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FDA grants fast track status for Merrimack’s pancreatic cancer drug MM-398

The US Food and Drug Administration (FDA) has granted fast track designation for Merrimack Pharmaceuticals' MM-398 (nanoliposomal irinotecan injection) to treat patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

Currently, the company is preparing a new drug application (NDA) for MM-398 in the US to treat these patients with metastatic pancreatic cancer.

The FDA fast track status is designed to facilitate and expedite the development and review of drugs that treat serious conditions and fill an unmet medical need, and it enables sections of the NDA to be submitted to the FDA as they are completed.

Based on this fast track status, the company plans to start the NDA submission in 2014 and intends to complete the submission late in the first quarter or early in the second quarter of 2015.

Merrimack vice-president and medical director for MM-398 Eliel Bayever 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 has been granted orphan drug designation in metastatic pancreatic cancer by both the FDA and European Medicines Agency (EMA).

In September, Merrimack and Baxter’s biopharmaceutical business (BAX) entered into an exclusive licensing agreement to develop and commercialize MM-398 outside of the US.

Baxter intends to submit for regulatory approvals outside of the US starting in 2015.