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pharmaengine inc (4162) Details

PharmaEngine, Inc., a biopharmaceutical company, is engaged in the development of drugs for the treatment of cancer and Asian prevalent diseases in Taiwan. The company develops, manufactures, and commercializes PEP02, a novel and stable nanoliposomal formulation of irinotecan, which has completed four Phase I studies and two Phase II studies for gastric and pancreatic cancers in Asia and Europe. It also develops PEP503, a crystalline hafnium oxide, which is in Phase I trial in France. 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 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.

Merrimack Pharmaceuticals and PharmaEngine Report Positive Phase III Results for MM-398 in Pancreatic Cancer

PharmaEngine and its partner Merrimack Pharmaceuticals have presented additional analyses from a global, randomised, open-label Phase III (NAPOLI-1) trial investigating the safety and efficacy of MM-398 (liposome irinotecan injection) in metastatic pancreatic cancer. The analyses of the trial lend further support to the positive top-line data that were presented in 2014 demonstrating a statistical increase in overall survival (OS) following treatment with MM-398 and 5-fluorouracil and leucovorin (5-FU/LV), with a hazard ratio of 0.67 (p=0.01) and a median OS of 6.1 months, compared with 4.2 months with 5-FU/LV alone. In the expanded analyses, the OS for MM-398 hazard ratio was 0.57 (p=0.0009) in the stratified analysis that accounts for pre-specified prognostic factors, while the analysis of the per protocol population, or those patients who received 80% of protocol-defined dose and remained on treatment for at least six weeks demonstrated more statistical improvement in median OS (8.9 months) compared with the control arm (5.1 months; p=0.0018). In addition, the trial revealed significant improvements in progression-free survival, objective response rate, and CA19-9 tumour market response following treatment with MM-398 compared with the control arm. The data were presented at the Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology on 16 January 2015.


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Price/Sales 29.7x
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