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
June
9, 2010
Date of
Report (Date of earliest event reported)
Discovery
Laboratories, Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
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000-26422
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94-3171943
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|
(State
or other jurisdiction
of
incorporation)
|
(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:
|
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)
|
|
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 June
9, 2010, Discovery Laboratories, Inc. (the “Company”) announced the release of
preliminary top line results in the Phase 2 clinical trial to determine whether
Surfaxin® (lucinactant) improves lung function and reduces the duration and
related risk exposure of mechanical ventilation in children up to two years of
age diagnosed with Acute Respiratory Failure. The full text of the
press release is set forth in Exhibit 99.1 to this Current Report on Form 8-K
and is incorporated herein by reference.
Item
9.01. Financial Statements and
Exhibits.
(d) Exhibits
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99.1
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Press
Release dated June 9, 2010.
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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.
| Discovery Laboratories, Inc. | |||
|
|
By:
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/s/ W. Thomas Amick | |
| Name: | W. Thomas Amick | ||
| Title: | Chairman of the Board and interim Chief Executive Officer | ||
Date: June
9, 2010
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Discovery
Labs Reports Preliminary Results from Phase 2 Clinical Trial of Surfaxin in
Pediatric Acute Respiratory Failure
Warrington, PA – June 9, 2010
— Discovery Laboratories, Inc.
(Nasdaq: DSCO), reports preliminary results from its Phase 2 clinical
trial of Surfaxin® in children
with Acute Respiratory Failure (ARF), a critical condition often caused in
children by severe respiratory infections. The objective of the study was to
evaluate the safety and tolerability of intratracheal administration of Surfaxin
and to assess whether Surfaxin treatment could decrease the duration of
mechanical ventilation in children with ARF.
The Phase
2 trial was a multicenter, randomized, masked, placebo-controlled estimation
trial that enrolled 165 children under the age of two with ARF and compared
Surfaxin treatment to standard of care alone, masked with sham air
control. All children enrolled received standard of care and were
randomized to receive either Surfaxin at 5.8 mL/kg of body weight or sham
air. The trial enrolled patients at 24 sites located in the northern
and southern hemispheres.
Key
preliminary observations in this Phase 2 trial are:
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·
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Relative
to the control treatment group, Surfaxin treatment reduced time on
mechanical ventilation by approximately 10%, although this observation was
not statistically significantly different. Duration on
mechanical ventilation was 3.8 days for the Surfaxin treatment group
versus 4.1 days for the control treatment group, expressed as the
geometric mean (primary analysis per
protocol).
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·
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Surfaxin
treatment appeared generally safe and well tolerated in this trial.
Statistically significant differences in the incidence of bradycardia and
desaturation were observed in the Surfaxin treatment group during the
dosing period versus the control treatment group. Generally, such
peri-dosing events are transient and expected with intratracheal
surfactant administration.
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Comprehensive
analysis of the data from this trial is ongoing. Further assessment of safety
and tolerability, as well as in-depth analysis of additional efficacy endpoints
and patient sub-populations, is expected to be completed in the third quarter of
2010. Following this analysis, Discovery Labs in collaboration with
the ARF Steering Committee plans to present the comprehensive results at
relevant medical congresses and submit these data for publication in a peer
review journal.
Robert
Segal, MD, Chief Medical Officer and Senior Vice President of Discovery Labs,
commented, “Pediatric Acute Respiratory Failure represents a significant medical
challenge and, unfortunately, there are no approved medical therapies that
effectively treat this disorder today. Pulmonary surfactant is
critical for normal respiration and may become impaired following patient
exposure to a pathogen such as influenza or respiratory syncytial
virus. The comprehensive data set from this Phase 2 trial is being
further analyzed with the study Steering Committee as we evaluate next steps.
These data are important as we are assessing, for the first time, the safety,
tolerability and efficacy of intratracheally administered Surfaxin in the ARF
patient population.”
Surfaxin
is an investigational drug candidate that has not been approved by the FDA or
any other world health regulatory authority.
