Janssen Biotech to market aprocitentan a proposed treatment for resistant hypertension.

Idorsia Ltd announced that Janssen Biotech, Inc. one of the Janssen Pharmaceutical Companies of Johnson & Johnson, has 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. Headline results from the phase II study were released on 22 May 2017.

Both parties have joint development rights over aprocitentan. Idorsia will oversee the Phase III development and regulatory submission for the treatment of patients with hypertension that is not controlled by at least three therapies (called resistant hypertension in the medical community). The costs will be shared equally between both partners. Janssen will oversee the Phase III development and submission for any additional indications. Commercialization: Janssen will have the sole worldwide commercialization rights. Idorsia is entitled to royalty payments on any future net sales generated. Royalty payments will amount to 20% of annual net sales up to USD 500 million, 30% of annual net sales between USD 500 million and USD 2 billion, 35% of annual net sales above USD 2 billion.

Comment: A Phase II study that evaluated the efficacy, safety and tolerability of aprocitentan in patients with essential hypertension to identify the optimal dose for further studies was completed in May 2017. Based on the positive dose-finding results and the feedback from health authorities, Idorsia is currently finalizing the design of a Phase III study.