{"id":34808,"date":"2025-03-17T22:52:00","date_gmt":"2025-03-17T22:52:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4643321_AE43321_0"},"modified":"2025-03-17T22:52:00","modified_gmt":"2025-03-17T22:52:00","slug":"illuccix-approved-for-prostate-cancer-imaging-in-brazil-first-marketing-authorization-in-latin-america","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=34808","title":{"rendered":"Illuccix\u00ae Approved for Prostate Cancer Imaging in Brazil: First Marketing Authorization in Latin America"},"content":{"rendered":"<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1920208\/Telix_Main_Logo_Logo.jpg?p=medium600\" border=\"0\" alt title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">MELBOURNE, Australia<\/span> and&nbsp;PORTO ALEGRE,&nbsp;Brazil<\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">March 18, 2025<\/span><\/span> \/PRNewswire\/ &#8212; Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company)&nbsp;today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or &#8216;ANVISA&#8217;) has approved Illuccix\u00ae (kit for the preparation of gallium-68 (<sup>68<\/sup>Ga) gozetotide injection) the Company&#8217;s lead prostate cancer imaging agent. Illuccix\u00ae is the first and only PSMA-PET<sup>[1]<\/sup> prostate cancer imaging agent to receive full regulatory approval in <span class=\"xn-location\">Brazil<\/span>.<\/p>\n<p>Illuccix\u00ae, after radiolabeling with <sup>68<\/sup>Ga, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:<\/p>\n<ul type=\"disc\">\n<li>With suspected metastasis who are candidates for definitive initial therapy treatment, and<\/li>\n<li>With suspected recurrence based on an elevated specific antigen (PSA) level in the serum.<\/li>\n<\/ul>\n<p>The marketing authorization is granted to Telix&#8217;s partner R2PHARMA, <span class=\"xn-location\">Brazil&#8217;s<\/span> leading cold kit manufacturer, nuclear pharmacy and cyclotron network, and a subsidiary of GSH Corp Participa\u00e7\u00f5es S.A. (Grupo GSH). Telix has provided Grupo GSH with an exclusive license to manufacture, distribute and market Illuccix\u00ae in <span class=\"xn-location\">Brazil<\/span><sup>[2]<\/sup>.<\/p>\n<p>PSMA-PET is a diagnostic technology demonstrated to detect advanced prostate cancer. ANVISA becomes the latest regulatory body worldwide to approve Illuccix\u00ae<sup>[3]<\/sup>, which is already commercially available in <span class=\"xn-location\">Australia<\/span>, <span class=\"xn-location\">Canada<\/span>, <span class=\"xn-location\">New Zealand<\/span> and <span class=\"xn-location\">the United States<\/span>, and has recently been approved in the <span class=\"xn-location\">United Kingdom<\/span> and in multiple countries within the European Economic Area (EEA).<\/p>\n<p>Dr. S\u00e9rgio <span class=\"xn-person\">Altino de Almeida<\/span>, nuclear medicine specialist, at Rede D&#8217;Or, the largest integrated healthcare network in <span class=\"xn-location\">Brazil<\/span> said, &#8220;The ANVISA approval of Illuccix provides access to advanced prostate cancer imaging for men across <span class=\"xn-location\">Brazil<\/span>, a large and rapidly growing market for gallium-68 based radiopharmaceuticals. The &#8216;cold kit&#8217; format with generator-produced gallium will facilitate broad equity of access for men living with prostate cancer, regardless of whether they are based in regional, rural or metropolitan areas.&#8221;<\/p>\n<p><b>JV to manufacture and distribute radiopharmaceuticals for clinical and commercial use in <span class=\"xn-location\">Brazil<\/span><\/b><\/p>\n<p>Telix also announces a joint venture (JV) with R2PHARMA to commercialize and distribute Telix&#8217;s therapeutic and diagnostic radiopharmaceutical products in Brazil,&nbsp;building on the existing partnership established in 2019. The JV further strengthens this relationship with a commitment to jointly bring to market innovative and first-in-class therapeutic radiopharmaceuticals and imaging agents in <span class=\"xn-location\">Brazil<\/span>.<\/p>\n<p>The market for radiopharmaceuticals in <span class=\"xn-location\">Brazil<\/span> is experiencing significant growth driven by the increasing prevalence of chronic diseases such as cancer, advancements in imaging technologies, and a growing senior population. Over the next decade, the Brazilian radiopharmaceuticals market is projected to reach <span class=\"xn-money\">US$330 million<\/span><sup>[4]<\/sup>, with this growth supported by rising investments in the healthcare industry, public health awareness, and the introduction of new and advanced radiopharmaceuticals.