About
Acute Respiratory Failure
ARF in
young children occurs primarily after they have been exposed to serious
respiratory infections, such as influenza (including the type A serotype
referred to as H1N1) or respiratory syncytial virus (RSV), and leads to an
impairment in lung function and the need for endotracheal intubation and
mechanical ventilation (the current standard of care). Children with
ARF usually suffer surfactant inactivation as part of the disease process. When
there is insufficient functional surfactant in the lung, the alveoli (air sacs)
collapse and are unable to support sufficient oxygenation. ARF
affects approximately 15,000 children under two years of age in the United
States with an estimated 30,000 – 40,000 children afflicted in developed
countries each year, depending on severity of the viral
season. Presently there are no approved drugs for the treatment of
ARF.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing KL4 surfactant
therapies for respiratory diseases. Surfactants are produced naturally in
the lungs and are essential for breathing. Discovery Labs’ novel
proprietary KL4 surfactant
technology produces a synthetic, peptide-containing surfactant that is
structurally similar to pulmonary surfactant and is being developed in liquid,
aerosol or lyophilized formulations. In addition, Discovery Labs’
proprietary capillary aerosolization technology produces a dense aerosol, with a
defined particle size that is capable of potentially delivering aerosolized
KL4
surfactant to the deep lung without the complications currently associated with
liquid surfactant administration. Discovery Labs believes that its
proprietary technology platform makes it possible, for the first time, to
develop a significant pipeline of surfactant products to address a variety of
respiratory diseases for which there frequently are few or no approved
therapies. For more information, please visit our website at www.Discoverylabs.com.
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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 are: risks relating to
the rigorous regulatory requirements required for approval of any drug or
drug-device combination products that Discovery Labs may develop, including
that: (a) Discovery Labs and the U.S. Food and Drug Administration (FDA) or
other regulatory authorities will not be able to agree on the matters raised
during regulatory reviews, or Discovery Labs may be required to conduct
significant additional activities to potentially gain approval of its product
candidates, if ever, (b) the FDA or other regulatory authorities may not
accept or may withhold or delay consideration of any of Discovery Labs’
applications, or may not approve or may limit approval of Discovery Labs’
products to particular indications or impose unanticipated label
limitations, and (c) changes in the national or
international political and regulatory environment may make it more difficult to
gain FDA or other regulatory approval; risks relating to Discovery Labs’
research and development activities, including (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 fail, and (ii)
the need for sophisticated and extensive analytical methodologies, including an
acceptable biological activity test, if required, as well as other quality
control release and stability tests to satisfy the requirements of the
regulatory authorities; risks relating to Discovery Labs’ ability to develop and
manufacture drug products and capillary aerosolization systems for clinical
studies, and, if approved, for commercialization of drug and combination
drug-device products, including risks of technology transfers to contract
manufacturers and problems or delays encountered by Discovery Labs, its contract
manufacturers or suppliers in manufacturing drug products, drug substances and
capillary aerosolization systems on a timely basis or in an amount sufficient to
support Discovery Labs’ development efforts and, if approved, commercialization;
the risk that Discovery Labs may be unable to identify potential strategic
partners or collaborators to develop and commercialize its products, if
approved, in a timely manner, if at all; the risk that Discovery Labs will not
be able in a changing financial market to raise additional capital or enter into
strategic alliances or collaboration agreements, or that the ongoing credit
crisis will adversely affect the ability of Discovery Labs to fund its
activities, or that additional financings could result in substantial equity
dilution; the risk that Discovery Labs will not be able to access credit from
its committed equity financing facilities (CEFFs), or that the minimum share
price at which Discovery Labs may access the CEFFs from time to time will
prevent Discovery Labs from accessing the full dollar amount potentially
available under the CEFFs; the risk that Discovery Labs or its strategic
partners or collaborators will not be able to retain, or attract, qualified
personnel; the risk that Discovery Labs will be unable to regain compliance with
The Nasdaq Capital Market listing requirements prior to the expiration of the
additional grace period currently in effect, which could cause the price of
Discovery Labs’ common stock to decline; the risk that recurring losses,
negative cash flows and the inability to raise additional capital could threaten
Discovery Labs’ ability to continue as a going concern; the risks that Discovery
Labs may be unable to maintain and protect the patents and licenses related to
its products, or other companies may develop competing therapies and/or
technologies, or health care reform may adversely affect Discovery Labs; risks
of legal proceedings, including securities actions and product liability claims;
risks relating to health care reform; and other 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.
Contact
Information:
John G.
Cooper, EVP and Chief Financial Officer
215-488-9300
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