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
November
17, 2009
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.
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Other
Events.
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On
November 17, 2009, Discovery Laboratories, Inc. (the “Company”) issued a press
release announcing that it has submitted to the U.S. Food and Drug
Administration (FDA) its proposed protocol for a Surfaxin®
(lucinactant) limited clinical trial. Discovery Labs proposed this
trial in response to a comment by the FDA that a limited clinical trial could
potentially resolve the key remaining issue for approval of Surfaxin for the
prevention of RDS in premature infants.
The
protocol incorporates a clinical trial design that is primarily intended to
assess a pharmacodynamic (PD) response following Surfaxin administration in
preterm infants with Respiratory Distress Syndrome (RDS). Typically,
PD-based clinical trials primarily assess short-term, physiologic responses to
therapy and, therefore, are generally less expensive and of shorter duration
than trials that have clinical outcomes as a primary endpoint. On
September 29, 2009, Discovery Labs held a teleconference with the FDA to
discuss, among other things, whether a PD approach would satisfy the FDA’s
requirement for a limited clinical trial. The FDA indicated that
Discovery Labs’ proposed concept of a PD trial design is acceptable and also
provided direction regarding certain trial design specifics.
The final
protocol and clinical trial design is subject to FDA review and
comment. In accordance with the FDA’s guidance, Discovery Labs
expects to receive the FDA comments early in the first quarter
2010. At that time, Discovery Labs will be in a position to estimate
the expected costs and duration of the trial and make a strategic assessment,
with existing and potential new partners, regarding any investment in a
potential limited clinical trial for Surfaxin for RDS.
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 November 17,
2009
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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.
| Discovery Laboratories, Inc. | |||
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By:
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/s/ W. Thomas Amick | |
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Name: W.
Thomas Amick
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|||
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Title: Chairman
of the Board and Interim
Chief Executive Officer |
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Date: November
18, 2009
3
Exhibit
99.1
Discovery
Labs Submits SURFAXIN Pharmacodynamic Trial Protocol
to
FDA
Potential
Resolution of Key Remaining Issue for Approval
Warrington, PA – November 17, 2009 --
Discovery Laboratories, Inc. (Nasdaq:DSCO) announced today that it has
submitted to the U.S. Food and Drug Administration (FDA) its proposed protocol
for a Surfaxin®
(lucinactant) limited clinical trial. The protocol incorporates a
clinical trial design that is primarily intended to assess a pharmacodynamic
(PD) response following Surfaxin administration in preterm infants with
Respiratory Distress Syndrome (RDS). Discovery Labs proposed this
trial design in response to a comment by the FDA that a limited clinical trial
could potentially resolve the key remaining issue for approval of Surfaxin for
the prevention of RDS in premature infants.
Discovery
Labs received a Complete Response Letter for Surfaxin in April
2009. At an end-of-review meeting with the FDA on June 2, 2009, the
FDA suggested that, to increase the likelihood of gaining Surfaxin approval,
Discovery Labs could consider conducting a limited clinical trial. On
September 29, 2009, Discovery Labs held a teleconference with the FDA to
discuss, among other things, whether a PD approach would satisfy the FDA’s
requirement for a limited clinical trial. Typically, PD-based clinical trials
primarily assess short-term, physiologic responses to therapy and, therefore,
are generally less expensive and of shorter duration than trials that have
clinical outcomes as a primary endpoint. The FDA indicated that Discovery Labs’
proposed concept of a PD trial design is acceptable and also provided direction
regarding certain trial design specifics.
Employing
the FDA’s guidance, Discovery Labs worked closely with leading academic
neonatologists to design the PD protocol. The final protocol and clinical trial
design is subject to FDA review and comment. In accordance with the FDA’s
guidance, Discovery Labs expects to receive the FDA comments early in the first
quarter 2010. At that time, Discovery Labs will be in a position to
estimate the expected costs and duration of the trial and make a strategic
assessment, with existing and potential new partners, regarding any investment
in a potential limited clinical trial for Surfaxin for RDS.
DISCLOSURE NOTICE: The
information in this press release includes certain “forward-looking” statements
relating, among other things, to Discovery Labs’ understanding of the remaining
questions identified in the April 2009 Complete Response Letter that must be
addressed to gain FDA approval of Surfaxin and the outcomes of a teleconference
held with the FDA on September 29, 2009. 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) if
Discovery Labs and the FDA do not reach agreement on the details of a formal
protocol for a limited clinical trial, Discovery Labs may be unable to gain
approval of Surfaxin; (ii) even if Discovery Labs and the FDA reach agreement on
the matters discussed above and Discovery Labs does complete the limited
clinical trial to the FDA’s satisfaction, the FDA may not approve Surfaxin or
may subject the marketing of Surfaxin to onerous requirements that significantly
impair marketing activities; (iii) 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 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 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 maintain The Nasdaq
Global Market listing requirements, causing 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
reimbursement and 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:
Lisa
Caperelli, Investor Relations
215-488-9413