Sanofi’s Enjaymo, the singular approved therapeutic for a rare and challenging blood disorder known as cold agglutinin disease, is being acquired by the Italian pharmaceutical company Recordati in a strategic move to enhance its rare disease product line and broaden its market reach. The deal involves a base payment of $825 million for global rights to Enjaymo, with the possibility of an additional $250 million contingent on future sales milestones. This acquisition, expected to finalize by year’s end, signifies a major step for Recordati in bolstering its portfolio in the rare disease sector.
Cold agglutinin disease triggers the immune system to mistakenly attack and destroy red blood cells at cold temperatures, leading to severe anemia. The disease is named for the process of ‘agglutination’ where antibodies, instead of targeting bacteria, bind to red blood cells causing them to clump together and subsequently be destroyed by the immune system. Enjaymo, an intravenous monoclonal antibody, counters this by specifically targeting and blocking the C1 protein in the complement system, preventing the destructive binding of immune system antibodies to the red blood cells.
Enjaymo has received regulatory approval across three major markets: the U.S., Japan, and Europe, with an estimated patient population between 11,000 and 12,000. Initially developed by True North Therapeutics and later coming under the wing of Sanofi through several acquisitions, Enjaymo marked sales of approximately $79 million last year, reflecting a 240% increase from its previous year. The drug’s growing sales have continued, with recent figures showing a revenue of about $109 million; however, it is not anticipated to reach blockbuster status. Recordati projects Enjaymo’s peak annual sales could be between approximately $274 million and $328 million, and has linked a portion of the payment to Sanofi to achieving these sales targets.
Recordati, headquartered in Milan, attributes about 34% of its annual revenue exceeding $2 billion to its rare disease sector, largely powered by its acquisitions, such as the 2022 purchase of EUSA Pharma. This element of their business primarily consists of treatments for rare cancers and has a significant market presence in the U.S.
One of the notable drugs in Recordati’s portfolio is Sylvant, an antibody that inhibits the inflammatory protein IL-6 and is approved in over 40 countries for a rare lymph node disorder called idiopathic multicentric Castleman disease. Although not a cancer, the disease’s progression mimics that of lymphoma. Recordati has been exploring other potential applications of Sylvant involving IL-6 signaling, suggesting its strategy to maximize the utility of its products in treating rare diseases.
The acquisition of Enjaymo aligns with Sylvant, enhancing Recordati’s offerings in the rare disease domain, particularly in key markets such as the U.S., Japan, and Europe. Recordati CEO Rob Koremans expressed that Enjaymo complements their portfolio well and is pivotal for addressing an unmet need in treating cold agglutinin disease, thus expecting it to positively impact the company’s financial health and offer critical benefits to patients suffering from this debilitating condition. This strategic acquisition marks a significant expansion of Recordati’s footprint in the rare diseases market, providing it with a unique product that addresses a critical gap in care.
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