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PharmaEngine Announces Taiwan FDA Approval of ONIVYDE (TM) (irinotecan liposome injection) for the Treatment of Metastatic Pancreatic Cancer

TAIPEI, Oct. 22, 2015 /PRNewswire/ -- PharmaEngine, Inc. (4162.TWO) announced that the Taiwan Food and Drug Administration (TFDA) has approved ONIVYDETM (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. ONIVYDE is not indicated for use as a single agent. The TFDA is the first regulatory authority in the world granting the approval of ONIVYDE.

"We are very grateful that the TFDA granted the regulatory approval in such a rapid pace, especially the accelerated efforts made by the Center of Drug Evaluation (CDE) and the TFDA," said C. Grace Yeh, Ph.D., President and CEO of PharmaEngine. "We are highly appreciative to our license partner, Merrimack Pharmaceuticals, Inc. (MACK), for their valuable collaboration, as well as their timely and full support during the review period. Also, we sincerely thank all the patients, the investigators and their caregivers for their participation and significant contribution to advance the management of pancreatic cancer patients. Lastly, PharmaEngine is proud of this remarkable achievement in our company's history, and we are indebted to many people who encouraged us to persevere for more than a decade in developing ONIVYDE."

ONIVYDE (formerly known as MM-398, PEP02, or nal-IRI) is a proprietary liposome encapsulation of irinotecan, a topoisomerase 1 inhibitor. The new drug application (NDA) to the TFDA was based on the NDA data package submitted by Merrimack to the U.S. FDA and the positive data from a global Phase 3 study (NAPOLI-1) conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. A total of 417 patients were recruited at 76 sites in 14 countries; 95 patients (22.8%) were from Taiwan which ranked the top enrollment rate. The study results of NAPOLI-1 showed ONIVYDE in combination with 5-FU/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 5-FU/LV. The ONIVYDE monotherapy arm in this study did not achieve the primary endpoint. The most common adverse reactions (>20%) with ONIVYDE were diarrhea, fatigue/asthenia, vomiting, nausea, decreased appetite, stomatitis and pyrexia and the most common severe laboratory abnormalities (>10% Grade 3 or 4) were lymphopenia and neutropenia. This was the first global Phase 3 study in a post-gemcitabine setting to demonstrate a survival benefit in this aggressive disease.

Merrimack submitted an NDA to the U.S. FDA in April 2015 and was granted priority review in June with a Prescription Drug User Fee Act (PDUFA) date of October 24, 2015. The marketing authorization application (MAA) submitted to the European Medicines Agency (EMA) by Baxalta Incorporated in May 2015, was accepted for review in June 2015, and there are plans for submissions to other countries. ONIVYDE has orphan drug designation in the US, EU and elsewhere.

About Pancreatic Cancer

According to the 2013 statistical data from the Department of Health of Taiwan (DOH), pancreatic cancer is the eighth leading cause of cancer deaths in Taiwan and about 1,700 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. Currently, the patients with metastatic pancreatic cancer who progressed following gemcitabine treatment have no set standard of care.

About ONIVYDE (MM-398, PEP02, or nal-IRI)

PharmaEngine licensed the Asian (2003) European (2005) development, manufacturing and commercialization rights of ONIVYDE from Hermes BioSciences, Inc., South San Francisco, CA. Hermes was acquired by Merrimack Pharmaceuticals, Inc., Cambridge, MA in 2009. After completed preclinical, Phase 1 and 2 clinical...