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news.Baxter International and Merrimack Pharmaceuticals have jointly announced that Baxter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for approval of MM-398 (irinotecan liposome injection), also known as "nal-IRI," an investigational treatment for patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
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The submission follows Merrimack’s recent filing of a new drug application (NDA) for this indication with the United States Food and Drug Administration (FDA).
"Our coordinated U.S. and EU filings illustrate our strong commitment to actively advancing this joint program and our desire to provide patients who are fighting pancreatic cancer with a new therapeutic option," said David Meek, head of Oncology at Baxter BioScience.
"MM-398 is an important asset in our oncology portfolio that will be investigated for other cancers where there remains unmet medical need."
Both the U.S. and European submissions were based on the positive results of the international Phase 3 NAPOLI-1 study, which was conducted among patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy.
MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin (LV) achieved its primary and secondary endpoints by demonstrating a clinically and statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control group of patients who received a combination of 5-FU and LV.
The most common Grade 3 or higher adverse events in patients receiving MM-398 and 5-FU/LV were neutropenia, fatigue and gastrointestinal effects. This was the first global Phase 3 study in a post-gemcitabine setting to show a survival benefit in this aggressive disease. The data were presented in June 2014.
"This submission represents significant progress in our collaborative efforts to deliver MM-398 as a new treatment option to pancreatic cancer patients across the globe," said Robert Mulroy, President and CEO at Merrimack.
"We look forward to working together as we move through the US and EU regulatory processes as well as additional submissions around the world."
MM-398 (irinotecan liposome injection), also known as "nal-IRI," 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.