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Discovery Labs Reports Fourth Quarter 2012 Financial Results
Date:3/13/2013

; "As we anticipate the availability of SURFAXIN® drug product in the second quarter, our specialty field force has been focused primarily on securing hospital formulary acceptance for SURFAXIN, as well as adoption of AFECTAIR®.  We continue to make progress on our AEROSURF® development program and plan to initiate our phase 2 clinical program in the fourth quarter of 2013."

Selected Program Updates:

SURFAXIN: SURFAXIN (lucinactant) intratracheal suspension is the first synthetic, peptide-containing surfactant approved by the Food and Drug Administration (FDA) and provides healthcare practitioners an alternative to animal-derived surfactants to prevent respiratory distress syndrome (RDS) in premature infants.  In the third quarter of 2012, the Company determined that one of the analytical chemistry methods used to assess SURFAXIN drug product conformance to specifications required improvement and that an update to product specifications was needed. As a result, the Company delayed the commercial launch of SURFAXIN.  The Company proactively communicated these findings to the FDA, improved and validated the analytical chemistry method, and submitted updated product specifications to the FDA.  The planned activities remain on track, and, pending confirmation from the FDA regarding the updated product specifications; the Company believes that SURFAXIN will be available for commercial sale in the second quarter of 2013.  

AEROSURF:  The Company is developing AEROSURF as a drug/device combination product to potentially allow neonatal practitioners to deliver aerosolized KL4 surfactant to premature infants without the need for invasive endotracheal intubation.  If efforts are successful, AEROSURF could enable the treatment of a significantly greater number of premature infants at risk for RDS.  The Company is progressing with third-party medical device ex
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SOURCE Discovery Laboratories, Inc.
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