PharmaEngine has announced that its license partner, Merrimack Pharmaceuticals, has received FDA acceptance and Priority Review designation for their NDA and its sublicense partner, Baxalta, a wholly owned subsidiary of Baxter International, has received Market Authorization Application (MAA) from the EMA, of MM-398 (irinotecan liposome injection, also known as nal-IRI) in the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.
A Priority Review designation is granted to medicines that the FDA determines have the potential to provide significant improvements in the safety or effectiveness. The goal is for the FDA to take action on the marketing application within six months of receipt (compared with 10 months under standard review) of the NDA submission.
"We are very excited to know that the two major regulatory agencies, the FDA and the EMA, have accepted the NDA and MAA applications in their respective jurisdictions for MM-398," said C. Grace Yeh, Ph.D., president and CEO of PharmaEngine. "We believe that MM-398 will provide an option to the limited armamentarium for the treatment of the metastatic pancreatic cancer in the foreseeable future."
In addition, as a result of the MAA acceptance, PharmaEngine is entitled to receive a total of $11 million from Merrimack as the milestone payment and sublicense revenue under the License and Collaboration Agreement between PharmaEngine and Merrimack.
In May 2011, PharmaEngine and Merrimack executed an exclusive license 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 U.S. and Taiwan to Baxter International's BioScience business.
In 2011, MM-398 received Orphan Drug designation from both the FDA and the EMA for the treatment of pancreatic cancer. In April and May 2015, all three partners submitted the NDA, MAA and NDA to the FDA, the EMA and the Taiwan FDA, respectively. In addition, MM-398 received Fast Track designation and Priority Review designation from the FDA in November 2014 and June 2015, respectively.