KBI Biopharma, Inc. (KBI), a JSR Life Sciences company, and AM-Pharma, an emerging leader focused on the development of therapeutics that protect organ function in patients with severe medical conditions, have signed a commercial manufacturing agreement to advance AM-Pharma’s recombinant human Alkaline Phosphatase (recAP) program towards commercialization. AM-Pharma is developing recAP for the potential treatment of Sepsis-Associated Acute Kidney Injury (SA-AKI).
SA-AKI is a devastating disease affecting hundreds of thousands of patients worldwide with high mortality rates and no approved pharmacological treatments.
Under the terms of the new commercial manufacturing agreement, KBI Biopharma will conduct drug substance manufacturing alongside the ongoing process characterization and validation work. The commercial manufacturing agreement will provide drug substance and regulatory support for the Phase III REVIVAL study and potential BLA filing. Based on the clinical results, KBI will continue to support drug substance manufacturing and release for commercial use.
“We have a successful history with KBI Biopharma and are looking forward to working together to advance our lead program through to commercial launch,” stated Erik van den Berg, Chief Executive Officer, AM-Pharma. “Acute kidney disease remains a critical unmet need and we look forward to working with KBI to help patients who are in need of treatment options.”
KBI will conduct manufacturing and validation in its existing facilities. AM-Pharma and KBI Biopharma began collaborating on the recAP program in 2011 when KBI performed initial process development and cGMP manufacturing for early clinical use.
“We are proud to have grown alongside our partners and to play an integral role in the development and manufacture of therapies that represent true advances to the treatment landscape for patients in need,” said KBI President and CEO Dirk Lange. “The analytics and cGMP capabilities of our facilities are strongly suited for AM-Pharma’s product launch requirements. We look forward to continuing our collaboration on the recAP program as it advances toward the treatment of acute kidney disease.”