- Johnson & Johnson has decided to help develop and commercialize an investigational blood pressure drug from Actelion Pharmaceuticals Ltd.'s recently spun out company, Idorsia Ltd.
- Through a one-time, $230 million milestone payment, the big drugmaker picked up sole worldwide commercialization rights to aprocitentan, an oral, dual endothelin receptor antagonist that earlier this year completed a Phase 2 study evaluating it as a treatment for patients with essential hypertension. Idorsia is working to finalize a Phase 3 study of patients with resistant hypertension.
- As for development, Idorsia is responsible for taking aprocitentan through the planned Phase 3 trial and a regulatory submission for resistant hypertension, but will split the associated costs equally with J&J's pharmaceutical arm, Janssen Biotech Inc. For any additional indications, Janssen is in charge of late-state testing and corresponding approval filings.
Idorsia was born in June amid the completion of J&J's $30 billion Actelion acquisition. The Swiss biotech started off with CHF 1 billion (about $1 billion) in cash — funded by Actelion and a J&J affiliate — and a fairly robust pipeline of early- to mid-stage drugs.
Aprocitentan is the most closely watched of Idorsia's candidates. In May, Actelion released results from a dose-finding Phase 2 study that pitted the drug against placebo and an active reference arm in treating patients with essential hypertension, a type of high blood pressure where the root cause is unknown.
The study enrolled nearly 500 patients, who received either placebo, 20 mg lisinopril or one of four aprocitentan regimens: 5 mg, 10 mg, 25 mg and 50 mg. Results showed that after eight weeks of treatment, mean reduction from baseline in diastolic blood pressure was between 6.3 and 12.0 mmHg for patients receiving the various doses of aprocitentan. The drug's performance was statistically significant in a dose-dependent manner, according to Actelion, and beat out the 4.9 mmHg decrease seen in the placebo group and 8.4 mmHg decrease seen in the lisinopril group.
As for safety, the placebo arm had higher rates of discontinuation than the experimental arm. There were two cases of increased liver enzymes that were at least three times higher than the upper limit of the normal range, of which one was in the aprocitentan 5 mg group; and there were four cases of peripheral edema, of which two were in the aprocitentan 25 mg group and two were in the aprocitentan 50 mg group.
Perhaps reflecting the value it saw in Actelion, J&J's recent moves demonstrate the promise it sees in aprocitentan — and Idorsia to a larger extent. The big pharma owned almost 10% of Idorsia's shares by the end of the third quarter, and could snag another 22.1% of the biotech's equity through a convertible loan. J&J has also maintained the option to collaborate on aprocitentan.
"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," Martine Clozel, Idorsia's chief scientific officer, said in a Dec. 4 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."
In addition to the milestone payment, Idorsia may also snag royalties on any potential net sales from aprocitentan. The royalties break down to 20% for annual net sales up to $500 million, 30% for annual net sales between $500 million and $2 billion, and 35% for annual net sales above $2 billion.