Telix Manufacturing Solutions, Brussels South Update: Cyclotron Installation Complete

MELBOURNE, Australia and INDIANAPOLIS, Dec. 19, 2024 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has completed the installation of two new cyclotrons at Telix Manufacturing Solutions (TMS) in Brussels South, Belgium, facilitating the production of radioisotopes and patient doses on-site from 2025^[1].

The installation of cyclotrons from GE HealthCare (Nasdaq: GEHC) and IBA (Ion Beam Applications S.A., EURONEXT), along with proprietary solid targets, establishes TMS Brussels South as a major nuclear medicine production facility, which will serve as the Company's primary manufacturing site for the Europe Middle East and Africa (EMEA) region and beyond. One cyclotron will be dedicated to clinical and commercial supply, and the other to research and development (R&D), meaning TMS Brussels South will serve as a vital hub for manufacturing scale-up and production of next generation radiopharmaceuticals, including diagnostics and both alpha- and beta therapeutics^[2].

Telix was granted an updated radiation licence in 2022 by the Belgian Federal Agency for Nuclear Control (FANC) for a broad range of commercially important medical isotopes^[3]. Both cyclotrons have multi-isotope capacity and will have ARTMS' QUANTM Irradiation System™ (QIS™) installed to support high efficiency, large-scale and cost-effective production. This includes clinical and commercial supply in Europe of gallium-68 (⁶⁸Ga), zirconium-89 (⁸⁹Zr), fluorine-18 (¹⁸F) and copper-64 (⁶⁴Cu), along with the capacity to produce R&D quantities of actinium-225 (²²⁵Ac) for targeted alpha therapy.

Darren Patti, Group Chief Operating Officer, Telix said, "This year, more than 10 million radiopharmaceutical procedures will be performed in the EU. These new cyclotrons, manufactured by the world leaders in particle accelerator technology, will deliver significant flexibility and reliable supply from Telix's first bench-to-bedside manufacturing facility, to help meet this growing demand. Since acquiring the site in Brussels South in April 2020, the speed at which the team and our partners have decommissioned and built out this facility has been nothing short of extraordinary. We would like to thank the Wallonia regional government for grant funding, and the Wallonia Export & Investment Agency (AWEX) for access to financing solutions, in support of these buildout works."

Commissioning of the cyclotrons is scheduled to begin in early Q1 2025, with first commercial good manufacturing practice (GMP) production anticipated in H2 2025, subject to requisite audits and accreditation.

About Telix Manufacturing Solutions, Brussels South

Located in the heart of Belgium's 'Radiopharma Valley', the 2,800 square metre facility is one of Europe's largest radiopharmaceutical production facilities, with nine GMP lines, clean rooms, a radiopharmacy, and two cyclotrons. The site will enable improved access to radiopharmaceuticals for patients across the EMEA region and worldwide as a primary GMP capable manufacturing site for Telix's clinical and commercial products.

TMS Brussels South also has extensive R&D capabilities, with a focus on alpha-emitting isotopes. The proximity of an alpha radiopharmaceutical laboratory (the 'AlphaLab') to a production GMP environment is a differentiated capability to our competition. We expect the site to evolve and develop as a hub for strategic collaborations via R&D facilities and a manufacturing line designated for university and small and medium-sized enterprise partners.

About Telix Pharmaceuticals Limited

Telix is a biopharmaceutical company focused on the development and commercialisation of therapeutic and diagnostic radiopharmaceuticals and associated medical technologies. Telix is headquartered in Melbourne, Australia, with international operations in the United States, Europe (Belgium and Switzerland), and Japan. Telix is developing a portfolio of clinical and commercial stage products that aims to address significant unmet medical needs in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX) and the Nasdaq Global Select Market (Nasdaq: TLX).

Telix's lead imaging product, gallium-68 (⁶⁸Ga) gozetotide injection (also known as ⁶⁸Ga PSMA-11 and marketed under the brand name Illuccix®), has been approved by the U.S. Food and Drug Administration (FDA)^[4], by the Australian Therapeutic Goods Administration (TGA) ^[5], and by Health Canada^[6]. No other Telix product has received a marketing authorisation in any jurisdiction.

Visit www.telixpharma.com for further information about Telix, including details of the latest share price, ASX and SEC filings, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also follow Telix on X and LinkedIn.

Telix Investor Relations

Ms. Kyahn WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: kyahn.williamson@telixpharma.com

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