WuXi Biologics and Amicus Therapeutics announced that the companies have entered into an exclusive commercial manufacturing partnership for Amicus' Pompe biologic ATB200.
Per the strategic agreement, WuXi Biologics will be the exclusive commercial drug substance manufacturing partner and key commercial drug product supplier. WuXi Biologics will enable and support Amicus with its "Global Dual Sourcing within WuXi Biologics" strategy and manufacture both the drug substance and drug product, each at two sites across its global commercial supply network in EU, China and US. This approach effectively ensures a global and robust supply chain while at the same time minimizes 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. This agreement showcases the strong commercial manufacturing expertise and global premier quality system of WuXi Biologics as well as its powerful "Follow-the-Molecule" strategy that enables a global client base from discovery to commercial manufacture. The ATB200 program 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.
"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. 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."