Prestige BioPharma receives positive EMA opinion on ODD for pancreatic cancer treatment

KUALA LUMPUR, Oct 19 -- Prestige BioPharma Ltd has been granted positive opinion for an Orphan Drug Designation (ODD) status to its first-in-class anti-PAUF monoclonal antibody, PBP1510, for pancreatic cancer treatment.

According to a statement by the Singapore-based biopharmaceutical company, the opinion was granted by the European Medicines Agency (EMA) Orphan Drug Commission (COMP).

Via the ODD status, Prestige BioPharma would receive numerous benefits including the exclusive rights to sale for 10 years after a successful regulatory approval in the future.

Its PBP1510 has already received ODD status from the US Food and Drug Administration and the Korean Ministry of Food and Drug Safety last June and July, respectively.

Prestige BioPharma chief executive officer, Dr Lisa Park said: “The positive opinion of EMA COMP confirms that PBP1510 has once again successfully established to be a globally innovative first-in-class drug.”

“It is expected that the development of PBP1510 will gain more resilience and will have a positive effect in terms of clinical trial procedures and product approval.”

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

-- BERNAMA