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PharmaEngine Announces U.S. FDA Approves Merrimack's ONIVYDE(TM) (irinotecan liposome injection)

TAIPEI, Taiwan, Oct. 23, 2015 /PRNewswire/ -- PharmaEngine, Inc. (4162.TWO) announced the U.S. FDA has approved Merrimack's (MACK) 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 for ONIVYDE was based on the results of the international Phase 3 study (NAPOLI-1). ONIVYDE plus 5-FU/LV achieved the study's primary endpoint by demonstrating a clinically and statistically significant improvement in overall survival, as well as demonstrating improvement in progression free survival compared to the control group of patients who received 5-FU/LV alone. The ONIVYDE monotherapy arm did not achieve the primary endpoint and, therefore, is not indicated as a single agent. 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. For additional safety information, please see the Important Safety Information below. This was the first global Phase 3 study in a post-gemcitabine setting to demonstrate a survival benefit in this aggressive disease.

The marketing authorization application (MAA) submitted to the European Medicines Agency by Baxalta Incorporated is under review 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 most recent information from World Health Organization (WHO), 330,000 people die of pancreatic cancer per year and pancreatic cancer is the seventh-leading cause of cancer-related death in the world. Metastatic pancreatic cancer is almost uniformly fatal, with an overall survival rate of approximately 6 percent at 5 years worldwide. Currently, patients with metastatic pancreatic cancer who progress after gemcitabine treatment have no set standard of care.

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

PharmaEngine licensed the Asian (2003) and European (2005) development, manufacturing and commercialization rights for 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 studies, PharmaEngine licensed its Asian and European rights, except Taiwan, back to Merrimack in 2011. From 2012 to 2014, Merrimack sponsored the global Phase 3 study in metastatic pancreatic cancer patients who progressed after receiving a gemcitabine-containing regimen. In September 2014, Merrimack licensed ONIVYDE outside of the U.S. and Taiwan to Baxalta Incorporated (BXLT), formerly Baxter International's BioScience business.



ONIVYDE™ (irinotecan liposome injection) is...