September 24, 2014
By Mark Terry, BioSpace.com Breaking News Staff
Baxter International Inc. today announced it had entered into an exclusive licensing and collaboration agreement with Cambridge, Mass.-based Merrimack Pharmaceuticals, Inc. to develop and commercialize lead cancer drug MM-398.
The drug, nanoliposomal irinotecan injection), is also labeled “nal-IRI.”
Deerfield, Ill.-based Baxter will hold exclusive commercialization rights for possible uses outside the U.S. and Taiwan. Merrimack holds commercialization rights in the U.S. Taiwanese rights are held separately.
In the deal, Merrimack will receive an upfront payment from Baxter of $100 million. Baxter will record it as a special pre-tax in-process R&D charge in Q3 2014. In addition, Merrimack may receive $120 million in regulatory milestones related to the first pancreatic cancer therapeutic, as well as a potential $280 million in developmental and regulatory milestone payments for anadditional indication of cancer of the pancreas.
For two more indications, Merrimack could receive another $220 million and yet another $250 million in sales milestones.
Merrimack is prepping an NDA for MM-398 in the U.S. for possible treatment of metastatic pancreatic cancer patients, specifically in patients previously treated by gemcitabine.
“With this new collaboration with Merrimack on MM-398, a promising new anti-cancer agent,” said Baxter BioScience president Ludwig Hantson in a press release, “we continue to augment our growing pipeline focused on challenging diseases with significant unmet needs, while capitalizing on our broad global reach.”
MM-398 received orphan drug status by the U.S. FDA as well as the European Medicines Agency. In addition to Merrimack’s intended 2014 NDA in the U.S., Baxter plans to submit the drug for approvals outside the country in 2015. MM-398 was part of the NAPOLI-1 Phase 3 trial announced in May 2014, in which the drug was used in combination with 5-fluorouracil (5-FU) and leucovorin.
It achieved its primary and secondary endpoints for metastatic pancreatic cancer patients. Compared to the control arm of 5-FU and leucovorin alone, the combination showed a statistically significant improvement in overall survival, as well as progression free survival. About 405 patients were enrolled in the worldwide study.
The company presented positive data in June 2014 at the European Society for Medical Oncology World Congress on Gastrointestinal Cancer (ESMO GI) held in Barcelona, Spain.
“These positive results further strengthen our belief in the MM-398 combination and design of NAPOLI-1,” said Eliel Bayever, vice president at Merrimack in a press release. “This Phase 3 success bolsters our confidence in our systems approach and continued commitment to engineering innovative therapies for difficult to treat cancer.”
