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Merrimack Pharmaceuticals, Inc.

Partner : Baxter International Inc.

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PLEASE SCROLL DOWN TO THE RESULTS SECTION (below) TO SEE THE OUTCOME OF THIS EVENT.

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May 4, 2015
Baxter Bioscience and Merrimack Pharmaceuticals Announce Filing for European Approval of MM-398, an Investigational Treatment for Post-Gemcitabine Metastatic Pancreatic Cancer
Filing Based on Positive Phase 3 Data Suggest Survival Benefit in Deadly Disease

DEERFIELD, Ill. & CAMBRIDGE, Mass.--(BUSINESS WIRE)-- Baxter International Inc. (NYSE:BAX) and Merrimack Pharmaceuticals, Inc. (Nasdaq:MACK) jointly announced that Baxter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) for approval of MM-398 (irinotecan liposome injection), also known as ''nal-IRI,'' an investigational treatment for patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The submission follows Merrimack's recent filing of a new drug application (NDA) for this indication with the United States Food and Drug Administration (FDA).

''Our coordinated U.S. and EU filings illustrate our strong commitment to actively advancing this joint program and our desire to provide patients who are fighting pancreatic cancer with a new therapeutic option,'' said David Meek, head of Oncology at Baxter BioScience. ''MM-398 is an important asset in our oncology portfolio that will be investigated for other cancers where there remains unmet medical need.''

Both the U.S. and European submissions were based on the positive results of the international Phase 3 NAPOLI-1 study, which was conducted among patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin (LV) achieved its primary and secondary endpoints by demonstrating a clinically and 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 LV. 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. The data were presented in June 2014.

''This submission represents significant progress in our collaborative efforts to deliver MM-398 as a new treatment option to pancreatic cancer patients across the globe,'' said Robert Mulroy, President and CEO at Merrimack. ''We look forward to working together as we move through the US and EU regulatory processes as well as additional submissions around the world.''
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Source: press release, 5/04/15. http://investors.merrimackpharma.com/releasedetail.cfm?ReleaseID=910466

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Compound/DeviceSpecialtyIndicationCompound ClassTarget
ONIVYDE (MM-398) Pancreatic cancerOncologyPancreatic cancerTopoisomerase I InhibitorTopoisomerase I-DNA covalent complexes

Mechanism of action: ONIVYDE (MM-398) is a liposomal formulation of the hydrochloride salt of the semisynthetic camptothecin analogue irinotecan with potential antineoplastic activity. During the S phase of the cell cycle, irinotecan selectively stabilizes topoisomerase I-DNA covalent complexes, inhibiting religation of topoisomerase I-mediated single-strand DNA breaks and producing lethal double-strand DNA breaks when complexes are encountered by the DNA replication machinery. MM-398 is designed to rely on the natural blood flow of the tumor to direct the therapy directly to the site of the cancer and minimize exposure to non-target cells. Also, liposome encapsulation of this agent promotes efficient drug delivery into the cytosol from the endosome compartment of the cell.

Phase of Development: Filed

Event Type: Regulatory EMA: CHMP Opinion (Estimate)

Dates: 2016-08-19

Results:

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Merrimack Announces ONIVYDE® Regimen Receives Positive CHMP Opinion in European Union
- Positive opinion is based on data from pivotal Phase 3 NAPOLI-1 study
- CHMP recommendation sets path for final review of Shire's marketing authorization application by European Commission
- Shire is responsible for the development and commercialization of ONIVYDE outside of the United States and Taiwan pursuant to an exclusive licensing agreement with Merrimack
CAMBRIDGE, Mass., July 25, 2016 /PRNewswire/ -- Merrimack Pharmaceuticals, Inc. (Nasdaq: MACK) today 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.
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Source: press release, 7/25/16. http://investors.merrimack.com/releasedetail.cfm?ReleaseID=980839

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