SINGAPORE, Oct 19 (Bernama-BUSINESS WIRE) — Prestige BioPharma Ltd. (hereinafter “Prestige BioPharma”) today announced that the European Medicines Agency (EMA) Orphan Drug Commission (COMP) has granted a positive opinion for an Orphan Drug Designation (ODD) status to its first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer.
Receiving the ODD status means that Prestige BioPharma would receive numerous benefits including the exclusive rights to sale for 10 years after a successful regulatory approval in the future. Prestige BioPharma’s PBP1510 has already received ODD status from the US Food and Drug Administration (FDA) and the Korean Ministry of Food and Drug Safety during June and July 2020 respectively.