The acquired rights will cover all potential indications in the hospital setting for the administration of inhaled AirNOvent at up to 80 parts per million.
One of the indications that will be covered under the agreement is hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN).
AirNOvent is a portable system that uses an electric voltage to generate precise volumes of nitric oxide (NO) from the nitrogen and oxygen contained in air. During the process, the system utilizes disposable smart filters to remove unwanted NO2.
AIT expects to apply for Premarket Approval (PMA) of its nitric oxide product to the US Food and Drug Administration (FDA) in the second quarter of this year. The PMA will target the use of the product in the treatment of PPHN.
Subject to the FDA approval, AIT hopes to launch the nitric oxide product in the first half of 2020 and subsequently will look to seek a label extension for its use in a related indication.
As per the terms of the licensing agreement, AIT will be paid an initial consideration of $7.35m by Circassia. AIT will be eligible for further payments, based on certain milestones, which amounts to about $25m, followed by tiered royalty payments related to the sales of the product.
Circassia CEO Steve Harris said: “Acquiring the US and Chinese commercialisation rights to the innovative product AirNOvent represents an important milestone in Circassia’s strategic transformation into a commercially-focused respiratory pharmaceutical business.
“With our commercial platform established in the United States and our rapid expansion in China nearing completion, we look forward to leveraging our infrastructure to commercialise this novel product, once approved.
“In the coming months we anticipate significant progress across our business, as we take full commercial control of Tudorza in the United States, the FDA completes its review of DuaklirINR’s NDA and AIT submits AirNOvent for approval.”