Merrimack Pharma Gets Fast Track Designation For MM-398

(RTTNews) - Merrimack Pharmaceuticals, Inc. (MACK) Wednesday said its investigational MM-398 received Fast Track designation from the U.S. Food and Drug Administration or FDA. MM-398, also called as nanoliposomal irinotecan injection, is indicated for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. Fast Track designation is granted for the development and review of drugs that treat serious conditions and fill an unmet medical need. Pancreatic cancer is the fourth leading cause of cancer-related deaths in the United States and is projected to be the second highest cause of death from cancer in the United States by 2020. The company said it is currently preparing a New Drug Application for MM-398 in the United States and expects to initiate the submission in 2014 with the goal of completing the NDA submission late in the first quarter or early in the second quarter of 2015.