PharmaEngine, Inc. is one of few companies for new drug development in Taiwan, which the ability of planning, designing and implementing a new drug clinical trial in Asia, Europe and the United States. The history and milestones of PharmaEngine are listed shortly as follows:
2011
►Received Research & Development Innovation Prize from the Dept. of Industrial Technology (DoIT) of MOEA for PEP02 project in phase II gastric cancer study.
►PharmaEngine, Inc. debut on Taiwan's emerging stock market on September 1, 2011
►US FDA grants orphan drug status to PEP02 (Merrimack Pharmaceuticals’ MM-398), for the treatment of pancreatic cancer
►PharmaEngine, Inc. approved by Taiwan Securities & Futures Bureau (SFB) for IPO.
►Presented a pre-clinical study of PEP02 for three xenograft models of human lung tumors at 14th World Conference on Lung Cancer (WCLC).
►Presented a poster of phase II study of PEP02 for patients with gemcitabine-refractory metastatic pancreatic cancer at 2011 ASCO Annual Meeting
►PharmaEngine, Inc. and Merrimack Pharmaceuticals, Inc. Enter into a Licensing and Collaboration Agreement on PEP02 (MM-398), Nanoliposomal Irinotecan
►Presented the PEP02 met the primary endpoints in phase II studies in gastric cancer and pancreatic cancer at the 2011 Gastrointestinal Cancers Symposium of the American Society of Clinical Oncology (ASCO)
2010
►Completed patient enrollment for a single agent phase II study as a second line therapy for metastatic pancreatic cancer in the US and Taiwan.
►Received China SFDA IND approval for a phase I/II colorectal cancer trial
2009
►Completed patient enrollment for a single agent randomized phase II study in gastric cancer in Asia and Europe.
►Initiated a phase II study as a second line therapy for metastatic pancreatic cancer in the US and Taiwan.
►Obtained government grant for PEP02 phase II pancreatic cancer study
►Initiated a phase I investigator sponsored trials for colorectal cancer in Taiwan.
2008
►Received US FDA approval for phase II pancreatic cancer trial
►Received Research & Development Innovation bronze medal for PEP02 project at the 5th Taipei Biotech Award
►Completed patient enrollment for a combination phase I study
►Presented a poster of “ Phase I study of liposome encapsulated irinotecan (PEP02) in advanced solid tumor patients ” at 2008 ASCO Annual Meeting
►Initiated a phase II single agent study in gastric cancer in Asia and Europe
2007
►Hermes, using our PEP02 data, was allowed to initiate a phase I study in brain tumor in the US
►Obtained government grant for PEP02 phase II gastric cancer study
2006
►Completed PEP02 a single agent phase I study
►Received the 10th Golden Peak and the 6th National Quality Assurance Golden Statue awards
2005
►Licensed PEP04 (TransMID) for China and Korea rights from Xenova
►Extended PEP02 license to the European territory
►Received Red Herring Asia 100 award
2004
►Completed fund raising and obtained government grant for PEP02 phase I study
►Completed PEP02 process scale-up and preclinical studies, and filed IND in Taiwan.
2003
►Licensed PEP02 for Asia (including Japan) from Hermes Biosciences, Inc.
►Licensed PEP03 for Asia (including Japan) from Millennium Pharmaceuticals, Inc
►Company begun operation on Feb. 6