Date: 2014-09-27
Type of information: Licensing agreement
Compound: MM-398 (nanoliposomal irinotecan injection)
Company: Baxter (USA - IL) Merrimack Pharmaceuticals (USA - MA)
Therapeutic area: Cancer - Oncology
Type agreement:
Action mechanism: MM-398 is a novel encapsulation of irinotecan in a long-circulating nanoliposomal formulation designed to increase drug deposition and prolong cytotoxic effects, with the goal of improving its anti-cancer properties. MM-398 has demonstrated extended circulation in comparison to free irinotecan in the clinical setting. The activated form of irinotecan is SN-38, which functions by inhibiting topoisomerase I. A Phase 1 clinical trial is assessing a potential companion diagnostic for MM-398 in patients with multiple cancer types as a first step toward determining which patients are most likely to benefit from treatment with the drug.
Disease: metastatic pancreatic cancer
Details: * On September 24, 2014, Baxter International and Merrimack Pharmaceuticals jointly announced an exclusive license and collaboration agreement for the development and commercialization of MM-398 (nanoliposomal irinotecan injection), also known as \'\'nal-IRI.\'\' Through the agreement, Baxter gains exclusive commercialization rights for all potential indications of MM-398 outside the United States and Taiwan. Merrimack retains commercialization rights in the United States ; the rights in Taiwan are held separately. Merrimack is currently preparing a New Drug Application (NDA) for MM-398 in the United States for the treatment of patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. In May 2014 , the company announced that the Phase 3 trial, known as NAPOLI -1, studying MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin achieved its primary and secondary endpoints for patients with metastatic pancreatic cancer who were previously treated with a gemcitabine-based therapy. In the study, the combination of MM-398 with 5-FU and leucovorin demonstrated a statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control arm of 5-FU and leucovorin alone. This was the first positive global Phase 3 study in a post-gemcitabine setting to show a survival benefit in this aggressive disease. The FDA and the European Medicines Agency have granted MM-398 orphan drug designation in metastatic pancreatic cancer. Merrimack is planning to submit a New Drug Application for MM-398 with the FDA in 2014. Baxter expects to submit for regulatory approvals outside of the United States beginning in 2015.
Financial terms: Under the terms of the agreement, Merrimack receives a $100 million upfront payment from Baxter, which will be recorded by Baxter as a special pre-tax in-process research and development charge in the third quarter of 2014. Merrimack is also eligible to receive $120 million in regulatory milestone payments related to the first pancreatic cancer indication as these milestones are achieved, and $280 million in development and regulatory milestone payments for a second pancreatic cancer indication.
Merrimack is also eligible to receive $220 million in future development and regulatory milestone payments related to two additional indications. Merrimack has the potential to receive $250 million in sales milestone payments, as well as tiered royalties on net sales of MM-398 in the licensed geographies.
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