Sanofi sells Enjaymo to Recordati for $825M upfront

Sanofi is divesting its rare autoimmune disease medication, Enjaymo, to an Italian pharmaceutical company, Recordati, for an upfront payment of $825 million. Additionally, Recordati has committed to paying up to another $250 million over time for the monoclonal antibody. Enjaymo was approved in the United States, Europe, and Japan in 2022 for the treatment of hemolysis in adults with cold agglutinin disease (CAD), a rare condition where the immune system destroys red blood cells prematurely, leading to severe anemia.

In the first half of 2024, Sanofi reported €55 million ($60 million) in sales from Enjaymo. Recordati projects that annual peak sales of the drug could reach between €250 million and €300 million (approximately $275 million to $330 million). This transaction underscores Enjaymo's long journey through the biotech and pharmaceutical sectors. Initially developed by True North Therapeutics, a biotech company in the Bay Area, the drug was acquired by Bioverativ for $400 million upfront in 2017. Less than a year later, Sanofi purchased Bioverativ for nearly $11.6 billion. After undergoing a setback with a rejection, Enjaymo finally gained approval in 2022.

For Recordati, this acquisition further cements its position in the rare disease market. The Milan-based company had previously acquired EUSA Pharma and its four rare disease drugs for almost $850 million in December 2021. Over the years, Recordati has also made agreements with major pharmaceutical firms like GSK and Almirall, among others.

Rob Koremans, CEO of Recordati, emphasized the importance of Enjaymo in addressing the unmet medical needs of patients suffering from CAD. He noted that Enjaymo has a strong clinical profile and is currently the only approved treatment for this debilitating disease. Earlier this year, companies like Sobi and Apellis Pharmaceuticals halted a Phase 3 trial in CAD, citing a decreased medical need and hence a limited pool of eligible patients for the study.

According to the National Organization for Rare Disorders, CAD impacts around one person per million annually. The deal with Recordati comes as Sanofi is recalibrating its portfolio under the leadership of new R&D head Houman Ashrafian and new Chief Scientific Officer Mike Quigley, who took office on September 30. Sanofi is currently focusing on immunology and inflammation and plans to divest its consumer health division, Opella.

Earlier this year, Sanofi sold some early-stage oncology projects to Vir Biotechnology and closed a cell therapy unit, although it continues to make strategic investments in oncology, including its first venture into radiopharmaceuticals. The French pharmaceutical giant has also made investments in companies such as Ventyx, Vicore, and Graviton.

Enjaymo's sale is part of a broader strategy by Sanofi to refine its focus and shed non-core assets while investing in promising areas of research and development. Recordati's acquisition signifies its growing emphasis on rare diseases, a niche market with substantial potential for growth and innovation. The deal highlights the evolving landscape of pharmaceutical mergers and acquisitions, especially in the specialized field of rare diseases.