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Idorsia Ltd recently announced that it has entered into an agreement with Janssen Biotech Inc., one of the Janssen Pharmaceutical Companies of Johnson & Johnson, for the return of rights for aprocitentan to Idorsia. In return, Idorsia is committed to pay up to 306 million Swiss francs, subject to marketing application approval by the US FDA and Europe’s EMA.
Jean-Paul Clozel, CEO of Idorsia, commented: “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. Revolutionising the use of endothelin receptor antagonism is something the team at Idorsia knows all about. We will now determine the best approach to maximising the value of our exciting new anti-hypertension therapy.”
The founding team at Idorsia brought the first oral, dual endothelin receptor antagonist (ERA) to market, followed by the discovery, development, and launch of a next generation oral, dual ERA. The team will now evaluate options for realising the value which the company has created by successfully developing aprocitentan, the first anti-hypertensive therapy which works via a new mechanism of action in 30 years.
About the Agreement
Idorsia will reacquire the development and commercialisation rights for aprocitentan from Janssen. In return, Idorsia will pay Janssen a conditional consideration up to a total cap of CHF 306 million, depending on Idorsia’s revenues, as follows:
30% of any consideration received by Idorsia from a potential out-licensing or divestment of aprocitentan,
- 10% of any consideration received by Idorsia from a potential out-licensing or the divestment of any other Idorsia product, following the first approval of aprocitentan, and
- low- to mid-single digit royalties on total group product net sales, beginning from the quarter after first aprocitentan approval.
Janssen funding obligations to aprocitentan cease at the effective date of the agreement. Janssen licenses to aprocitentan IP (excluding pulmonary hypertension) will terminate and Janssen will transfer the brand name and relating commercial materials to Idorsia. Janssen will retain licenses in the pulmonary hypertension field.
The agreement also eliminates the revenue-sharing agreement in respect of ponesimod.
The agreement will be effective following receipt of the clearance relating to the United States Hart-Scott Rodino Antitrust Improvements Act of 1976.
André C. Muller, Chief Financial Officer, commented: “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.”
Jean-Paul Clozel, concluded: “The review process with the US FDA is progressing well, though it is likely to require an extension to the review period of up to 3 months as the company will provide additional Risk Evaluation and Mitigation Strategy (REMS) materials to support a streamlined REMS which is designed specifically for patients taking aprocitentan.”