Pharmacoeconomic Analysis Shows SURFAXIN® May Reduce Hospital Cost Associated with Reintubation in Premature Infants

WARRINGTON, Pa., May 1, 2012 /PRNewswire/ -- 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.

IMPORTANT SAFETY INFORMATION

SURFAXIN (lucinactant intratracheal suspension) is intended for intratracheal use only.  The administration of exogenous surfactants, including SURFAXIN, can rapidly affect oxygenation and lung compliance.  SURFAXIN should be administered only by clinicians trained and experienced with intubation, ventilator management, and general care of premature infants in a highly supervised clinical setting. Infants receiving SURFAXIN should receive frequent clinical assessments so that oxygen and ventilatory support can be modified to respond to changes in respiratory status.

Most common adverse reactions associated with the use of SURFAXIN are endotracheal tube reflux, pallor, endotracheal tube obstruction, and need for 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 condition assessed 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 The Pediatric Academic Societies Annual Meeting

The Pediatric Academic Societies (PAS) consists of the American Pediatric Society, the Society for Pediatric Research and the Ambulatory Pediatric Association. The PAS annual meeting is recognized as the largest, most prestigious meeting dedicated to pediatric research and education in the world and brings together scientists and physicians with expertise in all areas of pediatrics. More than 7,000 pediatric healthcare providers, including approximately 1,100 neonatologists, attend this meeting annually.

ABOUT DISCOVERY LABS

Discovery Laboratories, Inc. is a specialty biotechnology company with one focus – to advance a new standard in respiratory critical care.  Discovery Labs' novel proprietary KL4 surfactant technology produces a synthetic, peptide-containing surfactant that is structurally similar to pulmonary surfactant and is being developed in liquid, lyophilized, and aerosolized dosage forms. Discovery Labs is also developing its proprietary drug delivery technologies to enable efficient delivery of aerosolized KL4 surfactant and other inhaled therapies. Discovery Labs believes that its proprietary technologies make it possible, for the first time, to develop a significant pipeline of products to address a variety of respiratory diseases for which there frequently are few or no approved therapies.  For more information, please visit our website at www.Discoverylabs.com.

Forward-Looking Statements

To the extent that statements in this press release are not strictly historical, all such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from the statements made. Examples of such risks and uncertainties, including those related to the timing of a commercial launch of SURFAXIN and market acceptance of SURFAXIN, are described in Discovery Labs' filings with the Securities and Exchange Commission including the most recent reports on Forms 10-K, 10-Q and 8-K, and any amendments thereto. Any forward-looking statement in this release speaks only as of the date on which it is made. The Company assumes no obligation to update or revise any forward-looking statements.

SOURCE Discovery Laboratories, Inc.