Merrimack Pharmaceuticals Inc (NASDAQ:MACK) and Baxter International Inc. (NYSE:BAX) jointly announced that Merrimack has completed the rolling submission of the New Drug Application (NDA) for MM-398 (irinotecan liposome injection), also known as “nal-IRI,” to the U.S. Food and Drug Administration (FDA). Merrimack is seeking U.S. marketing approval of MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The companies also announced that Merrimack has requested priority review of the MM-398 NDA by the FDA.
“The submission of Merrimack’s first ever NDA with the U.S. FDA is a major milestone in the company’s history and a significant step forward in our commitment to delivering new treatment options to cancer patients,” said Robert Mulroy, President and CEO at Merrimack. “We are encouraged by theFDA’s support in the process and look forward to working with them throughout the NDA review.”
Merrimack’s application is based upon the results of an international Phase 3 study (NAPOLI-1) conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin achieved its primary and secondary endpoints by demonstrating a 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 leucovorin. 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 previously presented in June 2014.
“This is an important achievement in our MM-398 collaboration and in our collective efforts to introduce a potentially valuable new standard of care treatment for patients with pancreatic cancer,” said David Meek, head of Oncology at Baxter BioScience. “We intend to maintain this positive momentum as we prepare for the European submission in the coming months, with additional global submissions to follow shortly thereafter.”
The FDA and European Medicines Agency have granted MM-398 orphan drug designation for patients with metastatic pancreatic cancer. MM-398 was granted Fast Track designation by the FDA in November 2014.
Merrimack and Baxter International’s biopharmaceutical business entered into an exclusive licensing agreement to develop and commercialize MM-398 outside of the United States. PharmaEngine, Inc. (Taipei, Taiwan) holds the rights to commercialize MM-398 in Taiwan. (Original Source)
Shares of Merrimack closed last Friday at $13.42 . MACK has a 1-year high of $13.77 and a 1-year low of $4.13. The stock’s 50-day moving average is $12.19 and its 200-day moving average is $10.42.
On the ratings front, Cantor Fitzgerald analyst Daniel Brims reiterated a Buy rating on MACK, with a price target of $16, In a report issued on February 26. The current price target implies an upside of 19.2% from current levels, In a report issued on February 26. The current price target implies an upside of 19.2% from current levels
According to TipRanks.com, Brims has a total average return of 4.3%, a 55.2% success rate, and is ranked #1585 out of 3581 analysts.
Merrimack Pharmaceuticals Inc is engaged in discovering, developing and preparing to commercialize medicines consisting of novel therapeutics paired with companion diagnostics for the treatment of cancer.