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.
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Telix Investor Relations
Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
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You should read this announcement together with our risk factors, as disclosed in our most recently filed reports with the Australian Securities Exchange (ASX), U.S. Securities and Exchange Commission (SEC), including our registration statement on Form 20-F filed with the SEC, or on our website.
The information contained in this announcement is not intended to be an offer for subscription, invitation or recommendation with respect to securities of Telix Pharmaceuticals Limited (Telix) in any jurisdiction, including the United States. The information and opinions contained in this announcement are subject to change without notification. To the maximum extent permitted by law, Telix disclaims any obligation or undertaking to update or revise any information or opinions contained in this announcement, including any forward-looking statements (as referred to below), whether as a result of new information, future developments, a change in expectations or assumptions, or otherwise. No representation or warranty, express or implied, is made in relation to the accuracy or completeness of the information contained or opinions expressed in the course of this announcement.
This announcement may contain forward-looking statements, including within the meaning of the U.S. Private Securities Litigation Reform Act of 1995, 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", "believe", "outlook", "forecast" and "guidance", or the negative of these words or other similar terms or expressions. 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 Telix's good-faith assumptions as to the financial, market, regulatory and other risks and considerations that exist and affect Telix'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 trials, 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 for Telix's product candidates, manufacturing activities and product marketing activities; Telix's sales, marketing and distribution and manufacturing capabilities and strategies; the commercialisation of Telix's product candidates, if or when they have been approved; Telix's ability to obtain an adequate supply of raw materials at reasonable costs for its products and product candidates; 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.
©2024 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals® and Illuccix® names and logos are trademarks of Telix Pharmaceuticals Limited and its affiliates – all rights reserved.
[1] Subject to GMP accreditation.
[2] Subject to GMP accreditation and applicable regulatory approvals.
[3] Telix media release December 2022.
[4] Telix ASX disclosure 20 December 2021.
[5] Telix ASX disclosure 2 November 2021.
[6] Telix ASX disclosure 14 October 2022.
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