Discovery Labs Responds to FDA Request for Clarification of Recently Submitted
SURFAXIN® (lucinactant) Updated Product Specifications
WARRINGTON, Pa., June 10, 2013
WARRINGTON, Pa., June 10, 2013 /PRNewswire/ --Discovery Laboratories, Inc.
(NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new
standard in respiratory critical care, today announced that on June 7, ^ 2013
it submitted a response to the U.S. Food and Drug Administration's (FDA)
recent correspondence relating to Discovery Labs' recently updated product
specifications for SURFAXIN^®. Discovery Labs expects that the FDA may take
up to four months to review the information provided.If its plan is
successful and the FDA agrees with the response, Discovery Labs expects to
proceed with the commercial introduction of SURFAXIN in the fourth quarter of
In the third quarter of 2012, during a routine review of the results and
processes related to the analytical testing and quality control of SURFAXIN
drug product, Discovery Labs determined that one of its analytical chemistry
methods used to assess SURFAXIN drug product conformance to specifications
required improvement and that an update to product specifications was
necessary.The Company proactively communicated these findings to the FDA,
improved and revalidated the analytical chemistry method, and submitted
updated product specifications to the FDA.Subsequently, 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 has now responded to the FDA's request.
Improvement of the method and the proposed change in SURFAXIN product
specifications is expected to have no impact on Discovery Labs' development
programs, including AEROSURF^®. The AEROSURF program currently remains on
track for the initiation of phase 2 clinical program in the fourth quarter of
SURFAXIN (lucinactant) Intratracheal Suspension is a synthetic,
peptide-containing surfactant. SURFAXIN is indicated for the prevention of
respiratory distress syndrome (RDS) in premature infants at high risk for
RDS.The safety and efficacy of SURFAXIN for the prevention of RDS in
premature infants was demonstrated in a large, multinational phase 3 clinical
program that included 1294 patients.
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.
AEROSURF (lucinactant for inhalation), Discovery Labs' aerosolized KL4
surfactant product, is under development to address respiratory distress
syndrome in premature infants.Through the effective delivery of aerosolized
KL4 surfactant using Discovery Labs' proprietary capillary aerosol generator
technology, AEROSURF may significantly expand the surfactant-eligible
treatment population by providing neonatologists with a means of administering
surfactant without the risks currently associated with invasive endotracheal
intubation and mechanical ventilation.
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
While Discovery Labs expects that the FDA will agree with its submission and
respond to its response within the time set forth above, there can be no
assurance that the FDA will accept Discovery Labs' proposed updated product
specifications and respond within the time set forth above, or that Discovery
Labs will be able to proceed with the commercial introduction of SURFAXIN, if
at all, in the fourth quarter of 2013.Any extended delay in the commercial
availability of SURFAXIN could have a material adverse effect on Discovery
Labs' ability to fund its operations and its development programs.Readers are
referred to, and encouraged to read in their entirety, the Form 8-K that
Discovery Labs filed with the Securities and Exchange Commission (SEC)
concurrently with the issuance of this press release, and Discovery Labs'
Quarterly Report on Form 10-Q for the quarter ended March 31, 2013 that was
filed with the SEC on May 7, 2013, which includes further detail on the
Company's business plans and operations, financial condition and results of
The information in this press release includes certain "forward-looking"
statements relating, among other things, to Discovery Labs' correspondence
with the FDA concerning its submission of updated SURFAXIN product
specifications and the FDA's response containing recommendations and requests
for information, and Discovery Labs' expectation that it will be able to
proceed with the commercial sale of SURFAXIN in the fourth quarter of
2013.These and other similar statements included herein are forward-looking
and are made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. While Discovery Labs currently believes that
it will succeed in meeting the timelines outlined above, such forward-looking
statements are subject to a variety of risks and uncertainties that could
cause actual results to be materially different. Examples of such risks and
uncertainties, including those related to the Company's research and
development and commercialization programs, are described in Discovery Labs'
filings with the SEC, 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: Investor Relations: Michael Rice, LifeSci Advisors - 646.597.6979;
Media Relations: Michael Parks, Pitch360 - 484.356.7105 or
Michael@pitch360inc.com; The Company: John Tattory, Vice President of Finance,
Discovery Labs - 215.488.9418
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