Telix Pharmaceuticals (ASX:TLX), an Australian biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or 'molecularly-targeted radiation', has announced a manufacturing partnership with JFE Engineering Corporation.
JFE is an engineering and manufacturing company with expertise in the installation of cyclotron infrastructure and radiopharmaceutical manufacturing in Japan.
The company has recently installed a new IBA Cyclone 18 MeV Cyclotron at its Yokohama (Kanagawa) facility and is preparing for beam activation and 89Zr (Zirconium) production in early 2018, representing the first commercial production in Japan.
Importation of radioactive isotopes into Japan is typically very challenging and therefore the prospect of domestic production of new medical isotopes has generated significant clinical interest in novel imaging and therapeutic radiopharmaceuticals.
According to Telix Co-Founder and CEO, Christian Behrenbruch, “Telix has an extensive commitment to 89Zr isotope in our diagnostic imaging portfolio, particularly for TLX-250 imaging (89Zr- girentuximab), our leadprogram. Japan generally represents potentially the second largest market for our imaging products after the United States and this agreement with JFE paves the way to making our products available to Japanesecancer patients. JFE’s tremendous experience and operational capability is a real asset to our commercial plans in Japan.”
"The agreement is an exclusive agreement that initially focuses on technology transfer and feasibility assessment for producing TLX-250 for the Japanese market," said Telix in a statement. "The parties intend to work together to conduct initial pilot studies at several key Japanese nuclear medicine centres, as well as engage with the Pharmaceuticals and Medical Devices Agency (PMDA) in relation to obtaining advice on extending Telix’s clinical development activity in the US and Europe to include Japan."
Shigeki Yamazaki, Director of JFE’s Medical Division, said, “We are very pleased to be working in partnership with Telix to develop a manufacturing and market access strategy for Japan. The unique geographical and regulatory requirements of the Japanese radiopharmaceutical industry means that centralized manufacturing of novel radiopharmaceutical products is a significant commercial opportunity that can deliver important benefit to patients.”