Actelion is now one of Johnson & Johnson’s Janssen Pharmaceutical Companies after J&J today completed its $30 billion cash acquisition of the Swiss drug developer—which immediately spun off its discovery operation and early-stage pipeline into a new publicly traded company.

The spinout, Idorsia, began trading shares today on the SIX Swiss Exchange, with the new company’s shares distributed to Actelion shareholders as a stock dividend. Idorsia shares debuted at a price of CHF 10 ($10.27) per share and jumped more than 25%, trading at CHF 12.55 ($12.88) per share as of 9:06 a.m. ET.

J&J, which announced its Actelion acquisition in January, holds a significant stake in Idorsia: J&J subsidiary Cilag Holding will initially hold 9.9% of the spinout’s outstanding equity and has the right to an additional 22.1% of Idorsia's shares through a convertible note, Actelion stated.

Additionally, a J&J subsidiary—Actelion’s announcement did not say if that was Cilag Holding or another entity—will hold an option on one of Idorsia’s pipeline assets, the resistant hypertension candidate aprocitentan (ACT-132577), which the company will seek to advance into Phase III following positive Phase II clinical results announced last month.

“We have a fantastic opportunity ahead,” Idorsia CEO Jean-Paul Clozel, M.D., who headed Actelion until the J&J deal, said in a separate statement from his new company. “We are starting out with an experienced team of highly qualified professionals, a full research and development pipeline, state-of-the-art facilities, and 1 billion Swiss francs [$1.026 billion] in cash—the ideal constellation for bringing research and development to successful medicines.”

Aprocitentan, an endothelin receptor antagonist, is one of Idorsia’s four Phase II candidates. The other three are:

  • ACT-541468, a dual orexin receptor antagonist indicated for chronic insomnia;
  • clazosentan, an endothelin receptor antagonist for vasospasm associated with aneurysmal subarachnoid hemorrhage;
  • cenerimod, a sphingosine-1-phosphate receptor 1 (S1P1) modulator for systemic lupus erythematosus.

On May 22, Actelion trumpeted positive clinical results for both aprocitentan/ACT-132577 and cenerimod. The company said that aprocitentan showed statistically significant mean reduction from baseline in diastolic blood pressure—between 6.3 and 12.0 mmHg, depending on dose—compared with a decrease of 4.9 mmHg for placebo patients and a decrease of 8.4 mmHg for patients randomized to lisinopril.

Actelion also announced positive safety results for cenerimod, saying the candidate was ready, as a result, to move into an exploratory Phase II dose-finding study to deliver information needed to design a Phase III clinical program.

“We are off to a great start with the recent results with aprocitentan and cenerimod and are eagerly awaiting key results for our dual orexin receptor antagonist in the coming months,” Dr. Clozel stated. “Beyond that we will be taking decisions on our Phase I pipeline assets before the end of the year, so we have a lot to look forward to.”

Idorsia’s early-stage assets include a Phase Ib candidate, the Fabry disease treatment lucerastat, and four Phase I candidates—ACT-246475 (a P2Y12 receptor antagonist indicated for acute coronary syndrome), ACT-774312 (a CRTH2 receptor antagonist for asthma and allergy disorders), ACT-539313 (a selective orexin 1 receptor antagonist for anxiety), and ACT-709478 (a T-type calcium channel blocker for epilepsy).

“Management intends to develop Idorsia into one of Europe's leading biopharmaceutical companies, with a strong scientific core,” the spinout added.

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