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
May
19, 2010
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.
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Other
Events.
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On May
19, 2010, Discovery Laboratories, Inc. (the “Company”) issued a press release
announcing that the revalidation of its optimized fetal rabbit Biological
Activity Test (an important quality control release and stability test) has been
completed. The optimization and successful revalidation of the BAT is
a key milestone in the Company’s plans to resolve the sole remaining Chemistry,
Manufacturing & Control issue necessary to potentially gain U.S. Food and
Drug Administration ("FDA") marketing approval for Surfaxin® (lucinactant) for
the prevention of Respiratory Distress Syndrome ("RDS") in premature
infants. The safety and efficacy of Surfaxin for neonatal RDS has
been previously demonstrated in a comprehensive Phase 3 clinical
program. If approved, Surfaxin would be the first synthetic,
peptide-containing surfactant for commercial use in neonatal
medicine.
The
information in this Form 8-K includes certain “forward-looking” statements
relating, among other things, to the Company’s understanding of the remaining
questions that must be addressed to gain FDA approval of
Surfaxin. Although the Company currently believes that it may still
succeed in gaining approval of its New Drug Application for Surfaxin for the
prevention of RDS in premature infants, these activities and the ultimate
outcomes remain subject to a variety of risks and uncertainties that could cause
actual results to be materially different. These risks and
uncertainties include, but are not limited to, risks that (i) the FDA may not
approve Surfaxin or may subject the marketing of Surfaxin to onerous
requirements that significantly impair marketing activities; and (ii) the
Company may identify unforeseen problems that have not yet been discovered or
the FDA could in the future impose additional requirements to gain approval of
Surfaxin. Any failure to secure FDA approval or further delay
associated with the FDA’s review process could potentially delay or prevent the
approval of Surfaxin or the Company’s other products and would have a material
adverse effect on the Company’s business.
The press
release is attached as Exhibit 99.1 hereto.
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Item
9.01.
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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 May 19, 2010
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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.
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:
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/s/ W. Thomas Amick | ||
| Name: | W. Thomas Amick | ||
| Title: | Chairman of the Board and Chief | ||
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Executive
Officer
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Date: May
21, 2010
Exhibit
99.1
Discovery
Labs Achieves Key Milestone Towards Potential Surfaxin®
Approval
Biological
Activity Test (BAT) optimization and revalidation completed with all
pre-specified acceptance criteria met
Warrington, PA – May 19, 2010
— Discovery Laboratories, Inc.
(Nasdaq: DSCO), announces today that the revalidation of its optimized
fetal rabbit Biological Activity Test (BAT, an important quality control release
and stability test) has been completed, having met all pre-specified acceptance
criteria. The optimization and successful revalidation of the BAT is a key
milestone in Discovery Labs’ plans to resolve the sole remaining Chemistry,
Manufacturing & Control (CMC) issue necessary to potentially gain U.S. Food
and Drug Administration (FDA) marketing approval for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome
(RDS) in premature infants. The safety and efficacy of Surfaxin for
neonatal RDS has been previously demonstrated in a comprehensive Phase 3
clinical program. If approved, Surfaxin would be the first synthetic,
peptide-containing surfactant for commercial use in neonatal
medicine.
The
successful optimization and revalidation of the BAT represents a key component
of the comprehensive preclinical program that Discovery Labs is now conducting
to potentially address the sole remaining issue to gain FDA approval of
Surfaxin. Prior to optimizing and revalidating the BAT, Discovery
Labs had several interactions with the FDA and submitted a proposed revalidation
protocol, which also included pre-specified acceptance criteria. The
BAT optimization and recently completed revalidation has taken into account FDA
suggestions and comments.
