title: The birth pangs of monoclonal antibody therapeutics: the failure and legacy of Centoxin.
abstract: This paper examines the development and termination of nebacumab (Centoxin®), a human IgM monoclonal antibody (mAb) drug frequently cited as one of the notable failures of the early biopharmaceutical industry. The non-approval of Centoxin in the United States in 1992 generated major concerns at the time about the future viability of any mAb therapeutics. For Centocor, the biotechnology company that developed Centoxin, the drug posed formidable challenges in terms of safety, clinical efficacy, patient selection, the overall economic costs of health care, as well as financial backing. Indeed, Centocor's development of the drug brought it to the brink of bankruptcy. This article shows how many of the experiences learned with Centoxin paved the way for the current successes in therapeutic mAb development.
authors.affiliation: Department of Primary Care and Public Health, King's College London, London, UK. Lara.Marks@kcl.ac.uk
authors.forename: Lara
authors.initials: L
authors.lastname: Marks
mesh_terms: D000911:Antibodies, Monoclonal / Q000627:therapeutic use*; D061067:Antibodies, Monoclonal, Humanized; D001702:Biopharmaceutics / Q000639:trends; D003365:Costs and Cost Analysis; D017277:Drug Approval; D055808:Drug Discovery; D006801:Humans; D007167:Immunotherapy; D057051:Product Recalls and Withdrawals; D018805:Sepsis / Q000276:immunology / Q000628:therapy*; D014481:United States
chemical_list: D000911:Antibodies, Monoclonal; D061067:Antibodies, Monoclonal, Humanized; C068069:nebacumab