Aprocitentan is currently under review with the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) set for 19 December. Image Credit: Wasan Tita / Shutterstock.

Idorsia has decided to reacquire the global rights for the oral endothelin receptor antagonist aprocitentan almost six years after they were sold to Janssen.

The news comes after Idorsia announced potential layoffs, and cost-reduction initiatives, including the sale of its Asia Pacific operations, in July due to “lower than anticipated” sales in H1 2023.

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The reacquisition of aprocitentan is expected to provide a much-needed boost to Idorsia’s profits. GlobalData forecasts aprocitentan to generate $241m in sales in 2029.

GlobalData is the parent company of Pharmaceutical Technology.

Idorsia CEO Jean-Paul Clozel said: “Aprocitentan has demonstrated significant and clinically meaningful sustained blood pressure lowering benefits with a good safety profile, particularly suited to the high-risk patient population with resistant hypertension.”

Aprocitentan is currently under review with the US Food and Drug Administration (FDA), with a Prescription Drug User Fee Act (PDUFA) set for 19 December. An EU approval application was filled with the European Medicines Agency (EMA) in January.

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Idorsia will pay Janssen up to Sfr306m ($343m), contingent on the EU and US approvals of aprocitentan. Additionally, Janssen will bear no funding obligations and terminate any licence to aprocitentan, except for the treatment of pulmonary hypertension. Idorsia will also give up its revenue share rights to Ponvory (ponesimod), a disease-modifying drug for treating relapsing forms of multiple sclerosis.

Of the total payment, 30% would come from any out-licensing or divestment payment from aprocitentan. The out-licensing or divestment payment for other Idorsia drugs would make 10% of the payout, after the first aprocitentan approval. The remaining consideration would consist of a portion of royalties on total group product net sales, starting from the quarter following the first approval of aprocitentan.