UCB and Immunomedics have entered 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 phase III clinical trials.

According to the release, Immunomedics will receive initial cash payments totalling US$ 38 million over the next 10 business days and could receive potential regulatory milestone payments of up to US$ 145 million in cash and US$ 20 million 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 is a promising molecule which we expect to complement our existing portfolio in autoimmune and inflammatory diseases. It offers a unique mechanism of action in targeting B-cells which is very complementary to UCB's T-cell expertise. UCB plans to escalate activity in the ongoing phase III studies, with timelines and milestones to be updated when fully integrated into our existing portfolio. The focus during our evaluation of epratuzumab was on autoimmune indications, driven by the very compelling clinical data in SLE, and our interest in furthering the molecule in this and other autoimmune diseases," said Melanie Lee, Executive VP Research & Development of UCB.

"We are excited to collaborate with UCB, since they have demonstrated leadership in the development of monoclonal antibodies. We believe that they are well suited to optimize the potential of epratuzumab in multiple autoimmune disease indications," Cynthia L. Sullivan, president and CEO of Immunomedics said adding, "Furthermore, our business strategy of out-licensing compounds in late stage clinical development for markets with unmet medical needs fits exceedingly well with UCB's focus on securing leading positions in severe disease categories through its successful worldwide marketing and sales organisation. We look forward to bringing epratuzumab to patients with autoimmune disorders through this collaboration."

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.