Firm will develop the off-patent compound in the PAH indication and hopes to gain orphan drug status.

Navitas Assets is selling assets related to its cicletanine business to Gilead Sciences. Cicletanine is an oral, once-daily agent that is approved in certain European countries for the treatment of hypertension.


Gilead gains the exclusive rights to development this compound for pulmonary arterial hypertension (PAH) and other indications in the U.S. Cicletanine’s patent has already expired, but Navitas has applied for orphan drug status for the compound in the PAH indication. If granted, Gilead will be able to take advantage of the seven-year exclusivity period.


Gilead plans to begin a Phase II study to evaluate cicletanine for the treatment of PAH before the end of this year. Cicletanine is already being evaluated for the treatment of PAH under an investigator-held compassionate-use IND.


Under the terms of the agreement, Navitas is eligible to an upfront payment and fees based on future net sales. Navitas may also earn milestones based on development and regulatory achievements.


Cicletanine is thought to act via enhanced coupling of endothelial nitric oxide synthase (eNOS), Gilead explains. Endothelial dysfunction, known to play a role in hypertension and PAH, is associated with a deficiency in vascular nitric oxide, which is caused by decoupling of eNOS. In vivo studies suggest that cicletanine’s eNOS coupling mechanism may directly target endothelial dysfunction by stimulating vascular synthesis of nitric oxide and inhibiting overproduction of superoxide.

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