WuXi Biologics and Amicus Therapeutics have entered into an exclusive commercial manufacturing partnership for Amicus' Pompe biologic ATB200.
The strategic agreement will see WuXi Biologics become the exclusive commercial drug substance manufacturing partner and key commercial drug product supplier.
WuXi Bio said the company will enable and support Amicus with its "Global Dual Sourcing within WuXi Biologics" strategy. In practice, the Chinese biotech giant will manufacture both the drug substance and drug product, each at two sites across its global commercial supply network in EU, China and the US.
US-based Amicus, headquartered in Cranbury, New Jersey, is a patient-centric biotechnology company engaged in the discovery, development and commercialisation of a diverse set of novel treatments for patients living with rare metabolic diseases.
Pompe biologic ATB200 is Amicus' investigational therapy that consists of recombinant human acid alpha-glucosidase (rhGAA) enzyme with an optimised carbohydrate structure (designated ATB200), administered with a small molecule pharmacological chaperone (designated AT2221).
"This long-term supply agreement is another significant step forward in our relationship with WuXi Biologics," said Mr Bradley L. Campbell, President and Chief Operating Officer of Amicus Therapeutics.
"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. We look forward to continuing this important manufacturing partnership as we advance our Pompe programme in a pivotal study to support global regulatory approvals, and we are confident in our ability to supply patients around the world."
The ATB200 programme was initiated at WuXi Biologics in 2012 and now progresses through a pivotal study enabled by the global leading technology platform and unparalleled manufacturing capacity at WuXi Biologics.
Intra-company technology transfer
The Amicus-Wuxi Bio is a strategic alliance. It gives Amicus access to Wuxi Bio's global supply chain while at the same time the capacity to minimise the intra-company technology transfer risk associated with traditional approaches of using different suppliers.
The contract has an initial five-year term and then automatically renewed every two years until cancelled.
For Wuxi Bio, this agreement showcases its strong commercial manufacturing expertise and global quality system.
Dr Chris Chen, Chief Executive Officer of WuXi Biologics, commented: "We are excited about this exclusive commercial manufacturing partnership with Amicus, our first since the inception of the company. WuXi Biologics has again been recognised as a global leader in enabling the success of our clients. This is particularly the case in overcoming the development and manufacturing challenges associated with difficult biologics, such as this recombinant enzyme with special glycoform to potentially achieve improved potency.
Chen said the agreement with Amicus is an important milestone and the first success of the company's 'Follow-the-Molecule' strategy progressing from cell line development to potential BLA filing.
"We wish Amicus every success in this program to benefit Pompe patients globally! We are proud to be associated with continually improving and transforming the development and commercial manufacture of biologics, and helping to improve the lives of many patients," Chen concluded.
