Sanofi has made a late entry to the radioligand party, paying 100 million euros ($110 million) upfront for global rights to a neuroendocrine tumor treatment that is nearing a filing for approval.
The French drugmaker has stayed on the sidelines as a who’s who of drugmakers, led by Novartis, have placed big bets on radioligand therapies. Sanofi is entering the sector through a deal with RadioMedix and Orano Med for a targeted alpha therapy that is designed to deliver a payload to cells that express somatostatin, a receptor found in most neuroendocrine tumors.
In clinical studies, 62.5% of patients who received the drug candidate, called AlphaMedix, had durable responses. The candidate is currently completing phase 2 development, and talks with the FDA about a potential regulatory filing are underway.
Sanofi will handle global commercialization of the therapy. The Big Pharma is paying RadioMedix and Orano Med 100 million euros upfront and committing up to 220 million euros in sales milestones for the rights to the asset. Orano Med will be responsible for the manufacturing of AlphaMedix.
Dietmar Berger, M.D., Ph.D., global head of development at Sanofi, discussed the decision to license AlphaMedix in a statement. Berger said the early clinical data have shown the treatment’s “differentiated biophysical and clinical profile, reinforcing its potential to be a transformative radioligand therapeutic for patients across multiple difficult-to-treat rare cancers.”
Novartis received FDA approval for its radioligand therapy Lutathera in certain neuroendocrine tumors in 2018. RadioMedix allowed enrollment of some patients who had received Lutathera in its phase 2 trial, generating data on AlphaMedix’s use as a first-line option and in people who progress on Novartis’ drug. Lutathera is a beta particle emitter, whereas AlphaMedix is an alpha therapy.
Sanofi fielded a question about its appetite for radiopharma on its second-quarter earnings call in July. In response, Houman Ashrafian, Ph.D., head of R&D at Sanofi, noted the resurgence of interest in radioligand therapy and said the company remained “watchful in this space.” Sanofi CEO Paul Hudson added details on what it would take for the company to go from watcher to participant.
“We've made trade-offs to stay very focused,” Hudson said. “We would have to feel there was something adding to make us want to go outside of what we do because we are really focused on the areas that we want to win and play.”