Health Canada Approves Label Expansion for Telix’s Illuccix® to Include Patient Selection for PSMA-Targeted Therapy

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MELBOURNE, Australia, Oct. 04, 2024 (GLOBE NEWSWIRE) — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that Health Canada has approved the use of Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection) in selecting patients for PSMA¹-targeted radionuclide therapy.

The label expansion means that Illuccix is now approved in Canada to select patients with progressive metastatic castration-resistant prostate cancer (mCRPC) for treatment with the only approved PSMA-targeted radionuclide therapy (lutetium (¹⁷⁷Lu) vipivotide tetraxetan, or Pluvicto®²). To qualify for PSMA-targeted therapy, patients must be imaged with an approved gallium-based PSMA-PET³ agent⁴, such as Illuccix.

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The latest approval expands the clinical utility for Illuccix, which has been approved in Canada since October 2022 for staging and re-staging intermediate and high-risk prostate cancer, and localizing tumor tissue in recurrent prostate cancer⁵. Illuccix is available across Canada through Telix’s partner Isologic Innovative Radiopharmaceuticals (Isologic), whose distribution network services 265 hospitals and clinics nationwide.

Dr. Francois Lamoureux, President of the Canadian Association of Nuclear Medicine said, “As targeted radionuclide therapy for prostate cancer becomes more prevalent in Canada, it is critical for doctors to understand who may or may not respond to those treatments. In the VISION trial⁶, ⁶⁸Ga-PSMA-11 PET/CT⁷ was shown to be a powerful and highly accurate tool for detecting prostate cancer and informing patient management.”

André Gagnon, President of Isologic added, “PSMA-targeted theranostics are widely considered to be the future of prostate cancer treatment. It is therefore tremendous that we can now offer Illuccix in this additional setting, for patients who are candidates for PSMA-targeted therapy, through our national network.”

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Kevin Richardson, Chief Executive Officer, Telix Precision Medicine continued, “We welcome Health Canada’s decision to expand the label for Illuccix. This will further improve access to advanced prostate cancer imaging and provide doctors with critical information to help make treatment decisions with confidence. This reflects Telix’s ongoing commitment to supporting patients with cancer and empowering the doctors who care for them across more stages of the patient journey.”

Healthcare professionals in Canada can order Illuccix kits by email orders@isologicradiopharm.ca or by phone 1-877-505-4711 ext 0. Unit doses can be ordered from local radiopharmacies.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. 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 and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX).

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Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.

About Illuccix®

Telix’s lead imaging product, gallium-68 (⁶⁸Ga) gozetotide injection (also known as ⁶⁸Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)⁸, by the Australian Therapeutic Goods Administration (TGA) ⁹, and by Health Canada¹⁰. No other Telix product has received a marketing authorization in any jurisdiction.

Indications and usage (Canada)

Illuccix®, after radiolabeling with gallium (⁶⁸Ga), is indicated for use with 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; and
• for identification of patients with progressive metastatic castration-resistant prostate cancer (mCRPC), for whom PSMA-targeted therapy is indicated.

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Illuccix is a Schedule C radiopharmaceutical product.

Click here for approved product monograph in Canada.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

Legal Notices

You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX) or on our website.

The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

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This announcement may contain 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”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. 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 Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’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 trials, 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 for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; 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.

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©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

¹ Prostate-specific membrane antigen.
² Pluvicto is a registered trademark of Novartis AG and/or its affiliates.
³ Imaging of prostate-specific membrane antigen with positron emission tomography.
⁴ Per the Pluvicto product monograph: Tumor PSMA expression should be verified before treatment with Pluvicto. In clinical trials, patients were selected on the basis of PSMA expression detected by PET diagnostic imaging using ⁶⁸Ga-PSMA-11.
⁵ Telix ASX disclosure 14 October 2022.
⁶ ClinicalTrials.gov ID: NCT03511664. VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix (TLX591-CDx) for PSMA-PET imaging.
⁷ Positron emission tomography/computed tomography.
⁸ Telix ASX disclosure 20 December 2021.
⁹ Telix ASX disclosure 2 November 2021.
¹⁰ Telix ASX disclosure 14 October 2022.

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