Pipeline Overview

We are a specialty biotechnology company focused on advancing a new standard in respiratory critical care through the development of novel technologies that have potential application across a broad range of respiratory disease. Specifically, we are dedicated to the development of novel surfactant therapies with broad potential application across many respiratory diseases, as well as the development of effective and efficient modes of delivery for its surfactant and other aerosolized respiratory therapies.

Respiratory Distress Syndrome (RDS)

Our lead surfactant product candidate is SURFAXIN^® (lucinactant), a liquid instillate formulation of KL₄ surfactant, which is currently under review by the U.S. Food and Drug Administration (FDA).

We are also developing product solutions for RDS through a variety of dosage forms, including SURFAXIN LS^TM, a lyophilized formulation of KL₄ surfactant, as well as AEROSURF^®, an aerosolized KL₄ surfactant.

AEROSURF could represent a transformational change in neonatal respiratory critical care by providing practitioners the ability to administer surfactants using less invasive means. By potentially reducing or eliminating complications associated with endotracheal intubation and mechanical ventilation, AEROSURF may also support a potentially significant increase in the number of infants with or at risk for RDS who could benefit from surfactant therapy.

Additional Respiratory Applications

We also believe that KL₄ surfactant may have application in the spectrum of respiratory critical care disorders, which includes acute respiratory failure (ARF), acute lung injury (ALI) and acute respiratory distress syndrome (ARDS). We plan to explore these areas once we have secured appropriate capital, which may be accomplished through strategic alliances or other collaborative arrangements.

Aersolized Drug Delivery

Discovery Labs’ lead drug delivery product is AFECTAIR, a series of novel ventilator circuit/patient interface connectors, the initial version of which is currently is being registered as a Class I, exempt medical device in the U.S. We are also pursuing the registration of AFECTAIR in the European Union and other non-U.S. jurisdictions.

We plan to initiate the commercial introduction of the initial AFECTAIR devices in the United States and the European Union in 2012.

Additional Drug Delivery Applications

Discovery Labs is also advancing its proprietary capillary aerosol generator (CAG) as part of its AEROSURF development program. The CAG has been designed to produce high volume, low-velocity aerosolized KL₄ surfactant for intra-pulmonary delivery for the prevention and/or treatment of RDS in premature infants, but may have other applications in the advancement of a new standard for respiratory critical care.

SURFAXIN (lucinactant) is an investigational drug, and is under review by the FDA. Several published and presented pre-clinical and clinical studies are referenced throughout this website; however, approved and final prescribing information for SURFAXIN is not available at this time.

AEROSURF is an investigational drug-device combination product not approved by the FDA.

The initial AFECTAIR device has been registered with the FDA, but is not commercially available at this time.