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Merrimack Provides Third Quarter 2013 Operating Update And Financial Results

CAMBRIDGE, Mass., Nov. 7, 2013 (GLOBE NEWSWIRE) -- Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK), a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer, today provided its third quarter 2013 operating update and financial results.

Merrimack will host a conference call today, Thursday, November 7 at 8 a.m., Eastern Time, to provide an update on its development pipeline. The call will also provide a summary of third quarter 2013 financial results.

Investors and the general public are invited to listen to the call by dialing (877) 564-1301 (domestic) or (224) 357-2394 (international) five minutes prior to the start of the call and providing the passcode 92590100. A listen-only webcast of the call and the accompanying slides can be accessed in the Investors section of Merrimack's website, http://investors.merrimackpharma.com , and a replay of the call will be archived there for six weeks following the call.

Merrimack Updates Guidance on Availability of Top Line Data for MM-398 Phase 3 Clinical Trial to Second Quarter of 2014

Merrimack now expects to report top line data for NAPOLI-1, its Phase 3 clinical trial of MM-398 in advanced pancreatic cancer, in the second quarter of 2014. Merrimack previously disclosed that top line data was expected in the fourth quarter of 2013 or the first quarter of 2014. This change is based on a blinded assessment of overall survival events across the entire trial, which are occurring later than forecasted. As previously disclosed, Merrimack met its enrollment target for the trial in August 2013.

MM-121 Ovarian Trial Meets Key Study Objective

As reported last week, Merrimack's Phase 2 clinical trial of MM-121 in combination with paclitaxel in patients with platinum-resistant or refractory ovarian cancer met a key study objective of identifying potential biomarkers that could be used to identify patients that would most benefit from treatment with MM-121 plus paclitaxel. These potential biomarkers were part of a pre-specified panel of biomarkers that had been identified through Merrimack's network biology approach. Patients in this trial submitted pre-treatment biopsies in order to inform the biomarker investigation. The findings related to these biomarkers are consistent with Merrimack's preclinical hypotheses. In this context:
  • The biomarker analysis identified a potential subpopulation of patients, representing 34% of the total patients in this trial, who benefitted from MM-121 in combination with paclitaxel;
  • Patients who were positive for these biomarkers had a hazard ratio of 0.37, signifying that these patients had a 63% lower risk of progression on MM-121 plus paclitaxel as compared to paclitaxel alone; and
  • Incremental toxicities were mostly mild to moderate with no impact on treatment, in line with the expected profile of ErbB inhibitors in combination with paclitaxel and consistent with observations from Merrimack's Phase 1 clinical trial (published ESMO 2012).

Dr. Joyce Liu, the Principal Investigator for this trial, stated: "These are exciting study results. The finding of improved progression free survival in a biomarker-defined subset of women with platinum-resistant ovarian cancer when MM-121 is added to weekly paclitaxel is particularly intriguing, as it builds upon research we have done here at the Dana-Farber Cancer Institute. These data highlight the need for individual tumor characterization and biomarker testing to identify women who may respond to the addition of MM-121 to chemotherapy. The two biomarkers selected from the pre-specified panel on this study may do exactly that: allow us to identify these biomarker positive patients who will derive a benefit from adding MM-121 to paclitaxel. The overall results of this study, coupled with a safety profile consistent with similar therapies, support advancing MM-121 in this biomarker positive setting, and I look forward to further exploring these findings."

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