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.” – BioSpace