<\/p>\n<p>Under the agreement, Telix and R2PHARMA will establish a JV company in <span class=\"xn-location\">Brazil<\/span> (Telix Innovations Brazil, Ltda.).&nbsp;Telix Innovations Brazil will hold the exclusive licence to commercialize and distribute Illuccix\u00ae as well as future product candidates from Telix&#8217;s industry-leading theranostic pipeline. Telix Innovations Brazil will leverage the local knowledge and expertise of R2PHARMA to obtain the necessary licenses and governmental authorizations in <span class=\"xn-location\">Brazil<\/span><sup>[5]<\/sup>.<\/p>\n<p>Rapha\u00ebl Ortiz, CEO Telix International, added, &#8220;Telix is pleased to bring Illuccix to <span class=\"xn-location\">Brazil<\/span> and <span class=\"xn-location\">Latin America<\/span>, with this new imaging modality now recognized in leading clinical practice guidelines and already being adopted in other parts of the world. We would like to acknowledge our partner R2PHARMA for their commitment to gallium-based PSMA-PET and the hope this brings for men living with prostate cancer in <span class=\"xn-location\">Brazil<\/span>. The JV takes our collaboration to the next stage with the aim to address unmet need for therapeutic and diagnostic radiopharmaceuticals across a range of disease areas.&#8221;<\/p>\n<p>R2PHARMA Nuclear Medicine &amp; Innovation Vice-President, <span class=\"xn-person\">Rafael Madke<\/span>, continued, &#8220;We are delighted to have been granted this marketing authorization for Illuccix in <span class=\"xn-location\">Brazil<\/span>. The combination of Telix&#8217;s innovative theranostic pipeline and R2PHARMA&#8217;s manufacturing and distribution capabilities will support widespread access for patients and physicians to Illuccix and future additional products that until now have not been available in <span class=\"xn-location\">Latin America<\/span>.&#8221;<\/p>\n<p><b>About Prostate Cancer in <span class=\"xn-location\">Brazil<\/span><\/b><\/p>\n<p>Prostate cancer is the most commonly diagnosed male cancer in <span class=\"xn-location\">Brazil<\/span> with an estimated 71,730 new cases in 2023<sup>[6]<\/sup>. Prostate cancer was also the second most common cause of cancer death in men (after lung cancer), with approximately 20,000 men dying from their disease in 2022. More than 250,000 men in <span class=\"xn-location\">Brazil<\/span> were estimated to be living with prostate cancer in 2022<sup>[7]<\/sup>.<\/p>\n<p><b>About Illuccix\u00ae<\/b><\/p>\n<p>Illuccix\u00ae is a kit for the preparation of gallium-68 (<sup>68<\/sup>Ga) gozetotide (also known as PSMA-11) injection, a radioactive diagnostic agent indicated for PET imaging combined with computerized tomography (CT) scan in case of suspicion of prostate cancer relapse in adult males to detect and localize recurrent cancerous lesions. <sup>68<\/sup>Ga gozetotide injection targets PSMA, a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix\u00ae enables gozetotide (PSMA-11) to be labelled with the radionuclide <sup>68<\/sup>Ga directly before injection by medical professionals.<\/p>\n<p>Illuccix\u00ae has been approved by the U.S. Food and Drug Administration (FDA)<sup>[8]<\/sup>, by the Australian Therapeutic Goods Administration (TGA)<sup>[9]<\/sup>, by Health Canada<sup>[10]<\/sup>, by the <span class=\"xn-location\">United Kingdom<\/span> (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)<sup>[11]<\/sup>, by the Brazilian Health Regulatory Agency (ANVISA)<sup>[12]<\/sup>&nbsp;and in multiple countries within the EEA<sup>[13]<\/sup> following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM<sup>[14]<\/sup>.<\/p>\n<p><b>About R2PHARMA <\/b><\/p>\n<p>Operating since 2002, R2PHARMA commercially delivers Cold Kits for <sup><span class=\"xn-money\">99m<\/span><\/sup>Tc and <sup>68<\/sup>Ga preparation for the Brazilian market. R2PHARMA is also the owner of the only private fully Good Manufacturing Practice (GMP) production facility in <span class=\"xn-location\">Brazil<\/span> for nuclear medicine products. R2PHARMA products are sold throughout <span class=\"xn-location\">Brazil<\/span>, serving more than 420 customers on a daily basis, and exports their products to more than 10 countries around the world. R2PHARMA is also a pioneer of the nuclear pharmacy model in <span class=\"xn-location\">Brazil<\/span> with two operating centers in S\u00e3o <span class=\"xn-person\">Paulo and Rio de Janeiro<\/span>. The company also operates the largest production network of cyclotrons in <span class=\"xn-location\">South America<\/span>, with five sites distributed in the states of Paran\u00e1, S\u00e3o Paulo, <span class=\"xn-location\">Rio de Janeiro<\/span> and Pernambuco. The last installed facility will include, in addition to the production of <sup>18<\/sup>F radiopharmaceuticals, a solid target for the production of <sup>89<\/sup>Zr, <sup>68<\/sup>Ga and <sup>64<\/sup>Cu, as well as a laboratory dedicated to the production of molecules labeled with <sup>177<\/sup>Lu. For more information visit: <a href=\"http:\/\/r2pharma.com\/\" target=\"_blank\" rel=\"nofollow noopener\">http:\/\/r2pharma.com<\/a>.