First Patient in Australia Dosed with Illuccix® - Telix's Approved Prostate Cancer Imaging Agent
MELBOURNE,Australia,Sept. 28,2022 --Telix Pharmaceuticals Limited (ASX: TLX,Telix,the Company)today announces the first commercial dose in Australia of its prostate cancer imaging agent,Illuccix® (Kit for Preparation of Ga-68 Glu-urea-Lys(ahx)-hbed-CC Injection),also known as 68Ga-PSMA-11 injection.
With Illuccix now available for delivery to all positron emission tomography (PET) imaging sites in Australia,Austin Health in Melbourne became the first to administer this new PSMA PET[1] imaging agent that can help health care professionals diagnose the stage and spread of disease – an important step for the optimal care of men with prostate cancer.
Illuccix,after radiolabelling with Ga-68,is a radioactive diagnostic agent indicated for use with PET imaging combined with computed tomography(CT) in patients with prostate cancer:
who are at risk of metastasis and who are suitable for initial definitive therapy.
who have suspected recurrence based on elevated serum prostate specific antigen (PSA) level.
Illuccix is the only PSMA-targeting PET agent approved and available in Australia for the diagnostic imaging of men with prostate cancer.Australia has one of the highest rates of prostate cancer in the world,and with diagnoses having increased 34% during the past 12 months,it is now the most common cancer in Australia,overtaking breast cancer. An estimated 24,217 men will be diagnosed with prostate cancer this year.[2]
The Australian launch of Telix's lead imaging product follows the recent listing of PSMA PET imaging for patients with prostate cancer on the Medicare Benefits Schedule (MBS). MBS funding covers the initial staging of intermediate to high-risk patients with prostate cancer and the re-staging of patients with recurrent prostate cancer,commensurate with the broad clinical indications granted in Australia for Illuccix.
Professor Andrew Scott AM,Director of the Department of Molecular Imaging and Therapy at Austin Health,Melbourne stated,"It is a privilege to be the first location in Australia to offer this approved imaging agent to patients. PSMA PET imaging for prostate cancer is now considered a standard of care worldwide and Illuccix has potential to dramatically improve access and availability for patients across Australia to this practice changing scan. Illuccix will provide information to more accurately stage disease,leading to improved patient management and outcomes and has been recently approved for Medicare funding."
Anne Savage,CEO Prostate Cancer Foundation of Australia continued,"Widespread availability of Illuccix for PSMA PET/CT imaging will help to facilitate equitable and affordable access to life-saving care for many thousands of Australian men with prostate cancer. Together with the recent Medicare listing,the arrival of Illuccix will help address significant unmet medical need,and bring hope to thousands of men and their families affected by this disease."
Dr. David N. Cade,CEO Telix Asia Pacific added,"This first commercial dose in Australia marks an important milestone for Australian men and for Telix as an Australian-headquartered company. As Illuccix rolls out nationally via our distribution partner,Global Medical Solutions Australia,we are pleased to deliver broad equity of access to PSMA PET imaging for prostate cancer,with the convenience and flexibility that this product affords."
Illuccix is available to order via Telix's distribution partner in Australia,at the following link: https://www.globalmedicalsolutions.com.au/pages/telix-gms-distribution-agreement
About Illuccix®
Telix's lead product,Illuccix (Kit for Preparation of Ga-68 Glu-urea-Lys(ahx)-hbed-CC Injection),also known as 68Ga-PSMA-11 injection,has been approved by the Australian Therapeutic Goods Administration (TGA),[3]and by the U.S. Food and Drug Administration (FDA).[4]Telix is also progressing marketing authorisation applications for this investigational candidate in Europe[5]and Canada.[6]
About Telix Pharmaceuticals Limited
Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic products using Molecularly Targeted Radiation (MTR). Telix is headquartered in Melbourne,Australia with international operations in Belgium,Japan,Switzerland,and the United States. Telix is developing a portfolio of clinical-stage products that address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). For more information visit www.telixpharma.comand follow Telix on Twitter (@TelixPharma) and LinkedIn.
Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: kyahn.williamson@telixpharma.com
This announcement has been authorised for release by Dr. Christian Behrenbruch,Managing Director and Group Chief Executive Officer.
Legal Notices
This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia,United States and the United Kingdom). This announcement may include forward-looking statements that relate to anticipated future events,financial performance,plans,strategies or business developments. Forward-looking statements can generally be identified by the use of words such as "may","expect","intend","plan","estimate","anticipate","outlook","forecast" and "guidance",or other similar words. Forward-looking statements involve known and unknown risks,uncertainties and other factors that may cause our actual results,levels of activity,performance or achievements to differ materially from any future results,performance or achievements expressed or implied by these forward-looking statements. Forward-looking statements are based on the Company's good-faith assumptions as to the financial,market,regulatory and other risks and considerations that exist and affect the Company's business and operations in the future and there can be no assurance that any of the assumptions will prove to be correct. In the context of Telix's business,forward-looking statements may include,but are not limited to,statements about: the initiation,timing,progress and results of Telix's preclinical and clinical studies,and Telix's research and development programs; Telix's ability to advance product candidates into,enrol and successfully complete,clinical studies,including multi-national clinical trials; the timing or likelihood of regulatory filings and approvals,manufacturing activities and product marketing activities; the commercialisation of Telix's product candidates,if or when they have been approved; estimates of Telix's expenses,future revenues and capital requirements; Telix's financial performance; developments relating to Telix's competitors and industry; and the pricing and reimbursement of Telix's product candidates,if and after they have been approved. Telix's actual results,performance or achievements may be materially different from those which may be expressed or implied by such statements,and the differences may be adverse. Accordingly,you should not place undue reliance on these forward-looking statements. You should read this announcement together with our risk factors,as disclosed in our most recently filed reports with the ASX or on our website.
To the maximum extent permitted by law,Telix disclaims any obligation or undertaking to publicly update or revise any forward-looking statements contained in this announcement,whether as a result of new information,future developments or a change in expectations or assumptions.
The Telix Pharmaceuticals and the Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates - all rights reserved.
[1]Prostate-specific membrane antigen (PSMA) positron emissiontomography(PET).
[2]Australian Institute of Health and Welfare (AIHW) data 2022.
[3]ASXdisclosure 2 November 2021.
[4]ASXdisclosure 20 December 2021.
[5]ASXdisclosure 10 December 2021.
[6]ASXdisclosure 16 December 2020.
