Recordati has reached an agreement with Sanofi for acquiring the worldwide rights to Enjaymo, the only approved treatment specifically targeting cold agglutinin disease (CAD), a rare B-cell lymphoproliferative disorder.The terms of the acquisition include an upfront payment of $825m from Recordati to Sanofi, plus additional milestone payments of up to $250m contingent on sales performance.This strategic move is set to enhance Recordati’s rare diseases franchise and address a critical unmet medical need.The humanised monoclonal antibody Enjaymo is indicated to treat haemolysis in adults with CAD.
With approvals from the US Food and Drug Administration (FDA), the European Commission, and the Japanese Ministry of Health, Labour and Welfare in 2022, Enjaymo offers a chronic intravenous treatment for this rare condition.
Over the last 12 months as of August 2024, Enjaymo generated revenue of approximately €100m ($110m) and is projected to generate more than €150m in financial year 2025, with peak sales potentially reaching €250-300m.
Enjaymo’s targeted mechanism of action inhibits the C1s in the classical complement pathway, preventing the abnormal breakdown of red blood cells.
The approval of Enjaymo by the FDA in February 2022 marked a significant milestone as the first and only treatment aimed at reducing the need for red blood cell transfusions in adults with CAD.
Subsequent approvals in Japan and Europe further established its role in treating this rare disease, with the EMA maintaining its orphan designation.
Recordati CEO Rob Koremans 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 US, 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.”
The transaction is expected to close by the end of this year, pending regulatory approvals.
CAD is characterised by the destruction of red blood cells due to autoantibodies produced by B cells.