The Company announced that it has initiated its first U.S. Biopump processing facility in Davis, California, a good manufacturing practice (GMP) certified facility. The Company’s contract manufacturing organization (CMO) processes EPODURE Biopumps here for the treatment of anemia. This marks the first Biopump processing site outside of Israel, and provides Medgenics (MDGN) with a significant ability to scale-up its clinical and commercial capabilities to address global therapeutic areas such as anemia and hemophilia.
In a key dry run test of the production system, "tissue micro-organs were obtained and loaded into individual closed processing chambers in Israel, and then shipped to the U.S. CMO Biopump processing center in California. There, the micro-organs were processed in their closed systems into fully functioning EPODURE Biopumps, meeting the release criteria for use in human clinical trials in the U.S. This demonstrates Medgenics capability to support the treatment of patients at remote clinical sites, transporting their Biopumps to and from strategically located processing facilities, thereby allowing for multicenter clinical trials and practical commercial implementation."
Medgenics recently announced that it had received clearance from the U.S. Food and Drug Administration (FDA) for its Investigational New Drug (IND) application to conduct a Phase IIb study of EPODURE for the treatment of anemia in dialysis patients in the U.S.
Andrew L. Pearlman, Ph.D., President and Chief Executive Officer of Medgenics, stated,
"The launch of this U.S. processing facility is another important step for advancing our U.S. clinical trials and product commercialization. The initial processing of Biopumps in the GMP facility of our U.S. CMO resulted in product that meets all quality requirements for use in human clinical trials. We plan to continue with processing additional lots of product to ensure consistency and reliability before the U.S. clinical trial commences. Importantly, this U.S. GMP processing center has been launched through an existing facility, which is much less capital intensive and simpler to establish than typical protein production facilities. As Medgenics grows and expands, we believe that similar Biopump processing facilities can be easily set up in other sites around the world."