The Janssen Biotech, Inc. unit of Johnson & Johnson has exercised its option to enter into a collaboration agreement with Idorsia Ltd. to jointly develop and commercialize Idorsia’s hypertension drug aprocitentan and its derivative compounds or products. Idorsia will receive a one-time milestone payment of $230 million that will be reflected in its Q4 2017 financial results.
Aprocitentan is an orally active dual endothelin receptor antagonist that is being investigated for patients whose hypertension is uncontrolled despite the use of at least three anti-hypertensive drugs, which are called resistant hypertension in the medical community.
Resistant hypertension is defined as persisting high systemic blood pressure — failure to lower blood pressure to a pre-defined threshold — despite concurrent administration of at least three antihypertensive therapies of different pharmacological classes at maximal or optimal doses, including a diuretic.
A Phase 2 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. Idorsia currently is finalizing the design of a Phase 3 study. It will consist of a specifically designed study evaluating the initial and long-term effect of aprocitentan on systolic and diastolic blood pressure in patients requiring resistant hypertension management.
The Phase 3 study is expected to start in 2018 and, if successful, will provide the basis for registration of the product, according to Idorsia.
Both parties have joint development rights over aprocitentan. Idorsia will oversee the Phase 3 development and regulatory submission for the treatment of patients with resistant hypertension. Janssen will oversee the Phase 3 development and submission for any additional indications.
Janssen will have the sole worldwide commercialization rights, while Idorsia is entitled to royalty payments on any future net sales generated. Royalty payments will consist of 20 percent of annual net sales up to $500 million, 30 percent of annual net sales between $500 million and $2 billion, and 35 percent of annual net sales above $2 billion.
(Source: Idorsia Pharmaceuticals Ltd.)
Filed Under: Drug Discovery