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Discovery Labs Receives FDA Recommendations and Request for Clarification Regarding Recently-Submitted SURFAXIN® (lucinactant)



  Discovery Labs Receives FDA Recommendations and Request for Clarification
     Regarding Recently-Submitted SURFAXIN® (lucinactant) Updated Product
                                Specifications

PR Newswire

WARRINGTON, Pa., April 15, 2013

WARRINGTON, Pa., April 15, 2013 /PRNewswire/ -- Discovery Laboratories, Inc.
(NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new
standard in respiratory critical care, today announced that the U.S. Food and
Drug Administration (FDA) has requested clarification and provided
recommendations regarding the recently-updated product specifications for
SURFAXIN^®.  Discovery Labs plans to provide a response to the FDA within two
months.  FDA procedure provides up to four months for FDA review of 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 2013.

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 validated the analytical chemistry method, and submitted updated
product specifications to the FDA. 

The recently-received FDA correspondence includes a request for specific
information intended to clarify certain aspects of the updated product
specifications and the revalidated analytical chemistry method, including:

  o Recommendations regarding how the product specifications should be
    documented and notated
  o A specific recommendation for the upper limit of a single product
    specification that Discovery Labs can readily accept
  o A request for two existing and readily available documents related to the
    improved analytical chemistry method
  o Request for supporting data using the recently improved and revalidated
    analytical chemistry method that is being generated from recent SURFAXIN
    batches.

"We appreciate the FDA's recommendations," said Dr. Russell G. Clayton, Senior
Vice President, Research & Development, at Discovery Labs. "Our team is
compiling the information and we will continue to communicate with the FDA to
ensure our response meets its needs."

Discovery Labs believes that its product portfolio and development pipeline
based on KL[4] surfactant and aerosol delivery technologies can bring
transformational improvements to neonatal respiratory critical care.  The
current improvement and validation of the analytical chemistry method used to
assess specification conformance for SURFAXIN drug product has no technical
impact on the AEROSURF^® program. The AEROSURF program currently remains on
track for the phase 2 clinical program in the fourth quarter of 2013. 

"We are committed to SURFAXIN, AFECTAIR^® and AEROSURF with the goal of
building a specialized biotechnology company that has the potential to
establish new standards in respiratory critical care, beginning with
neonatology," said John G. Cooper, President and Chief Executive Officer at
Discovery Labs. "As we address the FDA's recommendations on SURFAXIN, we will
also assess various strategic and financial alternatives to support the
execution of our fundamental strategy."

ABOUT SURFAXIN
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 (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 AFECTAIR
The AFECTAIR technology was developed as a proprietary, disposable device that
simplifies the delivery of aerosolized medications to critical-care patients
requiring ventilatory support such as intermittent mechanical ventilation or
continuous positive airway pressure.  To date, in vitro studies suggest that
the AFECTAIR technology may be an effective new solution for delivering
aerosolized medicine to infants receiving ventilatory support while providing
healthcare professionals with a simplified alternative to current practices. 
According to national health statistics and internal market assessment data,
it is estimated that each year approximately 355,000 pediatric patients in the
United States are eligible to receive aerosolized medications while requiring
ventilator support.

Discovery Labs is also pursuing European Conformity (CE) marking for potential
commercialization of AFECTAIR for infants in the European Union (EU) in 2013.

ABOUT AEROSURF
AEROSURF (lucinactant for inhalation), Discovery Labs' initial aerosolized
KL[4] surfactant product, is under development to address respiratory distress
syndrome in premature infants.  Through the effective delivery of aerosolized
KL[4] 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 KL[4] 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 KL[4] 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
www.Discoverylabs.com.

DISCLOSURE NOTICE
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 to be
filed with the SEC on or before May 10, 2013, which includes further detail on
the Company's business plans and operations, financial condition and results
of operations.

Forward-Looking Statements
The information in this press release includes certain "forward-looking"
statements relating, among other things, to Discovery Labs' plans related to
the recommendations and requests included in a recently-received FDA
communication, its plans to manufacture and release SURFAXIN drug product,
including to generate data for inclusion in its response to the FDA and for
commercial sale in the fourth quarter of 2013, and its plans to prepare and
submit to the FDA additional information supporting a request to update
SURFAXIN product specifications within an anticipated two months.  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.

Website: http://www.discoverylabs.com
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 G. Cooper, President and Chief
Executive Officer, 215.488.9490
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