Isologic Innovative Radiopharmaceuticals Ltd.

Illuccix is used for PET imaging to detect PSMA-positive lesions in male prostate cancer patients. Credit: Korawat photo shoot/Shutterstock. Health Canada has expanded the approved use of Telix Pharmaceuticals’ Illuccix for patient selection in prostate-specific membrane antigen (PSMA) targeted radionuclide therapy. This label expansion allows Illuccix, a gallium Ga 68 gozetotide injection kit, to be used for identifying progressive metastatic castration-resistant prostate cancer (mCRPC) patients eligible for lutetium (177Lu) vipivotide tetraxetan treatment, also known as Pluvicto. Since October 2022, Illuccix has been authorised in Canada for staging and re-staging intermediate and high-risk prostate cancer and pinpointing tumour tissue in recurrent cases. The latest approval enhances the clinical applications of Illuccix, which is distributed by Isologic Innovative Radiopharmaceuticals, reaching 265 hospitals and clinics across the country. Telix Precision Medicine CEO Kevin Richardson stated: “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. See Also: NUHS’s CD7 CAR-T cell therapy shows promise for leukaemia Editas trades part of Vertex CRISPR therapy licencing rights deal for $57m “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.” Illuccix, post radiolabelling with gallium (68Ga), is indicated for positron emission tomography (PET) imaging of PSMA-positive lesions in men with prostate cancer. The indications include cases with suspected metastasis who are candidates for initial definitive therapy, suspected recurrence based on elevated serum prostate specific antigen (PSA) levels, and now, for identifying mCRPC patients for whom PSMA-targeted therapy is indicated. Isologic president André Gagnon stated: “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.” In February 2024, Telix reached an agreement to buy US-based speciality radiopharmaceutical development and bioconjugation company IsoTherapeutics.

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. 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.” 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). 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; andfor identification of patients with progressive metastatic castration-resistant prostate cancer (mCRPC), for whom PSMA-targeted therapy is indicated. Illuccix is a Schedule C radiopharmaceutical product. Click here for approved product monograph in Canada. Telix Investor Relations Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: 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. 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. ©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.

MELBOURNE, Australia, May 1, 2023 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces first patients have been imaged in Canada with its commercially available prostate cancer imaging agent, Illuccix® [kit for the preparation of gallium (68Ga) PSMA-11 for intravenous injection]. With Illuccix now available nationwide in Canada through Telix's partner Isologic Innovative Radiopharmaceuticals (Isologic), INITIO Medical Group in Burnaby, BC (INITIO) became one of the first sites to administer this novel PSMA-PET imaging agent that can help healthcare professionals diagnose the stage and spread of prostate cancer – an important step for men with this disease. 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. Illuccix is the first and only PSMA-PET imaging agent to have been granted regulatory approval in Canada. Health Canada became the third regulatory body worldwide to approve Illuccix, which is also commercially available in Australia, New Zealand and the United States. Dr. Philip Cohen, INITIO Director and Division Head, Nuclear Medicine, Lions Gate Hospital in North Vancouver said, "Nuclear isotope therapy enters a new era with the ability to see and diagnose invisible cancers based on their molecular "signature" and then target them based on the same signature. Now if we can see the cancer we can treat it, and potentially control, and eventually someday cure this terrible disease." André Gagnon, President of Isologic added, "PSMA-PET is emerging as a standard of care worldwide, and it is tremendous that we can now provide Canadian physicians and their patients with this innovative new diagnostic tool via our national network, servicing 265 hospitals and clinics." Kevin Richardson, Chief Executive Officer for Telix Americas continued, "The launch of Illuccix in Canada marks an important milestone for Telix and the ~24,000 men who will be diagnosed with prostate cancer in the country this year.[1] Widespread availability of PSMA-PET imaging, via Telix's distribution partner Isologic, will help deliver on a significant unmet medical need for the men in Canada and their families affected by this disease." Healthcare professionals in Canada can order Illuccix kits by email [email protected] or by phone 1-877-505-4711 ext 0. Unit doses can be ordered from your local radiopharmacy. About Initio INITIO is Western Canada's only private PET/CT scan facility with over 20 years' experience, offering Rapid PET/CT and CT scans and nuclear medicine treatments with no wait list. INITIO has diagnostic scanning for cancer, cognitive impairment, and cardiac sarcoidosis, and now offers gallium-68 PSMA-PET imaging and lutetium-177 PSMA therapy for prostate cancer. With these latest additions, INITIO Medical Group reaffirms its commitment to providing the most advanced and effective treatments to patients and looks forward to the positive impact these will have on the lives of those affected by prostate cancer. About Isologic Innovative Radiopharmaceuticals Isologic is a Canadian radiopharmaceutical company, dedicated to nuclear medicine and radiopharmaceutical production. The head office is in Montreal, Quebec, and our sites are in Dorval, Lachine, Quebec, Toronto, Burlington, Ottawa, and Vancouver. Isologic is the leading Canadian manufacturer of positron-emitting radiopharmaceuticals (PERs) and distributor of radiopharmaceuticals for photon emission tomography (PET). Isologic operates an internal logistics and delivery structure, which allows it to control its radioisotope autonomy. LinkedIn 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). Visit 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 Twitter (@TelixPharma) and LinkedIn. About Illuccix® Telix's lead product, gallium-68 (68Ga) gozetotide (also known as 68Ga PSMA-11) injection, has been approved by the U.S. Food and Drug Administration (FDA),[2] and by the Australian Therapeutic Goods Administration (TGA),[3] and by Health Canada.[4] 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 Corporate Communications and Investor Relations Email: [email protected] Legal Notices 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. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website. ©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). SOURCE Telix Pharmaceuticals Limited