PharmaEngine, Inc. (TWO:4162) announces has filed post-approval change application for a new indication of ONIVYDE® to Taiwan Food and Drug Administration (TFDA). The new indication is using ONIVYDE® in combination with oxaliplatin, 5-fluorouracil and leucovorin as first line treatment for patients with metastatic adenocarcinoma of the pancreas.

According to the Cancer Registry Annual Report from Health Promotion Administration, in 2020, there were 3,012 patients with initial diagnosis of pancreatic cancer, and 2,450 patients’ cause of death was pancreatic cancer.

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About ONIVYDE®

ONIVYDE® (PEP02, MM-398, nal-IRI) is a proprietary liposome encapsulation of irinotecan, a topoisomerase 1 inhibitor. Irinotecan HCl (Camptosar®) is a broad-spectrum anti-cancer cytotoxic drug approved for the treatment of colorectal cancer.

As of today, ONIVYDE® has been approved by many countries as a second-line treatment for patients with metastatic adenocarcinoma of the pancreas. Moreover, PharmaEngine, Servier and Ipsen are eagerly developing other indications for ONIVYDE® in hope for ONIVYDE® to be used in various treatments for different cancers.

About PharmaEngine, Inc.

PharmaEngine, Inc. was established in February 2003 based on the international strategic alliance concept. The Company has been adopting the “Virtual Pharmaceutical Company Business Model” to focus on the R&D of new drug developments while lowering the related risks. In addition to conducting early drug development, PharmaEngine also licenses in and leads many new drug development projects. PharmaEngine uses extensive experience in project management to accelerate clinical trials and the post-launch product marketing.

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