First Patients Dosed with Illuccix® - Telix's Approved Prostate Cancer Imaging Agent

Physicians in Indiana, New York City, and Washington are among the first to administer Illuccix^® – demonstrating coast-to-coast availability of this new imaging agent

Typically diagnosed in men over 50, prostate cancer is the second leading cause of cancer death in American men, after lung cancer^[1]

INDIANAPOLIS, April 14, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces first commercial doses of its prostate cancer imaging agent, Illuccix^® (kit for preparation of gallium Ga-68 gozetotide injection), also known as ⁶⁸Ga-PSMA-11 injection.

As Illuccix rolls out nationally across the United States, physicians in Indianapolis (Indiana University School of Medicine), New York City, and Seattle are among the first to administer this new PSMA PET^[2] imaging agent that can help health care professionals (HCPs) diagnose the stage and spread of disease – an important step for the optimal care of men with prostate cancer.

Illuccix is indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in patients with prostate cancer with:

• suspected metastasis who are candidates for initial definitive therapy;
• suspected recurrence based on elevated serum prostate-specific antigen (PSA) level.

Prostate cancer is the most common cancer in American men after skin cancer. According to the American Cancer Society, more than 268,000 men in the U.S. will be diagnosed this year with prostate cancer, and nearly 35,000 will die from their disease. Reliable and flexible diagnostic tools are essential for treatment teams in narrowing the gap between understanding the spread of disease and appropriate individualized treatment by healthcare professionals. 

Illuccix is now widely available across the United States, significantly improving patient access to PSMA PET imaging. PSMA PET imaging is emerging as a standard of care in the U.S. having been included in latest NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines^®) for Prostate Cancer.^[3]

"Early detection and staging can help guide more informed disease management decisions. Tools such as Illuccix PSMA-PET are incredibly valuable as we look for better ways to manage prostate cancer in men," said Dr. Michael Koch, Professor and Chair of the Department of Urology at the Indiana University School of Medicine and a physician-scientist at the Indiana University Melvin and Bren Simon Comprehensive Cancer Center.

Professor Mark Green, Director of Radiopharmaceutical Sciences and Professor of Radiology & Imaging Sciences at the Indiana University School of Medicine, added "The success of Telix in gaining FDA-approval for kit-formulated ⁶⁸Ga-PSMA-11 represents an innovation for prostate cancer patients. Telix is providing a much-needed avenue for widespread clinical access to PSMA-targeted PET for improved understanding of the location and extent of a patient's disease. These imaging insights can be important as the physician develops an individualized treatment plan."

Illuccix is now available to order from 117 pharmacies in the Telix network, providing coverage to approximately 85 percent of PET imaging sites across the U.S. with more sites to be added over the coming months. 

Dr. Christian Behrenbruch, Group CEO and Managing Director of Telix Pharmaceuticals Limited said, "Telix is delivering on its promise to deliver product and a distribution network that will allow physicians and their patients greater convenience and flexible access to advanced prostate cancer imaging, a significant unmet medical need. Until now, PSMA-PET imaging has had patchy availability and limited patient scheduling flexibility. Illuccix changes this by enabling rapid on-site hospital preparation or convenient delivery from nearby commercial nuclear pharmacies."

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.

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),^[4] and by the Australian Therapeutic Goods Administration (TGA).^[5] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe^[6] and Canada.^[7]

INDICATIONS AND USAGE 

Illuccix®, after radiolabeling with Ga 68, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:  

• with suspected metastasis who are candidates for initial definitive therapy 
• with suspected recurrence based on elevated serum prostate-specific antigen (PSA) level 

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

Risk for Misdiagnosis

Image interpretation errors can occur with gallium Ga 68 gozetotide PET. A negative image does not rule out the presence of prostate cancer and a positive image does not confirm the presence of prostate cancer. The performance of gallium Ga 68 gozetotide for imaging of biochemically recurrent prostate cancer seems to be affected by serum PSA levels and by site of disease. The performance of gallium Ga 68 gozetotide for imaging of metastatic pelvic lymph nodes prior to initial definitive therapy seems to be affected by Gleason score. Gallium Ga 68 gozetotide uptake is not specific for prostate cancer and may occur with other types of cancer as well as non-malignant processes such as Paget's disease, fibrous dysplasia, and osteophytosis. Clinical correlation, which may include histopathological evaluation of the suspected prostate cancer site, is recommended.

Radiation Risks

Gallium Ga 68 gozetotide contributes to a patient's overall long-term cumulative radiation exposure. Long-term cumulative radiation exposure is associated with an increased risk for cancer. Ensure safe handling to minimize radiation exposure to the patient and health care workers. Advise patients to hydrate before and after administration and to void frequently after administration.

ADVERSE REACTIONS
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%.

DRUG INTERACTIONS
Androgen deprivation therapy and other therapies targeting the androgen pathway
Androgen deprivation therapy (ADT) and other therapies targeting the androgen pathway, such as androgen receptor antagonists, can result in changes in uptake of gallium Ga 68 gozetotide in prostate cancer. The effect of these therapies on performance of gallium Ga 68 gozetotide PET has not been established.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit MedWatch at www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report adverse reactions to Telix by calling 1-844-455-8638 or emailing [email protected]. 

See full U.S. Prescribing Information at illuccix-prescribing-information.pdf (illuccixhcp.com) 

Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: [email protected]

Telix Media Relations
Mr. Greg Kueterman
Email: [email protected]

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] American Cancer Society.
[2] Positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions
[3] NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Prostate Cancer V.3.2022. Available at: https://www.nccn.org/guidelines/category_1.
[4] ASX disclosure 20 December 2021.
[5] ASX disclosure 2 November 2021.
[6] ASX disclosure 10 December 2021.
[7] ASX disclosure 16 December 2020.

SOURCE Telix Pharmaceuticals Limited