Idorsia has entered into an agreement with J&J's Janssen Biotech for the return of rights for aprocitentan, a dual endothelin receptor antagonist currently under review with health authorities for the treatment of patients with resistant hypertension.
Per the deal, Swiss biotech Idorsia — which was spun out of Actelion as part of J&J's $30 billion acquisition in 2017 — will pay up to $343.9 million, subject to marketing application approvals by the U.S. FDA and Europe’s EMA.
Aprocitentan is an oral dual endothelin receptor antagonist which potently inhibits the binding of ET-1 to ETA and ETB receptors.
In late 2017, Janssen exercised its option to enter into a collaboration agreement with Idorsia to jointly develop and commercialize aprocitentan and any of its derivative compounds or products. Following Janssen's opt-in decision, Idorsia received a one-time milestone payment of $230 million. The terms of deal stipulated that Idorsia oversaw the phase 3 development and regulatory submission for the treatment of patients with resistant hypertension, with the costs will be shared equally between both partners.
In May 2022, the partners announced positive top-line results of PRECISION, a phase 3 study investigating aprocitentan for the treatment of patients whose blood pressure is not adequately controlled despite receiving at least triple antihypertensive therapy — known as resistant hypertension. During the trial, aprocitentan significantly reduced blood pressure when added to standardized combination background antihypertensive therapy in patients with resistant hypertension over 48 weeks of treatment.
Now, the drug has returned home to Idorsia. According to the company, an NDA for aprocitentan was filed with the FDA in December 2022 and the drug has a PDUFA date of December 19, 2023.