MELBOURNE, Australia and INDIANAPOLIS, April 4, 2022 /PRNewswire/ — Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) announces that its prostate cancer imaging agent, Illuccix® (kit for preparation of gallium Ga 68 gozetotide), also known as 68Ga-PSMA-11 injection, is now commercially available in the United States.

Illuccix is available to order from 117 Cardinal Health and PharmaLogic pharmacies, delivering coverage to ~85% of PET1 imaging sites across the United States. In addition, United Pharmacy Partners, Inc. (UPPI) has been added as a third pharmacy network partner on a select basis, delivering even greater regional coverage to ensure that patients are able to benefit from the flexibility and accessibility of Illuccix.

Dr. Christian Behrenbruch, Telix Group CEO and Managing Director said, “Physicians across the United States are now able to order doses and schedule patients for Illuccix scans. This important milestone significantly improves access to PSMA-PET imaging across the United States and allows physicians to confidently schedule dose delivery any time of the day, optimising flexibility and control for patients. With the recent approval in the United States2 of PSMA therapy – and the importance of 68Ga-PSMA-11 for patient selection – it is an exciting time for molecular imaging in GU-Oncology.”

First doses are already being scheduled for April in key academic centers across the U.S. including University of Washington. “We are excited to be one of the first locations to bring this new imaging to our patients,” says Dr. Delphine Chen, Professor of Radiology. “It brings a new dimension to our ability to stage and treat prostate cancer and can ultimately help us improve our ability to manage the full extent of their disease.”

Eligible customers can claim reimbursement for Illuccix under the Centers for Medicare & Medicaid Services (CMS) Not Otherwise Classified (NOC) code. The Healthcare Common Procedure Coding System (HCPCS) reimbursement code assignment is anticipated in the near term and will be completed in accordance with the publication timings set by CMS.

About Illuccix

Telix’s lead product, Illuccix (kit for preparation of gallium Ga 68 gozetotide (also known as 68Ga PSMA-11) injection), has been approved by the U.S. Food and Drug Administration (FDA),3 and by the Australian Therapeutic Goods Administration (TGA).4 Telix is also progressing marketing authorisation applications for this investigational candidate in Europe5 and Canada.6

The safety of gallium Ga 68 gozetotide was evaluated in 960 patients, each receiving one dose of gallium Ga 68 gozetotide. The average injected activity was 188.7 ± 40.7 MBq (5.1 ± 1.1 mCi). No serious adverse reactions were attributed to gallium Ga 68 gozetotide. The most commonly reported adverse reactions were nausea, diarrhea, and dizziness, occurring at a rate of < 1%.

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

Important Safety Information: https://www.illuccixhcp.com/important-safety-information

Please see full U.S. Prescribing Information at: https://illuccixhcp.com/wp-content/uploads/illuccix-prescribing-information.pdf

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).  

1 Positron emission tomography.
2 Novartis release 23 March 2022.
3 ASX disclosure 20 December 2021.
4 ASX disclosure 2 November 2021.
5 ASX disclosure 10 December 2021.
6 ASX disclosure 16 December 2020.