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pharmaengine inc (4162) Details

PharmaEngine, Inc., a biopharmaceutical company, engages in the development of drugs for the treatment of cancer and Asian prevalent diseases in Taiwan. The company licenses in drug candidates ranging from preclinical to clinical stages. It is developing ONIVYDE, a liposome formulation of irinotecan for target indications, including pancreatic, gastric, colorectal, lung, and brain cancers; PEP503, a nanoparticle formulation of hafnium oxide for indications comprising head and neck cancer, oral cancer, colorectal cancer, esophageal cancer, brain cancer and hepatocellular carcinoma, etc.; and PEP06. PharmaEngine, Inc. has collaborations with Merrimack Pharmaceuticals, Inc.; Nanobiotix S.A.; and Guangzhou BeBetter Medicine Technology Co., Ltd. The company was founded in 2003 and is based in Taipei, Taiwan.

Founded in 2003

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pharmaengine inc (4162) Key Developments

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

PharmaEngine Inc. 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. 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.

PharmaEngine Inc. Announces Filing of Drug Application of MM-398 (PEP02) to Taiwan FDA

PharmaEngine Inc. 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. and its sublicensing partner, Baxter International's BioScience business 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.

PharmaEngine Inc., Annual General Meeting, Jun 10, 2015

PharmaEngine Inc., Annual General Meeting, Jun 10, 2015.


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