Health Canada Approves Illuccix® for Prostate Cancer Imaging

MELBOURNE, Australia, Oct. 14, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces that Health Canada has approved Illuccix® [kit for the preparation of gallium (⁶⁸Ga) gozetotide injection] for use in staging and re-staging intermediate and high-risk prostate cancer and localizing tumour tissue in recurrent prostate cancer.

Illuccix™ [kit for the preparation of gallium (⁶⁸Ga) gozetotide injection], after radiolabeling with gallium (⁶⁸Ga), is indicated for use with the positron emission tomography (PET) of prostate specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

• with suspected metastasis who are suitable for initial definitive therapy
• with suspected recurrence with elevated serum prostate specific antigen (PSA) level.

"PSMA PET" (or the imaging of Prostate-Specific Membrane Antigen (PSMA) via a positron emission tomography (PET) scan) is a diagnostic tool demonstrated to detect advanced prostate cancer.

Illuccix is the first PSMA PET imaging agent to be granted regulatory approval in Canada. Health Canada is the third regulatory body worldwide to approve Illuccix, which is commercially available in Australia and the United States.

Dr. Norman Laurin, current president of the Quebec Association of Nuclear Medicine Specialists and past president of the Canadian Association of Nuclear Medicine said, "On average, 67 men in Canada are diagnosed with prostate cancer each day. Early detection, along with better understanding of the spread and stage of the disease can lead to more informed disease management decisions. Tools such as Illuccix are valuable as we look for better ways to detect prostate cancer in men."

Kevin Richardson, CEO Telix Americas said, "PSMA PET imaging has been one of the most important developments in prostate cancer detection in recent years and we are very pleased that we can now bring this important diagnostic imaging agent to physicians and their patients across Canada."

Illuccix will be made available in Canada to physicians and eligible patients through Telix's partner, Isologic Innovative Radiopharmaceuticals (ISOLOGIC), whose distribution network services 265 hospitals and clinics nationwide.^[1]

About Prostate Cancer in Canada

According to the Canadian Cancer Society, prostate cancer is the most common cancer and the third-leading cause of death from cancer among Canadian men. More than 24,000 men in Canada are estimated to be diagnosed with prostate cancer this year, and 4,600 will die from the condition.^[2] Reliable and flexible diagnostic tools are essential for medical teams in narrowing the gap between understanding the spread of disease and the development of individualized treatment plans.

About Illuccix® [kit for the preparation of gallium (⁶⁸Ga) gozetotide injection]

ILLUCCIX™ [kit for the preparation of gallium (⁶⁸Ga) gozetotide injection], after radiolabeling with gallium (⁶⁸Ga), is indicated for use with the positron emission tomography (PET) of prostate specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

• with suspected metastasis who are suitable for initial definitive therapy
• with suspected recurrence with elevated serum prostate specific antigen (PSA) level.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. Telix is headquartered in Melbourne, Australia with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix Investor RelationsMs. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com

This announcement has been authorised for release the disclosure committee of Telix Pharmaceuticals Limited.

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[1] Source: Isologic Innovative Radiopharmaceuticals.[2] Source: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/prostate-cancer.html