Baxter Licenses Merrimack's Nanoliposomal Irinotecan Injection For Pancreatic Cancer

Baxter International has licensed Merrimack Pharmaceuticals’ MM-398 (nanoliposomal irinotecan injection) for pancreatic cancer. Baxter announced the exclusive license and collaboration agreement in a press release, stating that it acquired worldwide rights, excluding the U.S. and Taiwan. Robert Mulroy, President and CEO at Merrimack, 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.”

Baxter and Merrimack Agreement

Merrimack retains the rights to develop MM-398 across multiple cancer indications in the U.S. Baxter’s license allows it exclusive worldwide commercialization rights for all potential indications of MM-398 outside the U.S. The rights for marketing in Taiwan are held separately. When the deal closes, Merrimack will receive a $100 million payment from Baxter, up to $120 million in regulatory milestone payments for the first approved indication, and up to $280 million for a second cancer indication. Merrimack is also eligible for additional milestone payments totaling $470 million and royalties on sales.

MM-398

MM-398 is an encapsulation of irinotecan in a long-circulating nanoliposomal formulation. It increases drug saturation to prolong cytotoxic effects. Merrimack is also developing imaging diagnostics and biopsy-based assays, which could help find patients that are likely to respond to MM-398 treatment. Merrimack is preparing a New Drug Application (NDA) for MM-398 to submit to the Food and Drug Administration (FDA) for the treatment of patients with metastatic pancreatic cancer previously treated with a gemcitabine-based therapy. MM-398 has received Orphan Drug designation in the U.S. and in the EU. Baxter plans to execute regulatory filings for approval in other countries in 2015.

A Phase 3 trial of MM-398 (NAPOLI-1) combined with 5-fluorouracil (5-FU) and leucovorin achieved a statistically significant improvement in overall survival, progression free survival, and overall response rate, meeting the trial’s endpoints.

Baxter states that it was the first Phase 3 study of patients that had been treated with gemcitabine-based therapy to show a survival benefit.  

In January 2014, Merrimack announced the beginning of enrollment in a Phase 1 trial of MM-398 in conjunction with cyclophosphamide for the treatment of pediatric solid tumors. The company believes that the agent shows promise in different kinds of tumors, including Ewing's sarcoma, rhabdomyosarcoma, neuroblastoma, and osteosarcoma.