Baxter, Merrimack Ink Exclusive License and Development Pact

Baxter International and Merrimack Pharmaceuticals entered an exclusive license and collaboration agreement for the development and commercialization of MM-398 (nanoliposomal irinotecan injection), an investigational drug in Phase III development for the treatment of metastatic pancreatic cancer in patients previously treated with a gemcitabine-based therapy. Baxter will have exclusive commercialization rights for all potential indications of MM-398 outside the U.S. and Taiwan, and Merrimack retains commercialization rights in the U.S.; the rights in Taiwan are held separately.
 
Merrimack will receive $100 million upfront and is eligible to receive $120 million in regulatory milestones for the first pancreatic cancer indication, and $280 million in milestones for a second pancreatic cancer indication. Merrimack is also eligible to receive $220 million for to two additional indications, and has the potential to receive $250 million in sales milestones, as well as royalties.
 
The FDA and European Medicines Agency have granted MM-398 orphan drug designation in metastatic pancreatic cancer. Merrimack is planning to submit a NDA with the FDA in 2014, and will seek regulatory approvals outside of the U.S. beginning in 2015.
 
“Oncology represents an exciting new area and growth driver for our biopharmaceutical business,” said Ludwig Hantson, Ph.D., president of Baxter BioScience. ”With this new collaboration with Merrimack on MM-398, a promising new anti-cancer agent, we continue to augment our growing pipeline focused on challenging diseases with significant unmet needs, while capitalizing on our broad global reach.”
 
“Baxter possesses the commercial and technical expertise, experience and vision to obtain market approval and accelerate the global commercialization of MM-398 in markets all over the world for patients with metastatic pancreatic cancer who have few treatment options following gemcitabine-based therapy,” said Robert Mulroy, president and chief executive officer at Merrimack. ”This partnership also complements our strategy by allowing us to develop our own commercial efforts in the United States while aggressively pursuing the development of MM-398 across multiple cancer indications.”