PharmaEngine announces EMA’s acceptance of ONIVYDE®’s Type II Variation application

PharmaEngine, Inc. (TWO:4162) announces our global partner, Servier, applied the Type II Variation of ONIVYDE to the European Medicines Agency (EMA). Today, EMA has accepted the application. 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 WHO GLOBOCAN 2020 report, in 2020, globally, there were 495,773 patients with initial diagnosis of pancreatic cancer and 466,003 patients’ cause of death was pancreatic cancer.


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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 (



Chihsing Chang
Vice President, Finance and Administration
TEL +886 2 2515 8228, ext. 700
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