Illuccix® Approved in the United Kingdom

MELBOURNE, Australia, Feb. 13, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) has approved the Marketing Authorization Application (MAA) for its prostate cancer PET^[1] imaging agent Illuccix® (kit for the preparation of gallium-68 gozetotide injection).

Illuccix is indicated in the UK for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, using PET. PSMA-PET imaging^[2] represents a major advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT^[3] scan) as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines highlight the superior accuracy of PSMA-PET for the staging of primary disease and evaluation of BCR/biochemical persistence (BCP)^[4].

Gary Cook, MD, Professor of Molecular Imaging at Kings College London School of Biomedical Engineering & Imaging Sciences, commented, "PSMA-PET supply shortages in the UK and Europe have escalated over the past 12 months as demand increases, which has led to delays for men in urgent need of a scan to direct clinical management. It is great news that Telix can now help address this unmet need and improve equity of access in the UK through their Illuccix imaging agent and network distribution model."

Raphaël Ortiz, Chief Executive Officer, Telix International added, "PSMA-PET imaging is one of the most important developments in prostate cancer detection in recent years and we are delighted that we can now bring Illuccix to physicians and their patients across the UK. A key advantage of Illuccix is that the radioisotope (gallium-68) can be produced using a generator locally, taking just a few minutes with minimal equipment. Reliable service delivery combined with greater scheduling flexibility, including in non-metropolitan locations, will benefit patients, physicians and clinical sites in the UK."

Illuccix will be made available in the UK through Telix's exclusive distribution partner, Xiel Limited, a specialist distributor of nuclear medicine, radiotherapy and diagnostic radiology technologies across the UK and Ireland. To order or enquire about Illuccix availability, UK healthcare professionals can email: radiopharm@xiel.co.uk^[1] or call +44 (0)1749 372217.

About Illuccix®  

Telix's prostate 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)^[5], by the Australian Therapeutic Goods Administration (TGA)^[6], by Health Canada^[7], by the Danish Medicines Agency^[8], and by the UK MHRA. Illuccix is currently in national approval review in 19 European countries following a positive decentralized procedure (DCP) opinion by BfArM^[9].

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialization of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Canada, 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. ARTMS, IsoTherapeutics, Lightpoint, Optimal Tracers and RLS are Telix Group companies. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX).

Telix's osteomyelitis (bone infection) imaging agent, technetium-99m (^99mTc) besilesomab, marketed under the brand name Scintimun®, is approved in 32 European countries and Mexico. Telix's miniaturized surgical gamma probe, SENSEI®, for minimally invasive and robotic-assisted surgery, is registered with the FDA for use in the U.S. and has attained a Conformité Européenne (CE) Mark for use in the European Economic Area. No other Telix product has received a marketing authorization in any jurisdiction.

Visit www.telixpharma.com^[2] 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 LinkedIn^[3], X and Facebook^[4].

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com^[5]

This announcement has been authorised for release by the Telix Pharmaceuticals Limited Disclosure Committee on behalf of the Board.

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), U.S. Securities and Exchange Commission (SEC), including our registration statement on Form 20-F filed with the SEC, 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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©2025 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Telix Group company, and Telix product names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved. Trademark registration status may vary from country to country.

References

1. ^{^} radiopharm@xiel.co.uk (www.prnasia.com)
2. ^{^} www.telixpharma.com (www.telixpharma.com)
3. ^{^} LinkedIn (www.linkedin.com)
4. ^{^} Facebook (www.facebook.com)
5. ^{^} kyahn.williamson@telixpharma.com (www.prnasia.com)