Telix's Illuccix® PSMA-PET Imaging Agent Approved in Portugal

MELBOURNE, Australia, June 4, 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 Portugal by INFARMED^[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 enhances the options available to healthcare providers across Portugal for PSMA-PET^[3] imaging using a clinically validated gallium-based radiopharmaceutical.

Illuccix, after radiolabelling with gallium-68, is indicated in Portugal 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 advancement 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 recognise 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]. Despite the proven benefits of PSMA-PET imaging, patients in Portugal have faced long wait times due to tracer shortages and infrastructure constraints.

Dr. Fernando Abreu, Director of Nuclear Medicine at the Santa Maria Local Health Unit, commented, "PSMA-PET imaging has significantly enhanced the accuracy and confidence in the detection and monitoring of prostate cancer. However, Portugal is currently facing a shortage of gallium-68 tracers, which has resulted in a national waiting list of up to six months. This delay has an impact on the timely diagnoses and treatments impacting patient care. The approval of Illuccix® in Portugal will be welcomed by physicians and patients as it allows hospitals and clinics to conduct PSMA-PET scans more efficiently, and with shorter wait times."

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.

Illuccix® will be distributed in Portugal by Sociedade Avanço, Unipessoal, LDA (Avanço), a specialist distributor of nuclear medicine, radiotherapy technologies and urology biopsy products.

"The approval of Illuccix® in Portugal marks an important milestone, providing healthcare professionals with access to a gallium-based PSMA-PET imaging agent supported by strong clinical validation. Our partnership with Avanço will help address the current shortages of gallium tracers and enable more efficient scanning processes. This collaboration reflects Telix's ongoing commitment to expanding access to high-quality prostate cancer imaging across Europe and reducing the barriers that currently delay diagnosis and treatment." said Raphaël Ortiz, Chief Executive Officer, Telix International.

Mr. Diogo Marcos, Managing Director of Avanço added: "We are delighted to partner with Telix for the distribution of Illuccix® in Portugal. As the official distributor of the GalliaPharm®^[7] generator, currently the only generator with marketing approval in the country, we are uniquely positioned to help address the national shortage of gallium-68. Our established distribution network ensures nationwide access, and our collaboration with Telix will enable us to support physicians in delivering timely and accurate PSMA-PET imaging."

Healthcare professionals in Portugal interested in ordering Illuccix® or learning more about availability can contact comercial@ams.pt or call (+351) 214 380 690.

Prostate Cancer in Portugal

Prostate cancer is the most common cancer in men in Portugal, with just over 7,500 new cases diagnosed annually, and a significantly higher incidence in men than either bowel (6,092 new cases) or lung cancer (4,253 new cases). Prostate cancer is also the third most common cause of cancer death in men, with just over 2,080 men dying from their disease in Portugal in 2022^[8].

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 United States Food and Drug Administration (FDA)^[9], by the Australian Therapeutic Goods Administration (TGA)^[10], by Health Canada^[11], by the Brazilian Health Regulatory Agency (ANVISA)^[12], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)^[13], by the French National Agency for the Safety of Medicine and Health Products (ANSM)^[14] and in multiple countries within the European Economic Area (EEA)^[15] following a positive decentralized procedure (DCP) opinion by the German medical regulator, BfArM^[16].

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: kyahn.williamson@telixpharma.com

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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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