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Telix Opens European Radiopharmaceutical Production Facility

2023-06-08

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Telix has unveiled its new, state-of-art radiopharmaceutical facility in Brussels South as part of its first stage investment of €14.1 million ($A21.2 million) Located in Walloon’s ‘Radiopharma Valley’ the facility will be a central hub for research and development for the region and facilitate patient access to this important class of cancer treatment. Melbourne (Australia) and Liege (Belgium) – 8 June 2023. Telix Pharmaceuticals Limited (ASX: TLX, Telix, the Company) today welcomes Willy Borsus, Vice-President of Wallonia, Minister of Economy, Research and Innovation, Digital, Agriculture, Urban Planning and Regional Planning to officially open Telix Manufacturing Solutions, the Company’s radiopharmaceutical production facility located in Brussels South (Seneffe), in the Wallonia region of Belgium. Located in the heart of Belgium’s ‘Radiopharma Valley’, the 2,800 square metre facility is one of Europe’s largest radiopharmaceutical production facilities. It will serve as the Company’s primary manufacturing site for radioisotopes and commercial and clinical products for patients in the Europe Middle East and Africa (EMEA) region and beyond. Radiopharmaceuticals use targeting agents (small molecules or antibodies) to deliver targeted radiation to cancer cells, regardless of where the cancer is in the body. These agents can be used for imaging (diagnosis) or therapy. Often referred to as “theranostics”, this approach has the potential to better inform treatment decisions and deliver personalised therapy for patients. Each year more than 10 million imaging procedures are performed in the EU using radiopharmaceutical agents.[1] Furthermore, due to increasing clinical development activity of imaging and therapeutics, the number of patients requiring treatment with radiopharmaceuticals worldwide is set to increase. According to industry analyst reports the market for radiopharmaceuticals is growing rapidly, up 10% year-on-year to US$6 billion in global sales in 2021 and are forecast to reach US$33 billion annual sales by 2031.[2] As demand for these products increases investment in supply chain and manufacturing is vital to ensure patient needs can be met. “Recent events – including COVID – have taught us that if we are to invest in developing radiopharmaceutical products, we must also invest in ensuring that patients can have access to this new generation of cancer treatments. Given the just-in-time manufacturing and complex logistics required for radiopharmaceuticals this is vital to building a foundation for long-term, commercial success in our field and delivering to the needs of patients,” said Raphael Ortiz, Telix’s CEO for the EMEA region. Telix acquired the 35,000 square metre site in April 2020.[3] After extensive redevelopment, which included the decommissioning and safe removal of two cyclotrons, the facility was granted a renewed licence for the production of an extensive list of radioisotopes required for the Company’s research, development, commercial and clinical activities. “Sites such as Telix Manufacturing Solutions in Brussels South are a rarity. There are very few places in the world where a site of this scale could be constructed and secure a licence to produce the array of isotopes that our licence allows,” said Dr Christian Behrenbruch, Managing Director and Group CEO of Telix. The first stage of the buildout – which is now complete – included installation of nine GMP[4] manufacturing lines, two research and development laboratories, quality control labs and warehousing space with capacity to support Telix’s operations. One of the first GMP lines will be dedicated for the use of industry and research partners and collaborators. The company is also preparing to install the first of two planned cyclotrons for the site. The Wallonia regional government provided grant funding and the Wallonia Export & Investment Agency (AWEX) provided access to financing solutions, in addition to the Company’s own funding, to support first stage buildout works. “Belgium’s “Radiopharma Valley” is a fundamental part of Telix’s innovation success – in fact, the technology that underpins our first commercial product was invented in Belgium. It is our vision that this facility, will not only exist for Telix but operate as a hub for research, development and manufacturing for our partners and collaborators across industry, academia and clinical practice. We are very grateful for the support of the Walloon regional government and AWEX and hope that this facility will contribute to the ongoing growth of our industry and drive further investment in the region,” added Mr Ortiz. Willy Borsus, Vice-President; Minister of Economy, Foreign Trade of the Walloon Government, “Belgium has a proud history as a pioneer in nuclear science and technology for healthcare and the Walloon region is home to a vital hub of research, production, talent and transport known as Radiopharma Valley. We recognise the current and future utility of radiopharmaceuticals and the need to increase capacity to ensure the community can access these innovative technologies. We welcome Telix’s commitment to the region through the creation of this state-of-the-art facility which will attract talent and drive increased investment across a broad range of areas in Wallonia including research, employment, education and health.” Today, Belgium is a world leader in medical isotope supply, and production of radiopharmaceuticals and nuclear medical equipment, with the nuclear medicine sector providing approximately 5,000 jobs indirectly, and over 2,600 jobs directly. Telix currently employs 32 people in Belgium. This number is expected to grow significantly as the commercial activity develops. ENDS Key Facts: Telix Manufacturing Solutions (TMS) The 2,800 sqm building includes a 965 sqm advanced radiopharmacy, with 9 clean rooms, 2 purification suites, 2 R&D laboratories, 2 quality control laboratories, 2 cyclotron vaults, 500 sqm of office space and 300 sqm warehousing. Safety is a key feature in building a site of this nature: The radiopharmacy floor is constructed with a 90cm reinforced concrete floor. That’s more than 4x thicker than the standard requirement for industrial concrete floors. The radiopharmacy has been fitted with 200 air filters, with double filtration and backup system for total security Telix will manufacture radiopharmaceuticals for clinical, commercial and compassionate use in Europe and globally. This will include radiolabelling of Illuccix, Telix’s prostate cancer imaging agent which has been approved by the U.S. Food and Drug Administration, by the Australian Therapeutic Goods Administration (TGA),[5] and by Health Canada.