MACK
Acuerdo de colaboración con Baxter
Baxter International (NYSE:BAX) and Merrimack Pharmaceuticals (NASDAQ:MACK) enter into an exclusive license and collaboration agreement to develop and commercialize the Orphan Drug-designated MM-398 (nanoliposomal irinotecan injection), also known as nal-IRI. The initial indication will be pancreatic cancer previously treated with gemcitabine for which Merrimack is preparing an NDA for submission in 2014.
Under the terms of the agreement, Baxter has exclusive commercial rights for all potential indications of MM-398 worldwide except the U.S. and Taiwan. Merrimack retains commercialization rights in the U.S. while the rights in Taiwan are held separately. Merrimack will receive an upfront payment of $100M, up to $120M in regulatory milestone payments related to the first pancreatic cancer indication, up to $280M in development and regulatory milestone payments for a second pancreatic cancer indication, up to $220M in development and regulatory milestone payments for two additional indications, up to $250M in sales milestone payments and tiered royalties on net sales of MM-398 in the licensed territories.
In a Phase 3 clinical trial, MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin demonstrated a statistically significant improvement in overall survival, progression-free survival and overall response rate compared to 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 pancreatic cancer.
Baxter plans to submit its regulatory applications outside of the U.S. beginning is 2015.
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