Big disappointment for Belgian UCB. After 9 years of research, its lead candidate in Immunology, designed to treat Systemic Lupus Erythematosus, failed in Phase III. The drug was acquired from Immunomedics in 2006 and costed at least $38M.
Epratuzumab is a monoclonal antibody for the treatment of Systemic Lupus Erythematosus, developed by Immunomedics. For the out-licensing in 2006, the company got an upfront payment of $38M and a potential portion of the milestone payments which were declared to be up to $165M. Despite FDA Fast Track designation of epratuzumab, it took UCB almost 5 years to get to the results of the two Phase III trials. And these are devastating…
In both tested doses, the treatment response in patients who received epratuzumab, in addition to standard therapy, was not significantly higher than those who received an additional placebo. The only good news: no new safety concerns were identified.
Nevertheless, UCB will stay commited to the treatment of lupus and other immunological conditions. They have another lupus drug in Phase I as shown in their pipeline.
Of course, the failure is also no good news for Immunomedics. In the last two days, the stockvalue of the NASDAQ-listed company just crashed by 62% to $2.3 as Epratuzumab is also their lead candidate. The New Jersey-based company had kept rights to develop the drug in cancer indication, but with the last results that won’t be easy now!