Immunomedics and UCB have amended their development, collaboration, and license agreement for the exclusive, worldwide rights to develop, market, and sell epratuzumab for all autoimmune disease indications. The restructuring allows UCB to select a partner to sublicense its rights for certain territories.
Under the terms of the amended agreement, in return for the right to sublicense, UCB returned its buy-in right for the cancer indication to Immunomedics. Immunomedics will receive $30 million upon execution of the amendment. In the event UCB exercises its right to sublicense, Immunomedics will be entitled to receive an additional cash payment of $30 million and additional payments upon achievement of regulatory and sales milestones pursuant to the amended agreement. In addition, Immunomedics will issue to UCB a five-year warrant to purchase one million shares of Immunomedics' common stock at an exercise price equal to $8.00 per share.
Epratuzumab is currently being evaluated in two Phase III randomized, double-blind, placebo-controlled, multicenter trials (EMBODY1 and EMBODY2) for the treatment of patients with moderate to severe lupus. The drug is also in a Phase II program as a treatment for lymphoma. The compound has fast-track status for the lupus indication.
“We are pleased with the amendment we have reached with Immunomedics,” said Iris Loew-Friedrich, evp and chief medical officer of UCB. “It allows UCB an opportunity to explore collaborations with third parties to take full advantage of the opportunities presented by epratuzumab.”
UCB has one other lupus candidate in its pipeline. CDP7657 is in a Phase I trial. The rest of UCB’s development efforts are focused on CNS diseases and immunology. Most advanced is its epilepsy program, composed of Vimpat in various stages of development as a monotherapy as well as adjunctive treatment, brivaracetam in Phase III as an adjunctive therapy, and UCB0941 in Phase I.
On the immunology side, it is developing Cimzia for RA, psoriatic arthritis, and ankylosing spondylitis. Olokizumab is another compound being developed for RA, while CDP7851 is being tested in fracture healing and post-menopausal osteoporosis.