J&J pulls out of Idorsia deal for hypertension drug

Idorsia has lost Johnson & Johnson's Janssen Biotech unit as the partner for its aprocitentan candidate for resistant hypertension, following a likely delay in the FDA's review of the drug.

The Swiss biotech said it has reacquired rights to the orally active, dual endothelin receptor antagonist with a payment of CHF 306 million ($343 million) due to Janssen if it gets approved by the FDA or EMA in the EU. 

Janssen licensed rights to aprocitentan and any derivatives in 2017 for a one-time payment of $230 million plus royalties on sales. It has retained one use of aprocitentan, however, in pulmonary hypertension, and will receive 30% of any fee received by Idorsia if it out-licenses the drug to another partner.

The timing of Janssen's exit is interesting, given that aprocitentan is currently under review by the FDA with a decision due by 19th December - although, Idorsia's chief executive, Jean-Paul Clozel, said this morning that it is likely to face a three-month delay due to an FDA request for more materials to support a risk evaluation and mitigation strategy (REMS) for the drug.

When Idorsia filed aprocitentan with the US regulator last December, analysts at Jefferies were predicting that it had the potential to become a $2.5 billion blockbuster, due to the urgent need for new therapies for people with hypertension that cannot be controlled using current drugs.

It is thought that around 10% of the 1.3 billion people with hypertension around the world struggle to control their blood pressure using the current main classes of antihypertensive, namely diuretics, calcium channel blockers, and renin-angiotensin system-targeting drugs.

In the phase 3 PRECISION trial, aprocitentan met its main objective of reducing systemic blood pressure compared to placebo, with an overall reduction of 3.8 mmHg with a daily dose of 12.5 mg aprocitentan at four weeks.

In its statement, Idorsia said that it is "initiating activities to determine the best approach to maximise the value of aprocitentan […] the first anti-hypertensive therapy which works via a new mechanism of action in 30 years."

The revised agreement also cancels a revenue-sharing deal between Idorsia and Janssen relating to oral multiple sclerosis therapy Ponvory (ponesimod), which was approved for marketing in 2021.

The Swiss company's chief financial officer, André Muller, said that if aprocitentan is approved in the US and Europe "as expected, Idorsia would have an additional product in its portfolio, giving the company more strategic flexibility."