Telix Pharmaceuticals Limited: Telix's Illuccix PSMA-PET Imaging Agent Approved in the Czech Republic

New approval provides hospitals and clinics in the Czech Republic with access to a proven PSMA-PET imaging agent

MELBOURNE, Australia, May 5, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, NASDAQ: TLX, Telix, the Company) today announces that its prostate cancer PET^[1] imaging agent, Illuccix® (kit for the preparation of gallium-68 gozetotide injection), has been granted marketing authorization in the Czech Republic by the SÚKL^[2] for the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adults with prostate cancer, a broad clinical label. This approval provides healthcare providers in the Czech Republic with broader access to PSMA-PET^[3] imaging, using a clinically validated gallium-based radiopharmaceutical.

Illuccix, after radiolabelling with gallium-68, is indicated in the Czech Republic for the detection of prostate-specific membrane antigen (PSMA)-positive lesions with PET in adults with prostate cancer (PCa) in the following clinical settings:

• Primary staging of patients with high-risk PCa prior to primary curative therapy.
• Suspected recurrent PCa in patients with increasing levels of serum prostate-specific antigen (PSA) after primary curative therapy.
• Identification of patients with PSMA-positive progressive metastatic castration-resistant prostate cancer (mCRPC) for whom PSMA-targeted therapy is indicated.

PSMA-PET imaging represents a significant advance in prostate cancer management, largely replacing conventional imaging methods such as bone scans and CT^[4] scans as the standard of care after initial diagnosis and biochemical recurrence (BCR). Global guidelines recognize its superior accuracy in staging primary disease and assessing BCR^[5]. Illuccix® PSMA-PET will help address an important clinical need by supporting timely and effective diagnosis, as well as identifying patients who may benefit from PSMA-targeted therapy.

Illuccix's broad approval is supported by robust clinical data, including the largest Ga-68-based PSMA data set from the VISION trial^[6].

President of the Czech Society of Nuclear Medicine, Dr. David Zogala commented on the approval, "Waiting for a diagnosis can be a difficult time for men with suspected prostate cancer. In this regard, PSMA-PET imaging has transformed how we assess the disease, offering greater accuracy and confidence in determining its stage, and guiding the correct course of action. The approval of Illuccix will increase access to advanced imaging in the Czech Republic, broadening the portfolio of available PSMA tracers and supporting precise detection and timely decision-making for patients."

With its broad indication, Illuccix® is designed to support healthcare providers in delivering efficient and reliable imaging. The approval comes as demand for PSMA-PET continues to grow across Europe, reinforcing the need for solutions that fit within existing hospital workflows.

"The Czech Republic has been at the forefront of adopting advanced diagnostics, with Czech nuclear medicine specialists playing a leading role in integrating PSMA-PET imaging into clinical practice. We are pleased to support their efforts by working with THP Medical Products to deliver Illuccix, a clinically validated imaging solution that will help ensure more men benefit from accurate prostate cancer detection and ongoing management." said Raphaël Ortiz, Chief Executive Officer, Telix International.

Illuccix® will be made available in the Czech Republic through Telix's distribution partner THP Medical Products a specialist supplier and distributor of nuclear medicine products and services. To order or enquire about Illuccix® availability, authorized healthcare professionals in the Czech Republic can email: [e-mail] or call [phone].

Prostate Cancer in the Czech Republic

Prostate cancer is the most common cancer in men in the Czech Republic, with close to 8,000 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (4,376 new cases) or lung cancer (3,709 new cases). Prostate cancer is also the third most common cause of cancer death in men, with over 1,600 men dying from their disease in the Czech Republic in 2022^[7].

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)^[8], by the Australian Therapeutic Goods Administration (TGA)^[9], by Health Canada^[10], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)^[11], by the Brazilian Health Regulatory Agency (ANVISA)^[12], by the French National Agency for the Safety of Medicine and Health Products (ANSM)^[13], and in multiple other European Economic Area (EEA) Member States^[14]. Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by BfArM^[15].

[1] Positron emission tomography.

[2] Státní Ústav Pro Kontrolu Léciv (State Institute for Drug Control).

[3] Imaging of prostate-specific membrane antigen with positron emission tomography.

[4] Computed tomography.

[5] European Association of Urology (EAU) Guidelines. Edn. presented at the EAU Annual Congress Paris 2024. ISBN 978-94-92671-23-3.: https://uroweb.org/guidelines/prostate-cancer; Prostate cancer: European Society for Medical Oncology (ESMO) Clinical Practice Guidelines for diagnosis, treatment and follow-up. 2023: https://www.esmo.org/guidelines/guidelines-by-topic/esmo-clinical-practice-guidelines-genitourinary-cancers/clinical-practice-guidelines-prostate-cancer/eupdate-prostate-cancer-treatment-recommendations

[6] ClinicalTrials.gov ID: NCT03511664. VISION study sponsored by Endocyte, a Novartis company. Telix provided Illuccix® (TLX591-CDx) for PSMA-PET imaging.

[7] Global Cancer Statistics 2022: GLOBOCAN survey. Published August 2024.

[8] Telix ASX disclosure 20 December 2021.

[9] Telix ASX disclosure 2 November 2021.

[10] Telix ASX disclosure 14 October 2022.

[11] Telix ASX disclosure 13 February 2025.

[12] Telix ASX disclosure 18 March 2025.

[13] National Agency for the Safety of Medicine and Health Products (Agence nationale de sécurité du médicament et des produits de santé). Telix media release 29 April 2025.

[14] Czech Republic, Denmark, Ireland, Luxembourg, Malta, the Netherlands, Norway and Sweden at time of release.

[15] The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Telix ASX disclosure 17 January 2025.

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, Brazil, 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).

Visit www.telixpharma.com 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, X and Facebook.

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: [e-mail]

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