NEW YORK – With a new licensing deal announced Thursday, Sanofi is the latest drugmaker to join the burgeoning radiopharmaceutical market.
The Paris-based firm inked a deal with Houston-based RadioMedix and Chatillon, France-based Orano Group to develop AlphaMedix (212Pb-DOTAMTATE). The firms are currently developing the lead-212-labeled targeted alpha therapy in somatostatin-positive neuroendocrine cancers in an ongoing Phase II clinical trial. To be eligible for the study, patients can't have received prior treatment with Novartis' Lutathera (lutetium Lu 177 dotatate). Additionally, their cancers must express somatostatin, as confirmed by a PET-imaging agent such as Novartis' NETSPOT (68Ga-DOTATATE) or RadioMedix's Detectnet (64Cu-DOTATATE).
Under the terms of the exclusive licensing agreement, Sanofi will pay RadioMedix and Orano €100 million ($110.3 million) upfront and up to €220 million ($242.7 million) in sales milestones. The firms may be eligible for tiered royalties, too, should the treatment make it to market. In exchange, Sanofi will acquire global commercialization rights to AlphaMedix, while Orano Med will manufacture the treatment with a global industrial platform that it's currently developing.
Earlier this year, the US Food and Drug Administration granted breakthrough therapy designation to AlphaMedix in this patient population based on a 62.5 percent overall response rate and encouraging tolerability. RadioMedix and Orano are in the process of discussing regulatory plans with the FDA as they continue their ongoing Phase II trial.