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^[1] and follow Telix on Twitter^[2] (@TelixPharma) and LinkedIn^[3].

Telix Investor RelationsMs. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Corporate Communications and Investor RelationsEmail: kyahn.williamson@telixpharma.com^[4]

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

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This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events, financial performance, plans, strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may", "expect", "intend", "plan", "estimate", "anticipate", "outlook", "forecast" and "guidance", or other similar words. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix's preclinical and clinical studies, and Telix's research and development programs; Telix's ability to advance product candidates into, enrol and successfully complete, clinical studies, including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals, manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates, if or when they have been approved; estimates of Telix's expenses, future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates, if and after they have been approved. Telix's actual results, performance or achievements may be materially different from those which may be expressed or implied by such statements, and the differences may be adverse. Accordingly, you should not place undue reliance on these forward-looking statements. You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the ASX or on our website.

To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement, whether as a result of new information, future developments or a change in expectations or assumptions.  

The Telix Pharmaceuticals and the Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

[1] Source: Isologic Innovative Radiopharmaceuticals.[2] Source: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/prostate-cancer.html^[5]

References

1. ^{^} www.telixpharma.com (www.telixpharma.com)
2. ^{^} Twitter (twitter.com)
3. ^{^} LinkedIn (www.linkedin.com)
4. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)
5. ^{^} https://www.canada.ca/en/public-health/services/publications/diseases-conditions/prostate-cancer.html (www.canada.ca)