Under the deal announced Friday, the Italian pharma will make an upfront payment of $825 million to Sanofi for global rights to a biologic for the treatment of cold agglutinin disease, with milestone payments of up to $250 million.
Sanofi sold Enjaymo, its humanized monoclonal antibody treatment for the rare autoimmune disorder cold agglutinin disease, to Italy’s Recordati in an agreement potentially worth more than $1 billion.
Under the terms of the deal, Milan-based Recordati will pay $825 million upfront and will pledge up to $250 million in sales-based milestones. Recordati will bankroll the purchase using its existing cash and new bank debt, though it maintains that its capital and dividend allocation policies will not be affected by the agreement. The companies expect to complete the acquisition by the end of 2024, subject to regulatory and antitrust clearances as well as other customary closing conditions.
Recordati CEO Rob Koremans in a statement said that the deal with Sanofi “further expands our rare diseases footprint in the U.S., Japan and Europe” while also addressing “a serious unmet medical need for patients living with this debilitating disease.” The Sanofi agreement will also “contribute positively to both our top and bottom lines,” Koremans said.
Afflicting approximately 11,000 patients in the U.S., Japan and Europe, cold agglutinin disease (CAD) is a rare lymphoproliferative disorder in which B-cells produce autoantibodies that attack and destroy the red blood cells. This pathologic process is triggered under cold conditions, typically between 3°C to 4°C. Patients with the disease can suffer severe debilitating fatigue, weakness and other typical symptoms of anemia.
To address CAD, Enjaymo selectively targets the C1 complement protein, which prevents the activation of the complement cascade. This mechanism of action allows Enjaymo to effectively block the complement-mediated destruction of red blood cells. Enjaymo does not inhibit the lectin and alternative complement pathways.
According to Recordati, Enjaymo is the only approved targeted therapy for CAD—it won the FDA’s nod in February 2022—though there are other ways of keeping the disease in check. Per the Cleveland Clinic, patients can adjust their lifestyles to avoid cold temperatures to prevent CAD-driven anemia. Rituxan, an anti-CD20 antibody from Genentech and Biogen, is also typically prescribed to patients.
Enjaymo has been a fast-growing asset for Sanofi, but its sales have been middling. In 2023, the therapy generated nearly $80 million, growing more than 200% from the year prior at constant exchange rates. In the first half of 2024, Enjaymo grew almost 73% year-over-year to bring in around $60 million.
For Sanofi, Enjaymo’s sale appears to be part of a wider strategic shift as CEO Paul Hudson hustles to regain investor confidence after the pharma abandoned its previous goal of hitting 32% operating profit margin by 2025. In December 2023, Sanofi announced in an R&D event that it has 12 investigational assets that could likely hit blockbuster status in the coming years.
