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Announced today, Melbourne-based biotech Telix Pharmaceuticals (ASX: TLX) is a step closer to launching its prostate cancer diagnostic agent Illuccix in Europe after securing authorisation for its commercial distribution.
The company announced it received a positive decision on its Marketing Authorization Application following approval from Germany’s Federal Institute for Drugs and Medical Devices (BfArM). This decision, made through a decentralised procedure, means all 18 participating European Economic Area countries have agreed to grant marketing authorisation.
The process will now move into the final administrative phase to enable the commercial rollout of Illuccix across Europe. The product will be used when diagnosing high-risk prostate cancer before starting treatment, checking for cancer that might have returned when prostate-specific antigen (PSA) levels rise after treatment and finding advanced prostate cancer that has spread.
“We are delighted by this positive outcome, setting the stage for a European commercial launch of Illuccix,” Telix Precision Medicine CEO Kevin Richardson said.
“This clinically important prostate cancer imaging modality is currently recommended in international clinical practice guidelines including European Association of Urology (EAU) and European Society for Medical Oncology (ESMO).”
Founded in 2015 by Dr Christian Behrenbruch and Dr Andreas Kluge, Telix manufactures Illuccix - a radioactive diagnostic agent has also been approved by the US Food and Drug Administration (FDA), the Australian Therapeutic Goods Administration (TGA) and Health Canada.
The news about European approval comes just four days after the company announced it secured a deal to acquire US antibody engineering biotech ImaginAb for $73 million.
In 2024, Telix acquired a number of companies, including Florida-based radiopharmacies group RLS for $366m, therapeutic radiopharmaceuticals firm QSAM $188 million and Canada-based radioisotope production tech firm ARTMS for $86 million.
The company has grown its international operations to the US, Japan, Switzerland and Belgium, where in June 2023 it opened a world-class $21 million radiopharmaceutical nuclear medicine facility.
Telix’s market capitalisation has grown rapidly, having initially listed on the ASX in late 2017 with a $128 million valuation. At the time of writing, shares are trading at $25.59 each. Over the past 12 months, shares in TLX have soared by 136 per cent.
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