Sanofi invests $110M in late-stage radioligand therapy, challenging Novartis

Sanofi has recently entered the radioligand therapy sector by acquiring global rights to a neuroendocrine tumor treatment for 100 million euros ($110 million). This move marks the French pharmaceutical giant's foray into a field that has garnered significant interest and investment from leading drugmakers, notably Novartis. The treatment in question, AlphaMedix, is a targeted alpha therapy designed to target cells expressing somatostatin, a receptor found in most neuroendocrine tumors.

AlphaMedix, developed by RadioMedix and Orano Med, has shown promising results in clinical trials. In these studies, 62.5% of patients treated with AlphaMedix experienced durable responses. Currently, the drug is in the final stages of phase 2 development, and discussions with the FDA regarding potential regulatory approval are ongoing. Sanofi has taken on the responsibility of global commercialization for the therapy, committing an additional 220 million euros in sales milestones beyond the initial upfront payment. Orano Med will handle the manufacturing of AlphaMedix.

Dietmar Berger, M.D., Ph.D., global head of development at Sanofi, expressed optimism about the licensing of AlphaMedix. Berger highlighted the early clinical data, emphasizing the treatment’s unique biophysical and clinical profile, which shows promise as a transformative radioligand therapeutic for patients with various hard-to-treat rare cancers.

The radioligand therapy market has been heating up, with Novartis being a notable pioneer. In 2018, Novartis received FDA approval for Lutathera, a radioligand therapy for certain neuroendocrine tumors. RadioMedix allowed some patients who had previously been treated with Lutathera to enroll in its phase 2 trial for AlphaMedix. This generated data on AlphaMedix’s efficacy both as a first-line treatment and for patients who had progressed on Novartis’ drug. While Lutathera is a beta particle emitter, AlphaMedix is an alpha therapy, offering a different mode of action.

Sanofi addressed its interest in radiopharmaceuticals during its second-quarter earnings call in July. Houman Ashrafian, Ph.D., head of R&D at Sanofi, remarked on the renewed interest in radioligand therapies, indicating that the company was maintaining vigilance in this promising field. Sanofi CEO Paul Hudson elaborated on the company’s strategic considerations, explaining that while Sanofi has remained focused on specific areas, the potential of radioligand therapies like AlphaMedix was compelling enough to warrant their entry into this space.

In summary, Sanofi’s acquisition of AlphaMedix marks a significant strategic move into the radioligand therapy market. With promising clinical data and a clear vision for commercialization and manufacturing, Sanofi aims to make a substantial impact on the treatment landscape for neuroendocrine tumors. By leveraging its global reach and resources, Sanofi is poised to navigate the regulatory process and bring this innovative therapy to patients in need.