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news.Baxter International and Merrimack Pharmaceuticals have entered into a license and collaboration agreement worth nearly $970m, to develop and commercialize MM-398 (nanoliposomal irinotecan injection), also called as nal-IRI.
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MM-398 is an investigational drug candidate designed to increase drug deposition and prolong cytotoxic effects, with the goal of improving its anti-cancer properties.
Currently, Merrimack is preparing a new drug application (NDA) in the US for MM-398 to treat patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy.
Under the deal, Baxter has exclusive commercialization rights for all potential indications of MM-398 outside the US and Taiwan, while Merrimack retains commercialization rights in the US; the rights in Taiwan are held separately.
Baxter BioScience president Ludwig Hantson said: "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."
The deal will see Merrimack receive an upfront payment of $100m, up to $120m in regulatory milestone payments related to the first pancreatic cancer indication and about $280m in development and regulatory milestone payments for a second pancreatic cancer indication.
Merrimack is also eligible to receive up to $220m in development and regulatory milestone payments for two additional indications and up to $250m in sales milestone payments and tiered royalties on net sales of MM-398 in the licensed territories.
Merrimack president and CEO Robert Mulroy said 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.
"This partnership also complements our strategy by allowing us to develop our own commercial efforts in the US while aggressively pursuing the development of MM-398 across multiple cancer indications," Mulroy said.
The company said that in a Phase III clinical trial (NAPOLI-1), MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin showed a significant improvement in overall survival, progression-free survival and overall response rate compared to 5-FU and leucovorin alone.
Merrimack is planning to submit a NDA for MM-398 to the US FDA in 2014, while Baxter plans to submit its regulatory applications outside of the US beginning in 2015.
Image: Baxter International headquarters in Deerfield, Illinois, US. Photo: courtesy of Coolieguy