In sustained rare disease push, Recordati lays out $825M upfront to acquire Sanofi's CAD drug Enjaymo

As Sanofi continues to clean out its medicine chest, Italy’s Recordati is getting in on the action.

Recordati is floating $825 million upfront—plus another $250 million in potential commercial milestones—to get its hands on the global rights to Sanofi’s rare disease biologic Enjaymo.

In 2022, Enjaymo became the first and only therapy specifically approved by the FDA for the treatment of hemolysis, or the destruction of red blood cells, in patients with the uncommon blood disorder cold agglutinin disease (CAD). That same year, Sanofi’s C1 inhibitor also scored CAD green lights in Europe and Japan, Recordati noted in a press release Friday.

The deal is expected to close by the end of 2024, which means Recordati is unlikely to see a revenue boost from Enjaymo before 2025. The Italian drugmaker figures there are around 11,000 CAD patients spread out between the U.S., Japan and Europe.

Enjaymo reeled in sales of around 100 million euros ($110 million) over 12 months ending in August, Recordati said in its release. The drug is expected to generate revenues in the vicinity of 150 million euros ($165 million) over the company’s 2025 fiscal year, with Recordati setting peak sales expectations for Enjaymo at around 250 million euros to 300 million euros ($274 million to $329 million).

“Enjaymo further expands our Rare Diseases footprint in the U.S., Japan and Europe, and will contribute positively to both our top and bottom lines,” Recordati’s CEO, Rob Koremans, said in a statement. “Most importantly, 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.”

Enjaymo has traded hands multiple times throughout its lifespan. Sanofi picked up the drug through its $11.6 billion buyout of Bioverativ in 2018, while Bioverativ itself acquired the medicine—then known simply as sutimlimab—in 2017 through a $400-million deal for True North Therapeutics.

When Sanofi charted its Bioverativ purchase, Citi analyst Peter Verdult dubbed Enjaymo the “most promising pipeline asset” at the acquired company.

Still, the path to approval for Enjaymo wasn’t easy, with the med receiving a complete response letter in November of 2020 after the FDA uncovered deficiencies during an inspection of a contract manufacturer’s plant. There were no clinical or safety issues cited in the FDA’s initial rejection.

For Recordati, the asset purchase marks a continuation of the company’s quest to push further into rare diseases.

In December 2021, the Italian firm paid 750 million euros to acquire U.K.-based EUSA’s portfolio of four drugs to treat rare cancers. Three years before that deal, private equity outfit CVC Capital Partners picked up a controlling stake in Recordati, stating at the time that its goal was to expand the company’s rare disease business.

Meanwhile, Sanofi has repeatedly pawned off assets over the past few years as the company continues to focus more heavily on lucrative areas like immunology.

In August, Sanofi sold a trio of early-stage T-cell engagers to Vir Biotechnology for an undisclosed price. The transaction also gave Vir exclusive use of the protease-cleavable masking platform Sanofi acquired in its $1 billion Amunix Pharmaceuticals buyout.

Before that, Sanofi offloaded 11 central nervous system drugs to life cycle management company Pharmanovia—a deal that itself followed Sanofi’s divestment of another 15 CNS products to Neuraxpharm in 2022.

Sanofi has also been gradually doling out consumer health products ahead of a planned separation of the unit, which makes products like Allegra, Gold Bond, Icy Hot and Selsun Blue.