PharmaEngine Announces ONIVYDE® Launched in the Third Major European Country


PharmaEngine, Inc. (TWO: 4162) announced that ONIVYDE® (liposome irinotecan) has been commercially launched in the third major European country by Shire (PharmaEngine’s sublicensee, LSE: SHP, NASDAQ: SHPG). In accordance with the License Agreement entered into as of May 2011 and the subsequent amendment with Ipsen (Euronext: IPN; ADR: IPSEY), PharmaEngine is eligible to receive US$3 million of milestone payment.

ONIVYDE® is indicated, in combination with fluorouracil (5-FU) and leucovorin (LV), for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy. The global phase 3 NAPOLI-1 study demonstrated that ONIVYDE in combination with 5-FU/LV extended overall survival, progression-free survival and increased tumor response rate, without compromising quality of life as compared to 5-FU/LV alone in metastatic pancreatic cancer patients who have progressed after gemcitabine-based therapy.

C. Grace Yeh, Ph.D., President and CEO of PharmaEngine

“We are very thankful to the regulatory and marketing teams at Shire for bringing ONIVYDE® to more patients in Europe.” “Europe is one of the major markets for ONIVYDE®. We expect that more pancreatic cancer patients will benefit from the adoption of ONIVYDE® as the best option for second line treatment according to the ESMO Clinical Practice Guidelines (2015).”


Owing to its extremely aggressive nature and poor 5-year survival rate in single digits, pancreatic cancer remains an important public health issue worldwide. Current therapies are designed to control disease and extend survival. According to GLOBOCAN, in 2012, 338,000 people were newly diagnosed with pancreatic cancer, and 331,000 people died from the disease, the seventh leading cause of cancer death in the world. Some projection studies have estimated that pancreatic cancer would escalate from the third to the second leading cause of cancer deaths in the United States by 2020.


ONIVYDE®, also known as nal-IRI, MM-398 or PEP02, is a novel encapsulation of irinotecan in a liposomal formulation. In May 2011, PharmaEngine licensed its Asian and European rights except Taiwan to Merrimack (NASDAQ: MACK). In September 2014, Merrimack licensed the rights to ONIVYDE® outside of the US and Taiwan to Baxalta Incorporated (NYSE: BXLT), formerly Baxter International’s BioScience business, subsequently Baxalta was acquired by Shire (LSE: SHP, NASDAQ: SHPG) in July 2016. Then in April 2017, Ipsen (Euronext: IPN; ADR: IPSEY) acquired the exclusive US commercial rights of ONIVYDE, as well as took over the licensing agreements with Shire and with PharmaEngine from Merrimack. So far, ONIVYDE® has been approved in Taiwan, US, EU, Australia, Canada, South Korea, and now Singapore, it also received orphan drug designations in the US, EU, and other countries. Learn more.


PharmaEngine, Inc. is a biopharmaceutical company headquartered in Taipei, Taiwan with a wholly owned subsidiary, PharmaEngine Europe Sarl in Paris, France. PharmaEngine focuses on the development of new medications for the treatment of cancer and Asian prevalent diseases. PharmaEngine has three ongoing projects: ONIVYDE® has received regulatory approvals in 37 countries; PEP503 (NBTXR3) is in a global pivotal trial of soft tissue sarcoma, and patient recruitment has been completed; and PEP06 is in preclinical development. Get to know more here.


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