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| EX-99.1 - WINDTREE THERAPEUTICS INC /DE/ | v209764_ex99-1.htm |
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
1, 2011
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:
¨ Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
¨ Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
¨ Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
¨ Pre-commencement communications
pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
Item
8.01. Other
Events.
On
February 1, 2011, Discovery Laboratories, Inc. (the “Company”) issued a press
release providing an expanded update regarding its ongoing efforts to file a
Complete Response intended to gain U.S. Food and Drug Administration (“FDA”)
marketing authorization of Surfaxin® for the prevention of respiratory distress
syndrome (“RDS”) in premature infants. The Company previously
announced on January 10, 2011, that the FDA had recently provided detailed,
written direction in response to an earlier submitted proposal by the Company to
its ongoing comprehensive preclinical program intended to gain Surfaxin
approval.
The
Company believes that a key remaining step to potentially gain FDA marketing
approval for Surfaxin is to satisfy the FDA as to the final validation of the
fetal rabbit biological activity test (“BAT”). The BAT is an important
quality control release and stability test for Surfaxin. Final BAT
validation is intended to satisfy the FDA with respect to the ability of the BAT
to adequately reflect the biological activity of Surfaxin throughout its shelf
life and to discriminate biologically active from inactive Surfaxin drug
product. The Company has been conducting a comprehensive preclinical
program with regard to this key remaining step. The BAT has undergone a
number of method refinements intended to optimize its performance and reduce
assay variability. The optimized BAT has subsequently been used to generate
data to support BAT validation as well as to demonstrate concordance between the
BAT and the well-established preterm lamb model of RDS by performing a series of
prospectively-designed, side-by-side preclinical studies (i.e., concordance
studies). Data from the preterm lamb model and BAT concordance studies are
intended to support final BAT validation and to demonstrate comparability of
drug product used in the Phase 3 clinical program with Surfaxin drug product to
be manufactured for commercial use.
The
Company has been interacting with the FDA in an effort to ensure that the
comprehensive preclinical program (and the Complete Response) ultimately will
satisfy the FDA as to the final validation of the BAT. The FDA's most
recent communication clearly indicates that several aspects of the Company's
proposed approach to the BAT validation are reasonable and provides detailed,
written direction regarding certain components of the Company’s comprehensive
pre-clinical program. The Company believes that it can incorporate the
FDA's direction into its ongoing efforts to complete the comprehensive
preclinical program and be in a position to file a Complete Response for
Surfaxin by early third quarter 2011, which, after an anticipated six-month FDA
review cycle, could lead to potential Surfaxin approval early in the first
quarter 2012.
The press
release is attached as Exhibit 99.1 hereto and the text of the press release is
incorporated herein by reference to such exhibit.
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The
information in this Form 8-K includes certain “forward-looking” statements
relating, among other things, to the Company’s understanding of the
recently-received written guidance from the FDA and the remaining questions
identified in the FDA’s April 2009 Complete Response Letter that must be
addressed to gain FDA approval of Surfaxin. Although the Company currently
believes that it may still succeed in submitting a Complete Response and gaining
approval of its New Drug Application for Surfaxin for the prevention of RDS in
premature infants, anticipated activities will require that the Company raise
significant amounts of additional capital. The Company has
initiated activities relating to this most recent FDA communication, and is
presently assessing whether to request further clarification from the FDA on
certain technical aspects of the comprehensive preclinical program, and also
anticipates potential further interactions with the FDA in advance of filing a
Complete Response. Such potential interactions with the FDA could affect the
ultimate timing, conduct and outcomes of remaining steps necessary to gain
Surfaxin approval, including the potential filing of the Complete Response. In
addition to uncertainties related to the FDA's review of the Complete Response,
the Company presently anticipates that the FDA will likely inspect and otherwise
assess the manufacturing and quality assurance/quality control facilities for
Surfaxin including those of third-party raw material suppliers and testing
laboratories. The outcomes of such FDA activities could also affect the
ultimate timing and remaining steps necessary to gain Surfaxin approval. In
addition, the foregoing 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 accept the additional data or may interpret
the data in a different manner such that, ultimately, the FDA may not approve
Surfaxin or that the FDA may subject the marketing of Surfaxin to onerous
requirements that significantly impair marketing activities; (ii) the Company
may be unable to complete the manufacture of additional Surfaxin batches to
address the FDA’s request for additional data in a timely manner, (iii) 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; (iv) the Company may be unable to raise sufficient additional capital,
through financings, strategic collaborations, or otherwise; and (v) other risks
included in the Company’s most recent reports on Forms 10-K, 10-Q and 8-K, and
any amendments thereto. 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 the Company’s other products and
would have a material adverse effect on the Company’s business.
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 February 1, 2011
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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 Chief
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Executive
Officer
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Date: February
2, 2011
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