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Telix and Isologic Sign License and Distribution Agreement for Illuccix® for Canada

MELBOURNE, Australia, June 23, 2022 /CNW/ -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces it has signed a license and distribution agreement with Isologic Innovative Pharmaceuticals Ltd (Isologic) for the commercialisation of Telix's investigational prostate cancer imaging agent, Illuccix® (kit for preparation of gallium Ga-68 gozetotide injection), also known as 68Ga-PSMA-11 injection, for the Canadian market.

(PRNewsfoto/Telix Pharmaceuticals Limited)

Isologic is the leading radiopharmaceutical network in Canada, servicing 265 hospitals and clinics across the country.[1] Under the terms of the agreement, Isologic will be the commercial distributor of Illuccix in Canada, for a period of four years from the Canadian regulatory approval date, subject to achievement of annual minimum sales commitments.

Isologic's President, Dr André Gagnon, said, "PSMA PET imaging is a disruptive new technology that is being rapidly adopted and which may transform the way prostate cancer is initially staged and managed. We are very pleased to be working with Telix to bring this diagnostic imaging agent to our customers and patients in Canada, following regulatory approval by Health Canada."

Telix Group CEO and Managing Director, Dr Christian Behrenbruch added, "Canada is an important market for Telix and we already have an active user base of physicians who are prescribing Illuccix under compassionate use programs. Therefore, we are pleased to have secured this agreement, which will help patients across Canada access PSMA PET imaging using Illuccix once we have regulatory approval."

The agreement is subject to industry-standard commercial performance and termination conditions.

Marketing authorization has not yet been obtained for Illuccix® in Canada.

About Prostate Cancer in Canada

According to the Canadian Cancer Society, prostate cancer is the most common cancer after non-melanoma skin cancers and is the third-leading cause of death from cancer among Canadian men. More than 24,000 men in Canada are estimated to be diagnosed with prostate cancer this year, and 4,600 will die from the condition.[2] Reliable and flexible diagnostic tools are essential for medical teams in narrowing the gap between understanding the spread of disease and the development of individualized treatment plans.

About Isologic Innovative Radiopharmaceuticals Ltd

ISOLOGIC Innovative Radiopharmaceuticals (ISOLOGIC) is a Canadian company dedicated to nuclear medicine and the science of radiopharmaceutical production. ISOLOGIC's commitment in these areas includes cyclotron centers, SPECT and PET radiopharmaceutical manufacturing facilities across Canada. We use our increased experience, expertise and radiopharmaceutical network to provide our customers and patients reliable, safe and high-quality radiopharmaceutical products and services. ISOLOGIC's radiopharmaceutical drug and medical device offers flexibility of choice, providing its clients with access to all radiopharmaceuticals that have Health Canada's market authorization.

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 and commercialising a portfolio of 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, gallium-68 (68Ga) 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 Europe[5] and Canada.[6]

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.

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

[1] Source: Isologic Innovative Radiopharmaceuticals

[2] Source: https://www.canada.ca/en/public-health/services/publications/diseases-conditions/prostate-cancer.html

[3] ASX disclosure 20 December 2021.

[4] ASX disclosure 2 November 2021.

[5] ASX disclosure 10 December 2021.

[6] ASX disclosure 16 December 2020.

SOURCE Telix Pharmaceuticals Limited

Cision View original content to download multimedia: http://www.newswire.ca/en/releases/archive/June2022/23/c6577.html

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