Supply Shortages Eased as Telix’s Illuccix Wins UK Regulatory Green Light

Regulatory Milestone in the UK

Telix Pharmaceuticals Limited (ASX: TLX, Nasdaq: TLX) has announced a significant regulatory achievement with the UK Medicines and Healthcare Products Regulatory Agency (MHRA) granting marketing authorization for Illuccix®, its gallium-68 gozetotide injection used in prostate cancer PET imaging. This approval marks a key expansion for Telix’s prostate cancer diagnostic portfolio, enabling the detection and localization of prostate-specific membrane antigen (PSMA)-positive lesions in adult patients.

PSMA-PET imaging represents a transformative advance over traditional bone scans and CT imaging, offering superior accuracy for staging primary prostate cancer and evaluating biochemical recurrence or persistence. The UK’s endorsement aligns with global clinical guidelines that increasingly recommend PSMA-PET as the new standard of care.

Addressing Supply Shortages and Access Challenges

One of the pressing challenges in the UK and Europe has been the shortage of PSMA-PET imaging agents, leading to delays in critical diagnostic scans. Professor Gary Cook of King’s College London highlighted the escalating demand and supply constraints, emphasizing the urgent need for reliable access. Illuccix’s approval and subsequent distribution are poised to alleviate these bottlenecks, improving equity of access for patients nationwide.

Telix’s CEO for International operations, Raphaël Ortiz, underscored the practical advantages of Illuccix, noting that the gallium-68 radioisotope can be produced locally using a generator system. This capability reduces dependence on complex supply chains and allows for rapid preparation with minimal equipment, facilitating broader availability including in non-metropolitan areas.

Strategic Distribution and Market Positioning

Illuccix will be distributed exclusively in the UK through Xiel Limited, a specialist in nuclear medicine and diagnostic radiology technologies. This partnership aims to ensure efficient supply and support for healthcare providers adopting PSMA-PET imaging. UK clinicians can now order Illuccix directly from Xiel, streamlining access to this advanced diagnostic tool.

Illuccix’s approval in the UK follows its earlier regulatory successes in the US, Australia, Canada, Denmark, and pending approvals across 19 European countries. This broad regulatory footprint positions Telix as a leading player in the emerging radiopharmaceutical imaging market for prostate cancer.

Implications for Telix and the Prostate Cancer Imaging Landscape

The MHRA approval is a critical commercial milestone for Telix, potentially driving revenue growth and market penetration in a high-demand segment. The ability to produce the imaging agent locally with a generator system may offer Telix a competitive edge in cost and logistics, particularly in decentralized healthcare settings.

As PSMA-PET imaging increasingly replaces conventional methods, Telix’s Illuccix could become a cornerstone diagnostic tool, influencing treatment decisions and patient outcomes. The company’s ongoing efforts to expand approvals and distribution networks will be key to capitalizing on this opportunity.