Telix and SHINE partner for Lutetium-177 Supply

MELBOURNE, Australia and INDIANAPOLIS, Feb. 10, 2022 (GLOBE NEWSWIRE) -- Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today announces a new global clinical supply agreement with Wisconsin-based SHINE Technologies, LLC (SHINE) for highly pure no-carrier-added (n.c.a.) lutetium-177 (¹⁷⁷Lu), a therapeutic isotope used in Telix’s portfolio of molecularly targeted radiation (MTR) investigational products.

As Telix advances its late-stage clinical trials using the medical radioisotope ¹⁷⁷Lu, it is building a global supplier network with proximity to major global markets, capable of consistently delivering high-quality, no-carrier-added ¹⁷⁷Lu to patients. SHINE will immediately commence supply of n.c.a. ¹⁷⁷Lu for use in clinical trials of Telix’s therapeutic candidates TLX591 (¹⁷⁷Lu-rosopatamab for advanced prostate cancer) and TLX250 (¹⁷⁷Lu-girentuximab for kidney cancer), with particular focus on the U.S. market.

Dr. Gabriel Liberatore, Telix Group Chief Operating Officer said, “SHINE’s investment in high quality isotope production places them at the forefront of the radiopharmaceutical supply chain with particular strength in servicing the U.S. market. Telix’s goal is to establish a global supply chain with the capacity and reliability to support an increasing level of clinical activity through Telix-sponsored and investigator-led studies and to scale-up to commercial stage.”

Greg Piefer, SHINE founder and CEO continued, “There continues to be a growing, critical need for more effective treatment of metastatic or late-stage cancers. Our exciting partnership with Telix allows us to bring hope to these patients as we continue to help deliver ¹⁷⁷Lu for highly precise treatments that produce little damage in the tissue around treatment sites.” 

About SHINE Technologies

is a next-generation nuclear technology company focused on deploying state-of-the-art fusion technology to help solve global problems as a scalable path to practical fusion energy. SHINE’s nuclear technology and proprietary isotope production process produces n.c.a. Lu-177 that does not contain impurity byproducts, such as the metastable Lu-177m. Without these impurity byproducts, n.c.a. Lu-177 is a stronger therapeutic concentration of medically useful radioisotopes and produces less radioactive post-procedure medical waste than carrier-added Lu-177. For more information, follow SHINE on , and .

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 and follow Telix on (@TelixPharma) and .

Telix’s lead product, gallium-68 (⁶⁸Ga) gozetotide (also known as ⁶⁸Ga PSMA-11) injection for prostate cancer imaging, 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 Europe³ and Canada.⁴

Telix has multiple therapeutic clinical trials underway using the medical radioisotope ¹⁷⁷Lu. Its global supplier network includes a commercial supply agreement with ITM Isotope Technologies Munich SE (ITM), and clinical supply agreements with the Australian Nuclear Science and Technology Organisation (ANSTO), Eczacıbaşı-Monrol (Monrol), Eckert & Ziegler Strahlen- und Medizintechnik AG (EZAG) and SHINE Technologies.

Telix Media Contact

Dr. Stewart Holmstrom

Telix Pharmaceuticals Limited

Director Corporate Communications

Email:

Important Information

This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States, or in any other jurisdiction in which such an offer would be illegal. The securities referred to herein have not been and will not be registered under the United States Securities Act of 1933 (the “U.S. Securities Act”), or under the securities laws of any state or other jurisdiction of the United States and may not be offered or sold within the United States, unless the securities have been registered under the U.S. Securities Act or an exemption from the registration requirements of the U.S. Securities Act is available. This announcement has been authorised for release by Dr. Christian Behrenbruch, Managing Director and Chief Executive Officer. The Telix Pharmaceuticals name and logo are trademarks of Telix Pharmaceuticals Limited and its affiliates (all rights reserved).

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¹ ASX disclosure 20 December 2021.

² ASX disclosure 2 November 2021.

³ ASX disclosure 10 December 2021.

⁴ ASX disclosure 16 December 2020.