5 2009 GLOBE NEWSWIRE Discovery Laboratories Inc

WARRINGTON, Pa., Jan. 5, 2009 (GLOBE NEWSWIRE) Discovery Laboratories, Inc.(Nasdaq:DSCO) announces the publication of results from its Phase 2 clinicaltrial of Surfaxin(r) for the prevention and treatment of BronchopulmonaryDysplasia (BPD) in Pediatrics, a premier medical journal for pediatriccritical-care healthcare practitioners. BPD is a chronic, debilitating lungdisease typically affecting premature infants who received treatment forRespiratory Distress Syndrome (RDS). Presently, there are no approved pharmaceutical therapies forBPD.These results appear in the following manuscript published in the January issueof Pediatrics: A Pilot Randomized, Controlled Trial of Later Treatment witha Peptide-Containing, Synthetic Surfactant for the Preventionof Bronchopulmonary Dysplasia (Laughon et al Pediatrics2009;123 89-96)Robert J.

Capetola, President and CEO of Discovery Labs commented, "We areextremely pleased that Pediatrics has published these data and made themavailable to the medical community. We believe that these data further validatethe pharmacology of our KL-4 surfactant and support our continued development ofour technology platform to address a broad range of unmet medical needs inpulmonary medicine."Discovery Labs conducted a Phase 2 clinical trial to evaluate the safety andpotential efficacy of Surfaxin in infants at risk for BPD. The clinical trialenrolled 136 premature infants that were randomized to receive, in addition tostandard of care, either Surfaxin standard dose (175 mg/kg), Surfaxin low dose(90 mg/kg), or sham air as a control. In this pilot estimation study, infantstreated with the Surfaxin standard dose, as compared to those in the controlgroup experienced a lower incidence of death or BPD (58 vs. No meaningful conclusions could be drawn from theSurfaxin low dose treatment group, likely due to this group containing infantswith more pre-existing medical risk conditions.Dr. Matthew Laughon, Assistant Professor, Department of Pediatrics, Division ofNeonatal-Perinatal Medicine, The University of North Carolina at Chapel Hill,commented, "The data from this Phase 2 estimation trial support additionaltrials to evaluate the potential of Surfaxin as a therapeutic option for theprevention of BPD.

BPD represents one of the most challenging clinical problemswe face in neonatology. Extremely low birth weight infants, particularly thosethat require mechanical ventilation, are at risk for this debilitatingdisorder."BPD is associated with surfactant deficiency and is diagnosed when prematureinfants require mechanical ventilation or supplemental oxygen at 36 weekspost-menstrual age. Premature infants are often born with a lack of natural lungsurfactant and are unable to absorb sufficient oxygen to survive, resulting inRDS. These infants often require endotracheal intubation to administer one ofthe currently-available, animal-derived surfactants (usually within the firsthours of birth) and to provide respiratory support via mechanical ventilation.Unfortunately, many infants relapse following initial SRT and requirereintubation and prolonged mechanical ventilation as well as supplementaloxygen, which increases the risk of developing BPD. Discovery Labs believes thatBPD may be prevented with repeated doses of Surfaxin administered after theinitial RDS SRT treatment (on day 1 or 2 of life) to improve the clinicaloutcome of these infants.SURFAXIN(r), an investigational drug, is the subject of an Approvable Letterfrom the FDA for the prevention of Respiratory Distress Syndrome in prematureinfants. The Executive Board and Officers of theAmerican Academy of Pediatrics select articles that appear in Pediatrics.