Salute e Benessere
Illuccix® Approved in Denmark
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.
Raphaël Ortiz, Chief Executive Officer, Telix International, commented, "We are delighted that Illuccix has been approved in Denmark with this broad label demonstrative of clinical utility at multiple critical points in the prostate cancer journey. Danish physicians and their patients will now have access to Telix's innovative gallium-based PSMA-PET imaging agent, along with the efficiencies and scheduling flexibility of generator-produced gallium."
Illuccix will be made available in Denmark 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 Denmark can email: info@wiikpharma.dk or call +45 5389 9010.
Prostate cancer is the most common cancer among Danish men, with a high incidence rate (5,250 new cases in 2022 ) and relatively poor survival compared to other Nordic countries .
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) , and by Health Canada . Illuccix is currently in national approval review in 19 European countries 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 , 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 ( Tc) 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 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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[1] Positron emission tomography.
[2] Imaging of prostate-specific membrane antigen with positron emission tomography.
[3] Computed tomography.
[4] 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: 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
[5] Global Cancer Statistics 2022: GLOBOCAN survey. Published
August 2024 .
[6] Brasso et al. European Journal of Cancer. 2013.
[7] Telix ASX disclosure 20 December 2021 .
[8] Telix ASX disclosure 2 November 2021 .
[9] Telix ASX disclosure 14 October 2022 .
[10] The German Federal Institute for Drugs and Medical Devices (Bundesinstitut für Arzneimittel und Medizinprodukte). Telix ASX disclosure
17 January 2025 .
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