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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 Initiation of Global Pivotal Trial of PEP503 (NBTXR3) in Soft Tissue Sarcoma in Asia Pacific Region

PharmaEngine Inc. announced that the first patient has been dosed in a global pivotal phase II/III trial of PEP503 (NBTXR3) in soft tissue sarcoma (STS) at Perpetual Succour Hospital, Cebu, Philippines. This multi-national, randomized, open-label, two-arm pivotal phase II/III trial, referred to as Study 301 (Act.in.sarc study), is being conducted in partnership with PharmaEngine's partner, Nanobiotix S.A. PharmaEngine is the co-sponsor of this Study 301 in the Asia-Pacific Region. The primary objective of Study 301 is to enhance the pathological complete response rate (pCR) by dosing PEP503 through intra-tumor injection and then activated by external beam radiation therapy (EBRT). The efficacy of PEP503 combined with radiotherapy in Study 301 will be compared with that of radiotherapy alone. The total patient enrollment of Study 301 is around 180 patients to be recruited in Europe and South Africa by Nanobiotix and in the Asia-Pacific region (Australia, Hong Kong, and Philippines) by PharmaEngine. The first patient in this global study was enrolled and dosed in Europe in the first quarter of 2015. The patient enrollment is actively ongoing now. The Global Principal Investigator is Prof. Sylvia Bonvalot, MD, PhD (Institut Curie, Paris, France). An interim analysis will be performed once two-thirds of patients have been recruited to ensure the safety of all patients enrolled in the study, the quality of the data collected and the continued scientific validity of the study design.

PharmaEngine Inc., Annual General Meeting, Jun 15, 2016

PharmaEngine Inc., Annual General Meeting, Jun 15, 2016.

PharmaEngine, Inc. Announces Taiwan FDA Granting the Product License of Onivyde™ for the Treatment of Metastatic Pancreatic Cancer

PharmaEngine Inc. announced that TFDA (Taiwan Food and Drug Administration) approved the product license of ONIVYDE (irinotecan liposome injection, nal-IRI). ONIVYDE is indicated, 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. There are two steps for the marketing approval of new drugs in Taiwan. The first step is to assess whether the chemistry, manufacturing and controls, preclinical and clinical data regarding the quality, safety and efficacy are sufficient to issue the regulatory approval letter; and the second step is to assess whether the product labeling and package insert are supported by the new drug application dossiers. Both steps are essential for product sales in the Taiwan market. ONIVYDE has been granted the TFDA regulatory approval letter on October 22, 2015. The approval of the commercial packaging materials and the GMP approval letters for two US manufacturing sites have been issued to allow the TFDA granting the product license of ONIVYDE.

 

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Valuation 4162 Industry Range
Price/Earnings 69.5x
Price/Sales 52.4x
Price/Book 8.4x
Price/Cash Flow 69.0x
TEV/Sales 46.5x
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