TAIPEI, May 31, 2015 -- PharmaEngine, Inc. (TWO:4162) today announced that a New Drug Application (NDA) has been submitted to the Taiwan Food and Drug Administration (TFDA) for MM-398 (irinotecan liposome injection, also known as nal-IRI) in patients with metastatic adenocarcinoma of the pancreas who have been previously treated with gemcitabine-based therapy. The filing of MM-398 to the TFDA follows the recent submissions of NDA and marketing authorization application (MAA) by its licensing partner, Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) and its sublicensing partner, Baxter International's BioScience business (NYSE: BAX) to the US FDA and to the European Medicines Agency (EMA), respectively.
The filing of MM-398 to the TFDA was supported by the positive data from a phase 3 study (NAPOLI-1) conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. "This submission represents a significant milestone in the history of PharmaEngine. We are extremely grateful to our investigators, patients and their caregivers for their participation in making Taiwan the top recruitment region in this pivotal study. We are also thankful for the support from Merrimack in preparing our NDA," said C. Grace Yeh, Ph.D., President and CEO of PharmaEngine. "We look forward to working with our regulatory authority to offer a new treatment option to help the patients in fighting against their pancreatic cancer."
About MM-398 (PEP02)
MM-398 (PEP02, irinotecan liposome injection), also known as "nal-IRI," 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 BioScience business. In 2011, MM-398 received orphan drug designation from both the US FDA and 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, and completed the rolling submission of the NDA for US FDA in April 2015 and the MAA to EMA in May 2015.
About NAPOLI-1 Study
The global, randomized, open label phase 3 study, referred to as NAPOLI-1 (NAPOLI acronym: NAnoliPOsomaL Irinotecan), was sponsored by Merrimack Pharmaceuticals, Inc. (Cambridge, MA, USA). Patients were recruited from over 100 sites in 15 countries (North America, South America, Europe, Asia and Australia). The total enrollment of 417 patients were randomized across the three arms: MM-398 (120 mg/m2, every three weeks) as a monotherapy, MM-398 (80 mg/m2, every two weeks) in combination with 5-FU/LV, and a shared control arm of 5-FU/LV. MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin (LV) achieved the primary and secondary endpoints by demonstrating a clinically and statistically significant improvement in overall survival, progression free survival and overall response rate compared to the control group of patients who received a combination of 5-FU and LV. This was the first global phase 3 study in a post-gemcitabine setting showing a survival benefit in this aggressive disease.
About PharmaEngine, Inc. (TWO: 4162)
PharmaEngine is a biopharmaceutical company established in Taipei, Taiwan. PharmaEngine focuses on the development of new medications for the treatment of cancer and Asian prevalent diseases. PharmaEngine has three projects: PEP02 (MM-398) in NDA stage; PEP503 (NBTXR3) in a global pivotal trial of soft tissue sarcoma; and PEP06 in drug discovery. For further information, please visit PharmaEngine's website at http://www.pharmaengine.com.
Peter Wu, Director, Corporate Development
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