Discovery Labs Announces FDA Approval of SURFAXIN® (lucinactant) Updated
Commercial Introduction of SURFAXIN Planned for the Fourth Quarter of 2013
WARRINGTON, Pa., Oct. 4, 2013
WARRINGTON, Pa., Oct. 4, 2013 /PRNewswire/ --Discovery Laboratories, Inc.
(NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new
standard in respiratory critical care, today announced the U.S. Food and Drug
Administration (FDA) has agreed to the Company's updated product
specifications for SURFAXIN^® (lucinactant) Intratracheal Suspension which was
approved for the prevention of respiratory distress syndrome (RDS) in
premature infants at high risk for RDS. The Company has initiated
manufacturing of SURFAXIN for its planned commercial introduction in the
fourth quarter of 2013. SURFAXIN is the first FDA-approved synthetic,
peptide-containing surfactant available for the prevention of RDS in premature
infants and the only approved alternative to animal-derived surfactants
currently used today.
"We are pleased that the FDA has agreed with our updated product
specifications and are appreciative of the process that has lead to this
decision," said John G. Cooper, Chief Executive Officer of Discovery Labs.
"SURFAXIN represents the first milestone in our goal of transforming the
treatment ofRDS and is an important medical advancement for the neonatology
community and parents of preterm infants who will soon have an effective
alternative to animal-derived surfactants for the prevention of RDS."
The U.S. Food and Drug Administration (FDA) approved SURFAXIN^® (lucinactant)
Intratracheal Suspension 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
IMPORTANT SAFETY INFORMATION
SURFAXIN 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
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 www.surfaxin.com.
ABOUT DISCOVERY LABS
Discovery Laboratories, Inc. is a specialty biotechnology company focused on
advancing 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. Discovery
Labs is also developing its proprietary drug delivery technologies to enable
efficient delivery of aerosolized KL4 surfactant and other inhaled therapies.
Discovery Labs' strategy is initially focused on neonatology and improving
the management of respiratory distress syndrome (RDS) in premature infants.
Discovery Labs believes that its RDS product portfolio has the potential to
become the new standard of care for RDS and, over time, significantly expand
the current worldwide RDS market.
For more information, please visit the Company's website at
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 Discovery Labs' plans to manufacture commercial lots of SURFAXIN
and the timing of the commercial launch andmarket 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.
Contact: Investor Relations: Michael Rice, LifeSci Advisors: 646.597.6979 or
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