Discovery Labs Updates on Surfaxin Marketing Authorization

Discovery Laboratories, Inc. (Nasdaq:DSCO), Warrington, Pa., is providing an expanded update regarding ongoing efforts to file a Complete Response intended to gain U.S. Food and Drug Administration (FDA) marketing authorization for Surfaxin(R) for the prevention of respiratory distress syndrome (RDS) in premature infants. On January 10, 2011, Discovery Labs issued a press release reporting that the FDA had recently provided detailed, written direction in response to an earlier submitted proposal by Discovery Labs relating to its ongoing comprehensive preclinical program intended to gain Surfaxin approval. Throughout the conduct of the program, Discovery Labs has been interacting with the FDA and incorporating the FDA's guidance into its efforts to complete the program and file the Surfaxin Complete Response. The filing of the Complete Response is currently targeted for early third quarter 2011 and anticipated to lead to a potential approval early in the first quarter 2012. If approved, Surfaxin would become the first synthetic, peptide-containing surfactant for commercial use in neonatal medicine. The safety and efficacy of Surfaxin for neonatal RDS has previously been demonstrated in a large, multinational Phase 3 clinical program.