SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
___________________________
FORM
8-K
CURRENT
REPORT
Pursuant
to Section 13 or 15(d) of the
Securities
Exchange Act of 1934
December
3, 2007
Date
of
Report (Date of earliest event reported)
Discovery
Laboratories, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-26422
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94-3171943
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(State
or other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
Number)
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2600
Kelly Road, Suite 100
Warrington,
Pennsylvania 18976
(Address
of principal executive offices)
(215)
488-9300
(Registrant's
telephone number, including area code)
(Former
name or former address, if changed since last report)
Check
the
appropriate box below if the Form 8-K filing is intended to simultaneously
satisfy the filing obligation of the registrant under any of the following
provisions:
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17
CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17
CFR
240.14d-2(b))
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|
o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17
CFR
240.13e-4(c))
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Item
8.01. Other
Events.
On
December 3, 2007, Discovery Laboratories, Inc. issued a press release to
announce that data from pre-clinical studies using Aerosurf™ in preterm lambs
were recently presented at the 2007 annual Hot Topics in Neonatology meeting
in
Washington, D.C. The studies were conducted using a well-established
pre-clinical model of respiratory distress syndrome (RDS) and key observations
demonstrate that Aerosurf improves both lung function and reduces inflammation
associated with lung injury and chronic lung disease. The press release is
filed
as Exhibit 99.1 to this report and is incorporated herein by
reference.
Aerosurf
is an aerosolized formulation of the Company’s novel KL4 surfactant technology
that is delivered non-invasively via novel aerosol generating technology
and
employs nasal continuous positive airway pressure (nCPAP). Aerosurf, like
Discovery’s lead product Surfaxin®, is a precision-engineered synthetic,
peptide-containing surfactant which is designed to closely mimic the essential
attributes of human lung surfactant. In clinical trials, Surfaxin has
demonstrated mortality and morbidity benefits versus currently available
animal-derived surfactants. Surfaxin for the treatment of RDS in premature
infants is currently under review by the U.S. Food and Drug Administration
(FDA)
with a May 1, 2008 target date for potential approval under the Prescription
Drug User Fee Act (PDUFA).
Item
9.01. Financial
Statements and Exhibits.
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(d)
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Exhibits
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99.1
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Press
release, dated December 3, 2007.
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Cautionary
Note Regarding Forward-looking Statements:
To
the
extent that statements in this Current Report on Form 8-K are not strictly
historical, including statements as to business strategy, outlook, objectives,
future milestones, plans, intentions, goals, future financial conditions, future
collaboration agreements, the success of the Company’s product development or
otherwise as to future events, such statements are forward-looking, and are
made
pursuant to the safe harbor provisions of the Private Securities Litigation
Reform Act of 1995. The forward-looking statements contained in this Current
Report are subject to certain risks and uncertainties that could cause actual
results to differ materially from the statements made. Such risks and others
are
further described in the Company’s 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.
2
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
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Discovery
Laboratories, Inc.
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By:
/s/ Robert J.
Capetola
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Robert
J. Capetola, Ph.D.
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President
and Chief Executive Officer
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Date:
December 4, 2007
3
Exhibit
99.1
Discovery
Labs’ Aerosurf™ Improves Lung Function and Reduces Inflammation in a Model of
Respiratory Distress Syndrome
Warrington,
PA, December 3, 2007—
Discovery Laboratories, Inc. (Nasdaq: DSCO), today announced that
data
from pre-clinical studies using Aerosurf™ in preterm lambs were presented at the
2007 Annual Hot
Topics in Neonatology
meeting
in Washington, DC. The studies were conducted using a well-established
pre-clinical model of respiratory distress syndrome (RDS) and key observations
demonstrate that Aerosurf improves both lung function and reduces inflammation
associated with lung injury and chronic lung disease.
Aerosurf
is an aerosolized formulation of Discovery Lab’s novel KL4 surfactant technology
that is delivered non-invasively via novel aerosol generating technology and
employs nasal continuous positive airway pressure (nCPAP). Aerosurf, like
Discovery’s lead product Surfaxin®,
is a
precision-engineered synthetic, peptide-containing surfactant which is designed
to closely mimic the essential attributes of human lung surfactant. In clinical
trials, Surfaxin has demonstrated mortality and morbidity benefits versus
currently available animal-derived surfactants. Surfaxin is currently under
review by the FDA with a May 1, 2008 PDUFA date for potential
approval.
The
study
was conducted at Temple University School of Medicine in Philadelphia, PA.
The
pre-term RDS lamb model was selected because it closely resembles the
development, structure, and function of human lungs and is the most relevant
system to study the pathophysiology and treatment of RDS. Key observations
from the study comparing lambs receiving Aerosurf plus CPAP with those receiving
CPAP alone include:
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·
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Treatment
with Aerosurf resulted in significant reductions in key markers of
inflammation, including interleukin-6 and 8 compared with CPAP alone
(p<0.05)
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·
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Treatment
with Aerosurf preserved structural integrity of the lung by preserving
the
tissue structure of the lung to a greater degree compared with CPAP
alone
(p<0.05)
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·
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Improvement
in lung function trended higher in the Aerosurf-treated
group
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·
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Aerosurf
was well tolerated and interfaced effectively with CPAP respiratory
support
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Dr.
