DISCOVERY LABS, FDA AGREE ON PATH TO SURFAXIN APPROVAL

Discovery Laboratories announced that it received guidance from the FDA at a recent meeting regarding the remaining steps necessary to receive approval for Surfaxin (lucinactant) for the prevention of respiratory distress syndrome in premature infants. The FDA guidance addresses key issues identified in the April 2006 approvable letter for its Surfaxin new drug application (NDA). Discovery anticipates filing its formal response to the approvable letter in September or October.

The defined pathway to potential Surfaxin approval does not include a requirement for additional clinical trials. The approvable letter primarily focused on the chemistry, manufacturing and controls section of the NDA and requested additional information predominantly involving drug product specifications and related controls.

Discovery provided information to the FDA regarding its comprehensive investigation and remediation of the April 2006 Surfaxin process validation stability failure including the identification of a most probable root cause. The comprehensive investigation focused on analysis of manufacturing processes, analytical methods and method validation, and active pharmaceutical ingredient suppliers.

Discovery is planning to begin manufacturing new Surfaxin process validation batches this week and will submit six months of related stability data in its response to the approvable letter. Additionally, the FDA indicated that Surfaxin shelf-life will be determined based on comparative stability data from historical Surfaxin batches.

Surfaxin is a synthetic surfactant that is designed to closely mimic the function of natural human lung surfactant and represents a potential alternative to animal-derived surfactants.