BioCryst Pharmaceuticals is selling the European rights and assets for its top product for $250 million, cash that the rare disease drug developer will use to pay off debt.
The buyer is privately held Neopharmed Gentili. Beyond the upfront payment, the deal terms announced Friday put Research Triangle Park, North Carolina-based BioCryst in line for $14 million in milestones payments associated with Central and Eastern European sales of the drug, Orladeyo.
Orladeyo was developed for hereditary angioedema (HAE), an inherited disorder that leads to swelling attacks in various parts of the body. These attacks can become fatal when they close off a patient’s airway. The BioCryst drug is an oral small molecule inhibitor of kallikrein, a protein that plays a role in the swelling and inflammation that develops in HAE attacks. The FDA approved BioCryst’s once-daily pill in 2020 for the prevention of HAE attacks in adults and children age 12 and older. It won marketing authorization in Europe the following year.
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Neopharmed Gentili has drug partnerships with Merck focused on diabetes products, and with Merck spinoff Organon, spanning multiple therapeutic areas. The Milan, Italy-based pharmaceutical company also has an alliance with Teva Pharmaceutical on the asthma drug DuoResp Spiromax. The company said landing European rights to Orladeyo broadens its business and gives it a presence in rare disease.
BioCryst and Neopharmed Gentili expect to close the deal by early October. BioCryst said it will use the proceeds to retire $249 million in remaining debt, eliminating about $70 million in future interest payments. Selling the European business will also save BioCryst about $50 million in annual expense. The company expects it will end 2027 with about $700 million in cash, an increase of $400 million from its prior 2027 cash guidance. In a prepared statement, CEO Jon Stonehouse said BioCryst’s increased profitability puts the company in a stronger position to continue to grow the Orladeyo business and the drug pipeline. The company may also explore external opportunities.
Orladeyo is BioCryst’s main source of revenue, accounting for $437.6 million in sales in 2024, according to the company’s annual report. Of that total, $385.9 million was from the U.S. The next growth opportunity for Orladeyo is reaching younger children. An oral granule formulation of the drug is under FDA priority review for the prevention of HAE attacks in children age 2 to 11; a regulatory decision is expected by Sept. 12. Takeda Pharmaceutical’s kallikrein inhibitor Takhzyro is also approved for preventing HAE in young children, but is administered by injection. BioCryst holds global rights to the oral granule formulation of Orladeyo, which would offer young children an easier dosing option.
There are other HAE drugs available for patients age 12 and older, but they’re all administered as injections. Pharming Group’s drug Ruconest is a C1 esterase inhibitor. Two weeks ago, CSL Behring landed FDA approval for Andembry, an inhibitor of a plasma protein called factor XIIa. CSL Behring already markets markets two C1 esterase inhibitors: Berinert, for acute treatment of HAE attacks, and Haegarda, for HAE prophylaxis.
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KalVista Pharmaceuticals has a once-daily oral kallikrein inhibitor, sebetralstat, currently under FDA review. Earlier this month, KalVista disclosed that the FDA said it would not meet the June 17 target date for a regulatory decision. KalVista is also studying this drug for use in children age 2 to 11.
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