History & Milestones

2019

  • Jun.

    The preliminary study results from phase II/III trial of ONIVYDE® in second-line small cell lung cancer and phase I/II trial of PEP503 (NBTXR3) in head and neck cancer were presented by Ipsen and Nanobiotix, respectively, at ASCO Annual Meeting 2019.

  • Apr.

    PEP503 (NBTXR3) received CE Mark approval for the treatment of locally advanced soft tissue sarcoma.

2018

  • Oct.

    Positive phase II/III results for PEP503 (NBTXR3) in soft tissue sarcoma were presented orally at ESMO 2018 Congress and 2018 ASTRO Annual Meeting.

  • Jul.

    ONIVYDE® obtained reimbursement from Taiwan’s National Health Insurance Administration.

  • Jul.

    ONIVYDE® launched in the third major European country.

  • Jun.

    Positive topline results from global pivotal trial of PEP503 (NBTXR3) in soft tissue sarcoma.

2017

  • Dec.

    The Singapore Health Sciences Authority approved ONIVYDE® for the treatment of metastatic pancreatic adenocarcinoma.

  • Oct.

    The study recruitment of PEP503 (NBTXR3) of phase II/III pivotal global trial for soft tissue sarcoma was completed.

  • Sep.

    The Korea Ministry of Food and Drug Safety approved ONIVYDE® for the treatment of metastatic pancreatic adenocarcinoma. PharmaEngine received the milestone payment of US$25 million.

  • Jun.

    The study results of phase I/II trial of PEP503 (NBTXR3) for head and neck cancer was presented by Nanobiotix at ASCO Annual Meeting 2017.

  • Mar.

    The independent data monitoring committee recommended the continuation of the ongoing phase II/III pivotal global trial of PEP503(NBTXR3) for soft tissue sarcoma.

2016

  • Oct.

    PharmaEngine treated the first patient of phase Ib/II trial of PEP503 (NBTXR3) for head and neck cancer in Taiwan.

  • Oct.

    European Medicines Agency (EMA) granted the marketing authorization of ONIVYDE® in combination with 5-fluorouracil and leucovorin for the treatment of metastatic pancreatic adenocarcinoma patients who have progressed following gemcitabine-based therapy. PharmaEngine received the milestone payment of US$25.5 million.

  • Sep.

    Submission for CE Marking of PEP503 (NBTXR3) in Europe by Nanobiotix was accepted.

  • Jul.

    PharmaEngine won the Go-Global Gold Medal Award of Taipei Biotech Award 2016 hosted by Taipei City Government.

  • Jul.

    PharmaEngine gained the Gold Medal Award of BioTaiwan 2016.

  • Jul.

    ONIVYDE® regimen received a positive opinion from Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency for the treatment of metastatic pancreatic adenocarcinoma.

  • May.

    PharmaEngine initiated the pivotal global trial of PEP503 (NBTXR3) in soft tissue sarcoma in Asia Pacific region.

  • May.

    Korean Ministry of Food and Drug Safety (MFDS) accepted the submission of new drug application (NDA) of ONIVYDE®. PharmaEngine acquired the milestone payment of US$10 million.

  • Mar.

    US National Comprehensive Cancer Network (NCCN) recognized the ONIVYDE® regimen as a category 1 second-line therapy in 2016 guidelines for metastatic pancreatic adenocarcinoma patients who have progressed following gemcitabine-based therapy.

  • Mar.

    Taiwan FDA approved the product license of ONIVYDE®.

2015

  • Dec.

    PharmaEngine won the Gold Prize of the Pharmaceutical and Technology Research Bioaward from Taiwan Ministry of Health & Welfare and Ministry of Economic Affairs.

  • Nov.

    The result of ONIVYDE® phase III NAPOLI-1 study was published in The Lancet.

  • Nov.

    PharmaEngine established a wholly owned subsidiary, PharmaEngine Europe SARL in Paris, France.

  • Oct.

    US FDA and TFDA approved ONIVYDE® (irinotecan liposome injection) for the treatment of metastatic pancreatic adenocarcinoma.

  • May.

    Marketing Authorization Application for MM-398 (PEP02) was filed to EMA. PharmaEngine received the milestone payment of US$11 million.

  • Apr.

    US FDA accepted New Drug Application (NDA) of ONIVYDE®. PharmaEngine received the milestone payment of US$5 million.

  • Jan.

    Expanded analyses of Phase III MM-398 NAPOLI-1 study showed the sustained positive finding of MM-398 in combination with 5-FU/LV, which was reported at the ASCO GI Cancer Symposium 2015.

2014

  • Oct.

    PharmaEngine and Nanobiotix launched a pivotal global trial of PEP503 (NBTXR3) for soft tissue sarcoma.

  • Sep.

    PharmaEngine and Merrimack amended MM-398 License Agreement. PharmaEngine received US$7 Million and was eligible for up to US$39.5 Million in sublicense revenues.

  • Jun.

    Full data of ONIVYDE® phase III NAPOLI-1 study for metastatic pancreatic adenocarcinoma were presented orally at ESMO World Congress on Gastrointestinal Cancer 2014.

