- Current report filing (8-K)
10 Enero 2011 - 4:22PM
Edgar (US Regulatory)
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
January
10, 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:
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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
January 10, 2011, Discovery Laboratories, Inc. (the “Company”) issued a press
release providing an update regarding its 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 has had multiple
interactions with the FDA regarding various aspects of the final validation of
an important quality control release and stability test for Surfaxin, the fetal
rabbit biological activity test (“BAT”). In response to a proposal
submitted by the Company, the FDA has recently provided detailed, written
direction regarding the verification of certain parameters related to final BAT
validation. The FDA indicated that several aspects of the Company’s proposed
approach to the BAT validation are reasonable; however, with respect to certain
parameters, the FDA is requesting additional data to further support ultimate
determination of BAT validation. Based on the Company’s preliminary
assessment, it believes that it could generate the additional data and be in a
position to file a Surfaxin Complete Response by early third quarter 2011, which
potentially could lead to approval of Surfaxin for the prevention of RDS
in premature infants 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.
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 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, 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 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.
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Item
9.01.
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Financial Statements
and Exhibits
.
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99.1
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Press
release dated January 10, 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.
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
Executive
Officer
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Date: January
10, 2011
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