Marla
R. Wolfson, Associate Professor, Departments of Pediatrics and Physiology at
the
Temple University School of Medicine, commented, “This novel approach allows for
a non-invasive administration of surfactant to improve lung function. In
addition we observed a significant reduction in pulmonary inflammation and
preservation of lung integrity. Historical attempts to achieve this ambitious
objective have been constrained by technological limitations that are overcome
by the Discovery Labs technology platform. The benefits of Aerosurf in reducing
lung inflammation and in preserving the lung integrity are especially promising
as we consider clinical therapeutic applications.”
In
order
to avoid endotracheal intubation and the risk of lung damage, nCPAP is
increasingly being employed to support preterm infants with respiratory
insufficiency. Unfortunately, many infants relapse following initial attempts
at
therapy with nCPAP alone and require intubation and mechanical ventilation,
each
with their attendant risks, as well as the increased risk for these infants
subsequently developing chronic lung disease. The neonatal, pediatric, and
adult
critical care medical communities recognize the potential for an aerosolized
lung surfactant, delivered non-invasively, to address a wide array of
respiratory disorders.
Robert
Segal, M.D., Senior Vice President and Chief Medical Officer of Discovery Labs,
commented, “The current treatment approach for premature babies with RDS
requires delivery of animal-derived surfactants via an endotracheal tube.
Aerosurf, a synthetic aerosolized surfactant that is delivered non-invasively,
has the potential to revolutionize the approach to treating preterm babies
who
are at great risk, not only for RDS, but also subsequent chronic lung disease,
such as bronchopulmonary dysplasia (BPD). Aerosurf also has the potential to
expand therapeutic options for a broad range of patients with respiratory
diseases. The potential benefits of reducing inflammation and preserving
structural lung integrity further support our excitement about our Aerosurf
development program. We are looking forward to advancing Aerosurf into Phase
2
clinical trials in 2008.”
Data
from
previous pre-clinical and clinical studies using Aerosurf were presented at
the
Pediatric
Academic Societies (PAS)
2006 and 2007 Annual Meetings. In these studies, Aerosurf maintained its
chemical structure and essential functional activity post-aerosolization. In
addition, Aerosurf was observed to be safe and well tolerated in human preterm
infants.
Both
Surfaxin and Aerosurf are investigational drugs that have not been approved
by
the U.S. FDA or any other world health regulatory authorities.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing Surfactant Replacement
Therapies (SRT) for respiratory diseases. Surfactants are produced naturally
in
the lungs and are essential for breathing. Discovery Labs’ technology produces a
precision-engineered surfactant that is designed to closely mimic the essential
properties of natural human lung surfactant. Discovery Labs believes that its
proprietary SRT pipeline has the potential to advance respiratory medicine
and
address a variety of respiratory diseases affecting neonatal, pediatric and
adult patients.
Discovery
Labs’ lead product candidate, Surfaxin®,
is the
subject of an Approvable Letter from the FDA for the prevention of Respiratory
Distress Syndrome in premature infants. Surfaxin is also being developed for
other neonatal and pediatric indications. Aerosurf™, Discovery Labs’ aerosolized
SRT, is being developed to potentially obviate the need for intubation and
conventional mechanical ventilation and holds
the
promise to significantly expand the use of surfactants in respiratory medicine.
For
more
information, please visit our website at www.Discoverylabs.com.
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. Among
the risk factors which could affect Discovery Labs actual results and could
cause results to differ from those contained in these forward-looking statements
are the risks that: Discovery Labs may be unable to profitably develop and
market its products; financial market conditions may change; Discovery Labs
may
not be able to raise additional capital or enter into additional collaboration
agreements; Discovery Labs may not be able to attract or retain qualified
personnel or timely provide for successful sales and marketing activities;
Discovery Labs’ research and development efforts may not progress; Discovery
Labs may not be successful in the FDA or other regulatory agency review process
generally, including that such regulatory authority will not approve the
marketing and sale of a drug product even after accepting an application or
may
withhold, delay and/or limit marketing a drug product by indication or impose
other label limitations; Discovery Labs’ recently-submitted response to the
Approvable Letter may not satisfy the FDA; Discovery Labs or its third party
manufacturers and development partners may be unable to manufacture or provide
adequate supplies of drug substances and expertise to allow for completion
of
any of Discovery Labs clinical studies; Discovery Labs and its collaborators
may
be unable to develop, manufacture and successfully commercialize products that
combine Discovery Labs drug products with innovative aerosolization
technologies; Discovery Labs may not be able to successfully manufacture its
drug product candidates; Discovery Labs’ significant, time-consuming and costly
research, development, pre-clinical studies, clinical testing and efforts to
gain regulatory approval for any products that it may develop (independently
or
in connection with collaboration arrangements) may not succeed; other companies
may develop competing therapies and/or technologies; reimbursement and health
care reform may adversely affect Discovery Labs; and Discovery Labs may become
involved in securities, product liability and other litigation. The foregoing
risks and others are further 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.
Company
Contact:
Lisa
Caperelli, Investor Relations
215-488-9413