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Circassia Pharmaceuticals has announced that it has entered into a definitive agreement with AIT Therapeutics (AIT) to acquire the exclusive US and China commercialisation rights for the ventilator compatible nitric oxide product, AirNOvent.

The rights cover every possible indication in a hospital setting for the administration of inhaled nitric oxide at up to 80 parts per million.

AirNOvent is a portable device that uses an electric voltage to produce precise quantities of nitric oxide from nitrogen and oxygen in atmosphere. The system contains disposable smart filters which can remove unwanted NO2 produced during the process.

AIT will receive contingent payments based upon the achievement of certain milestones, which Circassia currently expects to satisfy through the issuance of new Ordinary Shares in the Company, at a discount of 5% to a volume weighted average share price.

As well as contingent payments, Circassia will pay tiered royalty payments based on gross profits from future sales of the product. Initial payments will see Circassia paying $7.35m upfront and a further $3.15m upon successful completion of a pre-submission meeting with FDA.

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By GlobalData

Circassia specialises in medical devices and drugs for the treatment of respiratory diseases.

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 Duaklir’s NDA and AIT submits AirNOvent for approval.  As a result, we look forward to 2019 with great optimism.”

Inhaled nitric oxide is often used as part of a regimen in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN).

Approximately 1,500 – 26,200 babies in the US suffer with PPHN and 10% of those with moderate to severe forms of the condition do not survive.

In the US, the only inhaled nitric oxide product currently available on the market is Mallinckrodt Pharmaceuticals’ Inomax, which is commonly used in neonatal intensive care units for the treatment of hypoxic respiratory failure. The system generated US revenues of more than $400m in 2017.

Circassia said AirNOvent has several advantages over Inomax, including a lighter, cylinder-free form and the fact that it does not require special storage facilities, making it suitable for a wider range of intensive care units and clinics.