Telix Announces Cardinal Health as U.S. Commercial Distributor for Zircaix®

MELBOURNE, Australia, Sept. 18, 2024 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces that it has selected Cardinal Health, Inc. (NYSE: CAH, Cardinal Health) as a commercial radiopharmaceutical distributor to supply finished unit doses of its PET^[1] agent, Zircaix®^[2] (TLX250-CDx) for the imaging of kidney cancer in the United States (U.S.), subject to regulatory approval.

In preparation for a planned commercial rollout, Telix has contracted with Cardinal Health to enable Zircaix®^[2] availability across a wide range of U.S. locations.

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine said, “We are pleased to build on our existing relationship with Cardinal Health to maximise patient access to this breakthrough product for non-invasive kidney cancer diagnosis. Through their extensive nuclear pharmacy network, which enables broad geographic reach and flexible scheduling, Cardinal Health has been central to the commercial success of Illuccix® PSMA-PET ^[3] imaging and we look forward to adding Zircaix®^[2] to their U.S. roster.”

Mike Pintek, President of Cardinal Health Nuclear & Precision Health Solutions, added, “This new agreement builds upon our successful relationship with Telix and our continued commitment to supporting innovative diagnostics and therapeutics addressing cancer patients today. Pending regulatory approval, our extensive commercial distribution infrastructure and expertise will facilitate reliable supply of Zircaix®^[2] throughout the U.S. to help diagnose kidney cancer.”

Commencement of the distribution agreement between Telix and Cardinal Health is subject to regulatory approval and includes industry-standard commercial performance and termination conditions.

About Zircaix®^[2] (TLX250-CDx)

Zircaix®^[2] (TLX250-CDx, ⁸⁹Zr-girentuximab) is an investigational PET agent that is under development to characterise indeterminate renal masses as ccRCC or non-ccRCC in a non-invasive manner. Telix’s pivotal Phase III ZIRCON trial (ClinicalTrials.gov ID: NCT03849118) evaluating TLX250-CDx in 300 patients, of which 284 were evaluable, was completed in 2022 and met all primary and secondary endpoints, including showing 86% sensitivity and 87% specificity and a 93% positive-predictive value for ccRCC across three independent readers^[4]. We believe this demonstrated the ability of TLX250-CDx to reliably detect the clear cell phenotype and provide an accurate, non-invasive method for diagnosing ccRCC. Confidence intervals exceeded expectations in all three readers, showing evidence of high accuracy and consistency of interpretation.

As part of Telix’s commitment to access to medicine, the Company is running an expanded access program (EAP) in the U.S.^[5], named patient programs (NPPs) in Europe, and a special access scheme (SAS) in Australia to allow continued access to TLX250-CDx outside of a clinical trial to patients for whom there are no comparable or satisfactory alternate options.

Telix’s Policy on Offering Compassionate Use to Investigational Medicines can be downloaded at the following link.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical devices. Telix is headquartered in Melbourne, Australia, with international operations in the United States, 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. Telix is listed on the Australian Securities Exchange (ASX: TLX).

Telix’s lead 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)^[6], by the Australian Therapeutic Goods Administration (TGA) ^[7], and by Health Canada^[8]. No other Telix product has received a marketing authorisation in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.

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) 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 change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.

This announcement may contain 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”, “believe”, “outlook”, “forecast” and “guidance”, or the negative of these words or other similar terms or expressions. 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 Telix’s good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix’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 trials, 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 for Telix’s product candidates, manufacturing activities and product marketing activities; Telix’s sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix’s product candidates, if or when they have been approved; Telix’s ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; 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.

©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals®, Illuccix® and Zircaix®^[2] names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.

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SOURCE Telix Pharmaceuticals Limited