MELBOURNE, Australia and TOKYO, July 26, 2018 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX:TLX) (“Telix”, the “Company”), an Australian biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (“MTR”), has today announced that it has progressed to a definitive commercial manufacturing agreement with JFE Engineering Corporation (“JFE”).
JFE is an engineering and manufacturing company with extensive expertise in the installation of cyclotron infrastructure and radiopharmaceutical manufacturing in Japan. JFE has established a purpose-built facility for the production of 89Zr (zirconium), a key isotope used by Telix in its diagnostic imaging products.
Since the initial collaboration between the parties (ASX release 13/12/17) JFE has now completed cyclotron installation and beam line activation, and is now producing commercially useful quantities of zirconium at a quality and yield suitable for investigational clinical use. This definitive manufacturing agreement supersedes the previously announced technology transfer and feasibility agreement and commits to an initial 5-year production term on an exclusive basis, sufficient to complete clinical trials for Telix’s TLX250 product (renal cancer imaging) and commence commercialization in Japan.
Telix Japan President, Dr. Shintaro Nishimura stated, “JFE has made considerable progress over the past 6 months in terms of activating the cyclotron and establishing initial production capacity. We look forward to working closely with our JFE colleagues over the next six months to complete the implementation and validation of the manufacturing processes for TLX250, and prepare for first clinical studies in Japan.”
About Telix Pharmaceuticals Limited
Telix Pharmaceuticals Limited (Telix) is a global biopharmaceutical company focused on the development of diagnostic and therapeutic products based on targeted radiopharmaceuticals or “molecularly-targeted radiation” (MTR). The company is headquartered in Melbourne with international operations in Brussels (EU), Kyoto (JP) and Indianapolis (US). Telix is developing a portfolio of clinical-stage oncology products that address significant unmet medical need in renal, prostate and brain (glioblastoma) cancer. Telix is listed on the Australian Securities Exchange (ASX:TLX). For more information visit www.telixpharma.com.
About JFE Engineering Corporation
The JFE Engineering Group is continuing to accelerate the globalization of its engineering business and supply leading-edge technologies to countries around the world. JFE Engineering is committed to creating the foundation for life and a better standard of living through innovation in waste management, energy and healthcare. For more information, please visit www.jfe-eng.co.jp
Important Information
This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “US Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the US Securities Act or an exemption from the registration requirements of the US Securities Act is available.
None of the products described in this release have obtained a marketing authorization from the US Food and Drug Administration or the Japanese PMDA.