Circassia Pharmaceuticals will pay AIT Therapeutics $7.35 million up front plus potential milestone payments and royalties for the exclusive rights to commercialize AIT’s AirNOvent ventilator compatible nitric oxide in the US and China, the company said. The company will issue ordinary shares to AIT to cover the upfront payment and anticipates doing the same for potential milestones.
According to Circassia, the rights cover all indications in hospital settings, including respiratory failure due to persistent pulmonary hypertension of the newborn (PPHN). The company said that it plans to apply for premarket approval for AirNOvent in the US for that indication in the second quarter of 2019. If approved, the company plans to launch the product during the first half of 2020 and then apply for a label extension for “a related indication.”
Milestone payments included in the deal include “$3.15 million on successful completion of a pre-submission FDA meeting, $12.6 million on the sooner of the product’s US launch in PPHN or 90 days post FDA approval, $8.4 million on the US approval of the related indication and $1.05 million on the product’s launch in China.”
Circassia CEO Steve Harris commented, “Acquiring the US and Chinese commercialization 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 commercialize 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.”
Read the Circassia press release.
