Discovery Labs Announces U.S. Commercial Launch of SURFAXIN® (lucinactant)
WARRINGTON, Pa., Nov. 8, 2013
WARRINGTON, Pa., Nov. 8, 2013 /PRNewswire/ --Discovery Laboratories, Inc.
(NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new
standard in respiratory critical care, today announced that it has initiated
the U.S. commercial launch of SURFAXIN^® (lucinactant) Intratracheal
Suspension for the prevention of respiratory distress syndrome (RDS) in
premature infants at high risk for RDS. SURFAXIN is the first FDA-approved
synthetic, peptide-containing surfactant and the only alternative to
animal-derived surfactants available in the U.S.
"The commercial launch of SURFAXIN marks a significant milestone for Discovery
Labs, but more importantly represents a long-awaited therapeutic option for
the neonatology community and the fragile premature infants in its care," said
John G. Cooper, Chief Executive Officer of Discovery Labs.
Discovery Labs also announced today that, in accordance with the terms of its
February 2013 $30million secured loan facility with Deerfield Management
Company, L.P. (Deerfield), it will be notifying Deerfield that it has now met
the conditions to receive the final $20million advance under the facility.
Upon receipt of the $20 million advance in early December 2013, the Company
will issue warrants to Deerfield for approximately 4.7 million shares at an
exercise price of $2.81 per share.
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
surfactants in the U.S.
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 (ARDS).
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 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 and expectations with respect to the
commercial introduction of SURFAXIN, and its current and future financial
position, 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: Company, John Tattory, Vice President, Finance: 215.488.9418 or
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