To
complete the comprehensive preclinical program, Discovery Labs will now employ
the optimized BAT in a series of prospectively-designed, side-by-side
preclinical studies with the well-established preterm lamb model of
RDS. Multiple Surfaxin batches will be employed to assess the
short-term physiologic response following Surfaxin administration (via
measurement of respiratory compliance) in both the preterm lamb model and the
optimized BAT at various time points. The resulting data will be
examined to evaluate the relative changes, over time, in biological activity
upon Surfaxin administration to determine the degree of comparability between
the optimized BAT and the preterm lamb model. These studies are
intended to satisfy the FDA as to the BAT’s ability to adequately discriminate
biologically active from inactive Surfaxin drug product and establish the
Surfaxin drug product’s final acceptance criteria (with respect to biological
activity as assessed by the BAT) for release and ongoing stability.
Jerry
Orehostky, Senior Vice President, Quality Operations commented, “We believe that
optimizing and revalidating the BAT has improved its performance and increased
the likelihood that the results of our preclinical program will demonstrate, to
the FDA’s satisfaction, a level of comparability between data generated using
the BAT and the preterm lamb model.”
Discovery
Labs has also been communicating with the FDA regarding other important aspects
of the comprehensive preclinical program and submitted for FDA review and
comment a protocol outlining a proposed study design and success criteria for
the side-by-side preclinical studies. Recent communications with the
FDA indicate that its written feedback to the protocol should be anticipated in
June 2010. Subject to satisfactory FDA feedback, Discovery Labs
believes it remains on track to complete the preclinical program and submit its
Complete Response to the FDA in the first quarter of 2011.
W. Thomas
Amick, Chairman and interim Chief Executive Officer, commented, “We have worked
productively with the FDA to improve the performance of the BAT, an important
milestone for Surfaxin and our KL4 surfactant
pipeline. We will continue to avail ourselves of the FDA’s
willingness to provide guidance towards potential Surfaxin approval and
advancing our other KL4 surfactant
pipeline programs.”
The
BAT as a Quality Control Drug Product Release Assay
The BAT
has been validated as a quality control test in accordance with current Good
Manufacturing Practices (GMP) and International Conference on Harmonization
(ICH) guidelines. The BAT is one of numerous methods that Discovery
Labs employs in an extensive quality surveillance program to assess drug product
quality and stability. These highly sophisticated release tests
monitor drug product quality throughout shelf-life and represent very sensitive
methods for detecting changes in quality over time.
Discovery
Labs intends to employ the BAT for drug product release and stability testing
for Surfaxin and its other pipeline programs, including Surfaxin LS™ and
Aerosurf® (each in
development for RDS), Surfaxin for Acute Respiratory Failure (enrollment
recently completed in a Phase 2 clinical trial), and aerosolized KL4 surfactant
for Cystic Fibrosis (currently being evaluated in an investigator-initiated
Phase 2 clinical trial with enrollment currently 70% complete).
Surfaxin,
Surfaxin LS and Aerosurf are investigational drug candidates that have not been
approved by the FDA or any other world health regulatory
authority.
DISCLOSURE NOTICE: The
information in this press release includes certain “forward-looking” statements
relating, among other things, to Discovery Labs’ understanding of the remaining
issues that must be addressed to gain FDA approval of
Surfaxin. Although Discovery Labs currently believes that it
may still succeed in gaining approval of its NDA for Surfaxin for the prevention
of RDS in premature infants, these activities and the ultimate outcomes remain
subject to a variety of risks and uncertainties that could cause actual results
to be materially different. These risks and uncertainties include,
but are not limited to, risks that (i) the FDA may not approve Surfaxin or
may subject the marketing of Surfaxin to onerous requirements that significantly
impair marketing activities; and (ii) Discovery Labs may identify unforeseen
problems that have not yet been discovered or the FDA could in the future impose
additional requirements to gain approval of Surfaxin. Any failure to
satisfy the issues raised by the FDA, in the April 2009 Complete Response letter
or in related discussions, could significantly delay, or preclude outright,
gaining approval of Surfaxin, which could potentially delay or prevent the
approval of Discovery Labs’ other products.
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.
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 Global Market listing requirements prior to the expiration of the
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