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Shire's ONIVYDE OK'd in Europe for pancreatic cancer

Oct. 18, 2016 6:52 AM ETShire PLC (SHPG) StockSHPG, MACKBy: Douglas W. House, SA News Editor38 Comments
  • The European Commission approves Shire plc's (NASDAQ:SHPG) Marketing Authorization Application (MAA) seeking approval of ONIVYDE (pegylated liposomal irinotecan hydrochloride trihydrate), in combination with chemotherapy agents 5-fluorouracil (5-FU) and leucovorin (LV), for the treatment of adult patients with metastatic adenocarcinoma of the pancreas who have progressed after gemcitabine-based therapy. The approval follows a positive CHMP opinion in July.
  • The data supporting the application was generated in the Phase 3 NAPOLI-1 study which showed treatment with the combination extended overall survival, progression-free survival and objective response rate compared to 5-FU/LV alone.
  • ONIVYDE is a novel encapsulation of irinotecan, a drug that prevents DNA from unwinding via the inhibition of an enzyme called topoisomerase. Interfering with DNA transcription and replication promotes cell death. Encapsulating the drug prolongs its half-life in the body, ~26 hours. 95% of irinotecan remains liposome encapsulated for up to 169.5 hours following administration.
  • Shire has global development and commercialization rights to ONIVYDE except in the U.S. and Taiwan which is the responsibility of Merrimack Pharmaceuticals (NASDAQ:MACK).
  • MACK is up 8% premarket on average volume. SHPG is 2% on light volume.

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