Last week, Australia-based Telix acquired RLS, a major radiopharmacy network with 31 sites across the US, continuing a trend in radiopharma towards vertical integration, given the unique complexities of the supply chain.
Telix, which pulled a proposed US IPO at the last minute in June, has also acquired ARTMS and IsoTherapeutics (companies specializing in isotope production, radiochemistry, and bioconjugation), with the goal of expanding their presence in the U.S. radiopharmaceutical space.
The unique nature of radiopharmaceuticals, with their inherently short shelf-lives dictated by the radioisotope's half-life, heightens the urgency for a robust, tight supply chain. For instance, Pluvicto, the leading marketed radiopharmaceutical, has a shelf-life of a mere five days after calibration.
An instructive example of the fragility of the supply chain occurred with BMS/RayzeBio’s ACTION-1 phase 3 study, which had to pause some patient enrollment due to a shortage of the radioisotope actinium-225.
Similarly, Novartis faced challenges last year, temporarily halting Pluvicto distribution and new patient enrollment due to manufacturing issues. The company has continued to invest heavily in new production, including a $200M investment announced last month for a new facility in Carlsbad, CA.
Lilly is also active in the space, entering a collaboration worth $1.1 billion with Aktis Oncology to develop new radiopharmaceuticals to treat a range of solid tumors. Additionally, Lilly made a financing deal with Ionetix, an isotope manufacturer, to secure a reliable supply of radioisotopes.
Meanwhile, Sanofi has entered into licensing agreements with RadioMedix and Orano Med, worth a total of €100 million in upfront payments, to develop the breakthrough therapy-designation AlphaMedix for neuroendocrine tumors.
Currently in Phase 2 clinical trials, AlphaMedix is being developed for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and has potential to compete directly with Novartis’ RLTs.
Novartis has the largest radiopharmaceutical pipeline thus far, with 7 RLTs currently in clinical trials across 13 oncology indications. Telix follows closely with 4 RLTs at the clinical stage for various oncology indications.
As the radiopharmaceutical landscape continues to evolve, securing a reliable and resilient supply chain will remain critical, and will provide a true competitive advantage to serving patients effectively.
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