Prestige BioPharma Ltd, a Singapore-based biopharmaceutical company, stated that the Committee for Orphan Drug Commission (COMP), a European Medicines Agency’s (EMA) Committee, has granted judgment in its favor for an Orphan Drug Designation (ODD) status to its high-quality PBP1510, an anti-PAUF monoclonal antibody, for pancreatic cancer treatment.
By getting the ODD status, Prestige BioPharma can obtain various benefits like receiving exclusive rights to the sale for ten years after receiving a successful regulatory sanction in the future.
Prestige BioPharma’s CEO Dr. Lisa Park stated that EMA COMP’s positive opinion signifies that PBP1510 is successfully recognized as a globally innovative superior quality drug again. Dr. Park expects that the development of PBP1510 will gain more pliability and will create a positive effect related to clinical trial procedures and product approval.
PBP1510 of Prestige BioPharma had received ODD status from the Korean Ministry of Food and Drug Safety and US Food and Drug Administration (FDA) during July and June 2020 respectively
Pancreatic cancer is an extremely aggressive malignancy originating in the endocrine or exocrine pancreatic cells which are assumed to be caused by smoking, poor diet, and genetic factors. It subsidizes to extreme illness and mortality with a 9% survival rate at five years in the US. The only curative options present currently are limited to surgical resection along with adjuvant chemotherapy. However, only 10 to 15% of patients are applicants as the diagnosis occurs in metastatic or advanced stages that are not operable surgically.
Limited efficacy of treatment modalities and fast progression of this cancer can be clarified a little by Pancreatic Adenocarcinoma Up-regulated Factor (PAUF), overexpression of a gene, which is found in most of the pancreatic cancers. Although PAUF plays a crucial role in the growth of the disease, no targeted molecular therapy is found against it yet. PBP1510, anti-PAUF antibody from Prestige BioPharma is anticipated to provide notable substantial benefits in the patients suffering from PAUF-positive pancreatic cancer.