UPDATE: Discovery Labs Responds to FDA Request for Clarification of Recently Submitted SURFAXIN(R) (lucinactant) Updated Product Specifications

Discovery Laboratories, Inc.(NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing anew standard in respiratory critical care, today announced that on June 7,2013 it submitted a response to the U.S. Food and Drug Administration's(FDA) recent correspondence relating to Discovery Labs' recently updatedproduct specifications for SURFAXIN(R) . Discovery Labs expects that theFDA may take up to four months to review the information provided. If itsplan is successful and the FDA agrees with the response, Discovery Labsexpects to proceed with the commercial introduction of SURFAXIN in thefourth quarter of 2013. In the third quarter of 2012, during a routine review of the results andprocesses related to the analytical testing and quality control of SURFAXINdrug product, Discovery Labs determined that one of its analytical chemistrymethods used to assess SURFAXIN drug product conformance to specificationsrequired improvement and that an update to product specifications wasnecessary. The Company proactively communicated these findings to the FDA,improved and revalidated the analytical chemistry method, and submittedupdated product specifications to the FDA. Subsequently, the FDA requestedinformation and provided recommendations intended to clarify certain aspectsof the updated product specifications and the revalidated analyticalchemistry method. Discovery Labs has now responded to the FDA's request. Improvement of the method and the proposed change in SURFAXIN productspecifications is expected to have no impact on Discovery Labs' developmentprograms, including AEROSURF(R) . The AEROSURF program currently remains ontrack for the initiation of phase 2 clinical program in the fourth quarterof 2013. ABOUT SURFAXIN(R) SURFAXIN (lucinactant) Intratracheal Suspension is asynthetic, peptide-containing surfactant. SURFAXIN is indicated for theprevention of respiratory distress syndrome (RDS) in premature infants athigh risk for RDS. The safety and efficacy of SURFAXIN for the prevention ofRDS in premature infants was demonstrated in a large, multinational phase 3clinical program that included 1294 patients. IMPORTANT SAFETY INFORMATION SURFAXIN is intended for intratracheal use only. The administration ofexogenous surfactants, including SURFAXIN, can rapidly affect oxygenationand lung compliance. SURFAXIN should be administered only by clinicianstrained and experienced with intubation, ventilator management, and generalcare of premature infants in a highly supervised clinical setting. Infantsreceiving SURFAXIN should receive frequent clinical assessments so thatoxygen and ventilatory support can be modified to respond to changes inrespiratory status. Most common adverse reactions associated with the use of SURFAXIN areendotracheal tube reflux, pallor, endotracheal tube obstruction, and needfor dose interruption. During SURFAXIN administration, if bradycardia,oxygen desaturation, endotracheal tube reflux, or airway obstruction occurs,administration should be interrupted and the infant's clinical conditionassessed and stabilized. SURFAXIN is not indicated for use in acute respiratory distress syndrome(ARDS). For more information about SURFAXIN, please visit www.surfaxin.com. ABOUT AEROSURF(R) AEROSURF (lucinactant for inhalation), Discovery Labs'aerosolized KL4 surfactant product, is under development to addressrespiratory distress syndrome in premature infants. Through the effectivedelivery of aerosolized KL4 surfactant using Discovery Labs' proprietarycapillary aerosol generator technology, AEROSURF may significantly expandthe surfactant-eligible treatment population by providing neonatologistswith a means of administering surfactant without the risks currentlyassociated with invasive endotracheal intubation and mechanical ventilation.