Amicus Therapeutics and WuXi Biologics have been partnered on progressing ATB200, one part of an investigational Pompe disease therapy, since 2012.
The agreement has reached the commercial stage, in which WuXi will be the drug substance and drug product supplier. WuXi stated that both would be manufactured at two sites across its commercial supply network, which has a presence in Europe, China and the US.
The initial contract covers a five-year term, which will be automatically extended every two years unless one of the partners cancels.
ATB200 is the focus of the agreement and is one part of investigational therapy AT-GAA – comprised of a recombinant human acid alpha-glucosidase enzyme, an ‘optimised’ carbohydrate structure (ATB200) and a small molecule pharmacological chaperone (AT2221).
Bradley Campbell, COO of Amicus said in a statement, "Over the past five years we have successfully collaborated in the scale-up of our Pompe biologic from research to commercial scale while maintaining all key quality attributes.”
The investigational therapy is currently in Phase III trials, with an estimated study completion date of January 2021.
"We are excited about this exclusive commercial manufacturing partnership with Amicus, our first since the inception of the company,” said Chris Chen, CEO of WuXi Biologics.
Chen further explained that this partnership deal marked the company’s ability to produce ‘difficult biologics’, citing the structure of the drug candidate as a challenge in the development process.
WuXi Biologics has been on an investment drive to improve its capabilities, in recent years; beyond expanding its European presence and building out its capabilities in China where it is headquartered.