Fortress Biotech Subsidiary Caelum Biosciences Enters Biopharmaceutical Manufacturing Agreement with Patheon
Agreement will support Phase 2/3 studies of Caelum’s CAEL-101 in AL amyloidosis
NEW YORK, NY – June 1, 2017 – Fortress Biotech, Inc. (NASDAQ: FBIO) (“Fortress”), a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products, today announced that its subsidiary Caelum Biosciences (“Caelum”) has entered a biopharmaceutical manufacturing agreement with Patheon N.V. for process development and current good manufacturing practices (cGMP) production of Caelum’s lead therapy CAEL-101.
The agreement will support Phase 2/3 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 1b 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 program. The establishment of this important collaboration, now allows us to plan for our Phase 2/3 program.”
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.
About Caelum Biosciences
Caelum Biosciences, Inc. (“Caelum”), a Fortress Biotech (NASDAQ: FBIO) Company, is a clinical-stage biotechnology company developing treatments for rare and life-threatening diseases. Caelum’s lead asset, CAEL-101 (11-14F), is a novel antibody in Phase 1b clinical trials for the treatment of patients with amyloid light chain (“AL”) amyloidosis. Interim Phase 1a/1b data presented at the American Society of Hematology’s 58th Annual Meeting in December 2016 support CAEL-101’s potential to be a safe and well-tolerated therapy that promotes amyloid resolution. CAEL-101 has received Orphan Drug Designation from the U.S. Food and Drug Administration as a therapeutic agent for patients with AL amyloidosis, and as a radio-imaging agent in amyloidosis. For more information, visit www.caelumbio.com.
About Fortress Biotech
Fortress Biotech, Inc. (“Fortress”) is a biopharmaceutical company dedicated to acquiring, developing and commercializing novel pharmaceutical and biotechnology products. Fortress develops and commercializes products both within Fortress and through certain subsidiary companies, also known as Fortress Companies. In addition to its internal development programs, Fortress leverages its biopharmaceutical business expertise and drug development capabilities and provides funding and management services to help the Fortress Companies achieve their goals. Fortress and the Fortress Companies may seek licensings, acquisitions, partnerships, joint ventures and/or public and private financings to accelerate and provide additional funding to support their research and development programs. For more information, visit www.fortressbiotech.com.
Patheon is a leading global provider of pharmaceutical development and manufacturing services. With approximately 9,100 employees and contractors worldwide, Patheon provides a comprehensive, integrated and highly customizable set of solutions to help clients of all sizes satisfy complex development and manufacturing needs at any stage of the pharmaceutical development cycle. A Healthier World. Delivered. www.patheon.com
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Fortress Biotech, Inc.
Lucy Lu, MD, Executive Vice President & Chief Financial Officer
Caelum Biosciences, Inc.
Fortress Biotech Media Relations