PharmaEngine, Inc. is a biopharmaceutical company established in February 2003 with funding from TTY Biopharm and Taiwanese venture capital companies. PharmaEngine is a networked pharma company that operates according to a “No Research, Development Only (NRDO)” model. It is led by Dr. Yufang Hu and supported by a strong network of reputable advisors and consultants worldwide.
PharmaEngine focuses on the development of new drugs for the treatment of cancer diseases. There are 3 projects in the pipeline. ONIVYDE® (PEP02, MM-398, nal-IRI), a new formulation of an anti-cancer drug (irinotecan) for the patients with gemcitabine-treated metastatic pancreatic cancer, was approved by both the US FDA and Taiwan FDA in 2015, European Medicines Agency (EMA) in 2016, Korea MFDS and Singapore HAS in 2017, Japan MHLW in 2020. PEP503 (Hensify®,NBTXR3), a nanoparticle working as a radio-enhancer, has received CE Mark enabling commercialization in 27 European Union countries for the treatment of locally advanced soft tissue sarcoma, and the other ongoing studies are in Phase I/II trial in head and neck cancer and rectal cancer in Taiwan. PEP06, a new chemical entity (NCE) for cancer treatment, is currently in the pre-clinical stage.
In April 2017, Ipsen S.A., a French company, completed the acquisition of ONIVYDE® from Merrimack Pharmaceuticals, Inc. for the US marketing and sales and became the new corporate partner of PharmaEngine, Inc. PharmaEngine and Ipsen are now working closely to complete NDA for worldwide approval of ONIVYDE® in the post-gemcitabine metastatic pancreatic cancer and also life cycle management of ONIVYDE® of new indications.
Meanwhile, PharmaEngine continuously puts the best efforts to move forward the clinical and pre-clinical developments of PEP503 (Hensify®,NBTXR3) and PEP06. Furthermore, PharmaEngine is actively seeking to in-license new projects for preclinical/clinical development and commercialization.