Johnson & Johnson (J&J) is stepping back from its $230 million investment in a blood pressure treatment, aprocitentan, and returning the global rights for this near-approval therapy to Idorsia in a deal valued at up to 306 million Swiss francs ($343 million).
In 2017, J&J acquired the rights to aprocitentan, a dual endothelin receptor antagonist, with an upfront payment of $230 million and a royalty rate ranging from 20% to 35%. This move followed positive phase 2 data, with analysts at Jefferies projecting peak sales of $2.5 billion, primarily for reducing blood pressure in patients with resistant hypertension.
A phase 3 clinical trial met its primary endpoint in the previous year, prompting J&J to file for approval in both the U.S. and Europe as 2022 transitioned into 2023. However, the study revealed that aprocitentan effectively lowered blood pressure compared to a placebo, but it also indicated that 18% of individuals on the high dose experienced mild to moderate fluid retention. Notably, J&J had not included aprocitentan in its discussions about achieving its sales target of $60 billion by 2025.
J&J’s recent decision signals uncertainty regarding its commitment to aprocitentan. In the new agreement, J&J returns the rights to Idorsia and positions itself to recover some of its initial investment. The potential returns for J&J could reach 306 million Swiss francs, contingent on specific conditions. J&J will receive 30% of any revenue that Idorsia gains from out-licensing or divesting the asset. Additionally, after aprocitentan’s initial approval, J&J will receive 10% of the proceeds from any deal involving another Idorsia product. The deal also involves low- to mid-single-digit royalties.
Idorsia cautioned that the approval process for aprocitentan might face delays. While the FDA’s decision is currently expected in December, Idorsia’s CEO, Jean-Paul Clozel, anticipates a potential extension of the review period by up to three months. This extension is intended to allow the FDA to assess materials that Idorsia believes could support a streamlined risk mitigation plan for aprocitentan.
“I’m happy that we have come to an agreement for the return of aprocitentan to Idorsia. 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. Revolutionizing the use of endothelin receptor antagonism is something the team at Idorsia knows all about. We will now determine the best approach to maximizing the value of our exciting new anti-hypertension therapy.”
– Jean-Paul Clozel, CEO of Idorsia
Investors, however, had a less optimistic outlook, causing Idorsia’s shares to drop by 5.7% to below 4.80 Swiss francs during early trading in Switzerland, continuing the stock’s long-term decline