PharmaEngine Announces Filing by Baxter BioScience of Marketing Authorization Application of MM-398 (PEP02) to the European Medicines Agency for Post-Gemcitabine Metastatic Pancreatic Cancer Patients

TAIPEI, May 4, 2015 /PRNewswire/ -- PharmaEngine, Inc. (TWO:4162) today announced that its licensing partner, Merrimack Pharmaceuticals, Inc. (NASDAQ: MACK) with its sublicensing partner, Baxter International Inc. (NYSE: BAX) jointly announced that Baxter has submitted a marketing authorization application (MAA) to the European Medicines Agency (EMA) 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 MAA filing of MM-398 to the EMA follows Merrimack's recent new drug application (NDA) filing for the approval of the treatment with the US FDA, and was supported by the data from a Phase 3 study (NAPOLI-1) conducted in patients with metastatic pancreatic cancer who previously received gemcitabine-based therapy. MM-398 in combination with 5-fluorouracil (5-FU) and leucovorin (LV) achieved its primary and secondary endpoints by demonstrating a statistically significant improvement in overall survival, progression free survival, and overall response rate compared to the control arm of 5-FU/LV alone. This was the first global Phase 3 study in a post-gemcitabine setting to show a survival benefit in this devastating disease.  The topline and expanded analysis data were presented in June 2014 and January 2015.

"The filing of the MAA of MM-398 to the EMA is a significant step towards the regulatory approval in the European Union. We are very impressed by Baxter's expedited efforts in completing the MAA submission in such a short period of time," said C. Grace Yeh, Ph.D., President and CEO of PharmaEngine. "We are preparing the NDA filing of MM-398 (PEP02) to the Taiwan FDA, and hope to provide a new treatment option to pancreatic cancer patients soon."

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 biopharmaceutical 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.

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.

Contact

Peter Wu, Director, Corporate Development
Telephone No.: (+886)-2-2515-8228, ext. 500
Mobile phone No.: (+886)-935-154-559
Email: [email protected]

SOURCE PharmaEngine, Inc.

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