Circassia Pharmaceuticals is acquiring exclusive commercialization rights to nitric oxide product AirNOvent from from AIT Therapeutics Inc. The commercialization rights apply to the United States and China.
The rights cover all potential indications in the hospital setting for the administration of inhaled nitric oxide, which includes hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN). Estimates of PPHN in the US vary widely, from 1,500-26,200 newborns annually; approximately 10% of babies with PPHN die.
Inhaled nitric oxide is a pulmonary vasodilator which is approved in the United States for use as part of a regimen in the treatment of hypoxic respiratory failure associated with PPHN.
AirNOvent is a portable system that utilizes an electric voltage to produce precise quantities of nitric oxide from the nitrogen and oxygen in air. It uses disposable smart filters to remove unwanted NO2 produced during the process.
In the United States, only one inhaled nitric oxide product is currently available, Inomax. It is used in neonatal intensive care units (NICUs) and its delivery system administers nitric oxide from pressurized cylinders in conjunction with ventilator systems. The product generated estimated US revenues of over $400 million in 2017.
The AirNOvent system is cylinder-less, which will make it more accessible to NICUs and smaller clinics without the facilities required to manage nitric oxide cylinders, Circassia says.
AIT anticipates applying to the FDA for Premarket Approval for AirNOvent in Q2 2019 for use in the treatment of PPHN, and Circassia anticipates launching the product in the first half of 2020, once approved.