Baxter Submits EU Filing for Irinotecan Liposome Injection
Baxter International Inc. and Merrimack Pharmaceuticals, Inc., a specialty biopharmaceutical company, have jointly announced that Baxter has submitted a marketing authorization application (MAA) to the European Medicines Agency for approval of MM-398 (irinotecan liposome injection), an investigational treatment for patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The submission follows Merrimack’s recent filing of a new drug application for this indication with the US Food and Drug Administration.
MM-398 (irinotecan liposome injection) is a novel encapsulation of irinotecan in a long-circulating nanoliposomal formulation. The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I (an essential enzyme involved in DNA transcription and replication) and promoting cell death.
Merrimack and Baxter International’s biopharmaceutical business entered into an exclusive licensing agreement in September 2014 to develop and commercialize MM-398 outside of the United States. PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize MM-398 in Taiwan.