Fortress Biotech, Inc., a biopharmaceutical company dedicated to acquiring, developing and commercialising novel pharmaceutical and biotechnology products, has announced that its subsidiary, Caelum Biosciences, has entered a biopharmaceutical manufacturing agreement with Patheon NV for process development and current good manufacturing practices (cGMP) production of Caelum’s lead therapy CAEL-101.
The agreement will support Phase II/III studies of CAEL-101 for the treatment of amyloid light chain (“AL”) amyloidosis, a rare systemic disorder that leads to the buildup of amyloid proteins in and around tissues, nerves and organs, resulting in organ damage and high mortality rates.
CAEL-101 is currently being evaluated by study sponsor Columbia University in a Phase Ib study in AL amyloidosis.
Michael Spector, Chief Executive Officer of Caelum, said: “We believe this manufacturing agreement with Patheon will enable continued progression of the CAEL-101 clinical development programme. The establishment of this important collaboration, now allows us to plan for our Phase II/III programe.”
Patheon provides end-to-end, fully integrated services for both drug substances and drug products to help clients accelerate development in the rapidly evolving world of biologics.