Telix Pharma Files New Drug Submission with Health Canada for Prostate Cancer Imaging...

Melbourne (Australia) and Indianapolis, IN (USA) – 16th December 2020. Telix Pharmaceuticals Limited (ASX: TLX, ‘Telix’, the ‘Company’) announces today the filing of a New Drug Submission (NDS) with Health Canada for TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11), a radiopharmaceutical targeting Prostate Specific Membrane Antigen (PSMA) for the imaging of prostate cancer with Positron Emission Tomography (PET). Consistent with other jurisdictions, Telix is seeking a product approval in Canada for TLX591-CDx for the following indications: • Staging and re-staging of intermediate and high-risk prostate cancer • Localizing tumor tissue in recurrent prostate cancer Telix Americas President Dr Bernard Lambert stated, “We are pleased to have achieved this important milestone with the submission of the first commercial NDS for PSMA imaging in Canada. Subject to Health Canada approval, we look forward to bringing this product to market to serve the needs of Canadian men living with prostate cancer.” Telix has also submitted marketing authorisation applications for TLX591-CDx in the European Union, 1 United States, and Australia. In November 2020, the US Food and Drug Administration (FDA) accepted TLX591-CDx for filing, 2 and in December 2020 the Australian Therapeutic Goods Administration (TGA) granted priority review status.3 About Prostate Cancer Prostate cancer is the second most common cancer in men following skin cancer and, in 2018, 1.3 million men were diagnosed with prostate cancer for the first time. 4 Despite advances in treatment, prostate cancer still accounts for a large number of deaths and in 2018 more than 365,000 men died from their disease. Rates of diagnosis are increasing, and the highest levels of prostate cancer are found in the United States, Canada, Europe and Australia and New Zealand. About TLX591-CDx TLX591-CDx (Kit for the preparation of 68Ga-PSMA-11) is a proprietary formulation of PSMA-HBEDCC (PSMA-11), a novel imaging agent targeting prostate-specific membrane antigen (PSMA), originally developed by the Heidelberg group of the Deutsches Krebsforschungszentrum (German Cancer Research Centre, DKFZ).5 The ‘cold kit’ format of TLX591-CDx enables rapid radiolabelling at room temperature with high radiochemical purity and production consistency, optimised for the radiopharmacy setting.

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