Nearly $1.1 billion! Sanofi Sells a Rare Disease Monoclonal Antibody Drug

On October 4, 2024, Recordati announced an agreement with Sanofi to acquire global rights to its C1s monoclonal antibody, Enjaymo? (sutimlimab). Enjaymo targets the serine protease C1s in the C1 complex, which is associated with the activation of the classical complement system, thereby inhibiting hemolysis without affecting the lectin and alternative pathways. Notably, Enjaymo is the first and only approved treatment for cold agglutinin disease (CAD). 

Under the terms of the agreement, Recordati will make an upfront payment of $825 million, with an additional $250 million in milestone payments if net sales reach or exceed peak sales expectations. The deal is expected to close by the end of 2024, pending regulatory approval.

Enjaymo was approved in 2022 in the U.S., Europe, and Japan for treating adult hemolysis in patients with CAD. This is a rare autoimmune hemolytic anemia where the immune system's complement system mistakenly attacks healthy red blood cells, causing them to rupture (hemolysis). Enjaymo's approval was based on positive results from a 26-week, open-label, single-arm Phase 3 clinical trial. The trial results showed that Enjaymo met its primary efficacy endpoint, with 54% of patients achieving the composite endpoint, defined as either an increase in hemoglobin (Hgb) levels of at least 2 g/dL from baseline or normalization of Hgb levels to above 12 g/dL by the assessment period (the average of weeks 23, 25, and 26), without needing a blood transfusion from week 5 to week 26.

As of August 2024, Enjaymo? generated approximately €100 million (about $110 million) in revenue over the past 12 months, with revenue projected to exceed €150 million ($165 million) in fiscal 2025. Peak sales could reach €250-300 million ($274-329 million), more than double the current level. Depending on the closing date of the transaction, Recordati expects minimal revenue contribution for 2024. However, the deal is expected to immediately boost EBITDA, with profit margins surpassing the current average in the rare disease sector by 2025.

For Recordati, this deal strengthens its expansion into the rare disease market. In December 2021, the company acquired EUSA Pharma and its portfolio of four rare disease drugs for nearly $850 million. In recent years, Recordati has also struck deals with companies like GlaxoSmithKline (GSK) and Almirall. 

Recordati CEO Rob Koremans commented, "This transaction aligns with our broader strategy, reaffirming our commitment to the rare disease field and complementing our oncology portfolio, particularly Sylvant?. Enjaymo? further expands our rare disease business in the U.S., Japan, and Europe, contributing positively to our revenues and profits. Most importantly, Enjaymo? has demonstrated strong clinical performance and is the only approved treatment for CAD, addressing a significant unmet medical need for patients suffering from this debilitating disease."

The deal comes as Sanofi is also reshaping its portfolio. Under the leadership of its new Head of Research and Development, Houman Ashrafian, and new Chief Scientific Officer, Mike Quigley, who joined on September 30, the company plans to focus on the immunology and inflammation fields. Sanofi also intends to divest its consumer healthcare group, Opella. Earlier this year, Sanofi sold some early-stage cancer projects to Vir Biotechnology and closed a cell therapy unit, although it is still making some bets in oncology, including its first foray into radiopharmaceuticals. Sanofi has also invested in companies like Ventyx, Vicore, and Graviton.