Sanofi’s Enjaymo, the only approved drug therapy for a rare and debilitating blood disorder, is being acquired by Recordati in a deal that helps the Italian company build its rare disease portfolio and expand its commercial reach in key markets.
Recordati is paying $825 million up front for global rights to Enjaymo, a drug that is approved in the U.S., Japan, and Europe. If the drug achieves sales milestones, the company could pay out up to $250 million more, according to deal terms announced Friday. Sanofi and Recordati expect to complete the transaction by the end of this year.
Enjaymo treats cold agglutinin disease, a condition in which the immune system attacks red blood cells and causes them to rupture. This process happens at cold temperatures, giving the disease its name. At these temperatures, antibodies that normally attack bacteria instead attach to red blood cells, causing them to bind together, or agglutinate. The red blood cells are destroyed by the immune system, leading to anemia.
The resulting anemia can be managed with blood transfusions. Enjaymo takes a different approach by interfering with the process that leads to red blood cell destruction in cold agglutin disease. The drug, an intravenously infused monoclonal antibody, is designed to selectively target and block a complement system protein called C1. This in turn stops immune system antibodies from attaching to immune cells. The FDA approved Enjaymo in 2022. Approvals in Japan and Europe soon followed. In these three markets, the companies estimate cold agglutin disease affects between 11,000 and 12,000 patients.
Recordati, which is headquartered in Milan, is the latest stop in a long journey for Enjaymo. The drug was initially developed by True North Therapeutics, which itself was acquired by Bioverativ in 2017. In 2018, Sanofi paid $11.6 billion to buy Bioverativ. Enjaymo generated €72 million (about $79 million) in sales last year, a 240% increase over the product’s sales in 2022, according to Sanofi’s annual report.
Sales for Enjaymo are continuing to grow, but it’s not on track to become a blockbuster seller. Recordati said that in the 12 months ending in August, the drug accounted for €100 million (about $109 million) in revenue. The company projects the product’s peak sales could reach €250 million to €300 million (about $274 million to $328 million). Recordati said its milestone payment to Sanofi is tied to the achievement of net sales at or above the top end of peak year sales expectations.
Rare disease accounts for about 34% of Recordati’s more than €2 billion in annual revenue, according to a September investor presentation. Most of those rare disease sales are in the U.S. Much of the company’s rare disease portfolio is comprised of assets from its 2022 acquisition of EUSA Pharma, a developer of drugs for rare cancers.
In a prepared statement, Recordati CEO Rob Koremans said Enjaymo is particularly complementary to one of those products, Sylvant. This drug, an antibody designed to block the inflammatory signaling protein IL-6, has approvals in more than 40 countries for treating idiopathic multicentric Castleman disease, a rare disorder characterized by abnormal growth of the lymph nodes. While this disease is not cancer, its progression is similar to that of lymphoma, a cancer of the lymph nodes. Last year, Recordati began exploring the development of Sylvant for other diseases driven by IL-6 signaling.
“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,” Koremans said. “Most importantly, with a strong clinical profile and as the only product approved for the treatment of [cold agglutinin disease], Enjaymo addresses a serious unmet medical need for patients living with this debilitating disease.”
Image by istocksdaily, via Getty Images
