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MELBOURNE, Australia and INDIANAPOLIS, June 13, 2022 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) is pleased to announce that its prostate cancer imaging agent, Illuccix® (kit for preparation of gallium Ga 68 gozetotide), is now available at selected pharmacies in the Jubilant Radiopharma network. Illuccix is now available to order from 139 pharmacy sites across the United States, ensuring scheduling flexibility and patient access to advanced prostate cancer imaging.
The expansion of the distribution network facilitates broader patient access to Illuccix across the country, expanding availability into new regional markets that to date have had limited access to PSMA PET imaging.
Dr. Christian Behrenbruch, Telix Group CEO and Managing Director said, "A key feature of Illuccix is its flexibility and availability for physicians and patients alike. Our goal is to ensure broad access to PSMA PET imaging from the largest metropolitan cities to regional areas and the expansion of the distribution network to include Jubilant Radiopharma puts an Illuccix scan within reach of even more patients in need."
"We are pleased to be able to expand our range and service to include Illuccix, and offer our customers the added convenience of PSMA PET imaging with Illuccix," says Renato Leite, President, Jubilant Radiopharmacies Division.
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® (kit for the preparation of gallium Ga 68 gozetotide injection)
Telix's lead product, Illuccix® (kit for the preparation of gallium Ga 68 gozetotide injection), also known as 68Ga PSMA-11 injection, has been approved by the U.S. Food and Drug Administration (FDA),[1] and by the Australian Therapeutic Goods Administration (TGA).[2] Telix is also progressing marketing authorisation applications for this investigational candidate in Europe[3] and Canada.[4] Illuccix is currently being investigated in combination with BgRT treatment.
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:
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 suspected adverse reactions 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 via email to pharmacovigilance@telixpharma.com.
Please note this information is not comprehensive. Please see full Prescribing Information at www.illuccix.com/pi.
[1] ASX disclosure 20 December 2021.
[2] ASX disclosure 2 November 2021.
[3] ASX disclosure 10 December 2021.
[4] ASX disclosure 16 December 2020.
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 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.
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