Previous EU and Asian licensee will retain Taiwanese rights to Phase III-poised oncology drug formulation.

Merrimack Pharmaceuticals has regained nearly full worldwide rights to the Phase II-stage nanoliposomal irinotecan candidate MM-398, from its previous EU and Asian licensee, PharmaEngine. Under terms of the deal Taiwanese specialty pharmaceuticals firm PharmaEngine will receive a $10 million up-front payment from Merrimack and also retain rights to MM-398 in Taiwan.

The firms will continue to collaborate on development of the drug. PharmaEngine could also earn up to $210 million in development, regulatory, and sales milestones, plus royalties on sales of MM-398 in its previously licensed European and Asian territories.  

Merrimack says it now plans to move MM-398 into Phase III trials for indications including gemcitabine-refractory pancreatic cancer. A Phase II study in gastric cancer has been completed, and a Phase II pancreatic cancer trial is ongoing, along with a Phase I study in colorectal cancer patients. MM-398 is separately being evaluated in a Phase I glioma trial under an investigator-sponsored IND at the University of California, San Francisco.

“We believe that unifying the development strategy of MM-398 is critical as we plan to move the program forward into late-stage clinical trials,” comments Robert Mulroy, Merrimack CEO. “The PharmaEngine team has laid a great foundation for Phase III development and commercialization by conducting clinical trials across multiple indications.”

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