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
May
1, 2008
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
May 2,
2008, Discovery Laboratories, Inc. (the “Company”) announced the receipt of an
Approvable Letter from the U.S. Food and Drug Administration (FDA) for
Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. This official notification sets forth the remaining
conditions that must be satisfied to gain U.S. marketing approval for Surfaxin.
The Approvable Letter was received in the evening of May 1, 2008, the PDUFA
date
that had been established for Surfaxin. Prior to receiving this Approvable
Letter, Discovery Labs had finalized Surfaxin labeling discussions with the
FDA.
In addition, the FDA had completed its pre-approval inspection of Discovery
Labs’ manufacturing facility in Totowa, NJ. Within the next few days, Discovery
Labs will contact the FDA to discuss required actions and timing to gain
Surfaxin approval. Next week, Discovery Labs expects to be in a position to
provide guidance regarding its actions in response to the Approvable Letter.
The
press release, dated May 2, 2008, is filed as Exhibit 99.1 to this report and
is
incorporated herein by reference.
|
Item
9.01.
|
Financial
Statements and Exhibits.
|
|
(d)
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Exhibits
|
|
99.1
|
Press
release dated May 2, 2008
|
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. | ||
| |
|
|
| By: | /s/ Robert J. Capetola | |
|
Name: Robert J. Capetola, Ph.D. |
||
|
Title:
President and Chief Executive
Officer
|
||
Date:
May
2, 2008
3
Exhibit
99.1
Discovery
Labs Receives an Approvable Letter from
FDA
for
SurfaxinÒ
for RDS
Warrington,
PA — May 2, 2008 — Discovery
Laboratories, Inc. (Nasdaq: DSCO) today announced that it has received an
Approvable Letter from the U.S. Food and Drug Administration (FDA) for
Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. This official notification sets forth the remaining
conditions that must be satisfied to gain U.S. marketing approval for Surfaxin.
The
Approvable Letter was received in the evening of May 1, 2008, the PDUFA date
that had been established for Surfaxin. Prior to receiving this Approvable
Letter, Discovery Labs had finalized Surfaxin labeling discussions with the
FDA.
In addition, the FDA had completed its pre-approval inspection of Discovery
Labs’ manufacturing facility in Totowa, NJ and recently issued an Establishment
Inspection Report (EIR) reflecting a successful inspection.
Discovery
Labs is assessing the Approvable Letter and will contact the FDA within the
next
few days to discuss required actions and timing to gain Surfaxin approval.
Discovery Labs expects to be in a position early next week to provide guidance
regarding its plans and timeline considerations to address the Approvable
Letter.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing Surfactant Replacement
Therapies (SRT) for respiratory diseases. Surfactants are produced naturally
in
the lungs and are essential for breathing. Discovery Labs’ technology produces a
peptide-containing synthetic surfactant that is designed to closely mimic the
essential properties of natural human lung surfactant. Discovery Labs believes
that, with its proprietary technology, SRT has the potential, for the first
time, to advance respiratory medicine and address a variety of respiratory
diseases affecting neonatal, pediatric and adult patients.
Discovery
Labs’ lead product candidate, Surfaxin®,
is the
subject of an Approvable Letter from the FDA for the prevention of Respiratory
Distress Syndrome in premature infants. Surfaxin is also being developed for
other neonatal and pediatric indications. Aerosurf™, Discovery Labs’ aerosolized
SRT, is being developed to potentially obviate the need for intubation and
conventional mechanical ventilation and holds
the
promise to significantly expand the use of surfactants in respiratory medicine.
For
more
information, please visit our website at www.Discoverylabs.com.
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,
including, without limitation, the risks that: Discovery Labs may be unable
to
timely respond, if at all, to the recent approvable letter; Discovery Labs
may
not succeed in the FDA or other regulatory agency review process, including
that
such regulatory authority may not approve the marketing and sale of a drug
product or may withhold, delay and/or limit marketing of a drug product by
indication or impose other label limitations; Discovery Labs may not be able
to
raise additional capital or enter into additional collaboration agreements
(including strategic alliances for development or commercialization of SRT);
changes in the national or international political and regulatory environment
may make it more difficult to gain FDA or other regulatory approval of drug
products; Discovery Labs may be unable to profitably develop and market its
products; Discovery Labs’ significant, time-consuming and costly research and
development activities, including pre-clinical studies, clinical trials and
other efforts to gain regulatory approval for any products may not progress
or
may be subject to potentially significant delays or regulatory holds, or fail;
Discovery Labs may be unable to successfully manufacture or provide adequate
supplies of drug substances on a timely basis; Discovery Labs may be unable
to
transfer its manufacturing technology to third-party contract manufacturers
or
its contract manufacturers or any of its materials suppliers may encounter
problems manufacturing drug products or drug substances on a timely basis or
manufacture in amounts sufficient to meet demand; Discovery Labs and its
collaborators may be unable to develop, manufacture and successfully
commercialize products that combine Discovery Labs’ drug products with
innovative aerosolization technologies; Discovery Labs may be unable to maintain
and protect the patents and licenses related to its SRT; other companies may
develop competing therapies and/or technologies or health care reform may
adversely affect Discovery Labs; and Discovery Labs may become involved in
securities, product liability and other litigation. The foregoing risks and
others are further 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.
Company
Contact:
Lisa
Caperelli, Investor Relations
215-488-9413