Policy & Regulation
Prestige Biopharma Receives Positive EMA Opinion on Orphan Designation for PBP1510 for Treatment of Pancreatic Cancer
20 October 2020 - - The European Medicines Agency Orphan Drug Commission has granted a positive opinion for an Orphan Drug Designation status to Singapore-based Prestige BioPharma Ltd's first-in-class anti-PAUF monoclonal antibody, PBP1510, for the treatment of pancreatic cancer, the company said.

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 and the Korean Ministry of Food and Drug Safety during June and July 2020 respectively.

The positive opinion issued by COMP will be sent to the European Commission which is expected to grant the orphan designation within 30 days.

Prestige BioPharma is a Singapore-based biopharmaceutical company focusing on the development of biosimilars and new antibody therapeutics.

Its lead program, HD201 trastuzumab biosimilar, has been filed and accepted for review with the EMA in 2019 and will also be filed with the US FDA in 2020.

Prestige BioPharma´s next products in line include a Bevacizumab biosimilar (HD204) in Phase III, an Adalimumab biosimilar (PBP1502) in Phase I and an innovative anti-PAUF mAb (PBP1510) for the treatment of pancreatic cancer in Phase I stages.

Manufacturing facilities for global commercial supply are located in Osong, South Korea.