Discovery Labs Announces IND Submission for AEROSURF®

            Discovery Labs Announces IND Submission for AEROSURF®

Important Neonatal Clinical Development Program Expected to Begin 4Q'13

Conference Call Today at 10:00 a.m. EDT

PR Newswire

WARRINGTON, Pa., Oct. 17, 2013

WARRINGTON, Pa., Oct. 17, 2013 /PRNewswire/ --Discovery Laboratories, Inc.
(NASDAQ: DSCO), a specialty biotechnology company dedicated to advancing a new
standard of respiratory critical care, today announced that it has submitted
an investigational new drug (IND) application to the U.S. Food and Drug
Administration (FDA) to initiate its AEROSURF^® phase 2 clinical program. The
FDA has confirmed receipt of the IND and has indicated that, unless otherwise
notified during its review, the Company may initiate the phase 2 clinical
program after a 30-day period.Discovery Labs anticipates patient enrollment
could begin in the fourth quarter of 2013.The Company will host a conference
call this morning at 10:00 AM ET to discuss the AEROSURF program.Conference
call details are below.

"The filing of our AEROSURF IND with the FDA represents an important milestone
for our Company and a first step towards a potentially transformational
medical advancement for the neonatology community and the infants they care
for," said John G. Cooper, Chief Executive Officer at Discovery Labs.

AEROSURF is a novel investigational drug-device combination product being
developed to deliver Discovery Labs' KL4 surfactant in aerosolized form to
premature infants with respiratory distress syndrome (RDS).AEROSURF could
potentially allow for the administration of KL4 surfactant to premature
infants without invasive endotracheal intubation, and may enable the treatment
of a significantly greater number of premature infants who could benefit from
surfactant therapy but are currently not treated.

"The AEROSURF program is leveraging important advancements in our novel
technology platform," said Russell Clayton, DO, Senior Vice President,
Research and Development, at Discovery Labs. "Our synthetic KL[4] surfactant
technology was recently validated with the FDA approval of SURFAXIN^® for the
prevention of RDS in infants at high risk for RDS. We are now combining our
KL4 surfactant with our proprietary drug delivery technologies to potentially
deliver aerosolized KL[4] surfactant to patients with respiratory disease,
with an initial focus on the unmet medical needs in premature infants with

Conference Call and Webcast Details
Discovery Labs will hold a conference call and webcast today at 10:00 AM EDT
to discuss the foregoing.A live webcast of the conference call, including a
slide presentation, is available at and archive of the webcast will be available on
Discovery Labs' Investor Relations web site.

For "listen-only" participants and those who wish to take part in the question
and answer portion of the call, the dial-in numbers are (877) 215-0093 (U.S.)
or (706) 679-3237 (international).The passcode for the call is 86481667.The
replay number is (855) 859-2056 or (404) 537-3406 using the same conference
call passcode listed above. A replay will also be available at

About RDS and the Neonatologist's Dilemma

RDS is a condition in which premature infants are born with a lack of natural
lung surfactant and are unable to absorb sufficient oxygen.Premature infants
born prior to 37 weeks gestation have not fully developed their own natural
lung surfactant and therefore need treatment to sustain life.RDS is
experienced in approximately half of the babies born between 26 and 32 weeks
gestational age.The incidence of RDS approaches 100 percent in babies born
less than 26 weeks gestational age.RDS can result in long-term respiratory
problems and death.

Premature infants with RDS often require endotracheal intubation and
mechanical ventilation to provide respiratory support and to administer
surfactant (usually within the first hours of birth).Unfortunately, many
infants relapse following initial surfactant therapy and require reintubation
and prolonged mechanical ventilation as well as supplemental oxygen,
increasing their risk of developing further serious respiratory
complications.Neonatologists generally try to avoid intubation.As a result,
many neonatologists will only intubate in cases of severe respiratory disease,
where the benefits of invasive surfactant administration clearly outweigh the
associated risks.

For all but the very low birth weight infants with severe RDS, a common
ventilatory support treatment alternative to intubation and mechanical
ventilation is nasal continuous positive airway pressure
(nCPAP).Unfortunately, a significant number of infants do not respond
adequately to nCPAP, an outcome referred to as nCPAP failure, and require
subsequent surfactant administration via intubation and mechanical

As it is not possible to ascertain in advance which patients will experience
nCPAP failure, neonatologists are faced with a dilemma, because the outcome
for those infants who experience nCPAP failure and receive delayed surfactant
therapy may not be as favorable as the outcome for those infants who receive
surfactant therapy in the first hours of life.

Discovery Labs estimates that, on an annual basis, approximately 160,000
premature infants in the U.S. could potentially benefit from early surfactant
therapy to address surfactant deficiency or insufficiency.More than 70
percent of surfactant deficient infants (approximately 115,000) do not receive
first-line surfactant therapy and instead receive nCPAP alone.

Discovery Labs believes that the neonatal medical community increasingly
recognizes the potential of a synthetic, peptide-containing surfactant, such
as SURFAXIN and, importantly, a less-invasive method of delivering surfactant,
such as AEROSURF, to treat premature infants at risk of suffering from
respiratory disorders.

About Discovery Labs
Discovery Laboratories, Inc. is a specialty biotechnology company focused on
advancing a new standard in respiratory critical care. Discovery Labs'
technology platforms include a novel proprietary KL[4] surfactant, a
synthetic, peptide-containing surfactant that is structurally similar to
pulmonary surfactant, and proprietary drug delivery technologies being
developed 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, enable the treatment of a significantly greater number of premature
infants who could benefit from surfactant therapy but are currently not

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

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

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 include those
related to Discovery Labs' research and development activities, including,
among other things, (i)time-consuming and expensive pre-clinical studies,
clinical trials and other efforts, which may be subject to potentially
significant delays or regulatory holds, or failure, and (ii) regulatory
requirements relating to development and manufacture of the drug and aerosol
delivery components of Discovery Labs' combination drug/device products, as
well as those risks and uncertainties 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

SOURCE Discovery Laboratories, Inc.

Contact: Company, John Tattory, Vice President, Finance: 215.488.9418 or; Investor Relations, Michael Rice, LifeSci
Advisors: 646.597.6979 or; Media Relations, Michael
Parks, Pitch360: 484.356.7105 or
Press spacebar to pause and continue. Press esc to stop.