DISCOVERY PRESENTS DATA ON SYNTHETIC SURFACTANT

Discovery Laboratories has announced that additional clinical data from its SELECT and STAR Phase III clinical trials of Surfaxin (lucinactant) for the prevention of respiratory distress syndrome (RDS) in premature infants were presented at the European Academy of Paediatrics Congress in Barcelona. These data demonstrate that Surfaxin-treated infants require significantly less re-intubation and experience improved key clinical outcomes compared to those treated with the animal-derived surfactants Survanta and Curosurf, the current market-leading products in the United States and Europe.

Recent data from Discovery's Phase III clinical trials demonstrate statistically significant reductions in re-intubation rates for Surfaxin-treated infants. In the SELECT trial's comparison of Surfaxin with Survanta, re-intubation rates were significantly lower for infants treated with Surfaxin. In the STAR trial's comparison of Surfaxin with Curosurf, re-intubation rates were also significantly lower for infants treated with Surfaxin.

Surfaxin is a precision-engineered, peptide-containing, synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant and represents a potential alternative to the animal-derived and non-protein-containing synthetic surfactants. Surfactants are substances that are produced naturally in the lungs and are essential to the lungs' ability to absorb oxygen and maintain proper airflow through the respiratory system. Surfaxin has received an approvable letter from the FDA for the prevention of RDS in premature infants.