Repifermin. Human Genome Sciences/GlaxoSmithKline.

Abstract

Human Genome Sciences (HGS) and GlaxoSmithKline (formerly SmithKline Beecham) are developing topical and injectable formulations of repifermin, keratinocyte growth factor-2 (KGF-2), also known as fibroblast growth factor-10 (FGF-10) for the potential treatment of wound care, oral and intestinal mucositis, and inflammatory bowel diseases [385959,396786]. A phase IIb trial of the topical formulation in chronic venous ulcers is ongoing, as well as phase II trials for the systemic, injectable formulation in ulcerative colitis and in the prevention of mucositis after chemotherapy with bone marrow transplantation [352908,368013, 385959,404294]. In May 2001, UBS Warburg predicted that HGS would receive approval of repifermin for the treatment of venous ulcers by yearend 2004, mucositis in 2005, and ulcerative colitis in the second half of 2004 [412015]. In October 2000, SmithKline Beecham exercised an option to codevelop repifermin for phase III trials and beyond [385959,399183]. In May 2001, UBS Warburg valued repifermin's worldwide market at 2 billion dollars for treating venous ulcers and predicted sales of 33 million dollars in 2004 and 118 million dollars in 2005 for this indication. In addition, the analysts regarded repifermin as having potential in the treatment of diabetic foot ulcers and pressure ulcers (a market valued at over 1.8 billion dollars) and estimated that the drug might earn another 103.5 million dollars for these indications in 2005. Furthermore, the analysts predicted sales of 6.8 million dollars for repifermin's mucositis indication and, for ulcerative colitis, sales of 27.3 million dollars in 2004 and 54.8 million dollars in 2005. Overall, the analysts estimated that repifermin represented a 3.5 billion dollars market opportunity for HGS/ GlaxoSmthKline and that commercialization of the drug might earn more than 61 million dollars by 2004 [412015].