Recordati has announced 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) 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. Food and Drug Administration (FDA), the European Commission (EC) and the Japanese Ministry of Health, Labor and Welfare. Administered as chronic IV treatment, Enjaymo addresses a serious unmet medical need in patients with CAD.
Enjaymo generated approximately €100 million in revenue over the last 12 months as of August 2024 and is expected to generate revenue in excess of €150 million in FY 2025, with peak sales potential of €250-300 million, more than double current levels.
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 at or above the top end of peak year sales expectations. The transaction is expected to close by the end of 2024, subject to regulatory clearances.
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.”
