MELBOURNE, Australia, Feb. 11,
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
approved by the Danish Medicines Agency (Lægemiddelstyrelsen).
Illuccix, after radiolabelling with gallium-68, is indicated in
Denmark 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[2] represents a
significant advancement in prostate cancer management, largely
replacing conventional imaging methods (bone scan,
CT[3] 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)[4]. 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 in Denmark
Prostate cancer is the most common cancer among Danish men, with
a high incidence rate (5,250 new cases in 2022[5]) and
relatively poor survival compared to other Nordic
countries[6].
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)[7],
by the Australian Therapeutic Goods Administration
(TGA)[8], and by Health
Canada[9]. Illuccix is currently in national
approval review in 19 European countries following a positive
decentralized procedure (DCP) opinion by BfArM[10].
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 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.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
Legal Notices
You should read this announcement together with our risk
factors, as disclosed in our most recently filed reports with the
Australian Securities Exchange (ASX), U.S. Securities and Exchange
Commission (SEC), including our registration statement on Form 20-F
filed with the SEC, or on our website.
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
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to the accuracy or completeness of the information contained or
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This announcement may contain forward-looking statements,
including within the meaning of the U.S. Private Securities
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relating to Telix's competitors and industry; and the pricing and
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been approved. Telix's actual results, performance or achievements
may be materially different from those which may be expressed or
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Accordingly, you should not place undue reliance on these
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©2025 Telix Pharmaceuticals Limited. The Telix
Pharmaceuticals®, Telix Group company, and Telix
product names and logos are trademarks of Telix Pharmaceuticals
Limited and its affiliates – all rights reserved. Trademark
registration status may vary from country to country.
[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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