Propanc Health Group Corporation has announced it has executed a contract manufacturing agreement with AmatsiQBiologicals. The agreement covers the development and GMP (Good Manufacturing Practice) production of certain enzymes for development purposes, including but not limited to first-in-man studies for the Company's lead product, PRP. PRP is the Company's novel, patented, formulation consisting of two proenzymes mixed in a synergistic ratio to target cancer stem cells in solid tumors.
The GMP manufacture of PRP as an injectable drug product requires specialized and detailed activities to be carried out in order to meet the highest quality and safety standards for future human use. It is a significant undertaking by the Company, as it demonstrates the Company's commitment to initiating first-in-man studies in 2017.
"This major contract represents a significant step forward for the development of PRP," said James Nathanielsz, Propanc's Chief Executive Officer. "The process towards securing the services of AmatsiQBiologicals was extensive, taking a number of months to draft, plan and execute. I am very confident we have identified a highly capable partner who will assist us with delivering a quality finished product for human use."
"We are very pleased that Propanc has chosen to partner with AmatsiQBiologicals for the development and manufacturing of Propanc's lead product, PRP," said Annie Van Broekhoven, AmatsiQBiologicals' Chief Executive Officer. "This project really fits very well with our capabilities and we are confident we can deliver on time the GMP grade PRP material required for Propanc's clinical studies."
AmatsiQBiologicals, member of the Amatsigroup, is a biopharma contract development and manufacturing organization offering a range of process development and bio-manufacturing services including formulation and sterile fill and finish to customers in the biopharmaceutical industry and beyond. Recently, they have successfully delivered more than 75 R&D projects in less than three years with a focus on building strong relationships with clients.
In addition to the ongoing preclinical activities and planned GMP manufacture of PRP, the Company is also preparing Orphan Drug Designation applications to be submitted in the EU and U.S. in the near future. Furthermore, an outreach program has commenced with the Company's advisors to determine interest from suitors in licensing PRP and initial feedback has been received.
"We believe PRP represents a valuable strategic addition to our Company's pipeline and seeking orphan drug designation would add significant protection and upside potential. This is truly an exciting phase for our Company. Nevertheless, we remain committed to executing our plans to progress PRP into the clinic at the earliest opportunity," said James Nathanielsz.
The Company aims to fast track the development of proenzyme related oncology products into clinical trials initially for pancreatic, ovarian and colorectal cancers. According to Global Analyst Reports, the combined world market for pancreatic, ovarian and colorectal cancers is expected to reach over $12 billion by 2020.