Johnson & Johnson: Kooperation mit Pharmaunternehmen Idorsia
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Idorsia announces collaboration with Janssen Biotech on aprocitentan (ACT-132577)
- Idorsia to receive milestone payment of USD 230 million
- Idorsia and Janssen Biotech to share costs of Phase 3 development equally
- Idorsia entitled to royalty payments on potential future net sales
Allschwil, Switzerland - 4 December 2017 - Idorsia Ltd (SIX:IDIA) announced today that Janssen Biotech, Inc. (Janssen), 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 2 study were released on 22 May 2017.
Jean-Paul Clozel, CEO of Idorsia, commented: "I am delighted by Janssen's decision to collaborate on the development of aprocitentan, which is a strong endorsement for our product. Together we can accelerate the next steps of development and bring this compound to patients in need of new treatment options as quickly as possible."
Milestone: Following Janssen's opt-in decision, Idorsia will receive a one-time milestone payment of USD 230 million that will be reflected in its fourth quarter 2017 financial results.
André Muller, Chief Financial Officer of Idorsia, explained: "The one-time milestone payment will be recognized in two parts: about 160 million US dollars are expected to be recognized immediately as contract revenue in the fourth quarter 2017, while the remainder of the milestone payment is expected to be recognized as contract revenue over the next three and a half years. Hence, combining this revenue with our unchanged financial guidance on non-GAAP operating expenses between 160 and 170 million Swiss francs, Idorsia expects to report a net loss close to breakeven, barring unforeseen events."
Development: Both parties have joint development rights over aprocitentan. Idorsia will oversee the Phase 3 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 3 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.
Martine Clozel, Chief Scientific Officer of Idorsia, said: "With this decision, Janssen has recognized the potential of aprocitentan, the latest product from a research effort that was initiated nearly 30 years ago and resulted in a broad understanding of the endothelin system and two endothelin receptor antagonists on the market. Aprocitentan can be envisioned to have many other potential applications, in addition to hypertension. This makes the collaboration with Janssen even more meaningful for us."
About aprocitentan in development for resistant hypertension management (RHM)
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 (called resistant hypertension in the medical community). Resistant hypertension is defined as persisting high systemic blood pressure (i.e., 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. Resistant hypertension is associated with a higher risk of cardiovascular disease. Patients with resistant hypertension are also more likely to have a medical history of chronic kidney disease and diabetes mellitus, amplifying their vulnerability and the complexity of treatment.
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 2017. Based on the positive dose-finding results and the feedback from health authorities, Idorsia is currently 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 (RHM). The study is expected to start in 2018. If successful, the study will provide the basis for registration of the product.