Sanofi enters radiopharmaceuticals with $110M, targeting Novartis's market

Sanofi, a major player in the pharmaceutical industry, has recently emphasized becoming a leading force in immunology. However, the company has also demonstrated a renewed interest in oncology. On Thursday, Sanofi announced significant licensing agreements with radiopharmaceutical firms RadioMedix and Orano Med, accumulating to €100 million (approximately $110 million) in upfront payments. These two companies are collaborating on AlphaMedix, an innovative medication currently in Phase 2 trials that has received breakthrough therapy designation.

Sanofi plans to expedite the development and regulatory approval process for the experimental radioligand, which targets gastroenteropancreatic neuroendocrine tumors (GEP-NETs). This move places Sanofi in direct competition with Novartis, the producer of Lutathera, a radiopharmaceutical approved by the FDA in early 2018. The ongoing Phase 2 trials are nearing completion, and the data is being discussed with the FDA for potential regulatory filing and approval. AlphaMedix features a somatostatin receptor-targeting peptide radiolabeled with lead-212 (212Pb).

Although Sanofi has previously scaled back its oncology initiatives, including transferring T cell engager technology to Vir Biotechnology and shuttering a natural killer cell therapy biotech, the company is now entering the radiopharmaceutical sector. In a recent earnings call, Sanofi's head of R&D, Houman Ashrafian, mentioned that while the company had no active radiopharmaceutical projects, they remained vigilant and considered entering areas with truly differentiated therapies. A Sanofi spokesperson later confirmed that AlphaMedix is the first radioligand therapy in their pipeline.

The radiopharmaceutical domain has faced challenges related to supply chain and manufacturing issues, making it a competitive and complex field to penetrate. Nevertheless, this area has seen increased interest, with several large pharmaceutical companies such as Bristol Myers Squibb, AstraZeneca, Novartis, and Eli Lilly making moves in this space. Bayer is also active in the field, and its radioisotope supplier, PanTera, recently secured $103 million in financing.

In addition to the €100 million upfront payment, RadioMedix and Orano Med could potentially earn up to €220 million ($242 million) in aggregate sales milestones, along with tiered royalties. Sanofi will be responsible for commercialization while Orano Med will handle manufacturing.

RadioMedix CEO and chair, Ebrahim Delpassand, expressed confidence in the potential of lead-212 (212Pb) as an ideal alpha emitter, citing its favorable physical and supply characteristics. Delpassand, who has extensive experience in the field, was previously listed as a trial investigator in research on Lutathera.

Orano Med has been proactive in expanding its alpha therapy production capabilities. In June, the company unveiled a new production site near Indianapolis and initiated the construction of another facility in France for the European market last year. Additionally, Orano Med operates a research unit in Plano, TX. The company anticipates producing 10,000 doses annually by 2025, with projections to exceed 100,000 doses per year by the end of the decade.