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.
(PRNewsfoto/Telix Pharmaceuticals Limited)
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.
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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.
[1] Scintimun is indicated, after radiolabelling, with technetium (99mTc), in adults for scintigraphic imaging, in conjunction with other appropriate imaging modalities, for determining the location of inflammation/infection in peripheral bone in adults with suspected osteomyelitis. Scintimun should not be used for the diagnosis of diabetic foot infection.
[2] Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Liechtenstein, Lithuania, Luxembourg, Malta, Mexico, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and the United Kingdom.