<\/p>\n<p><b>About <\/b><b>Telix Pharmaceuticals Limited <\/b><\/p>\n<p>Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in <span class=\"xn-location\">Melbourne, Australia<\/span> with international operations in <span class=\"xn-location\">the United States<\/span>, <span class=\"xn-location\">Brazil<\/span>, <span class=\"xn-location\">Canada<\/span>, <span class=\"xn-location\">Europe<\/span> (<span class=\"xn-location\">Belgium<\/span> and <span class=\"xn-location\">Switzerland<\/span>), and <span class=\"xn-location\">Japan<\/span>. 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) and the Nasdaq Global Select Market (Nasdaq: TLX).<\/p>\n<p>Visit <a href=\"http:\/\/www.telixpharma.com\/\" target=\"_blank\" rel=\"nofollow noopener\">www.telixpharma.com<\/a> for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on <a href=\"https:\/\/www.linkedin.com\/company\/telixpharma\/\" target=\"_blank\" rel=\"nofollow noopener\">LinkedIn<\/a>,&nbsp;<a href=\"https:\/\/x.com\/TelixPharma\" target=\"_blank\" rel=\"nofollow noopener\">X<\/a>&nbsp;and <a href=\"https:\/\/www.facebook.com\/TelixPharma\" target=\"_blank\" rel=\"nofollow noopener\">Facebook<\/a>.<\/p>\n<p><b>Telix Investor Relations<\/b><\/p>\n<p>Ms. Kyahn Williamson<br \/>Telix Pharmaceuticals Limited<br \/>SVP Investor Relations and Corporate Communications<br \/>Email: <a href=\"mailto:kyahn.williamson@telixpharma.com\" target=\"_blank\" rel=\"nofollow noopener\">kyahn.williamson@telixpharma.com<\/a><\/p>\n<p><i>This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board. <\/i><\/p>\n<p>Legal Notices<\/p>\n<p><i>You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our Annual Report on Form 20-F filed with the SEC, or on our website. <\/i><\/p>\n<p><i>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 <span class=\"xn-location\">the United States<\/span>. The information and opinions contained in this announcement are subject to change without notification. &nbsp;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. <\/i><\/p>\n<p><i>This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, 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 &#8220;may&#8221;, &#8220;expect&#8221;, &#8220;intend&#8221;, &#8220;plan&#8221;, &#8220;estimate&#8221;, &#8220;anticipate&#8221;, &#8220;believe&#8221;, &#8220;outlook&#8221;, &#8220;forecast&#8221; and &#8220;guidance&#8221;, 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&#8217;s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix&#8217;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&#8217;s business, forward-looking statements may include, but are not limited to, statements about: the initiation, timing, progress and results of Telix&#8217;s preclinical and clinical trials, and Telix&#8217;s research and development programs; Telix&#8217;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&#8217;s product candidates, manufacturing activities and product marketing activities; Telix&#8217;s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix&#8217;s product candidates, if or when they have been approved; Telix&#8217;s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; estimates of Telix&#8217;s expenses, future revenues and capital requirements; Telix&#8217;s financial performance; developments relating to Telix&#8217;s competitors and industry; and the pricing and reimbursement of Telix&#8217;s product candidates, if and after they have been approved. Telix&#8217;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. <\/i><\/p>\n<p><i>\u00a92025 Telix Pharmaceuticals Limited. Telix Pharmaceuticals\u00ae, <\/i><i>Telix <\/i><i>Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates \u2013 all rights reserved. Trademark registration status may vary from country to country.<\/i><\/p>\n<div>\n<table border=\"0\" cellspacing=\"0\" cellpadding=\"1\" class=\"prnbcc\">\n<tbody readability=\"21\">\n<tr readability=\"4.5\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"6\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[1] Imaging of prostate-specific membrane antigen (PSMA) via a positron emission tomography (PET) scan (known as PSMA-PET).