Recordati has announced a landmark agreement to acquire the worldwide rights to Enjaymo from Sanofi, marking a significant expansion of its rare disease portfolio. The deal, valued at $825 million upfront with potential additional milestone payments of up to $250 million, centers around the only approved treatment specifically targeting cold agglutinin disease (CAD).
Strategic Acquisition Details and Market Potential
The transaction represents a major strategic move for Recordati, strengthening its position in the rare disease space. Enjaymo has demonstrated strong commercial potential, generating approximately €100 million ($110 million) in revenue over the last 12 months as of August 2024. Financial projections indicate revenues exceeding €150 million by 2025, with peak sales estimates ranging between €250-300 million.
Clinical Significance and Treatment Innovation
Enjaymo (sutimlimab) represents a breakthrough in CAD treatment as a humanized monoclonal antibody that specifically targets the C1s protein in the classical complement pathway. This mechanism of action prevents the abnormal destruction of red blood cells characteristic of CAD, a rare B-cell lymphoproliferative disorder where autoantibodies attack and destroy red blood cells.
Regulatory Status and Global Reach
The treatment has secured approval from major regulatory bodies worldwide, including:
- U.S. Food and Drug Administration (February 2022)
- European Commission (2022)
- Japanese Ministry of Health, Labour and Welfare (2022)
These approvals established Enjaymo as the first and only treatment specifically designed to reduce the need for red blood cell transfusions in adult CAD patients.
Impact on Patient Care
"This transaction reaffirms our commitment to the rare diseases space and is complementary to our oncology portfolio," stated Recordati CEO Rob Koremans. "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."
Transaction Timeline
The acquisition is expected to be completed by the end of the year, subject to standard regulatory approvals. The deal will expand Recordati's presence in key markets including the US, Japan, and Europe, while contributing positively to both top and bottom lines of the company's financial performance.
