Merrimack heads to the FDA after scoring positive PhIII for pancreatic cancer

Merrimack Pharmaceuticals got roughed up when it went public back in 2012, then took it on the chin--twice--when one of their cancer drugs partnered with Sanofi ($SNY) failed two mid-stage studies. But this morning its stock price sailed up about 90% on the news that its lead drug scored a win in Phase III in a population of patients with advanced pancreatic cancer.

Merrimack CEO Robert Mulroy

Cambridge, MA-based Merrimack ($MACK) IPO'd to raise cash for this Phase III. And this morning the company reports that MM-398 combined with 5-FU and leucovorin registered a 6.1 month rate of survival in the late-stage study, compared to 4.2 months for the combo alone. All the metastatic patients in the study had been treated with gemcitabine. Those numbers hit the mark on the study's primary endpoint.

MM-398 failed to register a statistically significant improvement as a monotherapy, with a 4.9-month median overall survival rate in the drug arm compared to the control arm, which hit 4.2 months. And you can expect plenty of kickback from some analysts who have been raising questions about marginal improvements in OS rates when considered against the backdrop of ever rising drug prices.

CEO Robert Mulroy, though, was happy to finally be able to focus on some positive news, saying that the goal now is getting the drug to patients with plans to file an NDA later this year.

"Given that there have only been a handful of successful Phase III trials in pancreatic cancer in the past 25 years, it is gratifying to have the first positive Phase III trial in the post-gemcitabine setting," the CEO said in a statement. "The results reinforce our confidence in our entire nanoliposomal pipeline."

Merrimack's big idea here was to take the chemo drug irinotecan and wrap it in a nanoliposomal capsule to provide extended circulation in patients, amping up its effect on cancer. MM-121 (SAR256212) failed two studies last year, though the biotech cited success with subpopulations of patients.

- here's the release

Special Report: 2011 Fierce 15 - Merrimack Pharmaceuticals