PharmaEngine (TWO: 4162) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion recommending the granting of a marketing authorization of ONIVYDE® (irinotecan liposome injection, nal-IRI) in combination with 5-fluorouracil (5-FU) and leucovorin (LV) for the treatment of metastatic adenocarcinoma of the pancreas in adult patients who have progressed following gemcitabine based therapy. The CHMP positive opinion for ONIVYDE® will now be reviewed by the European Commission for marketing authorization in the European Union (EU).
Based on this recommendation, a final decision regarding the marketing approval of ONIVYDE® is expected from the European Commission in 2016. The CHMP recommended approval of ONIVYDE® in combination with 5-FU/LV at a dose of 70 mg/m2 irinotecan free base (equivalent to 80 mg/m2 irinotecan hydrochloride salt), every two weeks, is also the FDA-approved dose regimen for pancreatic cancer in the United States.
Data supporting the CHMP positive opinion were based on findings from the phase 3 NAPOLI-1 study. ONIVYDE® in combination with 5-FU/LV extended overall survival and progression-free survival, increased tumor response rate, without compromising the quality of life as compared to 5-FU/LV in metastatic pancreatic cancer patients who have progressed after gemcitabine-based therapy. It is the first and only US FDA-approved therapy in this setting. The ONIVYDE® combination is also designated as a category 1 treatment option in the 2016 National Comprehensive Cancer Network (NCCN) guidelines for pancreatic adenocarcinoma in the United States.
“We are thankful to the joint team efforts from Merrimack and their licensee, Shire (formerly Baxalta), for having prepared and submitted the Marketing Authorization Application (MAA) to the EMA in May 2015, and glad to have participated during the review process.“
“We are thrilled that ONIVYDE®, once it is approved, will be available to treat the post- gemcitabine pancreatic cancer patients in the European Union which is one of the major markets that we licensed to Merrimack.“
C. Grace Yeh, Ph.D., President and CEO of PharmaEngine
ABOUT PANCREATIC CANCER
According to the statistical data from the World Health Organization, there were 11,858 people dying of pancreatic cancer in Southeast Asia in 2012. So far, metastatic pancreatic cancer is still a highly lethal disease. Therapies are designed to control disease and extend survival.
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.