Merrimack: ONIVYDE Regimen Gets Positive CHMP Opinion In EU -Quick Facts

(RTTNews) - Merrimack Pharmaceuticals, Inc. (MACK) announced Monday that ONIVYDE regimen has received positive CHMP opinion in European Union.

The Committee for Medicinal Products for Human Use or CHMP of the European Medicines Agency or EMA has issued a positive opinion for ONIVYDE (irinotecan liposome injection), also known as "nal-IRI", in combination with fluorouracil (5-FU) and leucovorin for the treatment of patients with metastatic pancreatic adenocarcinoma who have progressed after gemcitabine-based therapy.

The positive opinion was based on data from pivotal Phase 3 NAPOLI-1 study, which demonstrated that ONIVYDE in combination with 5-FU and leucovorin met its primary endpoint of significantly increased overall survival when compared to 5-FU and leucovorin alone.

The CHMP positive opinion for ONIVYDE will now be reviewed by the European Commission for marketing authorization.

Shire plc (SHP.L, SHPG) is responsible for the development and commercialization of ONIVYDE outside of the United States and Taiwan pursuant to an exclusive licensing agreement with Merrimack.