PharmaEngine, Inc's licensing partner, Merrimack Pharmaceuticals, Inc, has completed the rolling submission of the New Drug Application (NDA) for MM-398 (irinotecan liposome injection) to the US Food and Drug Administration (FDA) in patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
Merrimack also announced that they have requested priority review of the MM-398 NDA by the FDA.
MM-398 NDA application is supported by the data from a phase 3 study (NAPOLI-1) conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin achieved its primary and secondary endpoints by demonstrating a statistically significant improvement in overall survival, progression free survival, and overall response rate compared to the control arm of 5-FU and leucovorin alone.
This was the first global phase 3 study in a post-gemcitabine setting to show a survival benefit in this devastating disease. The topline and expanded analysis data were presented in June 2014 and January 2015.
“Drug development is similar to a relay race; PharmaEngine developed MM-398 (also known as PEP02) from preclinical to phase 2 clinical stages, and passed the baton to Merrimack who accelerated its development through a successful global phase 3 trial,” said C. Grace Yeh, Ph.D., president and chief executive officer of PharmaEngine. “We are pleased to have collaborated with Merrimack in the NAPOLI-1 study and the US NDA filing process. We will use the data package from the US NDA filing to form the basis of our Taiwan NDA submission.”
“The submission of Merrimack’s first ever NDA with the U.S. FDA is a major milestone in the company’s history and a significant step forward in our commitment to delivering new treatment options to cancer patients,” said Robert Mulroy, president and chief executive officer of Merrimack. “We are grateful for the work PharmaEngine did to bring MM-398 to phase 3 and look forward to working with them as they prepare for their submission in Taiwan.”
In accordance with the first amendment to the license and collaboration agreement signed by PharmaEngine and Merrimack in September 2014, Merrimack is contractually obligated to pay PharmaEngine a milestone of USD 5 million by April 30, 2015.
MM-398 (PEP02, irinotecan liposome injection) is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. In May 2011, PharmaEngine and Merrimack executed an exclusive license agreement. Under the terms of the agreement, PharmaEngine granted back Merrimack the rights to develop, manufacture, and commercialize PEP02 (designated as MM-398 by Merrimack) in Asia and Europe, and retained the same rights in Taiwan.
In September 2014, Merrimack licensed the rights to MM-398 outside of the US and Taiwan to Baxter International’s biopharmaceutical business. In 2011, MM-398 received orphan drug designation from both the US FDA and European Medicines Agency (EMA) for the treatment of pancreatic cancer. In addition, MM-398 received Fast Track designation for post-gemcitabine metastatic pancreatic cancer from the US FDA in November 2014.