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

MELBOURNE, Australia, Feb. 24, 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 by NOMA^[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 enables healthcare providers in Norway to offer PSMA-PET^[3] imaging using a clinically-validated gallium-based radiopharmaceutical.

Illuccix, after radiolabelling with gallium-68, is indicated in Norway 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, providing clinicians with more information than conventional imaging methods (bone scan, CT^[4] scan) thereby offering a new 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.

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

Illuccix® has the potential to improve access to PSMA-PET in Norway by enabling hospitals and clinics to prepare the product on-site. In particular, in settings where there is a reliance on fluorine-18 (¹⁸F) tracers, the availability of Illuccix®, a GMP-quality prostate cancer imaging product, will help to avoid delivery delays and other logistical barriers, improving access.

With its broad indication and ready-to-use formulation, 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.

Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "The approval of Illuccix® in Norway will enable a clinically-validated PSMA-PET product to be more widely available, allowing healthcare providers to benefit from the convenience and flexibility of generator-produced gallium. This milestone reinforces Telix's ongoing commitment to advancing prostate cancer care and expanding access to innovative diagnostic technologies across Europe".

Illuccix® will be made available in Norway 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 Norway can email: info@wiikpharma.dk or call +45 5389 9010.

Prostate Cancer in Norway

Prostate cancer is the most common cancer in Norway overall and also the most common cancer among Norwegian men, with more than 6,200 new cases diagnosed annually, and a significantly higher incidence in men than either bowel cancer (2,800 new cases) or lung cancer (1,800 new cases). Prostate cancer was also the most common cause of cancer death in men in Norway, with over 1,100 men dying from their disease 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 Danish Medicines Agency^[11], by the United Kingdom (UK) Medicines and Healthcare Products Regulatory Agency (MHRA)^[12] and by NOMA. Illuccix® is currently in national approval review in countries across the European Economic Area (EEA) following a positive decentralized procedure (DCP) opinion by BfArM^[13].

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 EEA. No other Telix product has received a marketing authorization in any jurisdiction.

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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