MM 398 (irinotecan liposome injection) is filed at EMA for treatment of adenocarcinoma of the pancreas- Baxter + Merrimack Pharma

Baxter International Inc.and Merrimack Pharmaceuticals, Inc.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. The submission follows Merrimack's recent filing of a new drug application (NDA) for this indication with the FDA.

Both the U.S. and European submissions were based on the positive results of the international Phase III 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 III study in a post-gemcitabine setting to show a survival benefit in this aggressive disease. The data were presented in June 2014.

Comment: MM 398 will compete with Abraxane ( nab-paclitaxel) + gemcitabine combination in pancreatic cancer.Baxter has all rights outside the US ( where they are held by Merrimack Pharma and Taiwan (where they are held by PharmaEngine Inc.