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Illuccix Prostate Cancer PSMA-PET Imaging Agent Approved in Finland

PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT[4] 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)[5]. Illuccix® PSMA-PET will help fulfil a critical unmet need by facilitating access to timely and effective diagnosis and patient selection for treatment with PSMA-targeted therapy.
MELBOURNE, Australia, (informazione.news - comunicati stampa - salute e benessere)

PSMA-PET imaging represents a significant advancement in prostate cancer management, largely replacing conventional imaging methods (bone scan, CT 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) . Illuccix® PSMA-PET will help fulfil a critical unmet need by facilitating access to timely and effective diagnosis and patient selection for treatment with 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 .

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "Telix is committed to supporting people living with prostate cancer by working to improve access to accurate and reliable diagnostic imaging. The approval of Illuccix in Finland reflects the increasing importance of PSMA-PET in clinical decision-making. In partnership with our distributor, WIIk Pharma, we are focused on ensuring that healthcare providers across Finland can access a clinically validated imaging solution that is both effective and practical to implement. This milestone reinforces our ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe ".

Illuccix® will be made available in Finland through Telix's distribution partner for the Nordic region, WIIK Pharma ApS (WIIk Pharma), a specialist supplier and distributor of nuclear medicine products and services. To order or enquire about Illuccix® availability, authorized healthcare professionals in Finland can email: info@wiikpharma.dk or call +45 5389 9010.

Prostate cancer is the most common cancer for men in Finland with over 5,900 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (2,123 new cases) or lung cancer (1,828 new cases). Prostate cancer is the second most common cause of cancer death in men in Finland , with just over 930 men dying from their disease in 2022 .

Telix's prostate imaging product, gallium-68 ( Ga) gozetotide injection (also known as Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA) , by the Australian Therapeutic Goods Administration (TGA) , by Health Canada , by the Brazilian Health Regulatory Agency (ANVISA) , by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA) , by the French National Agency for the Safety of Medicine and Health Products (ANSM) , and in multiple other European Economic Area (EEA) Member States . Illuccix® is currently in national approval review elsewhere in the EEA following a positive decentralized procedure (DCP) opinion by BfArM .

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.

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com

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