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
11, 2009
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))
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Item
8.01.
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Other
Events.
|
On May
11, 2009, Discovery Laboratories, Inc. (the “Company”) issued a press release
announcing that it has received written notification from the U.S. Food and Drug
Administration (FDA) that an end-of-review meeting has been scheduled for June
2, 2009 at the FDA offices in Rockville, Maryland. The purpose of
this meeting is to determine the resolution of the remaining primary issue
necessary for Discovery Labs to gain U.S. marketing approval of Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. Following the meeting and receipt of formal
written minutes from the FDA, Discovery Labs intends to provide an update
regarding the outcome and anticipated timeline to potential approval of
Surfaxin. The press
release is attached as Exhibit 99.1 hereto.
|
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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|
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99.1
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Press
release dated May 11, 2009
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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.
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:
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/s/ Robert J. Capetola | |
| Name: Robert J. Capetola, Ph.D. | |||
| Title: President and Chief Executive Officer | |||
Date: May
12, 2009
3
Exhibit
99.1
Discovery
Labs and FDA to Meet on June 2, 2009 to Discuss SURFAXIN Complete Response
Letter
Warrington, PA – May 11, 2009 --
Discovery Laboratories, Inc. (Nasdaq:DSCO) has received written
notification from the U.S. Food and Drug Administration (FDA) that an
end-of-review meeting has been scheduled for June 2, 2009 at the FDA offices in
Rockville, Maryland. The purpose of this meeting is to determine the
resolution of the remaining primary issue necessary for Discovery Labs to gain
U.S. marketing approval of Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants.
On April
17, 2009, Discovery Labs received a Complete Response letter from the FDA for
Surfaxin for RDS. In its letter, the FDA focused primarily on certain
aspects of a Surfaxin biological activity test (BAT, a quality control stability
and release test) that must be addressed before Surfaxin can be approved. The
FDA questioned whether the BAT can adequately distinguish change in Surfaxin
drug product over time and whether Discovery Labs has adequately validated the
BAT and determined its final acceptance criteria. Discovery Labs intends to rely
on data already submitted to the FDA, as well as limited existing data, to
support the comparability of Surfaxin clinical drug product to commercial
Surfaxin drug product and demonstrate that the BAT can adequately distinguish
change in Surfaxin over time and is an appropriate test for monitoring Surfaxin
biological activity throughout shelf-life.
Following
the meeting and receipt of formal written minutes from the FDA, Discovery Labs
intends to provide an update regarding the outcome and anticipated timeline to
potential approval of Surfaxin.
DISCLOSURE NOTICE: The
information in this press release includes certain “forward-looking” statements
relating, among other things, to Discovery Labs’ understanding of the approach
and timing required to address the remaining questions identified in the
Complete Response letter dated April 17, 2009 to gain FDA approval of Surfaxin
for the prevention of RDS in premature infants and the timing of the anticipated
FDA review period. Although Discovery Labs currently is hopeful that
it will succeed in gaining approval of its NDA for Surfaxin for the prevention
of RDS in premature infants within the timeline outlined above, these activities
and the ultimate outcomes are 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)
although Discovery Labs is hopeful that it will be able to reach agreement with
the FDA with respect to the validation of the BAT, finalization of acceptance
criteria for the BAT and use of the BAT to establish the comparability of
Surfaxin clinical drug product to commercial Surfaxin drug product, Discovery
Labs and the FDA may not reach agreement with respect any or all of these
issues; if Discovery Labs and the FDA do not reach agreement, the FDA will
likely require Discovery Labs to perform further studies or undertake other
activities, which potentially could include additional preclinical studies
and/or , if the FDA determines that Discovery Labs has failed to establish to
the FDA’s satisfaction the comparability of Surfaxin drug product used in the
clinical trials to the commercial Surfaxin drug product, new clinical trials,
which are presently not contemplated by Discovery Labs, and Discovery Labs may
be unable to gain approval of Surfaxin, if at all, within the timeline indicated
above; (iii) even if Discovery Labs were to agree to and did complete additional
activities required by the FDA, the FDA may in the future require other
activities as a condition to gaining Surfaxin approval, or may not approve
Surfaxin or may subject the marketing of Surfaxin to onerous requirements that
significantly impair marketing activities; (iv) although Discovery Labs thinks
it unlikely, the FDA may not be satisfied with Discovery Labs’ responses to
other items identified in the Complete Response letter and Discovery Labs may be
unable to gain approval of Surfaxin, if at all, within the timeline indicated
above; (v) Discovery Labs may identify unforeseen problems that have not yet
been discovered; and (vi) the FDA could impose additional requirements to
gain approval of Surfaxin. Any failure to satisfy the issues raised
by the FDA in the Complete Response letter could significantly delay, or
preclude outright, gaining approval of Surfaxin, which could potentially delay
or prevent the approval of Discovery Labs’ other products.
