Merrimack Pharmaceuticals Inc (NASDAQ:MACK) announced that the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has issued a positive opinion for ONIVYDE® (irinotecan liposome injection), also known as “nal-IRI”, in combination with fluorouracil (5-FU) and leucovorin for the treatment of patients with metastatic pancreatic adenocarcinoma who have progressed after gemcitabine-based therapy. The CHMP positive opinion for ONIVYDE will now be reviewed by the European Commission (EC) for marketing authorization. Shire plc (LSE: SHP, NASDAQ: SHPG) is responsible for the development and commercialization of ONIVYDE outside of the United States and Taiwan pursuant to an exclusive licensing agreement with Merrimack.
“This recommendation advances our mission to expand the availability of the ONIVYDE regimen to metastatic pancreatic cancer patients worldwide,” said Robert Mulroy, President and CEO of Merrimack. “The CHMP’s positive opinion is further validation of the clinical importance of the ONIVYDE regimen. We are grateful to all of the patients, families and investigators who contributed to the development of ONIVYDE, and to our partner Shire, together with whom we are committed to advancing the availability of this important therapy to patients facing this devastating disease with few treatment options.”
“This regulatory milestone is an important step for patients with metastatic pancreatic adenocarcinoma who have progressed after gemcitabine-based therapy,” said Philip J. Vickers, Ph.D., Head of R&D, Shire. “There has been little improvement in prognosis for patients in this setting for over 20 years, and given this high unmet need we look forward to receiving the final approval decision from the European Commission.”
The opinion was based on data from the pivotal Phase 3 NAPOLI-1 study, which demonstrated that ONIVYDE in combination with 5-FU and leucovorin met its primary endpoint of significantly increased overall survival when compared to 5-FU and leucovorin alone: 6.1 months vs 4.2 months (p=0.012, unstratified hazard ratio (HR) =0.67, 95% CI: [0.49-0.92]) i. Findings from an updated analysis of the NAPOLI-1 data showed that one in four patients treated with the ONIVYDE combination regimen survived a milestone one year or more: 12-month overall survival estimates of 26% (95% CI, 18-35%) were observed in the ONIVYDE combination treatment arm representing a 63% improvement when compared to 16% (95% CI, 10-24%) for 5-FU and leucovorin aloneii. This updated analysis was presented at the American Society of Clinical Oncology 2016 Gastrointestinal Cancers Symposium.
The primary NAPOLI-1 study results were the basis for the October 2015 U.S. Food and Drug Administration (FDA) and Taiwan FDA approvals of the ONIVYDE combination regimen for the treatment of patients with metastatic pancreatic adenocarcinoma whose disease progressed after gemcitabine-based therapy. It is the first and only U.S. FDA-approved therapy in this setting. The ONIVYDE combination is also designated as a category 1 treatment option in the 2016 National Comprehensive Cancer Network (NCCN) guidelines for pancreatic adenocarcinoma in the U.S. as well as a category 2B status in the 2015 European Society for Medical Oncology (ESMO) clinical practice guidelines in the EU. (Original Source)
Shares of Merrimack closed last Friday at $5.50, up $0.14 or 2.61%. MACK has a 1-year high of $11.18 and a 1-year low of $5.02. The stock’s 50-day moving average is $5.87 and its 200-day moving average is $6.62.
On the ratings front, Merrimack has been the subject of a number of recent research reports. In a report issued on May 26, Robert W. Baird analyst Michael Ulz initiated coverage with a Hold rating on MACK and a price target of $8, which represents a potential upside of 45.5% from where the stock is currently trading. Separately, on May 20, Brean Murray Carret’s Jonathan Aschoff reiterated a Buy rating on the stock and has a price target of $16.
According to TipRanks.com, which ranks over 7,500 financial analysts and bloggers to gauge the performance of their past recommendations, Michael Ulz and Jonathan Aschoff have a total average return of -17.6% and -11.3% respectively. Ulz has a success rate of 22.2% and is ranked #3695 out of 4081 analysts, while Aschoff has a success rate of 34.4% and is ranked #3980.
Merrimack Pharmaceuticals, Inc. engages in discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. It applies a systems biology-based approach to biomedical research, throughout the research and development process.