Baxter, Merrimack ink multimillion-dollar deal for MM-398
DEERFIELD, Ill. & CAMBRIDGE, Mass.—In hopes of taking aim at cancer, Baxter International Inc. and Merrimack Pharmaceuticals Inc. have begun an exclusive license and collaboration agreement to develop and commercialize MM-398 (nanoliposomal irinotecan injection), also known as “nal-IRI,” for which Merrimack is preparing a New Drug Application (NDA) for the treatment of patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. Under the agreement, Baxter will have exclusive commercialization rights for the compound in all potential indications outside of the United States and Taiwan, while Merrimack will retain commercialization rights in the United States, with Taiwan rights held separately.
“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,” Robert Mulroy, president and CEO at Merrimack, noted in a statement. “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.”
The agreement stipulates that Baxter will pay Merrimack $100 million up front, with the potential for an additional $120 million in regulatory milestone payments related to the first pancreatic cancer indication and $280 million in development and regulatory milestone payments for a second pancreatic cancer indication. Merrimack also stands to receive $220 million if future development and regulatory milestones are met in two additional indications, $250 million in sales milestone payments and tiered royalties on net sales of the compound in licensed territories.
MM-398 is a nanoliposomal encapsulation of the chemotherapeutic irinotecan. So far, the compound has shown extended circulation in comparison to free irinotecan in the clinic. A Phase 1 clinical trial is underway to evaluate a potential companion diagnostic for the drug in patients with multiple cancer types to try and assess which patients will most likely benefit from treatment with MM-398. Merrimack recently concluded a Phase 3 study of MM-398 as both a monotherapy and a combination therapy in patients with pancreatic cancer, with encouraging results for the compound’s potential in a combination therapy. (Check out ‘Cancer progress for Merrimack’ for further details.)
MM-398 has received orphan drug designation from both the U.S. Food and Drug Administration and the European Medicines Agency for metastatic pancreatic cancer. Merrimack intends to submit its NDA for MM-398 this year, with plans to submit for ex-U.S. regulatory approvals next year.
“Oncology represents an exciting new area and growth driver for our biopharmaceutical business,” Ludwig Hantson, Ph.D., president of Baxter BioScience, said in a press release. “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.”
Though pancreatic cancer is one of the rarer cancer types, accounting for only 3 percent of all cancer cases worldwide, it is the fourth leading cause of cancer death, according to the American Cancer Society. Some 140,000 new cases are diagnosed each year worldwide; the United States sees roughly 46,000 new cases each year, and approximately 40,000 patients die of this disease annually. Due to the cancer’s non-specific symptoms, the disease often goes undiagnosed until late in its progression—roughly 80 percent of patients are diagnosed with late-stage disease. In addition, they aren’t candidates for surgery, which is why the five-year survival rate is less than 6 percent, with less than 20 percent of newly diagnosed patients surviving more than two years.