Sanofi's Rare Blood Disease Drug Sold to Recordati for $825M

Sanofi’s Enjaymo, the sole approved therapy for a rare and debilitating blood disorder, is being acquired by Recordati. This acquisition aids the Italian company in bolstering its rare disease portfolio and extending its reach in key markets. Recordati will pay $825 million upfront for global rights to Enjaymo, a drug approved in the U.S., Japan, and Europe. The deal terms also include potential milestone payments up to $275 million contingent on sales achievements. Both companies aim to finalize the transaction by the year's end.

Enjaymo addresses cold agglutinin disease, an autoimmune condition where the immune system attacks red blood cells, leading to their rupture at low temperatures. In cold conditions, antibodies that usually target bacteria instead attach to red blood cells, causing them to stick together or agglutinate. This results in the red blood cells being destroyed by the immune system, leading to anemia.

Traditionally, anemia resulting from this condition is managed through blood transfusions. However, Enjaymo takes a different approach by interrupting the process that causes red blood cell destruction. The drug is an intravenously infused monoclonal antibody that selectively targets and blocks a complement system protein called C1. This action prevents immune system antibodies from attaching to red blood cells. The FDA approved Enjaymo in 2022, with subsequent approvals in Japan and Europe. Estimates suggest that cold agglutinin disease affects between 11,000 and 12,000 patients across these markets.

Recordati, based in Milan, adds Enjaymo as a significant acquisition in its portfolio. The drug's journey began with its development by True North Therapeutics, which Bioverativ later acquired in 2017. Sanofi purchased Bioverativ in 2018 for $11.6 billion. Enjaymo generated approximately €72 million ($79 million) in sales last year, marking a 240% increase from 2022, according to Sanofi’s annual report. The drug’s sales continue to grow, reaching €100 million ($109 million) in revenue over the 12 months ending in August. Recordati projects that Enjaymo’s peak sales could range between €250 million and €300 million ($274 million to $328 million). The milestone payments to Sanofi are linked to achieving net sales at or above the upper end of these projections.

Recordati's rare disease segment contributes roughly 34% of its annual revenue, which exceeds €2 billion, as per a September investor presentation. Most of these rare disease sales are generated in the U.S. Much of this portfolio was enhanced by the 2022 acquisition of EUSA Pharma, a developer of rare cancer therapies.

Recordati CEO Rob Koremans commented that Enjaymo complements their existing product Sylvant, which is approved in over 40 countries for treating idiopathic multicentric Castleman disease, a rare disorder marked by abnormal lymph node growth. Though not a cancer, its progression mimics lymphoma. Recordati has been investigating Sylvant’s potential for treating other diseases driven by IL-6 signaling.

Koremans emphasized that Enjaymo's strong clinical profile and its unique standing as the only approved treatment for cold agglutinin disease address a critical unmet medical need. He noted that the acquisition would enhance Recordati's rare disease presence in the U.S., Japan, and Europe while positively impacting their financial performance.