Amid likely FDA delay, J&J's deal with Idorsia on hypertension drug aprocitentan ends
06 Sep 2023
License out/inDrug ApprovalPriority Review
Johnson & Johnson's Janssen Biotech unit will return rights to the experimental drug aprocitentan to Idorsia, ending an agreement that was signed in 2017, the latter said Wednesday. The oral, dual endothelin receptor antagonistendothelin receptor antagonist, which inhibits the binding of ET-1 to ETA and ETB receptors, is under development for patients with resistant hypertension.
A marketing application for aprocitentan is currently under review in the US, with a target review date of December 19. Idorsia CEO Jean-Paul Clozel said Wednesday that while the assessment "is progressing well," the FDA is likely to extend its review by up to 3 months to give the company time to provide additional risk evaluation and mitigation strategy (REMS) materials. In the EU, a filing was submitted at the start of 2023.
Under the original deal, Janssen Biotech paid $230 million upfront for rights to jointly develop aprocitentan, with Idorsia also eligible for sales royalties of 20% to 35%. Idorsia said Wednesday that it will pay Janssen Biotech up to CHF 306 million ($344 million) to regain rights, subject to approval of the drug in the US and Europe, while the agreement also eliminates the revenue-sharing agreement between the parties for Johnson & Johnson's oral multiple sclerosis therapy Ponvory (ponesimod).
Meanwhile, Idorsia indicated that it is looking to determine "the best approach to maximise the value of aprocitentan." The company noted that the amount payable to Janssen Biotech includes 30% of any consideration received from a potential out-licensing or divestment of aprocitentan.
André Muller, Idorsia's chief financial officer, remarked "if aprocitentan is approved in the US and Europe as we expect, Idorsia would have an additional product in its portfolio giving the company more strategic flexibility, and potentially allows Janssen to recoup over time their investment in aprocitentan."
More to come.
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