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merrimack pharmaceuticals in (MACK) Key Developments

Merrimack Pharmaceuticals, Inc. Announces Executive Changes, Effective January 30, 2015

On January 15, 2015, Ulrik B. Nielsen provided notice of his resignation as Senior Vice President and Chief Scientific Officer of Merrimack Pharmaceuticals, Inc. (the Company), effective as of January 30, 2015. On January 19, 2015, Anthony J. Sinskey provided notice of his resignation from the Company's Board of Directors (the Board), effective as of January 30, 2015. Dr. Sinskey will continue to serve the Company as a scientific advisor. On January 20, 2015, the Board elected Dr. Nielsen as a director of the Company, effective as of January 30, 2015, to fill the vacancy created by the resignation of Dr. Sinskey.

Merrimack Pharmaceuticals, Inc. Board Changes, Effective January 31, 2015

Merrimack Pharmaceuticals, Inc. announced that Birgit M. Schoeberl, Ph.D. has been named the new head of its Discovery division. Ulrik B. Nielsen, Ph.D. will be stepping down as the head of the Discovery division and has been elected to serve on the company's board of directors. Anthony J. Sinskey, Sc.D. will also be resigning from the board of directors and will continue as a scientific advisor. All of these transitions will occur on January 30, 2015. Nielsen has been elected to serve on the company's board of directors, effective January 30, 2015. Prior to joining the company, Nielsen trained at University of California, San Francisco, and MIT.

Merrimack Pharmaceuticals and PharmaEngine Report Positive Phase III Results for MM-398 in Pancreatic Cancer

PharmaEngine and its partner Merrimack Pharmaceuticals have presented additional analyses from a global, randomised, open-label Phase III (NAPOLI-1) trial investigating the safety and efficacy of MM-398 (liposome irinotecan injection) in metastatic pancreatic cancer. The analyses of the trial lend further support to the positive top-line data that were presented in 2014 demonstrating a statistical increase in overall survival (OS) following treatment with MM-398 and 5-fluorouracil and leucovorin (5-FU/LV), with a hazard ratio of 0.67 (p=0.01) and a median OS of 6.1 months, compared with 4.2 months with 5-FU/LV alone. In the expanded analyses, the OS for MM-398 hazard ratio was 0.57 (p=0.0009) in the stratified analysis that accounts for pre-specified prognostic factors, while the analysis of the per protocol population, or those patients who received 80% of protocol-defined dose and remained on treatment for at least six weeks demonstrated more statistical improvement in median OS (8.9 months) compared with the control arm (5.1 months; p=0.0018). In addition, the trial revealed significant improvements in progression-free survival, objective response rate, and CA19-9 tumour market response following treatment with MM-398 compared with the control arm. The data were presented at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology on 16 January 2015.

Merrimack Pharmaceuticals Presents Additional Analyses of Phase 3 MM-398 NAPOLI-1 Study at the American Society of Clinical Oncology 2015 Gastrointestinal Cancers Symposium

Merrimack Pharmaceuticals, Inc. announced that additional analyses were presented on January 16, 2015 from the Phase 3 NAPOLI-1 study of MM-398 (irinotecan liposome injection), also known as 'nal-IRI' in patients with metastatic pancreatic cancer previously treated with gemcitabine-based therapy. The data were presented by Li-Tzong Chen, M.D., Ph.D. in an oral session at the American Society of Clinical Oncology (ASCO) 2015 Gastrointestinal Cancers Symposium in San Francisco, CA. Merrimack and Baxter International's biopharmaceutical business are collaborating on the development and commercialization of MM-398 outside of the United States and Taiwan. PharmaEngine, Inc. holds the rights to commercialize MM-398 in Taiwan. Additionally, Merrimack presented preclinical and clinical data from studies of its investigational agents MM-141 and MM-151 in pancreatic and colorectal cancer, respectively. An investigator-sponsored study of MM-398 in colorectal cancer was also presented. The primary analysis, presented at ESMO GI, demonstrated a statistically significant advantage in overall survival with an unstratified hazard ratio of 0.67 (95% CI [0.49-0.92], p=0.0122), and a median of 6.1 months for the combination of MM-398 plus 5-FU and leucovorin compared to 4.2 months in the control arm. Data presented at ASCO GI showed: Stratified analysis, which accounts for pre-specified prognostic factors included in the study randomization stratification, resulted in an overall survival hazard ratio of 0.57 (95% CI [0.41-0.80], p=0.0009). A forest plot sensitivity analysis of additional prognostic factors such as line of treatment, stage at diagnosis, prior lines of therapy, time since initial diagnosis, and time since last prior therapy, supported the primary efficacy results obtained. Evaluation of the Per Protocol population (defined by patients who were able to remain on treatment for >6 weeks) supported the primary Intent to Treat analysis and demonstrated a median overall survival of 8.9 months for MM-398 in combination with 5-FU and leucovorin versus 5.1 months in the control arm (stratified HR=0.47, 95% CI [0.29-0.77], p=0.0018). The safety profile of the MM-398 combination was reported to be manageable and consistent with previously reported safety results, with the most frequent adverse events including neutropenia (20% in the combination arm vs. 2% in the control arm), fatigue (14% vs. 4%) and gastrointestinal effects such as diarrhea (13% vs. 5%) and vomiting (11% vs. 3%).

Merrimack Pharmaceuticals, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-14-2015 09:30 AM

Merrimack Pharmaceuticals, Inc. Presents at 33rd Annual J.P. Morgan Healthcare Conference, Jan-14-2015 09:30 AM. Venue: Westin St. Francis Hotel, San Francisco, California, United States. Speakers: Robert J. Mulroy, Chief Executive Officer, President, Executive Director and Member of Executive Committee.

 

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