PharmaEngine, Merrimack's MM-398 Gets FDA Fast Track Designation

(RTTNews) - Taiwan-based biopharmaceutical company PharmaEngine, Inc. and its partner Merrimack Pharmaceuticals, Inc. (MACK) announced Thursday that nanoliposomal irinotecan injection MM-398, also known as PEP02, has been granted the Fast Track designation by the U.S. Food and Drug Administration or FDA. The injection is for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

MM-398 is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan. In May 2011, PharmaEngine and Merrimack executed a license agreement, under which, PharmaEngine has 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.

Fast Track is designed by the FDA to facilitate the development and expedite the review of drugs that are intended to treat a serious condition or disease, and nonclinical or clinical data demonstrate the potential to address unmet medical need.

In addition, the FDA allows the rolling submission, which means that a drug company can submit completed sections of its New Drug Application or NDA for review by the FDA, rather than waiting until every section of the application is completed before the entire application can be submitted.

Merrimack expects to begin the NDA submission in 2014.

In 2011, MM-398 has separately received orphan drug designation from the FDA and European Medicines Agency or EMA for the treatment of pancreatic cancer.

Grace Yeh, PharmaEngine President and Chief Executive Officer said, "The Fast Track designation for MM-398 (PEP02) is one of the important regulatory milestones. We are thrilled to be one step closer in getting MM-398 to reach the market expeditiously."