LONDON (ShareCast) - (Sharecast News) - Specialty pharmaceutical company Circassia Pharmaceuticals has entered into a definitive agreement to acquire exclusive commercialisation rights from AIT Therapeutics to its ventilator compatible nitric oxide product, 'AirNOvent', in the United States and China, it announced on Thursday.
The London-listed firm said the rights covered all potential indications in the hospital setting for the administration of inhaled nitric oxide at up to 80 parts per million, which included hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn.

It said AIT anticipated applying to the US Food and Drug Administration (FDA) for Premarket Approval (PMA) for AirNOvent in the second quarter of this year for use in the treatment of PPHN, with Circassia expecting to launch the product in the first half of 2020, once approved.

Following that, AIT planned to seek a label extension for the product's use in a related indication.

Under the terms of the agreement, Circassia will pay AIT initial consideration of $7.35m.

Further deferred contingent consideration would be payable upon certain milestones, including $3.15m on successful completion of a pre-submission FDA meeting, $12.6m on the sooner of the product's US launch in PPHN or 90 days post-FDA approval, $8.4m on the US approval of the related indication, and $1.05 m on the product's launch in China.

In addition, the company would pay tiered royalty payments based on gross profits from future sales of the product.

Circassia said it intended to satisfy the initial consideration, and currently anticipated satisfying the contingent consideration, through the issuance of new ordinary shares in the company to AIT.

"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," said Circassia chief executive officer Steve Harris.

"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."

Harris said that In the coming months, the company anticipated "significant progress" across its business, as it took full commercial control of 'Tudorza' in the United States, the FDA completed its review of the new drug application for 'Duaklir', and AIT submitted 'AirNOvent' for approval.

"As a result, we look forward to 2019 with great optimism."

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