Recordati has entered an agreement with Sanofi to acquire the global rights to Enjaymo (sutimlimab), a biologic which is the only approved targeted product for the treatment of cold agglutinin disease (CAD), a rare B-cell lymphoproliferative disorder.
 
Enjaymo (sutimlimab), administered as chronic IV treatment, is a humanized monoclonal antibody indicated for the treatment of hemolysis in adults with CAD. In 2022, it was granted approval by the U.S. FDA, the European Commission and the Japanese Ministry of Health, Labor and Welfare.  
 
Under the terms of the agreement, Recordati will make an upfront payment of $825 million and additional commercial milestone payments of up to $250 million, if net sales reach certain thresholds. The transaction is expected to close by the end of 2024.
 
Rob Koremans, Chief Executive Officer of Recordati, said, “This transaction is in-line with our broader strategy, reaffirms our commitment to the Rare Diseases space and is complementary to our Oncology portfolio, specifically Sylvant®. Enjaymo® further expands our Rare Diseases footprint in the U.S., Japan and Europe, and will contribute positively to both our top and bottom lines. Most importantly, with a strong clinical profile and as the only product approved for the treatment of CAD, Enjaymo addresses a serious unmet medical need for patients living with this debilitating disease.”
 
Cold agglutinin disease (CAD) is a rare B-cell lymphoproliferative disorder, a subgroup of autoimmune hemolytic anemia (AIHA). CAD symptoms include severe, debilitating fatigue and other anemic manifestations that can significantly impact quality of life.