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
October
17, 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
October 17, 2008, Discovery Laboratories, Inc. (the “Company”) issued a press
release announcing that it has submitted a Complete Response to the May 2008
Approvable Letter issued by the U.S. Food and Drug Administration (FDA) for
Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. Under the FDA guidelines, within 14 calendar days, the FDA
will classify the submission and notify the Company of the statutory target
date
for potential approval of Surfaxin. The
Company believes, based on its understanding of the FDA guidelines and advice
of
experts, that the FDA may designate the Complete Response as a Class 1
resubmission, which would result in a target review period of 60 days and
potential approval of Surfaxin in 2008. However, the FDA has discretion to
designate the submission as Class 2, which would result in a 6-month target
review period.
The
Company’s Complete Response includes, among other things, (i) data and other
information intended to demonstrate that the lipid-related impurities in the
two
phospholipid drug substances can be produced at levels that satisfy guidelines
promulgated by the International
Conference of Harmonization (ICH),
and
(ii) data from additional pre-clinical studies (conducted at a dose level
requested by the FDA) using a Surfaxin biological activity test (a quality
control and stability release test) and a well-characterized RDS animal
model,
which
data the Company believes further confirms the comparability of Surfaxin
drug product used in Discovery Labs’ Phase 3 clinical trials to the product to
be made using
the
commercial Surfaxin manufacturing process and further supports the determination
of final acceptance criteria for the Surfaxin biological activity
test.
Prior
to generating these additional data, on June 18, 2008, the Company held a
teleconference with the FDA to clarify and reach agreement on these and other
key requirements identified in the May 2008 Approvable Letter.
The
May
2008 Approvable Letter did not require additional clinical trials. Prior to
receiving the Approvable Letter, the Company had reached agreement with the
FDA
on the content of the Surfaxin package insert and the FDA had concluded a
satisfactory pre-approval inspection of the Company’s manufacturing operations.
The
press
release, dated October 17, 2008, is filed as Exhibit 99.1 to this report and
is
incorporated herein by reference.
| Item 9.01. |
Financial
Statements and Exhibits.
|
| (d) |
Exhibits
|
|
99.1
|
Press
release dated October 17, 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:
October 22, 2008
3
Discovery
Labs Submits Complete Response to May 2008 FDA Approvable Letter for
SurfaxinÒ
for RDS
Warrington,
PA — October 17, 2008 — Discovery Laboratories, Inc. (Nasdaq:
DSCO)
today
submitted its Complete Response to the May 2008 Approvable Letter issued
by the
U.S. Food and Drug Administration (FDA) for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. The FDA’s guidelines provide that by October 31, the FDA will
determine the classification of the submission and notify Discovery Labs
of its
target date for potential approval of Surfaxin. Discovery Labs believes that
the
FDA may designate the Complete Response as a Class 1 resubmission, which
would
result in a target review period of sixty-days and potential approval of
Surfaxin in 2008.
The
May
2008 Approvable Letter contains requirements that must be addressed to gain
U.S.
marketing approval for Surfaxin. All of these requirements have been addressed
in the Complete Response. Discovery Labs met with the FDA on June 18, 2008
to
clarify and reach agreement on addressing certain key requirements in the
Approvable Letter, including the following:
| · |
Discovery
Labs must satisfy International Conference of Harmonization (ICH)
guidelines for the proposed specifications for certain lipid-related
impurities in two phospholipid drug substances that are contained
in the
Surfaxin drug product. The Complete Response includes data and
other
information to demonstrate that the lipid-related impurities in
the two
phospholipids can be produced at levels that satisfy ICH guidelines.
|
| · |
Discovery
Labs agreed to conduct additional Surfaxin preclinical studies,
at a dose
level requested by the FDA, using a Surfaxin biological activity
test (a
quality control and stability release test) and a well-characterized
RDS
animal model. The Complete Response includes data from these successfully
concluded studies. Discovery Labs believes that the data obtained
further
confirms the comparability of Surfaxin drug product used in Discovery
Labs’ Phase 3 clinical trials to the commercial manufacturing process
for
Surfaxin and supports the determination of final acceptance criteria
for
the Surfaxin biological activity test.
|
The
May
2008 Approvable Letter did not require any additional clinical trials. 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
content of the Surfaxin package insert and successfully concluding a
pre-approval inspection of Discovery Labs’ manufacturing operations.
Discovery
Labs believes, based on its understanding of the FDA guidelines, that the
FDA
may designate this Complete Response as a Class 1 resubmission, which would
result in a target review period of 60 days and potential approval of Surfaxin
in 2008. However, the FDA has the discretion to designate any resubmission
as
Class 2, which would result in a 6-month target review period.
DISCLOSURE
NOTICE:
The
information in this press release includes certain “forward-looking” statements
relating, among other things, to the remaining steps necessary for FDA approval
of Surfaxin for the prevention of RDS in premature infants and the timing
of the
anticipated FDA review period. 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) although Discovery Labs believes that the FDA will deem Discovery Labs’
formal response to be “complete” under the FDA guidelines, the FDA may
nevertheless determine, for a reason not presently known to Discovery Labs,
that
the formal response filed by Discovery Labs is not “complete”, which
determination would further delay the FDA review of the Surfaxin NDA and
could
result in Discovery Labs’ conducting additional activities to potentially gain
Surfaxin approval, (ii) although Discovery Labs believes that the Complete
Response may be designated a Class 1 resubmission, which would result in
a
target review period and potential approval of Surfaxin within 60 days after
submission, under the FDA guidelines the FDA may for a variety of reasons,
in
its discretion, designate the Complete Response as a Class 2 submission,
which
would result in a target review period of up to 6 months, potentially delaying
the potential approval of Surfaxin, (iii) although Discovery Labs believes
that it has been successful in generating the additional data and other
information requested by the FDA, the FDA may not be satisfied and may require
Discovery Labs to perform further studies or undertake other activities that
are
presently not contemplated by Discovery Labs, (iv) although Discovery Labs
believes that its suppliers can successfully and consistently reduce the
lipid-related drug substance impurities in the two phospholipid drug substances
comprising Surfaxin, its suppliers could encounter unanticipated manufacturing
problems in the future, which could adversely affect Discovery Labs’ ability to
manufacture its drug product, (v) the FDA may not be satisfied with
Discovery Labs’ responses to other items identified in the Approvable Letter and
Discovery Labs may be unable to gain approval of Surfaxin within the timeline
indicated above, (vi) Discovery Labs may identify unforeseen problems that
have
not yet been discovered, and (vii) the FDA could impose additional
requirements to gain approval of Surfaxin. Any failure to provide information
requested by the FDA or to inadequately 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 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
respond, if at all, to the recent Approvable Letter for Surfaxin within the
anticipated timeline and the response, when filed, may not satisfy the FDA;
the
FDA or other regulatory authorities may not accept, or may withhold or delay
consideration of, any applications that Discovery Labs may file for its
products, or may not approve any such applications or may limit marketing
of
such products to particular indications or impose unanticipated label
limitations; 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 raise
additional capital or enter into additional collaboration agreements (including
strategic alliances for development or commercialization of SRT); Discovery
Labs’ lengthy and costly research and development programs, including
pre-clinical studies, clinical trials and other efforts to gain regulatory
approval for any of its products, including Surfaxin, may not progress or
may be
subject to potentially significant delays or regulatory holds, or fail;
Discovery Labs or its contract manufacturers or materials suppliers may be
unable to successfully manufacture adequate supplies of its drug product
or drug
substances when needed or in amounts sufficient to meet demand; Discovery
Labs
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 profitably develop and market
its
products; 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