PharmaEngine, Inc. (TWO:4162) announces obtaining approval of supplemental new drug application from Taiwan's Food and Drug Administration (TFDA) for ONIVYDE® in combination with oxaliplatin, fluorouracil, and leucovorin, for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma.

 

According to Taiwan's Cancer Registry Annual Report from Health Promotion Administration, in 2021, there were 3,190 patients with initial diagnosis of pancreatic cancer and 2,659 patients’ cause of death was pancreatic cancer in Taiwan.

 

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About ONIVYDE®

ONIVYDE® is a cancer medicine that blocks an enzyme called topoisomerase I, which is involved in copying cell DNA needed to make new cells. By blocking the enzyme, cancer cells are prevented from multiplying and eventually die. In ONIVYDE®, irinotecan is enclosed in tiny fat particles called ‘liposomes’, which accumulate in the tumor and release slowly over time.

 

ONIVYDE® is currently approved in most major markets including the U.S., Europe and Asia in combination with fluorouracil and leucovorin for the treatment of adult patients with metastatic pancreatic adenocarcinoma after disease progression following gemcitabine-based therapy. On 13 February 2024, the U.S. Food and Drug Administration approved ONIVYDE® in combination with oxaliplatin, fluorouracil and leucovorin (NALIRIFOX), for the first-line treatment of adult patients with metastatic pancreatic adenocarcinoma in the U.S.

 

PharmaEngine is responsible for the commercialization of ONIVYDE® in Taiwan. Ipsen has exclusive commercialization rights for the current and potential future indications for ONIVYDE® in the U.S. and Canada. Servier, an independent international pharmaceutical company with an international presence in 150 countries, is responsible for the commercialization of ONIVYDE® outside of the U.S., Canada and Taiwan.

 

About PharmaEngine, Inc.

PharmaEngine, Inc., headquartered in Taipei, began operations in February 2003. PharmaEngine focuses on new drug development by adopting “Virtual Pharmaceutical Company Business Model”. PharmaEngine has another R&D project in development, PEP07, which is a checkpoint kinase 1 (CHK1) inhibitor that targets the DNA Damage Response (DDR) pathway, is currently undergoing Phase 1 clinical trials. PharmaEngine also conducts, collaborates or licenses-in early-stage new drug discovery and development projects. With extensive experience in drug development and project management, we continue to promote and expand our pipeline, and accelerate drug development and the subsequent commercialization of new medicines.

 

Media Contact: ChiHsing Chang, Spokesperson/Vice President (info@pharmaengine.com)