Baxter International Inc. and Merrimack Pharmaceuticals, Inc., a biopharmaceutical company, have formed an exclusive license and collaboration agreement for the development and commercialization of MM-398, a nanoliposomal encapsulation of the chemotherapeutic drug, irinotecan. Under the agreement, Baxter gains exclusive commercialization rights for all potential indications of MM-398 outside the United States and Taiwan, and Merrimack retains commercialization rights in the United States.The rights in Taiwan are held separately by PharmaEngine, Inc., a specialty pharmaceutical company based in Taipei,Taiwan, which holds the rights to commercialize MM-398 in Taiwan under a 2011 agreement with Merrimack. MM-398 is an investigational drug candidate for which Merrimack is preparing a new drug application (NDA) in the United States for the treatment of patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.

Under 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.

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. In May 2014, Merrimack announced that the Phase III 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.

The US Food and Drug Administration (FDA) and European Medicines Agency have granted MM-398 orphan drug designation in metastatic pancreatic cancer. Merrimack is planning to submit a NDA for MM-398 with the FDA in 2014. Baxter expects to submit for regulatory approvals outside of the United States beginning in 2015.

Merrimack is a biopharmaceutical company discovering, developing and preparing to commercialize innovative medicines paired with companion diagnostics for the treatment of cancer. Merrimack currently has six oncology therapeutics in clinical development and three additional candidates in late-stage preclinical development. 

Source: Baxter International