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 deep 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. Discovery Labs is focused initially on developing its
KL4
surfactant pipeline to build a pediatric franchise that will potentially address
several respiratory conditions affecting neonates and young children. 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 are: risks relating to
the rigorous regulatory requirements required for approval of any drug or
drug-device combination products that Discovery Labs may develop, including
that: (i) Discovery Labs and the U.S. Food and Drug Administration (FDA) will
not be able to agree on the matters raised by the FDA in its Complete Response
letter dated April 17, 2009, or the FDA may require Discovery Labs to conduct
significant additional activities to potentially gain approval of Surfaxin, if
ever, (ii) the FDA or other regulatory authorities may not accept or may
withhold or delay consideration of any of Discovery Labs’ applications, or may
not approve or may limit approval of Discovery Labs’ products to particular
indications or impose unanticipated label limitations, and (iii) changes in the national or
international political and regulatory environment may make it more difficult to
gain FDA or other regulatory approval; risks relating to Discovery Labs’
research and development activities, including time-consuming and expensive
pre-clinical studies, clinical trials and other efforts, which may be subject to
potentially significant delays or regulatory holds, or fail; risks relating to
Discovery Labs’ ability to develop and manufacture drug products and capillary
aerosolization systems for clinical studies, and, if approved, for
commercialization of drug and combination drug-device products, including risks
of technology transfers to contract manufacturers and problems or delays
encountered by Discovery Labs, its contract manufacturers or suppliers in
manufacturing drug products, drug substances and capillary aerosolization
systems on a timely basis or in an amount sufficient to support Discovery Labs’
development efforts and, if approved, commercialization; risks that (a) market
conditions, the competitive landscape or otherwise, may make it difficult to
launch and profitably sell products, (b) Discovery Labs may be unable to
identify potential strategic partners or collaborators to market its products,
if approved, in a timely manner, if at all, and (c) Discovery Labs’
products will not gain market acceptance by physicians, patients, healthcare
payers and others in the medical community; the risk that Discovery Labs or its
strategic partners or collaborators will not be able to attract or maintain
qualified personnel; the risk that Discovery Labs will not be able in a changing
financial market to raise additional capital or enter into strategic alliances
or collaboration agreements, or that the ongoing credit crisis will adversely
affect the ability of Discovery Labs to fund its activities, or that additional
financings could result in substantial equity dilution; the risk that Discovery
Labs will not be able to access credit from its committed equity financing
facilities, or that the share price at which Discovery Labs may access the
facilities from time to time will not enable Discovery Labs to access the full
dollar amount potentially available under the facilities; the risk that
Discovery Labs will be unable to maintain The Nasdaq Global Market listing
requirements, causing the price of Discovery Labs’ common stock to decline; the
risk that recurring losses, negative cash flows and the inability to raise
additional capital could threaten Discovery Labs’ ability to continue as a going
concern; the risks that Discovery Labs may be unable to maintain and
protect the patents and licenses related to its products, or other companies may
develop competing therapies and/or technologies, or health care reform may
adversely affect Discovery Labs; risks of legal proceedings, including
securities actions and product liability claims; risks relating to reimbursement
and health care reform; and other risks and uncertainties 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:
Lisa
Caperelli, Investor Relations
215-488-9413