Scintimun® Commercialization Partnership with Curium Pharma

MELBOURNE, Australia and LIÈGE, Belgium, Jan. 13, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX; Nasdaq: TLX, Telix, the Company) today announces that it has entered into an agreement with Curium Pharma for the transfer of marketing and distribution rights for Scintimun® (^99mTc-besilesomab, also known as TLX66-CDx), a diagnostic radiopharmaceutical used for infection imaging^[1]. The agreement also includes a strategic contract manufacturing agreement appointing Curium as the manufacturer of the product for Telix.

Scintimun is an internationally approved product^[2] and has previously been manufactured and distributed by Curium Pharma through an out-license from Telix via the acquisition of TheraPharm in 2020^[3]. Following a strategic review of the asset, Telix has elected to bring sales and marketing in-house, with plans to significantly augment commercial distribution and indication expansion. The Company also intends to further develop Scintimun as a companion patient selection and safety assessment tool for TLX66 (⁹⁰Y-besilesomab), its therapeutic bone marrow conditioning candidate for hematopoietic stem cell transplantation (HSCT).

Kevin Richardson, Chief Executive Officer, Telix Precision Medicine, said, "We are pleased to be bringing Scintimun back to Telix, and see it as a valuable addition to our portfolio. In the near-term, the plan is to increase sales for its current indication by improving product availability, pricing and commercial consistency. There is significant potential to expand clinical utility, including as a "companion imaging" tool for Telix's TLX66 bone marrow conditioning candidate. We look forward to leveraging its potential for expanded clinical indications in serious diseases that represent an unmet medical need."

Ciril Faia, Chief Executive Officer, Curium Pharma Europe, added, "This agreement is a milestone for our Saclay site, as it recognizes our capabilities and expertise as a contract manufacturing organization in the field of nuclear medicine. It underscores the trust placed in our teams and the quality of their work. We are pleased that Scintimun will continue to benefit thousands of patients worldwide, and we are proud to support Telix in maximizing the potential of this impactful diagnostic tool."

About Scintimun and osteomyelitis

The worldwide incidence of osteomyelitis is estimated to be as high as 21.8 cases per 100,000 persons per year. The diagnosis of osteomyelitis remains a challenge for conventional diagnostic imaging modalities and timely identification/localization of pathology can be of critical importance for appropriate management of patients.

Techniques used to diagnose osteomyelitis may include X-ray, bone scintigraphy, computed tomography (CT), and magnetic resonance imaging (MRI). These modalities are typically combined with imaging of white blood cells to distinguish infection, sterile inflammation, and other disorders. White blood cell imaging is typically performed using in vitro separation and labelling of white blood cells, which requires significant preparation time and complexity, and carries the inherent risk of contamination and misdiagnosis.

Scintimun has been shown to be more sensitive than white blood cell imaging in certain patients, with faster preparation time and lower production complexity relative to white blood cell radiolabelling^[4]. Since CD66 is a key neutrophil marker, Scintimun may be used for imaging, localization, and pathological characterization in a wide variety of infection, immunology and oncology applications^[5].

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)^[6], by the Australian Therapeutic Goods Administration (TGA) ^[7], and by Health Canada^[8]. 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 WilliamsonTelix Pharmaceuticals LimitedSVP Investor Relations and Corporate CommunicationsEmail: 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.

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