Illuccix® Approved for Prostate Cancer Imaging in Brazil: First Marketing Authorization in Latin America

MELBOURNE, Australia and PORTO ALEGRE, Brazil, March 18, 2025 /PRNewswire/ -- Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX, Telix, the Company) today announces that the Brazilian Health Regulatory Agency (Agencia Nacional de Vigilancia Sanitaria or 'ANVISA') has approved Illuccix® (kit for the preparation of gallium-68 (68Ga) gozetotide injection) the Company's lead prostate cancer imaging agent. Illuccix® is the first and only PSMA-PET[1] prostate cancer imaging agent to receive full regulatory approval in Brazil.

Illuccix®, after radiolabeling with 68Ga, is a radioactive diagnostic agent indicated for positron emission tomography (PET) of prostate-specific membrane antigen (PSMA) positive lesions in men with prostate cancer:

• With suspected metastasis who are candidates for definitive initial therapy treatment, and
• With suspected recurrence based on an elevated specific antigen (PSA) level in the serum.

The marketing authorization is granted to Telix's partner R2PHARMA, Brazil's leading cold kit manufacturer, nuclear pharmacy and cyclotron network, and a subsidiary of GSH Corp Participações S.A. (Grupo GSH). Telix has provided Grupo GSH with an exclusive license to manufacture, distribute and market Illuccix® in Brazil[2].

PSMA-PET is a diagnostic technology demonstrated to detect advanced prostate cancer. ANVISA becomes the latest regulatory body worldwide to approve Illuccix®[3], which is already commercially available in Australia, Canada, New Zealand and the United States, and has recently been approved in the United Kingdom and in multiple countries within the European Economic Area (EEA).

Dr. Sérgio Altino de Almeida, nuclear medicine specialist, at Rede D'Or, the largest integrated healthcare network in Brazil said, "The ANVISA approval of Illuccix provides access to advanced prostate cancer imaging for men across Brazil, a large and rapidly growing market for gallium-68 based radiopharmaceuticals. The 'cold kit' format with generator-produced gallium will facilitate broad equity of access for men living with prostate cancer, regardless of whether they are based in regional, rural or metropolitan areas."

JV to manufacture and distribute radiopharmaceuticals for clinical and commercial use in Brazil

Telix also announces a joint venture (JV) with R2PHARMA to commercialize and distribute Telix's therapeutic and diagnostic radiopharmaceutical products in Brazil, building on the existing partnership established in 2019. The JV further strengthens this relationship with a commitment to jointly bring to market innovative and first-in-class therapeutic radiopharmaceuticals and imaging agents in Brazil.

The market for radiopharmaceuticals in Brazil is experiencing significant growth driven by the increasing prevalence of chronic diseases such as cancer, advancements in imaging technologies, and a growing senior population. Over the next decade, the Brazilian radiopharmaceuticals market is projected to reach US$330 million[4], with this growth supported by rising investments in the healthcare industry, public health awareness, and the introduction of new and advanced radiopharmaceuticals.

Under the agreement, Telix and R2PHARMA will establish a JV company in Brazil (Telix Innovations Brazil, Ltda.). Telix Innovations Brazil will hold the exclusive licence to commercialize and distribute Illuccix® as well as future product candidates from Telix's industry-leading theranostic pipeline. Telix Innovations Brazil will leverage the local knowledge and expertise of R2PHARMA to obtain the necessary licenses and governmental authorizations in Brazil[5].

Raphaël Ortiz, CEO Telix International, added, "Telix is pleased to bring Illuccix to Brazil and Latin America, with this new imaging modality now recognized in leading clinical practice guidelines and already being adopted in other parts of the world. We would like to acknowledge our partner R2PHARMA for their commitment to gallium-based PSMA-PET and the hope this brings for men living with prostate cancer in Brazil. The JV takes our collaboration to the next stage with the aim to address unmet need for therapeutic and diagnostic radiopharmaceuticals across a range of disease areas."

R2PHARMA Nuclear Medicine & Innovation Vice-President, Rafael Madke, continued, "We are delighted to have been granted this marketing authorization for Illuccix in Brazil. The combination of Telix's innovative theranostic pipeline and R2PHARMA's manufacturing and distribution capabilities will support widespread access for patients and physicians to Illuccix and future additional products that until now have not been available in Latin America."

For more information visit: http://r2pharma.com.