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
February
16, 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
February 16, 2010, Discovery Laboratories, Inc. (the “Company”) issued a press
release announcing that, in response to written guidance recently received from
the U.S. Food and Drug Administration (FDA), it will now focus on a plan that
entails solely performing additional preclinical work, instead of conducting a
limited clinical trial, to potentially gain FDA marketing approval for
Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. Based on prior guidance received from the FDA, the
Company expected that a limited, pharmacodynamic-based (PD) clinical trial in
preterm infants would be required to address the sole remaining Chemistry,
Manufacturing & Control (CMC) issue regarding the final validation of a
fetal rabbit Biological Activity Test (BAT, an important quality control release
and stability test) necessary for Surfaxin approval. The
recently-received guidance from the FDA advises that, since an acceptable and
well-established animal model (preterm lamb) of RDS already exists,
which could be used as an acceptable alternative to a clinical trial in
human preterm infants, a PD clinical trial approach is not
appropriate.
In
September 2009, the Company discussed in detail with the FDA a proposed process
to optimize the precision of the BAT method and its subsequent
validation. Following the FDA’s supportive assessment of the proposed
optimization process, the Company initiated BAT optimization activities and a
related revalidation program, which is well underway and presently meeting all
pre-specified acceptance criteria. Upon successful conclusion of BAT
optimization and revalidation, the Company plans to conduct a series of
prospectively-designed, side-by-side preclinical studies employing the optimized
BAT and the well-established preterm lamb model of RDS.
The
comprehensive preclinical program will employ several different Surfaxin batches
to assess the short-term physiologic responses to Surfaxin (via measurement of
respiratory compliance) after administration 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. The Company plans to seek FDA advice regarding important
aspects of the preclinical program, including study design and appropriate
success criteria and believes that continued interactions with the FDA are an
important element in assuring the adequacy of the preclinical
program.
The
comprehensive preclinical program will utilize the Company’s extensive
experience with both the BAT and the well-established preterm lamb model and
take into account (i) the FDA’s recent supportive assessment of the Company’s
proposed BAT optimization and revalidation, (ii) the encouraging progress
of the ongoing BAT optimization and revalidation, (iii) the FDA’s recognition of
the utility of the well-established preterm lamb RDS model as an acceptable
animal model for human preterm RDS, and (iv) the Company’s comprehensive
experience and existing relationships with well-recognized academic centers of
excellence who routinely employ the preterm lamb model and have demonstrated
expertise in measuring respiratory compliance in this model.
2
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 identified in the April 2009 Complete Response Letter for Surfaxin
that must be addressed to gain FDA approval of Surfaxin and the outcomes of the
June 2, 2009 end-of-review meeting, the September 29, 2009 teleconference held
with the FDA, and the recently-received written guidance from the
FDA. Although the Company 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) 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. Although the
Company is encouraged that its revalidation processes are well underway and
presently meeting all pre-specified acceptance criteria, even if the Company’s
efforts to optimize and revalidate the BAT are successful, it may not succeed
with its planned side-by-side studies or, even if it does succeed with the
side-by-side studies, the FDA may not accept the results or may interpret the
data in a different manner such that, ultimately, the FDA may not approve
Surfaxin for RDS in premature infants. Any failure to secure FDA approval
or further delay associated with the FDA’s review process could potentially
delay or prevent the approval of 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 February 16,
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.
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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.
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Discovery
Laboratories, Inc.
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By:
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/s/ W. Thomas Amick
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Name:
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W.
Thomas Amick
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Title:
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Chairman
of the Board and Interim
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Chief
Executive Officer
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Date: February
16, 2010
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