Discovery Laboratories, Inc. a speciality biotechnology company dedicated to improving the standard of respiratory critical care through its KL4 surfactant and aerosolized drug delivery technology platform, announced its intent to seek regulatory approval to market Afectair, a potential new product offering. Afectair originates from the Aerosurf development programme and is a proprietary disposable patient interface adapter that simplifies the delivery of any aerosolized medication to critical-care patients requiring ventilatory support from either intermittent mechanical ventilation or continuous positive airway pressure.
According to national health statistics and market assessment data recently obtained from an independent consulting firm, it is estimated that more than 1.3 million patients annually in the United States and European Union receive aerosolized medications while requiring ventilator support.
“We are excited about the prospect of expanding the Discovery Labs’ pipeline through our Afectair patient interface technology, a product that emerged as a result of the outstanding work being done to advance Aerosurf,” said W Thomas Amick, chairman of the Board and chief executive officer, Discovery Labs. “With both Afectair and Surfaxin potentially arriving on the market in 2012, we are making great progress toward our goal of improving the standard of respiratory critical care.”
In addition to its ongoing efforts to gain approval from the US Food and Drug Administration (FDA) to market Surfaxin for the prevention of Respiratory Distress Syndrome (RDS) in premature infants, Discovery Labs has made advancements in the delivery of aerosolized KL4 surfactant to critical care patients through the Aerosurf programme. In connection with that programme, Discovery Labs developed Afectair, a disposable patient interface adapter that introduces aerosolized medications into the ventilator airflow close to the patient and reduces the number of connections to the ventilator circuitry without compromising ventilatory support.
To date, studies suggest that the Afectair technology is an effective option for delivering aerosolized medicine to all patients receiving ventilator support while providing healthcare professionals with a simplified alternative to conventional methods. Discovery Labs expects to file for market authorization of the initial Afectair product in the United States in the fourth quarter of 2011, and in the European Union in the first half of 2012. If approved, Discovery Labs believes that it may be in a position to introduce the Afectair product line in both markets in 2012.
“We have completed and are encouraged by our comprehensive assessment of the operational, regulatory, and commercial landscape for Afectair,” said John G Cooper, president and chief financial officer, Discovery Labs, “Through consultation with independent experts, we believe that Afectair represents an incremental revenue opportunity of approximately $ 50-75 million, which could provide a source of non-dilutive funds to further support the development of our KL4 surfactant pipeline.” Afectair product attributes and performance data will be presented at multiple medical conferences in 2011 and 2012.
Surfaxin (lucinactant intratracheal suspension) is Discovery Labs’ lead product based on its proprietary KL4 surfactant technology and represents the first synthetic, peptide-containing surfactant that, if approved, will provide healthcare practitioners with an alternative therapy to the currently approved, animal-derived surfactants that are standard of care today. The safety and efficacy of Surfaxin for the prevention of RDS has previously been demonstrated in a comprehensive phase III clinical programme.
Discovery Labs filed a New Drug Application (NDA) for Surfaxin for the prevention of RDS in premature infants and received a Complete Response Letter from the FDA in April 2009. Discovery Labs anticipates filing response to the Complete Response Letter in the third quarter of 2011, which after a six-month FDA review period, could lead to the potential approval of Surfaxin as early as the first quarter of 2012.
Aerosurf (lucinactant for inhalation), the company’s 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 aerosolization technology and related patient interface technology, 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.