Telix Opens European Radiopharmaceutical Production Facility

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Jun 08, 2023, 08:00 ET

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, June 8, 2023 /PRNewswire/ -- 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 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, Group Managing Director and 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, continued, "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.

Download the Telix Manufacturing Solutions fact sheet 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 www.telixpharma.com 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),^[5] and by the Australian Therapeutic Goods Administration (TGA),^[6] and by Health Canada.^[7]Telix is also progressing marketing authorisation applications for this investigational candidate in the United Kingdom and the European Union.^[8]

Telix Investor Relations

Ms. Kyahn Williamson
Telix Pharmaceuticals Limited
SVP Corporate Communications and Investor Relations
Email: [email protected]

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.

^[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 https://data.europa.eu/doi/10.2760/911131

^[2]Medrays Intell Nuclear Medicine market report 2022.

^[3]Telix ASX disclosure 3 April 2020.

^[4]Good Manufacturing Practice, subject to certification.

^[5] Telix ASX disclosure 20 December 2021.

^[6]Telix ASX disclosure 2 November 2021.

^[7]Telix ASX disclosure 14 October 2022.

^[8]Telix ASX disclosure 3 April 2023.

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