September 27, 2024
One factor potentially limiting the progress of radiopharmaceuticals is supply: securing a reliable and resilient supply chain. Disruptions in the radiopharmaceutical supply chain can have severe consequences, including halting clinical trials and impeding patient access to life-saving treatments.
Supply Chain Vulnerabilities: A Stark Reality
Recent events have highlighted the vulnerabilities inherent in the radiopharmaceutical supply chain. In a sobering example, RayzeBio, a subsidiary of Bristol Myers Squibb, was forced to pause patient enrollment for the international arm of its ACTION-1 Phase 3 clinical trial due to a shortage of the radioisotope actinium-225. Similarly, Novartis faced manufacturing challenges last year, temporarily halting the distribution of its radiopharmaceutical Pluvicto and preventing new patient enrollment.
The unique nature of radiopharmaceuticals, with their inherently short shelf-lives dictated by the radioisotope's half-life, heightens the urgency for a robust and tightly controlled supply chain. For instance, Pluvicto's shelf-life is a mere five days after calibration, leaving a narrow window for distribution and administration to patients.
Vertical Integration: A Strategic Imperative
Recognizing these challenges, several companies are taking proactive steps to vertically integrate and fortify their supply chains. Telix Pharmaceuticals, an Australian radiopharmaceutical company, has embarked on an acquisition spree. This includes the $230 million purchase of RLS Radiopharmacies, which boasts 31 radiopharmacies across 18 U.S. states.
Telix 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. Additionally, Telix acquired QSAM Biosciences and its clinical pipeline, including the lead asset samarium-153-DOTMP for pain management in patients with bone metastases and osteosarcoma.
Strategic Partnerships and Investments
Other pharmaceutical giants are also making strategic moves to secure their radiopharmaceutical supply chains. Eli Lilly entered into a collaboration worth $1.1 billion with Aktis Oncology to develop new radiopharmaceuticals targeting a range of solid tumors. Additionally, Lilly made a financing deal with Ionetix, an isotope manufacturer, to secure a reliable supply of radioisotopes. Prior to Ionetix, Lilly acquired POINT Biopharma and their radiopharmaceutical pipeline.
Sanofi has also made strategic moves, entering into licensing agreements with RadioMedix and Orano Med, worth a total of €100 million in upfront payments, to develop the breakthrough therapy-designated AlphaMedix for neuroendocrine tumors. Currently in Phase 2 clinical trials, AlphaMedix is being developed for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) and has the potential to compete directly with Novartis' Lutathera, the first FDA-approved radiopharmaceutical for GEP-NETs.
Expanding Pipelines and Future Outlook
Novartis currently has the largest radiopharmaceutical pipeline, with seven radioligand therapies in clinical trials across 13 oncology indications. Telix follows closely with four RLTs at the clinical stage for various oncology indications. Other notable players in the radiopharmaceutical space include Mariana Oncology, acquired by Novartis for $1 billion upfront, and its lead program MC-339, a novel RLT designed to target small cell lung cancer.
As the industry continues to expand and more radiopharmaceuticals enter the market, the demand for reliable isotope supply and efficient manufacturing and distribution networks will only intensify. Companies that proactively address these challenges through strategic partnerships, acquisitions, and investments in vertically integrated supply chains will be better positioned to capitalize on the potential of radiopharmaceuticals in the fight against cancer.
