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
June
18, 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
June
19, 2008, Discovery Laboratories, Inc. (the “Company”) issued a press release
announcing that it held a teleconference on June 18, 2008 with the U.S. Food
and
Drug Administration (FDA). The purpose of the teleconference was to discuss
the
Company’s approach to addressing key remaining items identified in the May 1,
2008 Approvable Letter that the Company received from the FDA in connection
with
its New Drug Application (NDA) for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. The Company indicated its belief that, with the exception
of
two items, the Company can prepare its formal response to the Approvable Letter
using readily available data. To respond to the remaining two items, the FDA
has
requested that the Company provide additional preclinical data and related
information. The Company believes that (a) the activities related to finalizing
these two items can be completed in a timeframe that will enable it to file
a
formal response to the Approvable Letter in September 2008, and (b) the
Company’s formal response may potentially be designated by the FDA as a Class 1
resubmission with a target review period of 60 days. The press release, dated
June 19, 2008, is filed as Exhibit 99.1 to this report and is incorporated
herein by reference.
Although
the Company believes that it will succeed in filing its formal response to
the
Approvable Letter and in gaining approval of its NDA for Surfaxin for the
prevention of RDS in premature infants within the timeline outlined above,
the
activities involved and the ultimate outcome are subject to a variety of risks
and uncertainties, including without limitation that (i) the Company may be
unable to generate the additional data requested by the FDA and file its formal
response to the Approvable Letter within the timeline indicated above,
(ii) the FDA may not be satisfied with the new data and may require the
Company to perform further studies or undertake other activities that the
Company does not presently contemplate, (iii) the Company may not succeed in
adequately addressing other items identified in the Approvable Letter that
were
not discussed during the teleconference and be unable to gain approval of
Surfaxin, if at all, within the timeline indicated above, and (iv) the Company
may in the future identify unforeseen problems that have not yet been
discovered. Any failure to provide information requested by the FDA or to
adequately address in the Company’s formal response to the Approvable Letter the
items raised in the Approvable Letter could significantly delay, or preclude
outright, gaining approval of Surfaxin, which would have a material adverse
effect on its business and could potentially prevent the approval of the
Company’s other products.
Item
9.01. Financial
Statements and Exhibits.
| (d) |
Exhibits
|
|
99.1
|
Press
release dated June 19, 2008
|
2
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/ Robert J. Capetola | |
|
Name: Robert J. Capetola, Ph.D. |
||
| Title: President and Chief Executive Officer | ||
Date:
June 23, 2008
4
Exhibit
99.1
Discovery
Labs and FDA Meet to Clarify Limited Items in SURFAXIN Approvable
Letter
Warrington,
PA - June 19, 2008, -- Discovery Laboratories, Inc. (Nasdaq:DSCO)
held
a
teleconference on June 18, 2008 with the U.S. Food and Drug Administration
(FDA)
to discuss Discovery Labs’ approach to addressing key remaining items identified
in the May 1, 2008 Approvable Letter to potentially gain U.S. marketing approval
of SURFAXIN®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. Discovery Labs received clarification on its proposals
and,
although timeline assessment is continuing, believes that it could submit
its
formal response to the Approvable Letter in September 2008. Discovery Labs
also
believes that this response may be designated by the FDA as a Class 1
resubmission with a target review period of 60 days.
On
May 1,
2008, Discovery Labs received an Approvable Letter from the FDA for SURFAXIN.
Prior to receiving the Approvable Letter, Discovery Labs had made notable
progress towards gaining FDA approval of SURFAXIN, including agreeing with
the
FDA on the form of the SURFAXIN package insert and successfully concluding
a
pre-approval inspection of Discovery Labs’ manufacturing operations. The
Approvable Letter did not require any additional clinical trials to gain
SURFAXIN approval.
On
May
14, Discovery Labs submitted a pre-meeting information package to the FDA
that
outlined Discovery Labs’ proposals for responding to select items identified in
the Approvable Letter. The purpose of the meeting was to clarify and reach
agreement with the FDA on the remaining steps necessary to achieve SURFAXIN
approval, prior to filing a formal response to the Approvable Letter.
Importantly, the meeting confirmed Discovery Labs’ approach to finalizing
SURFAXIN drug product specifications. With the exception of two items, Discovery
Labs can prepare its responses using readily available data. The FDA has
requested that Discovery Labs provide additional preclinical data and related
information for two items.
One
of
the two items requires additional SURFAXIN biological activity test data.
These
additional data will be correlated with results of previously conducted
preclinical studies and also will be used to justify the acceptance criteria
for
this biological activity test. The other item involves justifying the proposed
specifications for certain lipid-related impurities in the individual active
pharmaceutical ingredients (APIs) that comprise SURFAXIN. Discovery Labs’
approach to justifying the levels of these lipid-related API impurities was
based, in part, on their being present in the human lung at levels equal
to or
greater than that in SURFAXIN. The FDA has requested additional information
about the levels of these lipid-related API impurities in the neonatal lung.
Discovery Labs believes that it will be able to develop this information
based
on existing scientific literature. Discovery Labs presently anticipates
completing the activities related to finalizing these two items in order
to
submit its formal response to the Approvable Letter in September
2008.
DISCLOSURE
NOTICE: The information in this press release includes certain “forward-looking”
statements relating to, among other things, the remaining steps necessary
for
FDA approval of Surfaxin for the prevention of RDS in premature infants,
including information about the outcome of Discovery Labs’ June 18, 2008 meeting
with the FDA and Discovery Labs’ plans and expected timing to respond to the May
1, 2008 Approvable Letter. Although Discovery Labs believes that it has made
significant progress towards gaining approval of Surfaxin, gaining approval
of
Surfaxin involves ongoing activities, the final results of which could vary
materially from Discovery Labs’ expectations and the results obtained to date.
Discovery Labs currently believes 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; however, these activities and the ultimate outcomes
are
subject to a variety of risks, including but not limited to risks that
(i) even if Discovery Labs is able to generate the additional data
requested by the FDA and file its formal response to the Approvable letter
within the timeline indicated above, the FDA may not be satisfied with the
new
data and may require Discovery Labs to perform further studies or undertake
other activities that are presently not contemplated by Discovery Labs, (ii)
Discovery Labs may not succeed in adequately addressing other items identified
in the Approvable Letter and be unable to gain approval of SURFAXIN within
the
timeline indicated above, and (iii) Discovery Labs, in the process of preparing
its response to the Approvable Letter, may identify unforeseen problems that
have not yet been discovered. Any failure to provide information requested
by
the FDA or to adequately address the items raised in the Approvable Letter
in
Discovery Labs’ formal response to the Approvable Letter could significantly
delay, or preclude outright, gaining approval of SURFAXIN, which could
potentially prevent the approval of Discovery Labs’ other products.
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 structurally similar to
pulmonary 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.
SURFAXIN®,
the
Company’s lead product from its SRT pipeline, 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 for Surfaxin;
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 Surfaxin or any other drug product that Discovery Labs may develop,
or such regulatory agency may further delay and/or limit marketing of Surfaxin
or any of Discovery Labs’ drug products 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
for Discovery Labs to gain FDA or other regulatory approval of its 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 of its 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
John
Cooper, EVP & CFO
215-488-9490