Discovery Labs Announces Newly-Released SURFAXIN® (lucinactant) Publications

WARRINGTON, Pa., March 29, 2013 /PRNewswire/ -- Discovery Laboratories, Inc. (NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new standard in respiratory critical care, today announced the release of two peer-reviewed publications related to SURFAXIN^® (lucinactant) Intratracheal Suspension. SURFAXIN, currently the only FDA approved synthetic alternative to animal-derived surfactants in the U.S., was highlighted in the December issue of the Journal of Pediatric Pharmacology and Therapeutics (JPPT), in an article titled "A Pharmacoeconomic Analysis of In-Hospital Costs Resulting from Reintubation in Preterm Infants Treated with Lucinactant, Beractant, or Poractant Alfa", as well as this month's issue of Expert Reviews in Clinical Pharmacology in an article titled "Lucinactant for the Prevention of Respiratory Distress Syndrome in Premature Infants".

"We believe the growing body of peer-reviewed scientific literature for SURFAXIN will better inform physicians and other decision makers considering formulary adoption of SURFAXIN," said Dr. Russell G. Clayton, Senior Vice President, Research & Development, of Discovery Labs. 

The publications are as follows:

A Pharmacoeconomic Analysis of In-Hospital Costs Resulting from Reintubation in Preterm Infants Treated with Lucinactant, Beractant, or Poractant Alfa – JPPT July-September 2012, Vol. 17, No. 3, pp. 220-227

A pharmacoeconomic analysis previously presented at the 2012 Pediatric Academic Society Annual Conference and now published in the most recent issue of JPPT shows the lower rate of reintubation previously observed in infants treated with SURFAXIN, when compared with infants treated with the market leading surfactants, Curosurf^® and Survanta^®, resulted in a potential hospital cost savings associated with a reduction in need for mechanical ventilation. 

Lucinactant for the Prevention of Respiratory Distress Syndrome in Premature Infants - Expert Rev. Clin. Pharmacol. March 2013, Vol. 6, No. 2, Pages 115-121

In an independent review, Expert Reviews authors provide a comprehensive assessment of lucinactant based on a compilation of available peer-reviewed publications that have discussed the safety, efficacy, and potential pharmacoeconomic impact of lucinactant in the prevention of respiratory distress syndrome (RDS). As the first synthetic, peptide-containing surfactant approved by the FDA, the authors indicate that SURFAXIN can be reproducibly manufactured and may reduce certain cultural or religious objections sometimes presented by parents with the use of animal-derived medications in their infants who are at risk for RDS. Furthermore, the authors discuss the future of surfactant replacement therapy, including potential aerosolization of lucinactant, which could allow for a less invasive approach to treating RDS.

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 Journal of Pediatric Pharmacology and Therapeutics
The Journal of Pediatric Pharmacology and Therapeutics is the official journal of the Pediatric Pharmacy Advocacy Group. JPPT is a peer-reviewed multi disciplinary journal that is devoted to promoting the safe and effective use of medications in infants and children. To this end, the journal publishes practical information for all practitioners who provide care to pediatric patients. Each issue includes review articles, original clinical investigations, case reports, editorials, and other information relevant to pediatric medication therapy.

About Expert Reviews in Clinical Pharmacology
Expert Reviews Ltd is a leading publisher of commentary and analysis in modern healthcare. Founded in 2000, Expert Reviews Ltd is a privately owned publishing company headquartered in North London. Their goal is to publish thought-provoking, authoritative and significant articles from international opinion leaders to inform clinical practice. Their journals are published according to industry-leading standards of peer review, presentation, speed of publication, online functionality and author service.

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 potential benefits 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.