Biopharmaceutical manufacturing agreement forged for production of CAEL-101

An agreement between Fortress Biotech subsidiary, Caelum Biosciences, and Patheon has been made that will involve the process development and current good manufacturing practices (cGMP) production of CAEL-101, Caelum’s lead product for the treatment of amyloid light chain (AL) amyloidosis.

Under the terms of the agreement, the Phase II and III studies of CAEL-101 will be supported. The product is currently being evaluated for the treatment of AL amyloidosis, a rare systemic disorder leading to the build-up of amyloid proteins in and around tissues, nerves and organs, in a Phase Ib study by Columbia University.

“We believe this manufacturing agreement with Patheon will enable continued progression of the CAEL-101 clinical development programme,” said Michael Spector, chief executive officer of Caelum. “The establishment of this important collaboration, now allows us to plan for our Phase II/III programme.”

Caelum is a clinical-stage biotechnology company developing treatments for rare and life-threatening diseases. Patheon is a global provider of pharmaceutical development and manufacturing services.