Gallium-68 P16-093

MELBOURNE, Australia and PORTO ALEGRE, Brazil, Nov. 30, 2021 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or ‘Anvisa’) has granted an exceptional authorisation for Illuccix® (TLX591-CDx) the Company’s lead prostate cancer imaging product. Illuccix (Kit for the preparation of 68Ga PSMA-11 Injection) is a positron emission tomography (PET) imaging agent targeting prostate specific membrane antigen (PSMA) for the staging of prostate cancer. The exceptional authorisation grants permission to commence selling Illuccix in Brazil, ahead of a full regulatory approval, expected next year. The authorisation is granted to Telix’s partner MJM Produtos Farmacêuticos e de Radioproteção LTDA (Grupo RPH), Brazil’s leading cold kit plant and radiopharmacy network. RPH has an exclusive licence agreement with Telix to manufacture and distribute Illuccix in Brazil.1 The Anvisa approval facilitates wide-spread clinical access to state-of-the-art prostate cancer imaging for all men across Brazil, a large and rapidly growing market for gallium-68 based radiopharmaceuticals. Dr. Christian Behrenbruch, CEO and Managing Director of Telix said, “Prostate cancer is the most commonly diagnosed male cancer in Brazil, with approximately 65,840 new cases each year.2 PSMA-PET imaging has the potential to have a profound impact on the management of prostate cancer, enabling clinicians to detect prostate cancer right throughout the body. We look forward to working closely with our partner RPH to facilitate widespread patient access to Illuccix for men living with prostate cancer in Brazil.” Grupo RPH Nuclear Medicine & Innovation Vice-President, Rafael Madke, added, “We are very pleased to have received this exceptional authorisation for Illuccix in Brazil, which is only given in select circumstances, and we look forward to playing an important role in transforming outcomes for men with prostate cancer. Grupo RPH is pleased to be working with a global leader such as Telix. We have extensive capability to manufacture and distribute nuclear medicine products in this region, and our objectives to support physicians and patients in Brazil are closely aligned.” About Illuccix® Illuccix (TLX591-CDx) is a preparation for imaging prostate cancer with positron emission tomography (PET), targeting prostate specific membrane antigen (PSMA), a protein that is overexpressed on the surface of more than 90% of primary and metastatic prostate cancer cells. Illuccix enables PSMA-11 to be labelled with the radionuclide Ga-68 directly before injection by medical professionals. After preparing the radiopharmaceutical and injecting it into the patient, PSMA positive lesions are localised by PET imaging. Illuccix (TLX591-CDx) for prostate cancer imaging, has been approved by the Australian Therapeutic Goods Administration (TGA),3 and accepted for filing by the U.S. Food and Drug Administration (FDA).4 Telix is also progressing marketing authorisation applications for Illuccix in the European Union5 and Canada.6 About Prostate Cancer in Brazil In 2020, prostate cancer was the most commonly diagnosed male cancer in Brazil with approximately 65,840 new cases per year. Prostate cancer was also the second most common cause of cancer death in men (after lung cancer), with more than 18,000 men dying from their disease in 2020. More than 320,000 men in Brazil were estimated to be living with prostate cancer in 2020.7 About Grupo RPH Operating since 2004, Grupo RPH commercially delivers eight different Cold Kits for 99mTc and 68Ga preparation for the Brazilian market. Grupo RPH is also the proud owner of the only private-owned fully GMP production facility in Brazil for nuclear medicine products. Grupo RPH’s products are sold throughout the whole Brazilian territory, serving nearly 400 customers on a daily basis. Grupo RPH is also a pioneer of the centralized radiopharmacy model in Brazil. For more information visit: About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne, Australia with international operations in Belgium, Switzerland, Japan, and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit and follow Telix on Twitter (@TelixPharma) and LinkedIn. With the exception of Illuccix in Australia, none of Telix’s products have received a marketing authorisation in any jurisdiction. In Brazil, Illuccix has been granted exceptional authorisation. Telix Media Contact Dr. Stewart Holmstrom Telix Pharmaceuticals Limited Director Corporate Communications Email: stewart.holmstrom@telixpharma.com Important Information This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not beenandwillnotberegisteredundertheUnitedStatesSecuritiesActof1933(the“U.S.SecuritiesAct”),orunderthe securitieslawsofanystateorotherjurisdictionoftheUnitedStatesandmaynotbeofferedorsoldwithintheUnited States,unlessthesecuritieshavebeenregisteredundertheU.S.SecuritiesActoranexemptionfromtheregistration requirements of the U.S. Securities Act isavailable. None of the technologies or products described in this document have received a marketing authorisation in any jurisdiction. This announcement has been authorised for release by Dr Christian Behrenbruch, Managing Director and Chief Executive Officer. The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved). 1 ASX disclosure 03/07/19. 2 Brazilian Cancer Institute. 3 ASX disclosure 02/11/21. 4 ASX disclosure 24/11/20. 5 ASX disclosure 01/05/20. 6 ASX disclosure 16/12/20. 7 Globocan 2021, Brazilian Cancer Institute.