FDA Fast Tracks Merrimack's, Baxter's MM-398 For Pancreatic Cancer

By Cyndi Root

Merrimack Pharmaceuticals announced in a press release that the Food and Drug Administration (FDA) has granted MM-398 (nanoliposomal irinotecan injection) Fast Track designation. The compound developed and slated for marketing with Baxter is for patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The agent is an Orphan Drug in the U.S. and the EU.

Eliel Bayever, M.D., VP at Merrimack and medical director for MM-398, said, "It is crucial to develop new therapies for patients with pancreatic cancer, particularly for those patients who have previously received gemcitabine-based therapy where there is currently no consensus on the standard of care. We will continue to work diligently on our NDA submission in an effort to bring MM-398 to patients who are facing this aggressive disease as quickly as possible."

MM-398

MM-398 encapsulates irinotecan in a nanoliposomal formulation. The long-circulating agent prolongs cytotoxic effects. Merrimack is developing companion diagnostics, such as imaging and assays, to find patients most likely to respond to MM-398. In a trial (NAPOLI-1) of patients who had previously been treated with gemcitabine, a combination of MM-398, 5-fluorouracil (5-FU), and leucovorin gave participants improvements in survival and response rates. Merrimack states that it is preparing a New Drug Application (NDA) for MM-398, which it hopes to initiate in 2014 and to complete in the first quarter of 2015.

Baxter, Merrimack Agreement

Baxter and Merrimack entered into a partnership agreement to commercialize MM-398 in September 2014. The exclusive licensing agreement allows Baxter to submit for regulatory approvals outside of the United States beginning in 2015 except for Taiwan as PharmaEngine of Taipei, Taiwan holds the marketing rights in Taiwan. Robert Mulroy, President and CEO at Merrimack, stated that Baxter possesses the experience and vision to secure approvals worldwide and accelerate MM-398’s progress in markets all over the world.

About Merrimack

Merrimack still holds the rights to develop MM-398 across multiple cancer indications. The company began enrolling patients in January 2014 for a Phase 1 trial of MM-398 combined with cyclophosphamide to treat pediatric solid tumors. Merrimack believes its lead candidate has efficacy in a number of cancer indications, including Ewing's sarcoma, rhabdomyosarcoma, neuroblastoma, and osteosarcoma.