Discovery Labs Presents Final Assessment in a Series of Pharmacoeconomic Analyses that Explore Impact of Reintubation on

   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

PR Newswire

WARRINGTON, Pa., June 11, 2013

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: )

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:

  oInfants 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).
  oInfants who required reintubation had significantly higher rates of major
    complications of prematurity, including BPD, air leak, sepsis, NEC and
  oInfants 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).
  oInfants 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.


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.


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

For more information about SURFAXIN, please visit


The Pediatric Pharmacy Advocacy Group (PPAG) is aninternational, 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.


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

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.

Contact: Media Relations: Michael Parks, Pitch360 - 484.356.7105 or; or Investor Relations: Michael Rice, LifeSci
Advisors: 646.597.6979 or; or Company Contact: John
Tattory, Vice President, Finance- 215.488.9418
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