Merrimack Pharmaceuticals Inc (NASDAQ:MACK) and Baxalta Incorporated, a wholly-owned subsidiary of Baxter International Inc (NYSE: BAX), today jointly announced that the New Drug Application (NDA) for MM-398 (irinotecan liposome injection), also known as “nal-IRI,” has been accepted for review by 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.
In addition, the FDA has classified the NDA as having Priority Review status. A Priority Review designation is for drugs that treat serious conditions and, if approved, would provide significant improvements in the safety or effectiveness of the treatment of serious conditions compared to available therapies. The FDA has set a goal of October 24, 2015 to take action under the Prescription Drug User Fee Act (PDUFA).
“The rapid timeline associated with Priority Review designation brings Merrimack closer to our goal of making MM-398 available to patients with pancreatic cancer who have been previously treated with gemcitabine and are in significant need of treatment options,” said Robert Mulroy, President and CEO at Merrimack. “We look forward to working with the FDA as they review the application over the next several months.”
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. Data for the study were presented at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer (ESMO GI) in June 2014 and the American Society of Clinical Oncology 2015 Gastrointestinal Cancers Symposium (ASCO GI) in January 2015.
The European Medicines Agency (EMA) has also accepted for review a Marketing Authorization Application (MAA) for MM-398 for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The acceptance of the MAA marks the beginning of the review process in the European Union for MM-398 in this indication.
“The acceptance of our Marketing Authorization Application for review by the European Medicines Agency is a positive indicator of the promise of this treatment to address a significant unmet need for patients with metastatic pancreatic cancer and the support for innovative new options,” said David Meek, head of Oncology at Baxalta. “We are actively advancing our plans to introduce nal-IRI following approval and look forward to extending the utility of the treatment to patients around the world.”
The FDA and EMA 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 Baxalta have 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 Pharmaceuticals Inc. closed yesterday at $11.9 . MACK has a 1-year high of $13.84 and a 1-year low of $5.53. The stock’s 50-day moving average is $11.81 and its 200-day moving average is $11.33.
On the ratings front, Cantor Fitzgerald analyst Daniel Brims maintained a Buy rating on MACK, with a price target of $16, in a report issued on June 15. The current price target implies an upside of 34.5% from current levels.
According to TipRanks.com, Brims has a total average return of 3.0%, a 47.2% success rate, and is ranked #1728 out of 3632 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.