<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"6\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"7\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[2]&nbsp;Telix ASX disclosure 3 July 2019. The license for Illuccix\u00ae in Brazil was granted by Telix to MJM Produtos Farmac\u00eauticos e de Radioprote\u00e7\u00e3o S.A., a subsidiary of Grupo R2PHARMA.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"4.5\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"6\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[3]&nbsp;Illuccix\u00ae has been previously available in Brazil under an exceptional authorisation granted in December 2021 (Telix ASX disclosure 1 December 2021).<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"3\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"5\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[4]&nbsp;Allied Market Research 2022.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"7.5\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"8\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[5]&nbsp;Marketing authorizations in Brazil will be held by Telix Innovations Brazil, Ltda., returned to Telix on expiry or termination of the relevant license agreement.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"3\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"5\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[6]&nbsp;Brazilian Cancer Institute.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"3\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"5\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[7]&nbsp;Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"3\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"5\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[8]&nbsp;Telix ASX disclosure 20 December 2021.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"3\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"5\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[9]&nbsp;Telix ASX disclosure 2 November 2021.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"3\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"5\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[10]&nbsp;Telix ASX disclosure 14 October 2022.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"3\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"5\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[11]&nbsp;Telix ASX disclosure 13 February 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"9\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"9\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[12]&nbsp;Resolution-RE No. 954, of 13&nbsp;March 2025, published at D.O.U. No. 51, page 75, 17 March 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"7.5\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"8\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[13]&nbsp;Denmark, Luxembourg, Malta, and Norway at time of release.<\/span><\/p>\n<\/td>\n<\/tr>\n<tr readability=\"3\">\n<td class=\"prngen2\" colspan=\"1\" rowspan=\"1\" readability=\"5\">\n<p class=\"prnml4\"><span class=\"prnews_span\">[14]&nbsp;Telix ASX disclosure 17 January 2025.<\/span><\/p>\n<\/td>\n<\/tr>\n<\/tbody>\n<\/table><\/div>\n","protected":false},"excerpt":{"rendered":"<p>MELBOURNE, Australia and&nbsp;PORTO ALEGRE,&nbsp;Brazil, March 18, 2025 \/PRNewswire\/ &#8212; Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company)&nbsp;today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or &#8216;ANVISA&#8217;) has approved Illuccix\u00ae (kit for the preparation of gallium-68 (68Ga) gozetotide injection) the Company&#8217;s lead prostate cancer imaging agent. Illuccix\u00ae is the [&hellip;]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-34808","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v27.9 - https:\/\/yoast.com\/product\/yoast-seo-wordpress\/ -->\n<title>Illuccix\u00ae Approved for Prostate Cancer Imaging in Brazil: First Marketing Authorization in Latin America - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=34808\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Illuccix\u00ae Approved for Prostate Cancer Imaging in Brazil: First Marketing Authorization in Latin America - My Blog\" \/>\n<meta property=\"og:description\" content=\"MELBOURNE, Australia and&nbsp;PORTO ALEGRE,&nbsp;Brazil, March 18, 2025 \/PRNewswire\/ &#8212; Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company)&nbsp;today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or &#8216;ANVISA&#8217;) has approved Illuccix\u00ae (kit for the preparation of gallium-68 (68Ga) gozetotide injection) the Company&#8217;s lead prostate cancer imaging agent. 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