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Circassia Pharmaceuticals PLC

Circassia Pharmaceuticals says partner AIT Therapeutics successfully completes FDA pre-submission meeting

The group said AIT anticipates submitting a Premarket Approval application for AirNOvent in the second quarter of 2019 for use in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn

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Circassia said it anticipates launching the product in the first half of 2020, once approved

Circassia Pharmaceuticals PLC (LON:CIR) revealed that its partner, AIT Therapeutics Inc. has successfully completed a pre-submission meeting with the US FDA for the ventilator-compatible nitric oxide product AirNOvent.

The AIM-listed specialty pharmaceutical company, which is focused on respiratory disease, said AIT anticipates submitting a Premarket Approval application (PMA) for AirNOvent in the second quarter of 2019 for use in the treatment of hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN).

WATCH: Circassia's AirNOvent drug a step closer to market with FDA pre-submission meeting

Circassia said it anticipates launching the product in the first half of 2020, once approved.

The group announced on 24 January 2019 that it had entered a definitive agreement to acquire the exclusive commercialisation rights to AirNOvent in the United States and China from AIT. 

Under the agreement, the successful completion of the FDA meeting triggers a milestone payment of US$3.15mln, which Circassia said it intends to satisfy through the issuance of new ordinary shares in the company to AIT.

Steve Harris, Circassia's CEO, commented: "Successful completion of this pre-submission meeting represents a further key milestone in advancing AirNOvent towards the market. 

“We are excited at the potential benefits offered by AirNOvent, once approved, and look forward to AIT submitting this novel nitric oxide product for regulatory approval in the coming months."

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