WuXi Biologics will be the exclusive commercial drug substance manufacturing partner and key commercial drug product supplier. WuXi Biologics will support Amicus with its "Global Dual Sourcing" strategy for the manufacture of both the drug substance and drug product, each at two sites across its commercial supply network in EU, China and U.S. This approach aims to ensure a global and robust supply chain while minimizes the intra-company technology transfer risk associated with traditional approaches of using different suppliers.
The ATB200 program was initiated at WuXi Biologics in 2012 and now progresses through a pivotal study leveraging WuXi’s technology platform and manufacturing capacity.
"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, Inc. "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 program in a pivotal study to support global regulatory approvals, and we are confident in our ability to supply patients around the world."
"We are excited about this exclusive commercial manufacturing partnership with Amicus, our first since the inception of the company. WuXi Biologics has again been recognized 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," said Dr. Chris Chen, chief executive officer of WuXi Biologics. "This important milestone is also the first success of our 'Follow-the-Molecule' strategy progressing from cell line development to potential BLA filing.”