About Us - Executive Summary

PharmaEngine, Inc. is a biopharmaceutical company established in February 2003 with funding from TTY Biopharm and Taiwanese venture capital. We are a networked pharma company that operates according to a “No Research, Development Only (NRDO)”model. Our company is led by Dr. Grace Yeh, 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 and Asian-prevalent diseases. We have three projects in this area. Our first project, ONIVYDE™(nal-IRI, MM-398, PEP02)is a new formulation drug for the second-line treatment of metastasis pancreatic patients and was approved both by the US FDA and Taiwan FDA in 2015. The two other projects are PEP503 (NBTXR3) and PEP06. PEP503 (NBTXR3), is in a global pivotal trial in soft tissue sarcoma that includes several countries in Asia Pacific. Meanwhile, a phase 1/2 study in rectal cancer is being conducted in Taiwan. PEP06 is a new chemical entity (NCE) for cancer treatment which is currently in the lead optimization stage.

We are working with our license partner Merrimack Pharmaceuticals, Inc. to complete NDA for worldwide approval of ONIVYDE. We are also developing other potential indications for ONIVYDE, and have two more development projects in our pipeline (PEP503; NBTXR3 and PEP06). In addition, we are actively seeking potential new projects to in-license for clinical development and further commercial development.