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
November
1, 2007
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
November 1, 2007,
Discovery Laboratories, Inc. (the “Company”) issued a press release announcing
that
it
has submitted its formal response to the U.S. Food and Drug Administration’s
(FDA) April 2006 Approvable Letter for Surfaxin®
for the
prevention of Respiratory Distress Syndrome (RDS) in premature infants.
The
FDA’s
guidelines provide that within 14 days of receipt of the formal submission,
if
the FDA has accepted the submission as a complete response, it should provide
a
review classification that determines the targeted review timeframe. Discovery
Labs anticipates that the FDA will designate the formal response as a Class
2
submission, thereby allowing for a six-month review period, with a target PDUFA
date in the second quarter of 2008. The
full
text of the press release, dated November 1, 2007, 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 November 1,
2007
|
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.
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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 | |
|
Robert J. Capetola, Ph.D. |
||
| President and Chief Executive Officer | ||
| Date: November 2, 2007 | ||
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Exhibit
99.1
[logo]
Discovery
Labs Submits Response to FDA Approvable Letter for SurfaxinÒ
for RDS in Premature Infants
Warrington,
PA — November 1, 2007 — Discovery Laboratories, Inc. (Nasdaq:
DSCO)
announced that it has submitted its formal response to the U.S. Food and Drug
Administration’s (FDA) April 2006 Approvable Letter for Surfaxin®
for the
prevention of Respiratory Distress Syndrome (RDS) in premature infants. The
FDA’s guidelines provide that within 14 days of receipt of the formal
submission, if the FDA has accepted the submission as a complete response,
it
should provide a review classification that determines the targeted review
timeframe. Discovery Labs anticipates that the FDA will designate the formal
response as a Class 2 submission, thereby allowing for a six-month review period
with a target PDUFA date in the second quarter of 2008.
The
April
2006 Approvable Letter for Surfaxin primarily focused on the chemistry,
manufacturing and controls (CMC) section of the Surfaxin New Drug Application
(NDA). The Approvable Letter did not require any additional clinical trials,
but
did request additional information predominantly involving drug product
specifications and stability, analytical methods and related controls. In
December 2006, Discovery Labs met with the FDA to clarify certain of the key
CMC
matters identified in the Approvable Letter, and obtained guidance from the
FDA
on the appropriate path to potentially gain approval of Surfaxin. Based on
the
guidance obtained, Discovery Labs completed a number of projects to generate
additional data that it believes addresses the outstanding CMC issues identified
in the Approvable Letter. These additional data are included in the formal
response.
The
formal response also includes six-month stability data on the new Surfaxin
process validation batches that were manufactured after the December 2006
meeting with the FDA. At that meeting, Discovery Labs presented information
regarding its comprehensive investigation and remediation of the April 2006
process validation stability failure. The meeting also established that
Discovery Labs’ new Surfaxin process validation batches must demonstrate
acceptable stability through six-months prior to the filing of the formal
response to the Approvable Letter. Since their manufacture, these new process
validation batches have been monitored in accordance with a comprehensive
stability testing protocol that complies with International Conference on
Harmonization (ICH) guidelines, and will continue to be monitored at least
through the Surfaxin proposed shelf-life.
About
Surfaxin®
Surfaxin
is a precision-engineered version of natural human lung surfactant and contains
Discovery Labs’ novel KL-4 peptide. Surfaxin, administered as a
liquid-instillate, represents a potential alternative to the commercially
available animal-derived surfactants. Data from Discovery Labs’ pivotal,
multinational SELECT study demonstrate that Surfaxin is significantly more
effective in the prevention of RDS and results in improved survival (continuing
through at least one year of life) and other outcomes versus comparator
surfactants. The SELECT
and STAR (a supportive Phase 3 study) trials, as well as a pooled analysis
of
the Phase 3 studies, have been presented at several international medical
meetings and the results from the two studies were published in Pediatrics.
In
addition, top-line results from Discovery Labs’ Phase 2 clinical trial for the
prevention and treatment of Bronchopulmonary Dysplasia (BPD) suggested that
infants treated with up to five incremental standard doses of Surfaxin tended
to
have a lower incidence of death or BPD, a higher survival rate through 36 weeks
post-menstrual age, and fewer days on mechanical ventilation. Discovery Labs
recently initiated a
Phase 2
clinical trial evaluating the use of Surfaxin in
children up to two years of age suffering from Acute Respiratory Failure (ARF).
This new trial will explore the expanded application of surfactant therapy
to
pediatric critical care medicine.
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 included in Discovery Labs’ formal response to the
Approvable Letter. Although Discovery Labs is encouraged by the progress that
it
believes it has made to date in filing its formal response to the Approvable
Letter and in achieving six months stability with its new process validation
batches, gaining approval of Surfaxin involves ongoing activities, the final
results of which could vary materially from Discovery Labs’ expectations and
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 timeframe indicated above; however, these
activities are subject to a variety of risks, including but not limited to
risks
that (i) Discovery Labs may not have succeeded in adequately responding to
the
matters raised in the Approvable Letter, (ii) the new process validation batches
may after the 6-month stability period fail to meet designated stability or
other release parameters, and (iii) Discovery Labs may identify unforeseen
problems that have not yet been discovered. Any failure to provide information
required by the FDA in our response to the Approvable Letter could result in
significant delays or additional requirements and could potentially prevent
the
approval of Surfaxin or other Discovery Labs’ 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
precision-engineered surfactant that is designed to closely mimic the essential
properties of natural human lung surfactant. Discovery Labs believes that its
proprietary SRT pipeline has the potential 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.
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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. Among
the risk factors which could affect Discovery Labs actual results and could
cause results to differ from those contained in these forward-looking statements
are the risks that: Discovery Labs may be unable to profitably develop and
market its products; financial market conditions may change; Discovery Labs
may
not be able to raise additional capital or enter into additional collaboration
agreements; Discovery Labs may not be able to attract or retain qualified
personnel or timely provide for successful sales and marketing activities;
Discovery Labs’ research and development efforts may not progress; Discovery
Labs may not be successful in the FDA or other regulatory agency review process
generally, including that such regulatory authority will not approve the
marketing and sale of a drug product even after accepting an application or
may
withhold, delay and/or limit marketing a drug product by indication or impose
other label limitations; Discovery Labs’ recently-submitted response to the
Approvable Letter may not satisfy the FDA; Discovery Labs or its third party
manufacturers and development partners may be unable to manufacture or provide
adequate supplies of drug substances and expertise to allow for completion
of
any of Discovery Labs clinical studies; 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 not be able to successfully manufacture its
drug product candidates; Discovery Labs’ significant, time-consuming and costly
research, development, pre-clinical studies, clinical testing and efforts to
gain regulatory approval for any products that it may develop (independently
or
in connection with collaboration arrangements) may not succeed; other companies
may develop competing therapies and/or technologies; reimbursement and 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
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