Singapore-based biopharmaceutical company Prestige BioPharma Ltd said on Sunday that it has received a positive opinion for an Orphan Drug Designation (ODD) status for its first-in-class anti-PAUF monoclonal antibody PBP1510 for the treatment of pancreatic cancer.
The company received the positive opinion for an ODD status for PBP1510 from the European Medicines Agency's (EMA) Orphan Drug Commission (COMP). The positive opinion will be sent to the European Commission which is expected to grant the orphan designation within 30 days. The manufacturing facilities for global commercial supply are reportedly located in Osong, South Korea.
Through the EMA's ODD status, the company would receive numerous benefits including the exclusive rights to sale for ten years after a successful regulatory approval in the future.
In addition, the company has received PBP1510's 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.
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