Recordati to acquire rights to CAD treatment Enjaymo from Sanofi
Acquisition bolsters company’s footprint in rare disease market
Recordati agreed to acquire the global rights to Enjaymo (sutimlimab), the only approved targeted therapy for cold agglutinin disease (CAD), from Sanofi.
“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,” Rob Koremans, MD, CEO of Recordati, said in a company press release. “This transaction is in line with our broader strategy [and] reaffirms our commitment to the rare diseases space.”
Recordati will pay Sanofi an up-front amount of $825 million, with potential additional payments of up to $250 million based on future sales performance. The transaction, expected to close by the end of the year, is subject to regulatory approval.
CAD is a rare autoimmune disorder in which self-reactive antibodies, called cold agglutinins, mistakenly attack red blood cells at cold temperatures, leading to the cells’ destruction. CAD, which is most common in older adults, is estimated to affect about 11,000 people in the U.S., Europe, and Japan.
Mild cases may require only avoidance of cold temperatures to control disease symptoms, which include fatigue and muscle weakness. But in severe cases, red blood cell destruction (hemolysis) may lead to the need for blood transfusions and other kind of treatments, like rituximab, an immunosuppressive medication used off label in CAD.
CAD treatment approved in 2022
Enjaymo was first cleared by the U.S. Food and Drug Administration in 2022 for treating CAD patients with a history of blood transfusions, and its approval was expanded in 2023 to include also those without such history. The treatment was also approved for CAD in Europe and Japan in 2022.
The treatment is an antibody-based therapy that targets and blocks C1, a protein of a part of the immune system called the complement cascade that plays a critical role in CAD-associated autoimmune attacks. Enjaymo is administered directly into the bloodstream every week for two weeks, and every other week thereafter.
Clinical trial data showed Enjaymo helps prevent hemolysis, ease symptoms, reduce the need for blood transfusions, and improve quality of life in CAD patients.
“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,” Koremans said.
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