New Pharmacoeconomic Analysis Shows Lower Rate of Reintubation Observed With SURFAXIN® Treatment May Reduce Hospital Costs Associated with Bronchopulmonary Dysplasia

WARRINGTON, Pa., Dec. 4, 2012 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO) today announced the release of data from a new pharmacoeconomic analysis demonstrating that the previously-reported reduced rate of reintubation in preterm infants treated with SURFAXIN^® may also result in an average potential hospital cost savings of $389,247 per 100 treated infants by reducing the frequency of bronchopulmonary dysplasia (BPD) when compared with reintubation rates of infants treated with the current global market leading surfactants, Curosurf^® and Survanta^®.  The analysis was presented at the 2012 Hot Topics in Neonatology Annual Meeting held December 2-4 in Washington D.C.  Hot Topics in Neonatology is an internationally recognized medical meeting dedicated to advancing the practice of neonatology.

"It has been previously reported that infants who require reintubation are three times more likely to develop BPD compared with those infants who are not reintubated," said Dr. Russell G. Clayton, Senior Vice President, Research & Development, of Discovery Labs.  "This new pharmacoeconomic analysis suggests that the selection of a specific surfactant could significantly impact hospital costs by potentially reducing the risk of developing BPD associated with reintubation.  These data may be important to physicians and pharmacists as they consider SURFAXIN for inclusion on hospital formularies."

The current standard of care for managing preterm infants with 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 a subsequent intubation, or reintubation.  Reintubation and extended exposure to mechanical ventilation is often associated with an increased incidence of other complications such as BPD – a chronic lung condition that affects some preterm infants who were at risk for or afflicted with RDS or required respiratory support via mechanical ventilation during the neonatal period.

This pharmacoeconomic analysis is based on data from a retrospective study, published in the Journal of Neonatal- Perinatal Medicine (Volume 4, Number 2, 2011).  This previously-published study, based on data from Discovery Labs' two large phase 3 trials involving a total of 1546 patients, assessed the influence of reintubation on the risk of morbidity and mortality in preterm infants receiving surfactant therapy for the prevention of RDS, as well as the relative rates of reintubation between surfactant therapies.  This article, the first published full description of the consequences of reintubation in a preterm neonate population, indicates that practitioners of neonatal medicine should choose therapeutic options that will optimize chances of successful extubation.  This previously-published study concluded:

• Infants who were successfully extubated and did not require reintubation experienced a statistically significantly lower mortality rate across all treatment groups compared with infants who subsequently required reintubation (0.5 percent vs. 18 percent, respectively p<0.05).
• Infants who required reintubation had significantly higher rates of six major complications of prematurity, including BPD, necrotizing enterocolitis (a severe intestinal condition often requiring surgery and loss of bowel), sepsis, and intraventricular hemorrhage (bleeding into the brain).
  • Nearly half of the infants requiring reintubation developed BPD, whereas only 15 percent of infants developed BPD if they were not reintubated (p<0.05).
• Infants treated with SURFAXIN demonstrated a significantly lower reintubation rate compared with those infants treated with animal-derived surfactants Curosurf (33 percent vs. 47 percent respectively; p<0.05) and Survanta (35 percent vs. 43 percent respectively; p<0.05).
• Infants treated with SURFAXIN demonstrated a significantly higher combined outcome of survival without reintubation compared with those infants treated with animal-derived surfactants Curosurf (67 percent vs. 53 percent respectively; p<0.05) and Survanta (65 percent vs. 57 percent respectively; p<0.05).
• Initial extubation rates were similar among surfactant treatments in both trials (80 to 84 percent; p=ns)

Earlier this year, Discovery Labs reported results from its first pharmacoeconomic analysis based on this retrospective study, which focused on additional days of mechanical ventilation in reintubated infants.  That analysis demonstrated that the lower rate of reintubation observed in infants treated with SURFAXIN resulted in a potential:

• Decreased costs related to direct hospital expenses associated with the need for extended mechanical ventilation due to reintubation.
• Hospital cost savings of approximately $160,000 to $252,000 per 100 infants when compared with infants treated with Curosurf and Survanta.

The first pharmacoeconomic analysis is expected to be published in the next issue of the Journal of Pediatric Pharmacology and Therapeutics (JPPT), a peer-reviewed multi-disciplinary journal that is devoted to promoting the safe and effective use of medications in infants and children.

In both pharmacoeconomic studies, authors noted that additional analyses investigating potential reduction in other reintubation-associated morbidities are warranted.  As such, Discovery Labs is conducting a third analysis of the potential pharmacoeconomic impact of these complications and expects to report the results in 2013.

In March 2012, 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 early in the second quarter of 2013.

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 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 potential pharmacoeconomic benefits of SURFAXIN, the timing of a commercial launch of SURFAXIN, and Discovery Labs' products under development 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. Discovery Labs assumes no obligation to update or revise any forward-looking statements.

SOURCE Discovery Laboratories, Inc.