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Sanofi sells rare disease drug Enjaymo to Recordati for $825M upfront

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Sanofi is offloading its rare autoimmune disease medicine Enjaymo to an Italian pharmaceutical company for $825 million upfront.

Recordati, based in Milan, said Friday it will pay up to an additional $250 million over time for the monoclonal antibody, which was greenlit in the US, Europe and Japan in 2022 for hemolysis in adults with cold agglutinin disease (CAD). In patients with the rare condition, their immune system prematurely demolishes red blood cells, and it can lead to severe anemia.

Sanofi recorded €55 million ($60 million) in Enjaymo sales in the first six months of 2024, it said in July. Recordati predicts the drug could reach annual peak sales of €250 million to €300 million (about $275 million to $330 million).

It marks a winding road for Enjaymo, which has gone through the full biotech-to-pharma journey. A Bay Area biotech called True North Therapeutics developed the drug and then was bought by Bioverativ for $400 million upfront in 2017. Less than 12 months later, Sanofi acquired Bioverativ for almost $11.6 billion. Two years after that, Sanofi was handed a rejection for the drug before it was approved in 2022.

For Recordati, the deal pushes it further into the rare disease market. The company bought EUSA Pharma and its four rare disease drugs for nearly $850 million in December 2021. It’s also struck deals with GSK, Almirall and others in recent years.

With “a strong clinical profile and as the only product approved for the treatment of CAD, Enjaymo addresses a serious unmet medical need for patients living with this debilitating disease,” Recordati CEO Rob Koremans said in a press release.

Earlier this year, Sobi and Apellis Pharmaceuticals stopped a Phase 3 in CAD, citing “a decreased medical need in CAD and therefore a limited number of patients eligible for the study.”

CAD affects about one person per million every year, according to the National Organization for Rare Disorders.

The Recordati deal comes as Sanofi adjusts its portfolio. It now plans to hone in on immunology and inflammation under new R&D head Houman Ashrafian and new CSO Mike Quigley, who joined Sept. 30. It’s also planning to divest its consumer health group Opella.

Earlier this year, Sanofi sold some early-stage cancer projects to Vir Biotechnology and shuttered a cell therapy unit, though it’s still making a few bets in oncology, including its first foray into radiopharma. The French drugmaker also has invested in several companies, including Ventyx, Vicore and Graviton.


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