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)
|
Delaware
|
000-26422
|
94-3171943
|
|
(State
or other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
Number)
|
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
|
Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
|
|
o
|
Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
|
|
o
|
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
|
|
o
|
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
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.
2
|
Item
9.01.
|
Financial Statements
and Exhibits.
|
|
|
(d)
|
Exhibits
|
|
|
99.1
|
Press
release dated January 10, 2011
|
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.
3
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. | |||
|
|
By:
|
/s/ W. Thomas Amick | |
| Name: | W. Thomas Amick | ||
| Title: | Chairman
of the Board and Chief
Executive
Officer
|
||
Date: January
10, 2011
4
Exhibit
99.1
Discovery Labs Provides Update Regarding
its Program for Surfaxin® U.S. Marketing
Authorization
Warrington, PA — January 10, 2011
— Discovery Laboratories,
Inc. (Nasdaq: DSCOD), a biotechnology company developing its
novel, synthetic, peptide-containing surfactant, is 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. Discovery Labs 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
Discovery Labs, 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 Discovery Labs’ 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.
W. Thomas Amick, Chairman of the Board
and Chief Executive Officer of Discovery Labs commented, “We have made considerable
progress towards the filing of a Surfaxin Complete Response. The work that we originally
proposed to the FDA relating to the comprehensive preclinical program has been
completed. We have generated data that demonstrate a meaningful reduction in
variability in the optimized BAT and have conducted supportive side-by-side
studies with the well-established pre-term lamb model of RDS. We appreciate the
FDA’s willingness to provide guidance and, based on our preliminary assessment,
believe that we could generate the additional data and be in a position to file
a Surfaxin Complete Response by early third quarter 2011.”
Discovery Labs has conducted a
comprehensive pre-clinical program employing an optimized BAT in a series of
prospectively-designed, side-by-side preclinical studies with the
well-established preterm lamb model of RDS. Discovery Labs engaged in several
interactions with the FDA intended to ensure that the comprehensive preclinical
program would satisfy the FDA. At the FDA’s suggestion, Discovery Labs submitted
a proposal seeking clarification regarding specific and detailed aspects of
final BAT validation. To address certain technical criteria relating to final
BAT validation, the FDA’s recent correspondence advises Discovery Labs to
increase the sample size of a specific data set by testing additional Surfaxin
batches. Discovery Labs currently has data from batches that have already been
manufactured and, to be responsive to the FDA’s advice, anticipates
manufacturing additional batches in January and February of this
year.
Later this month, Discovery Labs expects
to provide to the public a detailed overview of its program and anticipates
holding a conference call.
DISCLOSURE NOTICE:
The information in this
press release includes certain “forward-looking” statements relating, among
other things, to Discovery Labs’ 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 Discovery Labs currently believes that it may still succeed
in submitting a Complete Response and gaining approval of its NDA for Surfaxin
for the prevention of RDS in premature infants, anticipated activities will
require that Discovery Labs raise significant amounts of additional capital.
Discovery Labs 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 approve Surfaxin or may
subject the marketing of Surfaxin to onerous requirements that significantly
impair marketing activities; (ii) Discovery Labs may be unable to complete the
manufacture of additional Surfaxin batches within the time frame set forth
above, (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; and (iv) Discovery Labs may be unable to raise
sufficient additional capital, through financings, strategic collaborations, or
otherwise. 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.
Surfaxin is an investigational drug
product and is not approved by the FDA or any other world health regulatory
authority for use in humans. If approved, Surfaxin would become the first
synthetic, peptide-containing surfactant for commercial use in neonatal
medicine.
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 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, including those related to the Company’s comprehensive
non-clinical program, development and manufacturing activities and related
regulatory efforts, are 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, President and Chief
Financial Officer
215-488-9490