PharmaEngine, and its partner Merrimack Pharmaceuticals, announced that MM-398 (nanoliposomal irinotecan injection, also known as PEP02) has been granted the Fast Track designation by the US Food and Drug Administration (US FDA) for the treatment of patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy.

Fast Track is designed by the US 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 (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.

“The Fast Track designation for MM-398 (PEP02) is one of the important regulatory milestones,“ said Grace Yeh, president and chief executive officer. “We are thrilled to be one step closer in getting MM-398 to reach the market expeditiously.”

MM-398 (PEP02) is a novel, stable nanotherapeutic encapsulation of the marketed chemotherapy drug irinotecan (nanoliposomal irinotecan injection or nal-IRI). In May 2011, PharmaEngine and Merrimack executed a license agreement. Under the terms of the agreement, 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. In 2011, MM-398 has separately received orphan drug designation from the US FDA and European Medicines Agency (EMA) for the treatment of pancreatic cancer.

According to the information from the Department of Health (DOH) in 2010, pancreatic cancer is the ninth leading cause of cancer deaths in Taiwan and about 1,500 people die of pancreatic cancer every year. Metastatic pancreatic cancer is almost uniformly fatal, with an overall survival rate of approximately 6 percent at 5 years worldwide. The drug used for the first-line therapy of the pancreatic cancer is gemcitabine. However, the treatment effect of gemcitabine is limited in extending the survival period and improving the quality of life for pancreatic cancer patients. The patients with metastatic pancreatic cancer who failed gemcitabine treatment, have no second-line or third-line standard therapies approved by the regulatory authorities.

PharmaEngine is a biopharmaceutical company established in Taipei, Taiwan in 2003. PharmaEngine focuses on the development of new drugs for the treatment of cancer and Asian prevalent diseases. PharmaEngine has three projects, two in clinical development (PEP02 / MM-398 and PEP503 / NBTXR3) and one in drug discovery (PEP06).