Circassia to Acquire Rights to Newborn Respiratory Device

Circassia logo

Circassia Pharmaceuticals, a British company with U.S. headquarters in Morrisville, will acquire the exclusive commercialization rights to a life-saving medical device for newborns facing a potentially deadly respiratory condition.

Circassia has entered into a definitive agreement for the rights to AirNOvent, a ventilator-compatible nitric oxide product, from AIT Therapeutics in the United States and China. The rights cover all potential indications in the hospital setting for the administration of inhaled nitric oxide at up to 80 parts per million, which includes hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn (PPHN).  

“Acquiring the U.S. 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,” said Steve Harris, Circassia’s chief executive officer. “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.”

The AirNOvent device
The AirNOvent device.
-- Circassia photo

Under the terms of the agreement, Circassia will pay AIT $7.35 million initially and more later if certain milestones are met.  The company will pay $3.15 million on successful completion of a pre-submission FDA meeting, $12.6 million on the sooner of the product’s U.S. launch in PPHN or 90 days post-FDA approval, $8.4 million on the U.S. approval of the related indication and $1.05 million on the product’s launch in China.

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

Circassia will meet the obligations by issuing new ordinary shares of Circassia stock to AIT.

AIT anticipates applying to the FDA for Premarket Approval for AirNOvent in the second quarter of 2019 for use in the treatment of PPHN. The company anticipates launching the product, once approved, in the first half of 2020. 

Circassia said that once AirNOvent is approved it will add “a modest number” of personnel to its field force to launch and promote the product. The new hires will include additional key accounts and medical affairs experts who will target top hospitals with neonatal intensive care units (NICUs), many of which are already called on by the company’s existing device sales team, as well as units that do not currently use inhaled nitric oxide. 

Device delivers nitric oxide

AirNOvent is a portable system that uses an electric voltage to produce precise quantities of nitric oxide (NO) from the nitrogen and oxygen in air. It uses disposable smart filters to remove unwanted nitrogen dioxide produced during the process.

Inhaled nitric oxide is a pulmonary vasodilator that is approved in the United States for treating hypoxic respiratory failure associated with persistent pulmonary hypertension of the newborn.

Circassia said AirNOvent offers a number of potential benefits over an existing product. It is cylinder-free and is smaller, lighter and more convenient. 

It is designed for compatibility with current ventilators, and does not require special storage and handling.  As a result, it has the potential for use by NICUs, as well as smaller clinics without the facilities required to manage nitric oxide cylinders.

Under the companies’ agreement, AIT will remain responsible for the product’s development, U.S. regulatory filings and manufacture, with Circassia managing the regulatory process in China. 

The FDA has confirmed a Premarket Approval (PMA) regulatory route for AirNOvent and AIT anticipates submitting an application for an initial indication in hypoxic respiratory failure associated with PPHN in the second quarter of 2019.  The FDA typically completes its review of a PMA within 180 days of accepting the filing, so the company anticipates launching the product, once approved, in the first half of 2020,.

Persistent pulmonary hypertension of the newborn is the failure of normal circulatory transition after birth. It occurs in 1,500 to 26,200 newborns in the United States each year, and despite modern treatment the mortality rate remains about 10 percent in babies with moderate to severe forms of the condition.

Management of the condition can be complex involving a number of treatments, which in addition to supplemental oxygen can include the administration of inhaled nitric oxide.

Circassia growing in respiratory disease market

Circassia is a specialty pharmaceuticals company focused on respiratory disease. It sells its market-leading NIOX asthma-management products directly to specialists in the United States, the United Kingdom and Germany, and in a wide range of other countries through its network of partners. 

In 2017, Circassia established a commercial collaboration with AstraZeneca in the United States in which it promotes the chronic obstructive pulmonary disease (COPD) treatment Tudorza.  The company also has the commercial rights to NDA-stage COPD product Duaklir. 

“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,” Harris said. “As a result, we look forward to 2019 with great optimism.”

Circassia was established in 2006 and has global headquarters in Oxford, England. In 2014 it completed an initial public offering on the London Stock Exchange. The company has operations in Sweden, Germany and China, and a global presence through a distributor network.

The company moved its U.S. headquarters from New Jersey to Morrisville in 2012 with financial incentives provided by the Town of Morrisville and assistance from other local partners including the North Carolina Biotechnology Center, the N.C. Department of Commerce, the N.C. Community College System, Wake County and the Morrisville Chamber of Commerce.

The Morrisville site employs about 50 people who work in management, customer service, accounting, marketing, training and other administration.

AIT Therapeutics, based in Garden City, N.Y., 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.

Barry Teater, NCBiotech Writer
Thu, 01/24/2019 - 15:12