[6] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom and the European Union.[7] Telix was granted an updated radiation licence by the Belgian Federal Agency for Nuclear Control in December 2022. Today, TMS has one of the broadest private sector medical isotope licences in Europe, which delivers significant operational flexibility to Telix. Radiopharma Valley and the nuclear medicine industry in Belgium TMS is located within an operational hub that is home to many radiopharma, pharmaceutical and logistics companies, several of whom Telix has existing relationships with, and is in close proximity to logistics networks. Known as Radiopharma Valley, the area is internationally recognised for its expertise in radiopharmaceuticals, including universities and university hospitals which are pioneers in theranostics. Today, Belgium is a world leader in medical isotope supply, and production of radiopharmaceuticals and nuclear medical equipment, with the nuclear medicine sector providing approximately 5,000 jobs indirectly, and over 2,600 jobs directly. Belgium produces the second-largest amount of 99Mo - molybdenum (mother isotope of 99mTc - technetium) worldwide, benefiting over 7 million patients. Belgian technology is utilised by a third of hospitals worldwide. Belgium provides a favourable environment for innovative sectors like nuclear medicine, offering various tax incentives and subsidy programs, such as withholding tax exemptions for researchers involved in R&D programs. Wallonia-Belgium is strategically located between Northern and Southern Europe and is home to five major airports, including Liege Cargo. Most European destinations are under two hours away by train or air travel. This advantageous location and connectivity foster an efficient supply chain for medical radioisotopes and equipment, benefiting Europe and beyond. The Wallonia-Belgium region alone is home to 37 hospitals, with close proximity to around 400 hospitals in neighbouring regions of France, Luxembourg, the Netherlands, and Germany. Belgium has one of the highest concentrations of nuclear medicine equipment and specialists per capita, in the world: 35,000 shipments of radionuclides for medical applications from Belgium each year 160 SPECT/CT cameras: 15 per million inhabitants 33 PET/CT cameras: 3 per million inhabitants 136 (N)MRI cameras: 12 per million inhabitants 8 cyclotrons (7 for production of radioisotopes and 1 for proton therapy) 350 nuclear medicine specialists: 30 per million inhabitants Environmental considerations As a licenced nuclear facility, TMS will be subject to regular inspections by Belgium’s Federal Agency for Nuclear Control (FANC) and FANC’s subsidiary in charge of the regulatory controls and safety assessments, BEL-V. Telix’s obligations with respect to these regulations have been met and are up to date. In December 2022 Telix received from FANC an updated operation authorisation and environmental permit for the facility valid until 7 October 2042. The Company’s commitment to sound environmental practices was integrated into the development of building works plans and is a key consideration in ongoing future operations. Telix’s most recent Environmental, Social, Governance and Sustainability (ESGS) report can be downloaded here. About Telix Pharmaceuticals Limited Telix is a biopharmaceutical company focused on the development and commercialisation of diagnostic and therapeutic radiopharmaceuticals. 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-stage products that aims to address significant unmet medical need in oncology and rare diseases. Telix is listed on the Australian Securities Exchange (ASX: TLX). Visit for further information about Telix, including details of the latest share price, announcements made to the ASX, investor and analyst presentations, news releases, event details and other publications that may be of interest. You can also 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),[8] and by the Australian Therapeutic Goods Administration (TGA),[9] and by Health Canada.[10] Telix is also progressing a marketing authorisation application for this investigational candidate in the United Kingdom and the European Union.[11] Telix Investor Relations Ms. Kyahn Williamson Telix Pharmaceuticals Limited SVP Corporate Communications and Investor Relations Email: kyahn.williamson@telixpharma.com Legal Notices This announcement is not intended as promotion or advertising directed to any healthcare professional or other audience in any country worldwide (including Australia, United States and the United Kingdom). 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 risks and 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. Except as required by applicable laws or regulations, Telix does not undertake to publicly update or review any forward-looking statements. Past performance cannot be relied on as a guide to future performance. Readers should read this announcement together with our material risks, as disclosed in our most recently filed reports with the ASX and on our website. ©2023 Telix Pharmaceuticals Limited. The Telix Pharmaceuticals and Illuccix name and logo are trademarks of Telix Pharmaceuticals Limited and it [1] European Commission, Joint Research Centre, Mario, N., Kolmayer, A., Turquet, G.et al., Study on sustainable and resilient supply of medical radioisotopes in the EU [2] Medrays Intell Nuclear Medicine market report 2022. [3] Telix ASX disclosure. [4] Good Manufacturing Practice, subject to certification. [5] Telix ASX disclosure 2 November 2021. [6] Telix ASX disclosure 14 October 2022. [7] Telix ASX disclosure 3 April 2023. [8] Telix ASX disclosure 20 December 2021. [9] Telix ASX disclosure 2 November 2021. [10] Telix ASX disclosure 14 October 2022. [11] Telix ASX disclosure 3 April 2023.