Sanofi Enters Radiopharmaceuticals with €100M Therapy to Compete with Novartis

Sanofi has joined several other major pharmaceutical companies in the field of radiopharmaceuticals by licensing AlphaMedix, a therapy intended for a rare form of gastrointestinal cancer. The agreement, disclosed on Thursday, involves Sanofi paying an initial €100 million (approximately $110 million) to RadioMedix and Orano Med, the developers of AlphaMedix. Sanofi will also provide up to €220 million (approximately $242 million) in additional payments if certain milestones are achieved, along with royalties from future sales.

AlphaMedix is being developed to treat neuroendocrine tumors (NETs), which are rare cancers originating in neuroendocrine cells found throughout the body. These tumors are most commonly found in the gastrointestinal tract and pancreas. The majority of NETs exhibit high levels of somatostatin receptors, a protein that the therapy targets.

This radiopharmaceutical uses a radioactive isotope attached to a molecule specifically designed to target these receptors. AlphaMedix uses 212Pb linked to a peptide complex that seeks out somatostatin. Under the guidance of Houston-based RadioMedix, AlphaMedix has reached Phase 2 clinical trials. This open-label study included patients new to peptide receptor radionuclide therapy as well as those who had previously undergone such treatments. Early results indicate that the therapy was well tolerated and significantly reduced tumor burden, achieving a durable response rate of 62.5%.

RadioMedix Chairman and CEO Ebrahim Delpassand commented that alpha emitters deliver higher energy over shorter distances in tissue, potentially overcoming the limitations of current beta emitter therapies. He emphasized that 212Pb is an optimal alpha emitter due to its favorable physical and supply characteristics compared to other alpha emitters.

While the Phase 2 trial is ongoing, Sanofi and RadioMedix are already discussing the data with the FDA for a potential regulatory submission. According to the licensing agreement, Sanofi will be responsible for the global commercialization of AlphaMedix. Orano Med will handle the manufacturing using a platform that is still in development.

The first radiopharmaceutical approved for gastroenteropancreatic neuroendocrine tumors (GEP-NETs) was Novartis's Lutathera, which received FDA approval in 2018. Lutathera targets somatostatin receptors and delivers a beta-emitting radioactive substance to the cancer cells.

In recent years, other pharmaceutical companies have also made significant investments in radiopharmaceuticals. Bristol Myers Squibb has a GEP-NETs drug candidate in late-stage development following its $4 billion acquisition of RayzeBio last year. Eli Lilly acquired Point Biopharma Global for $1.4 billion, and AstraZeneca agreed to acquire Fusion Pharmaceuticals for $2 billion in March.

With these strategic moves, pharmaceutical companies are increasingly recognizing the potential of radiopharmaceuticals to provide targeted, effective treatments for various cancers, including rare types like NETs. Sanofi’s entry into this space with AlphaMedix highlights the growing interest and investment in this innovative field of oncology.

How to obtain the latest research advancements in the field of biopharmaceuticals?

In the Synapse database, you can keep abreast of the latest research and development advances in drugs, targets, indications, organizations, etc., anywhere and anytime, on a daily or weekly basis. Click on the image below to embark on a brand new journey of drug discovery!