Today, Janssen Biotech announced it had exercised its option to enter into a collaboration deal with Idorsia to jointly develop and market aprocitentan and any derivative compounds.
In January 2017, Johnson & Johnson acquired Swiss-based Actelion for $280 per share. As part of that deal, Actelion spun out its drug discovery operations and early-stage development assets into a new company based in Switzerland. That company is called Idorsia.
Today, Janssen Biotech, a J&J company, announced it had exercised its option to enter into a collaboration deal with Idorsia to jointly develop and market aprocitentan and any derivative compounds. Aprocitentan is in development for hypertension.
Aprocitentan is an orally active dual endothelin receptor antagonist. Positive results from a Phase II trial were released in May 2017, and the company is now finalizing the design of a Phase III trial. The specific type of high blood pressure the drug is being developed for is called resistant hypertension. That is defined as hypertension that is not controlled by at least three therapies.
In the Phase II trial, 490 patients received varying doses of aprocitentan, placebo or lisinopril 20 mg. After eight weeks, blood pressure, specifically the mean reduction from baseline in diastolic blood pressure, was 6.3 and 12.0 mmHg in the aprocitentan group, which is a statistically significant drop compared to 4.9 mmHg in the placebo group and 8.4 mmHg in the lisinopril group.
As part of this deal, Janssen will pay a one-time milestone payment of $230 million, although it’s actually an upfront payment of $160 million with the rest scattered over the next three and a half years. “The one-time milestone payment will be recognized in two parts: about 160 million U.S. dollars are expected to be recognized immediately as contract revenue in the fourth quarter 2017,” said Andre Muller, Idorsia’s chief financial officer, in a statement, “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.”
Janssen and Idorsia will have joint development rights. Idorsia will handle Phase III development and regulatory submission. The costs will be split evenly between both companies. Janssen will handle Phase III development and submission for any other indications. There will also be royalties paid by J&J between 20 percent and 35 percent of sales.
“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,” said Martine Clozel, Idorsia’s chief scientific officer, in a statement. “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.”
John Carroll, with Endpoints News, writes, “Idorsia was launched with a hot stock on the Swiss exchange (SWX: IDIA), initially priced around the considerable cash it was given. Shares have more than doubled since the spinout occurred.”
