AIT Receives Milestone Payment From Commercialization Partner
AIT Therapeutics, Inc. recently announced it has received a milestone payment of $3.15 million from its commercialization partner Circassia Pharmaceuticals for the successful completion of the pre-submission meeting with the US FDA. This pre-submission meeting satisfied the conditions of the recently announced commercial licensing agreement. Circassia Pharmaceuticals has licensed the commercial rights for AIT’s novel cylinder-free nitric oxide (NO) generator and phasic-flow delivery system (AirNOvent) in the US and China for use in the hospital setting at NO concentrations < 80 ppm. In addition to this milestone payment, AIT received an upfront payment of $7.35 million upon signing of the licensing agreement on January 24, 2019, bringing the total payments received to $10.5 million.
“We are very excited about our recently signed commercial licensing agreement with Circassia,” said Steve Lisi, Chairman and Chief Executive Officer of AIT. “Receipt of this milestone payment is another example of AIT’s ability to execute. We remain on track to make our PMA submission to the FDA in the second quarter of 2019 and anticipate a US launch in the first half of 2020.”
Nitric oxide (NO) is a crucially important molecule proven to play a critical role in a broad array of biological functions. Inhaled nitric oxide is currently approved for treating term and near-term neonates with Persistent Pulmonary Hypertension of the Newborn (PPHN) in the US and most major markets. In Europe, Japan, and Australia, inhaled NO is approved to treat PPHN as well as pulmonary hypertension during the peri-operative cardiac surgery period in neonates, children, and adults. In the airways, NO is believed to play a key role in the innate immune system at concentrations of approximately 200 ppm. In vitro studies suggest that NO possesses anti-microbial activity not only against common bacteria, both gram-positive and gram-negative, but also against other diverse organisms including mycobacteria, fungi, yeast and parasites, and has the potential to eliminate their multi-drug resistant strains.
Persistent pulmonary hypertension of the newborn (PPHN) is a life-threatening condition secondary to failure of normal circulatory transition at birth. It is a syndrome characterized by elevated pulmonary vascular resistance (PVR) that causes labile hypoxemia due to decreased pulmonary blood flow and right-to-left shunting of blood. Its incidence has been reported as 1.9 per 1000 live births (0.4–6.8/1000 live births) with mortality rate ranging between 4%-33%. This syndrome complicates the course of about 10% of infants with respiratory failure and remains a source of considerable morbidity and mortality. NO gas is a pulmonary vasodilator and is approved in dozens of countries to improve oxygenation and reduce the need for extracorporeal membrane oxygenation (ECMO) in term and near-term (>34 weeks gestation) neonates with hypoxic respiratory failure associated with clinical or echocardiographic evidence of pulmonary hypertension in conjunction with ventilator support and other appropriate agents.
AIT’s ventilator-compatible NO Generator and Delivery System is a cylinder-free, phasic flow nitric oxide delivery system and has been designated as a medical device by the US FDA. The device can generate NO on demand for delivery to the lungs at concentrations ranging from 1 part per million (ppm) to 80 ppm. The elimination of the need for large, high-pressure cylinders for NO is a significant advantage in the hospital setting by greatly reducing inventory and storage requirements and improving overall safety with the elimination of NO2 purging steps, among other benefits.
AIT Therapeutics Inc. is a clinical-stage medical device and biopharmaceutical company using nitric oxide (NO) to treat respiratory and other diseases. The company is currently applying its therapeutic expertise to treat lower respiratory tract infections that are not effectively addressed with current standards of care, as well as pulmonary hypertension, in various settings. AIT Therapeutics is currently advancing its revolutionary NO Generator and Delivery System in clinical trials for the treatment of bronchiolitis and nontuberculous mycobacteria (NTM). For more information, visit www.AIT-Pharm.com.
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