Discovery Laboratories, Incorporation is a biopharmaceutical company developing its own surfactant technology as Surfactant Replacement Therapies for respiratory diseases. Surfactants are compositions, which are produced naturally in the lungs and essential for breathing. Discovery's technology does produce an engineered version of natural human lung surfactant that is designed to closely mimic the essential properties of human lung surfactant. Discovery does believe that through its technology, pulmonary surfactants have the potential, for the first time, to be developed into a series of respiratory therapies for critical care and other hospitalized patients where there are few or no approved therapies available

Surfaxin, if approved, would be the world's next generation surfactant?significantly improving and expanding the current surfactant therapy for RDS and treating other neonatal intensive care unit respiratory conditions for which the only treatment today is mechanical ventilation. The potential attributes of Surfaxin create an opportunity for improving critical care respiratory medicine?a market that could exceed $1.5 billion.

Discovery laboratories have conducted a pivotal Phase 3 trial which enrolled 1,294 patients and was designed as a multinational, multicenter, randomized, masked, controlled, prophylaxis, event-driven, superiority trial to demonstrate the safety and efficacy of Surfaxin over Exosurf?, an approved, non-protein containing synthetic surfactant. Survanta?, a cow-derived surfactant and the leading surfactant used in the United States, served as a reference arm in the trial.

Key trial results were assessed by an independent committee comprised of leading neonatologists and pediatric radiologists. This committee provided a very consistent and standardized method for assessing critical efficacy data in the trial. An independent Data Safety Monitoring Board was responsible for monitoring the overall safety of the trial and no major safety issues were identified