MELBOURNE, Australia, Oct. 14, 2019 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX:TLX, “Telix”, the “Company”) a clinical-stage biopharmaceutical company focused on the development of diagnostic and therapeutic products based on “molecularly-targeted radiation” (MTR), today announced the completion of the integration of GE Healthcare’s cyclotron-based ⁶⁸Ga (gallium) production data with Telix’s regulatory package for TLX591-CDx for the imaging of prostate cancer with Positron Emission Tomography (PET)¹.

In June of this year, GE Healthcare and Telix entered into a collaborative agreement in order to validate ⁶⁸Ga produced on the PETtrace® cyclotron with Telix’s illumet™ prostate imaging product and to enable the data to be included in Telix’s product dossier. This validation has now been successfully completed and the data has been presented to regulators as part of Telix’s preparation for a marketing authorisation in the US and Europe.

Telix USA President Dr. Bernard Lambert stated, “The GE Healthcare-Telix collaboration to generate the validation data required for our regulatory submissions has been very productive. The PETtrace® cyclotron platform has enormous potential to meaningfully augment the supply chain for ⁶⁸Ga. This will be important for not only PSMA, but for a whole class of PET radiopharmaceuticals that are currently under development around the globe.”

The existing manufacturing base for ⁶⁸Ge/⁶⁸Ga generators was initially insufficient to meet the early adoption of gallium-based PET radiopharmaceuticals. In August last year, the US Society of Nuclear Medicine and Molecular Imaging (SNMMI) urged the Food and Drug Administration (FDA) to adopt a more flexible stance on the regulation of generators in order to meet a significant isotope shortfall. Manufacturers have since responded by significantly increasing production volumes to meet existing and future needs. However, in high population density regions, there is a strong commercial case for cyclotron-based production.

Telix Group CEO Dr. Christian Behrenbruch noted, “We are currently aware of over 20 cyclotron-based gallium projects underway in the United States with the express objective of meeting the potential market demand for ⁶⁸Ga. As such the commitment by manufacturers to cyclotron-based production of gallium by manufacturers such as GE Healthcare and IBA is an important augmentation of the existing supply chain that will improve accessibility of this commercially important isotope.”

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.

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¹ Kit for the production of ⁶⁸Ga-PSMA-11, marketed as illumet™ in the United States

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 mentioned in this release have obtained a marketing authorisation in any jurisdiction.

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