Immunomedics, UCB suspend epratuzumab trials due to manufacturing concerns

By Lisa Kerner

Charlotte, N.C., Sept. 26 - Immunomedics, Inc. said its licensing partner, UCB, SA, has temporarily suspended the clinical trials of epratuzumab in patients with systemic lupus erythematosus due to end-stage manufacturing observations that might result in a lack of consistent assurance of sterility in the final dosage form.

UCB took the voluntary, precautionary measure which resulted in a clinical hold of all trials by the Food and Drug Administration, according to an 8-K filing.

Both Immunomedics and UCB remain said they committed to the development of epratuzumab in lupus and possible other indications, while working remove the clinical hold status and make epratuzumab available to patients.

UCB and Immunomedics are biopharmaceutical companies based in Brussels, Belgium, and Morris Plains, N.J., respectively.

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