UCB and Immunomedics announce worldwide development collaboration and license agreement for Epratuzumab
UCB and Immunomedics, Inc. announced a collaboration and license agreement for Immunomedics' lead product, epratuzumab. The agreement grants UCB the exclusive worldwide rights to develop, market and sell epratuzumab for all autoimmune disease indications. Epratuzumab's most advanced program is for the treatment of systemic lupus erythematosus (SLE): it has been granted FDA Fast Track designation and is currently undergoing two phase III clinical trials.
Immunomedics will receive initial cash payments totaling 38 million U.S. dollars over the next 10 business days and could receive potential regulatory milestone payments of up to 145 million U.S. dollars in cash and 20 million U.S. dollars in equity investments, depending on geography approval and approval in different indications over several years. In addition to receiving royalties on sales, Immunomedics could also receive sales bonuses upon reaching certain sales target levels.
Epratuzumab, a humanized monoclonal antibody against the CD22 marker expressed on activated B-cells, was developed and manufactured internally at Immunomedics, and is covered by worldwide patent estate. It is Immunomedics' lead product candidate being evaluated in two international pivotal Phase III ("ALLEVIATE A and B") trials for the treatment of moderate and severe SLE. The FDA granted a Fast Track designation to the clinical development program for epratuzumab for the treatment of patients with SLE, following Immunomedics' completion of a Phase II trial.
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