  • Jun.

    The result of Phase I trial of NBTXR3 (PEP503) for soft tissue sarcoma was presented by our licensing partner Nanobiotix at ASCO Annual Meeting 2014.

  • May.

    PharmaEngine announced that MM-398 (PEP02) in combination with 5-FU/LV met the primary endpoint for overall survival in phase III NAPOLI-1 study for metastatic pancreatic adenocarcinoma post-gemcitabine metastatic treatment.

2013

  • Aug.

    PharmaEngine and Merrimack completed patient enrollment of MM-398 (PEP02) phase III NAPOLI-1 study for metastatic pancreatic adenocarcinoma.

  • Aug.

    ParmaEngine completed patient enrollment of PEP02 in combination with 5-FU/LV in phase II PEPCOL study for unresectable metastatic colorectal cancer.

  • Jul.

    PharmaEngine published the result of nanoliposomal irinotecan (PEP02, MM-398) phase II study for late-stage pancreatic adenocarcinoma in British Journal of Cancer.

  • Feb.

    PharmaEngine published the result of nanoliposomal irinotecan (PEP02, MM-398) phase II study for late-stage gastric cancer in Annals of Oncology.

  • Jan.

    PharmaEngine and Guangzhou BeBetter Medicine Technology signed a Collaboration and Research Agreement.

2012

  • Sep.

    PharmaEngine debuted IPO on Taipei Exchange Securities Market and began trading under the ticker “4162.TT” on Sept. 18, 2012.

  • Sep.

    PharmaEngine won Technology Transfer Gold Medal for the PEP02 project at the Taipei Biotech Award 2012.

  • Aug.

    PharmaEngine and Nanobiotix S.A. entered into an Asia-Pacific Exclusive License and Collaboration Agreement for NBTXR3, a radio-enhancer.

  • Jan.

    PharmeEngine and Merrimack initiated global phase III study on PEP02/MM-398 for metastatic pancreatic adenocarcinoma. PharmaEngine received the milestone payment of US$5 million after the first patient was dosed.

  • Jan.

    PharmaEngine presented the phase I study of biweekly PEP02 in metastatic colorectal cancer at the ASCO Gastrointestinal Cancers Symposium 2012.

2011

  • Dec.

    PharmaEngine received Research & Development Innovation Prize from the Department of Industrial Technology of Ministry of Economic Affairs for the PEP02 project in phase II gastric cancer study.

  • Dec.

    EMA granted orphan drug status to PEP02 (MM-398) for the treatment of pancreatic adenocarcinoma.

  • Sep.

    PharmaEngine debuted on Taiwan’s emerging stock market on Sept. 1, 2011.

  • Aug.

    PharmaEngine completed patient enrollment of PEP02 phase I study (PIST-CRC-01) for colorectal cancer in Taiwan.

  • Jul.

    US FDA granted orphan drug status to PEP02 (MM-398) for the treatment of pancreatic cancer.

  • Jul.

    Taiwan Securities & Futures Bureau (SFB) approved PharmaEngine stock to go public.

  • Jun.

    PharmaEngine presented a poster “Phase II study of PEP02 for patients with gemcitabine-refractory metastatic pancreatic cancer” at ASCO Annual Meeting 2011.

  • May.

    PharmaEngine, Inc. and Merrimack Pharmaceuticals, Inc. entered into a Licensing and Collaboration Agreement on PEP02 (MM-398, Nanoliposomal Irinotecan) for US$220 million plus tiered royalties. PharmaEngine received an upfront payment of US$10 million.

  • Jan.

    PEP02 phase II studies for both gastric cancer and pancreatic cancer met the primary endpoints. The results were orally presented at the ASCO Gastrointestinal Cancers Symposium 2011.

2010

  • Sep.

    PharmaEngine completed patient enrollment of PEP02 single-agent phase II study (PEP0208) for second-line metastatic pancreatic adenocarcinoma in the US and Taiwan.

2008

  • May.

    PharmaEngine completed patient enrollment for a combination of PEP02 with 5-FU/LV phase I study (PEP0203) in solid tumor.

  • Jun.

    PharmaEngine presented a poster Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients at ASCO Annual Meeting 2008.

2006

  • Jan.

    PharmaEngine completed a PEP02 single-agent phase I study.

2005

  • Sep.

    PharmaEngine expanded PEP02 license to the European territory.

2004

  • Dec.

    PharmaEngine completed PEP02 process scale-up and preclinical studies. PharmaEngine filed IND in Taiwan.

  • Sep.

    PharmaEngine completed the first round of fundraising with NTD630 million (~US$20 million).

2003

  • Jun.

    PharmaEngine licensed liposomal irinotecan (PEP02) for Asia territory, including Japan, from Hermes Biosciences, Inc.

  • Feb.

    PharmaEngine began operation on Feb. 6, 2003.

20009

  • Sep.

    PharmaEngine completed patient enrollment of PEP02 single-agent phase II study (PEP0206) for advanced gastric cancer in Asia and Europe.

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