Discovery Labs Presents Final Assessment in a Series of Pharmacoeconomic Analyses that Explore Impact of Reintubation on Healthcare Costs Follow-up SURFAXIN® (lucinactant) Data Analysis Presented at 2013 Pediatric Pharmacy Advocacy Group Annual Meeting

WARRINGTON, Pa., June 11, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO) today announced the presentation of the last in a series of pharmacoeconomic analyses indicating that a reduction in the rate of reintubation among preterm infants may potentially result in hospital cost-savings related to fewer reintubation-related diagnoses of bronchopulmonary dysplasia (BPD), air leak, sepsis, necrotizing enterocolitis (NEC), or intraventricular hemorrhage (IVH), including savings of up to $562,000 per 100 patients diagnosed with BPD.  The pharmacoeconomic model was developed using an observation from a previously published study that preterm infants who receive SURFAXIN® may have lower rates of reintubation when compared with preterm infants who received either Curosurf® or Survanta®. 

The findings from this third and final pharmacoeconomic analysis were presented recently at the 2013 Pediatric Pharmacy Advocacy Group (PPAG) Annual Meeting held in Indianapolis, IN.

Inpatient hospital costs for treating neonates with the primary diagnoses of BPD, air leak, sepsis, NEC, or IVH was obtained from a 2009 database of more than seven million U.S. hospital discharges, and multiplied by the intubation rate observed in each surfactant treatment group and the incidence of each morbidity in reintubated infants.  The model compared projected costs between the SURFAXIN treatment group and the comparator surfactant treatment groups from two phase 3 trials, SELECT and STAR, and yielded potential differences in hospital costs per 100 patients ranging from $34,000 for air leak alone to $562,000 for BPD (Figure 1).

(Photo: http://photos.prnewswire.com/prnh/20130611/NY29795 )

Discovery Labs expects to submit this analysis to a peer-reviewed, neonatology-focused medical journal later this year.

"A substantial proportion of infants with RDS, especially those under 1,000 grams, need to be reintubated.  The occurrence of major morbidities associated with reintubation in preterm children may potentially have a profound impact on healthcare resource utilization in the neonatal population," said Fernando R Moya, MD, SELECT Trial Principle Investigator and Director of Neonatology at New Hanover Regional Medical Center, Wilmington, NC. "Lower reintubation rates such as those observed with SURFAXIN therapy may significantly lower in-hospital costs for the treatment of reintubated infants."

The series of pharmacoeconomic analyses is based on the observations reported in the first ever, full description of the consequences of reintubation in preterm neonates published in the Journal of Neonatal- Perinatal Medicine (Volume 4, Number 2, 2011).   Those observations include:

  • Infants who were successfully extubated and did not require reintubation had a significantly lower mortality rate 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 major complications of prematurity, including BPD, air leak, sepsis, NEC and IVH.
  • Infants treated with SURFAXIN demonstrated a significantly lower reintubation rate compared with 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).

The first published pharmacoeconomic analysis suggested that the lower rate of reintubation resulted in a potential decrease in direct hospital expenses of approximately $160,000 to $252,000 per 100 infants when compared with infants treated with Curosurf and Survanta based solely on the need for extended time on mechanical ventilation due to reintubation.  Authors in that analysis noted that additional analyses investigating potential reduction in other reintubation-associated morbidities were warranted. 

The second pharmacoeconomic analysis in the series suggested that the reduced rate of BPD related to reintubation might also result in an average potential hospital cost savings of $389,247 per 100 infants. 

This study presented at the PPAG annual meeting is the third and final pharmacoeconomic analysis and includes a further analysis related to BPD, as well as other key morbidities such as air leak, IVH, NEC and sepsis.

ABOUT SURFAXIN®

The U.S. Food and Drug Administration (FDA) approved SURFAXIN® for the prevention of RDS in premature infants who are at high risk for RDS.  SURFAXIN is the first synthetic, peptide-containing surfactant approved by the FDA and the only alternative to animal derived surfactants. 

In the third quarter of 2012, during a routine review of our processes related to analytical testing and quality control of SURFAXIN drug product, Discovery Labs determined that one analytical chemistry method used to assess SURFAXIN drug product required improvement and that an update to SURFAXIN product specifications was needed.  Discovery Labs notified the FDA, improved and revalidated the analytical chemistry method, and submitted updated product specifications to the FDA.  In April 2013, the FDA requested information and provided recommendations intended to clarify certain aspects of the updated product specifications and the revalidated analytical chemistry method.  Discovery Labs responded to the FDA on June 7, 2013 and expects that the FDA may require up to four months to review this type of submission.  If the FDA agrees with its submission and responds within the anticipated time, Discovery Labs anticipates that it will proceed with the commercial introduction of SURFAXIN in the fourth 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 THE PEDIATRIC PHARMACY ADVOCACY GROUP

The Pediatric Pharmacy Advocacy Group (PPAG) is an international, nonprofit, professional association representing the interests of pediatric pharmacists and their patients. PPAG is dedicated to improving medication therapy in children, with their sole purpose being to promote safe and effective medication use in children through communication, education, and research.

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 Discovery Labs' 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, timing of the anticipated commercial introduction 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.



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