Lower rate of reintubation observed in infants receiving SURFAXIN

Discovery Laboratories, Inc. (NASDAQ: DSCO) today announced the presentation of a new pharmacoeconomic analysis demonstrating that the lower rate of reintubation previously reported in infants treated with SURFAXIN^®, when compared with infants treated with Curosurf^® and Survanta^®, the current global market leading surfactants, also resulted in a potential hospital cost savings of $160,000 to $252,000 per 100 infants.  The analysis, which is expected to appear in publication later this year, was presented at the 2012 Pediatric Academies Society Annual Conference (April 28 – May 1, 2012) in Boston, MA.

"This analysis suggests that the selection of a specific surfactant can significantly impact hospital costs based on the rate of reintubation observed with each therapy," said Dr. Russell G. Clayton, Senior Vice President, Research & Development, of Discovery Labs.  "In this pharmacoeconomic model, the lower rate of reintubation observed in infants receiving SURFAXIN also resulted in a potential reduction in healthcare resource utilization and per-patient hospital cost when compared to treatment with today's market leading animal-derived surfactants."

The current standard of care for respiratory distress syndrome (RDS) typically requires that the infant undergo intubation (insertion of a breathing tube into the infant's airway) to allow for surfactant administration and respiratory support via mechanical ventilation.  If therapy is successful, the breathing tube is removed to allow the infant to breathe independently.  However, over one third of infants have difficulty breathing independently after the breathing tube is removed and require reintubation. 

Retrospective analysis of data from Discovery Labs' two large phase 3 trials involving a total of 1546 patients shows that the reintubation rate in SURFAXIN-treated infants ranged from 33 to 35 percent and was significantly lower (p < 0.05) compared with treatment with Curosurf (47 percent), the current global market leader, and Survanta (43 percent).  These data were previously published in the Journal of Neonatal- Perinatal Medicine (Volume 4, Number 2, 2011) in a manuscript entitled "Reintubation and risk of morbidity and mortality in preterm infants after surfactant replacement therapy" (Guardia et al.).  Based on these data, pharmacoeconomic modeling reveals that the higher rates of reintubation observed with the use of Curosurf and Survanta also results in potential increases in direct hospital costs related to the need for extended mechanical ventilation and the daily cost of care for these infants.  Although the retrospective analysis also demonstrates that reintubation results in an increase in morbidities, such as bronchopulmonary dysplasia and air leak, the pharmacoeconomic modeling does not include the additional costs associated with these morbidities.  The study authors noted that additional pharmacoeconomic analyses of potential reduction in reintubation-associated morbidities are warranted.

Dr. Clayton continued, "Analysis of our phase 3 data has already demonstrated that reintubation appears to be related to higher mortality as well as increases in key morbidities.  These observations, along with the results of this pharmacoeconomic analysis, represent important information for neonatal health care providers to consider when choosing a surfactant for their patients."

Discovery Labs estimates that approximately 360,000 low birth weight premature infants are born annually in the United States and at risk for RDS.  Of that total, the Company estimates that approximately 130,000 are diagnosed with RDS and nearly 90,000 are treated with surfactant replacement therapy.

On March 6, 2012, Discovery Labs announced that the U.S. Food and Drug Administration (FDA) approved SURFAXIN for the prevention of RDS in premature infants who are at high risk of developing RDS.  SURFAXIN is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal derived surfactants.  The U.S. commercial introduction of SURFAXIN is anticipated in late 2012.