Specialty biotechnology company, Discovery Laboratories Inc., announced that the company has registered Afectair with the US Food and Drug Administration (FDA) and is cleared to be marketed in the United States.

Afectair is a proprietary patient interface technology that simplifies delivery of aerosolized medications to patients requiring ventilator support.

“We are pleased to have Afectair registered with the FDA and we are eager to move this proprietary technology to commercialization in the latter part of 2012,” said W Thomas Amick, chairman of the Board and CEO of Discovery Labs. Our ability to bring Afectair to market is a testament to our commitment to advancing a new standard in respiratory critical care. Afectair originates from the Aerosurf development programme and is a proprietary disposable ventilator circuit/patient interface connector that simplifies the delivery of aerosolized medications to critical-care patients requiring ventilatory support from either intermittent mechanical ventilation or continuous positive airway pressure. To date, in vitro studies suggest that the Afectair technology may be an effective new solution for delivering aerosolized medicine to patients receiving ventilator support while providing healthcare professionals with a simplified alternative to current practices. According to national health statistics and market assessment data, it is estimated that each year more than 1.3 million patients in the United States and European Union receive aerosolized medications while requiring ventilator support. It is estimated that Afectair represents a potential revenue opportunity of approximately $50-75 million for Discovery Labs.

In preparation for this milestone, we identified a number of operational and commercial options intended to support the commercial introduction of Afectair, said Thomas F Miller, senior vice president and chief operating officer of Discovery Labs. We are now focused on implementing a commercial plan that includes the establishment of key strategic manufacturing and distribution relationships. Discovery Labs is also pursuing a European Conformity (CE) marking for commercialization of the initial Afectair products in the European Union (EU) and believes that it may be in a position to initiate the commercial introduction of the initial Afectair products in EU in late 2012.

Afectair is a series of proprietary ventilator circuit/patient interface connectors and related componentry. It simplifies the delivery of inhaled therapies to critical care patients requiring ventilatory support. According to national health statistics and market assessment data, it is estimated that each year more than 1.3 million patients in the United States and European Union receive aerosolized medications while requiring ventilator support. Discovery Labs is implementing a business plan that potentially will allow for the commercial introduction of Afectair in the United States and the European Union in 2012.

Aerosurf (lucinactant for inhalation), Discovery Labs’ initial aerosolized KL4 surfactant product, is under development for the prevention of RDS in premature infants. Through effective delivery of aerosolized KL4 surfactant using Discovery Labs’ proprietary capillary aerosol generator technology and related ventilator circuit / patient interface connectors, Aerosurf may significantly expand the surfactant-eligible treatment population by providing neonatologists with a means of administering surfactant without the risks currently associated with surfactant administration, which requires invasive endotracheal intubation and mechanical ventilation.

Discovery Laboratories, Inc. is a specialty biotechnology company with one focus to create life-saving products for patients with respiratory disease and improve the standard of care for pulmonary medicine.