PSMA-PET Imaging to be Funded through Medicare in Australia from July 2022

MELBOURNE, Australia, April 6, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) welcomes the listing of prostate-specific membrane antigen (PSMA) positron emission tomography (PET) (PSMA-PET) imaging for patients with prostate cancer on the Medicare Benefits Schedule (MBS) from 1 July 2022.

MBS funding will cover the initial staging of intermediate to high-risk patients with prostate cancer and the restaging of patients with recurrent prostate cancer, commensurate with the broad clinical indications granted in Australia for Telix's prostate cancer imaging product, Illuccix^®.

Illuccix (Kit for the preparation of ⁶⁸Ga-PSMA-11) is the only regulatory approved PET agent for the diagnostic imaging of men with prostate cancer available in Australia, having received marketing approval from the Australian Therapeutic Goods Administration (TGA) in November 2021.^[1] Australia has one of the highest rates of prostate cancer in the world. In 2020, prostate cancer was the most commonly diagnosed cancer in men in Australia with approximately 18,000 new cases.^[2]

CEO Telix Asia Pacific, Dr. David N. Cade stated, "This is an important step in enabling Australian men equitable access to this new imaging modality, which was recently approved by the Australian TGA. This decision by the Federal Government sets an encouraging baseline, confirming the importance of this new form of imaging in the staging and management of prostate cancer and is reflective of the growing body of clinical evidence and adoption of PSMA-PET imaging in global clinical guidelines.^[3]"

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, Switzerland, Japan, 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.com and follow Telix on Twitter (@TelixPharma) and LinkedIn.

Telix's lead product, Illuccix^® (kit for preparation of gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection) for prostate cancer imaging, has been approved by the U.S. Food and Drug Administration (FDA),^[4] and by the Australian Therapeutic Goods Administration (TGA). Telix is also progressing marketing authorisation applications for this investigational candidate in Europe^[5] and Canada.^[6]

This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Group Chief Executive Officer.

Legal Notices

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, levels of activity, 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 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.

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 name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).