Immunomedics, Inc., (NASDAQ: IMMU) ("Immunomedics" or the "Company"), a leading biopharmaceutical company in the area of antibody-drug conjugates (ADC), today announced that it has entered into a promotion agreement in which Immunomedics will provide detailing services to Janssen Biotech Inc. (Janssen), for erdafitinib in the U.S.
"We are delighted to be collaborating with Janssen and we look forward to working closely with the Janssen team to help promote erdafitinib," said Brendan Delaney, Chief Commercial Officer of Immunomedics. "We have built strong commercial capabilities at Immunomedics and this agreement allows us to leverage our experienced oncology sales force to educate the U.S. market on this potential new treatment option for patients with metastatic urothelial cancer upon FDA approval."
Under the terms of the agreement, Immunomedics' sales team will provide product detailing from the launch of erdafitinib until the end of the First Quarter 2020, but only requires Immunomedics to support the product in first position detail until the FDA approval of sacituzumab govitecan. Immunomedics is eligible to receive low double digit royalties and milestone payments based on U.S. sales throughout 2019 and 2020, subject to sales thresholds in each year, respectively.
A New Drug Application (NDA) for erdafitinib is currently under review by the U.S. Food and Drug Administration for the treatment of patients with locally advanced or metastatic urothelial cancer and certain fibroblast growth factor receptor (FGFR) genetic alterations whose tumors have progressed after prior chemotherapy. Erdafitinib is an investigational, once-daily, pan-FGFR kinase inhibitor that received Breakthrough Therapy Designation from the FDA in March 2018.
