inhibit background degradation of vital elements such as enzymes. As well as helping treat genetic disorders, it could also potentially change proteins in vaccines and have even wider use in the fight against viruses.
GlycoSyn general manager Paul Benjes said his unit was one of a handful of places worldwide that produce the complex ingredient and the only one that met the high quality standards required for GMP (good manufacturing practice) which gave it a four times premium over research grade material.
“We have a process patent over the way we make it, rather than the material itself, which is a barrier to competition, particularly in the US where the patent holds,” he said.
The drug material was originally developed by the former government-owned Industrial Research Ltd that Callaghan grew out of. It met a hitch when the original client walked away from the project, leaving behind the significant development costs.
“It left us in a precarious position of whether to continue to self invest the development or pack it in," Benjes said. "I’m pleased now to say we elected to continue and came up with a very scaleable process that we patented in 2003 and another client came on the scene that has stayed with us ever since.”
It won the commercial deal award in the KiwiNet Research Commercialisation awards in 2014 with the product. Business development manager Tony Davidson said a benefit from commercialising the product itself was that it established credibility for GlycoSyn's carbohydrate work worldwide and built relationships with international pharma that could prove useful to other Kiwi companies.
The manufacture of kifunensine is GlycoSyn's only piece of intellectual property the business unit holds. Its other work is to help Kiwi companies develop their own IP and contract manufacturing drugs for international partners at its pilot plant.
GlycoSyn has worked with about nine Kiwi companies in the past six months.
One recent example of its work was helping develop a new vaccine technology that can be used to treat cancer. The research was led by the Malaghan Institute of Medical Research and involved Associate Professor Ian Hermans in collaboration with Auckland University’s Professor Margaret Brimble, and synthetic chemist Gavin Painter from the Ferrier Research Institute (recently spun out of GlycoSyn) at Victoria University.
Benjes said its role was to develop a chemical called a glyco lipid adjuvant which is an immune booster administered along with an antigen to make the vaccine more effective.
In another recent example, GlycoSyn helped Australian based biotech company Spinifex Pharmaceuticals develop a new treatment for chronic pain where the underlying cause is nerve dysfunction. GlycoSyn was the contract developer for Spinifex’s lead candidate, EMA401, which is currently in Phase 2 clinical trials proving its safety and efficacy on patients suffering pain after contracting shingles.
Callaghan Innovation, which grew out of IRL to help Kiwi companies commercialise their innovation, makes about $8 million revenue from GlycoSyn. That’s half its budgeted commercial revenue with taxpayers funding most of its 2014/2015 annual income of $244.8 million.
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