PharmaEngine Announces FDA Approves Merrimack's ONIVYDE

PharmaEngine, Inc. announced the U.S. FDA has approved Merrimack's

ONIVYDE TM (irinotecan liposome injection) in combination with fluorouracil (5-FU) and leucovorin (LV) for the treatment of patients with metastatic adenocarcinoma of the pancreas after disease progression following gemcitabine-based therapy on October 22. Earlier on the same day, the Taiwan FDA approved ONIVYDE/5-FU/LV for the same indication. ONIVYDE is not indicated for use as a single agent. "ONIVYDE is the first cancer drug to begin its clinical development in Taiwan and go on to receive regulatory approval by the US FDA," said C. Grace Yeh, Ph.D., President and CEO of PharmaEngine. "We applaud Merrimack for achieving this important milestone and we are pleased to have supported Merrimack in completing the final phase of the development for this new drug application (NDA). We believe that ONIVYDE will become an established therapeutic option for the management of metastatic pancreatic cancer in the foreseeable future."  ONIVYDE (formerly known as MM-398, PEP02, or nal-IRI) is a proprietary liposomal encapsulation of irinotecan, a topoisomerase inhibitor. The NDA