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
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
October 1, 2007, Discovery Laboratories, Inc. (the “Company”) issued a press
release announcing that its new Surfaxin® (lucinactant) process validation
batches have demonstrated acceptable stability at six months under the Company’s
comprehensive testing protocol. This six-month stability data will be included
in a 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, to be filed with the FDA in the October
2007 timeframe, followed by an anticipated six-month review cycle by the FDA
for
the potential approval of the Surfaxin New Drug Application. The press release,
dated October 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 October 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.
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 4, 2007 | |||
3
Surfaxin®
Process Validation Batches Achieve Stability Milestone to Enable Filing of
Response to FDA Approvable Letter
Warrington,
PA — October 1, 2007 — Discovery Laboratories, Inc. (Nasdaq: DSCO)
today
announces that its new Surfaxin®
(lucinactant)
process validation batches have demonstrated acceptable stability at six months
under Discovery Labs’ comprehensive stability testing protocol. This six-month
stability data will be included, along with other data and information, in
a
formal response to the U.S. Food and Drug Administrations’ (FDA) April 2006
Approvable Letter for Surfaxin for the prevention of Respiratory Distress
Syndrome (RDS) in premature infants. Discovery Labs remains on track to file
its
response to the FDA Approvable Letter in the October 2007 timeframe, followed
by
an anticipated six-month review cycle by the FDA for potential approval of
the
Surfaxin New Drug Application (NDA).
Discovery
Labs manufactured three new Surfaxin process validation batches in 2007 after
guidance was obtained from the FDA at a December 2006 meeting. 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 a 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, have demonstrated acceptable
stability through six months, and will continue to be monitored through Surfaxin
proposed shelf-life.
The
FDA
Approvable Letter for Surfaxin primarily focuses on the CMC (chemistry,
manufacturing and controls) section of the Surfaxin NDA. The Approvable Letter
does not require any additional clinical trials, but requests 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 obtain guidance on the appropriate path to potentially
gain approval of Surfaxin. The FDA’s guidance provided a defined pathway for
Discovery Labs to generate additional data from selected experiments that are
essential for approval of Surfaxin.
Discovery
Labs believes it has made significant progress in addressing the outstanding
CMC
issues identified in the Approvable Letter and is currently focused on
generating, compiling and analyzing supporting information for submission to
the
FDA. Discovery Labs believes that its progress to date, including achieving
the
six month process validation stability milestone, supports the filing of the
formal response to the Approvable Letter in the October 2007 timeframe.
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 Phase 3
analysis, 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 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 being prepared for inclusion in Discovery Labs’ formal
response to the Approvable Letter and the potential results of both Discovery
Labs’ comprehensive manufacturing investigation and the ongoing release and
stability testing of the investigational batches and the new process validation
batches. Although Discovery Labs is encouraged by the progress that it believes
it has made to date, the development of data and other relevant information
for
the formal response to the Approvable Letter, including the release and
stability testing of the investigational batches and the new process validation
batches, are ongoing and the final results of these efforts could vary
materially from the observations and results obtained to date. Discovery Labs
currently believes that it will succeed in submitting its formal response to
the
Approvable Letter, with six months of successful stability data for the new
process validation batches, within the timeframe indicated above, subject,
however, to a variety of risks, including that (i) Discovery Labs may not
succeed in completing its experiments or developing the data and other
information necessary for the formal response, (ii) the new process validation
batches may in the future fail to meet designated stability or other release
parameters, and (iii) Discovery Labs may identify unforeseen problems that
have
not yet been discovered. The reader of this release should understand that
the
failure to develop all necessary information required to respond to the
Approvable Letter, including at least six months of stability data for the
new
process validation batches, could result in significant delays or additional
requirements and 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.
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 factors which could affect Discovery Labs actual results and could cause
results to differ from those contained in these forward-looking statements
are
the risk that Discovery Labs may not profitably develop and market its products,
the risk that financial market conditions may change, the risk that Discovery
Labs will not be able to raise additional capital or enter into additional
collaboration agreements, the risk that Discovery Labs will not be able to
attract or retain qualified personnel or timely provide for a successful sales
and marketing organization, risks relating to the progress of Discovery Labs
research and development,, risks 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 acceptance of an application
or
that approval by such regulatory agency may be withheld, delayed and/or limited
by indications or other label limitations, risks that the Chemical,
Manufacturing and Controls section of Discovery Labs New Drug Application will
not satisfy the FDA, risks relating to the ability of Discovery Labs or
Discovery Labs third party manufacturers and development partners to manufacture
or provide Discovery Labs with adequate supplies of drug substances and
expertise for completion of any of Discovery Labs clinical studies, risks
related to the ability of Discovery Labs and its collaborators to develop,
manufacture and successfully commercialize products that combine Discovery
Labs
drug products with innovative aerosolization technologies, risks relating to
drug manufacturing by Discovery Labs, risks relating to the significant,
time-consuming and costly research, development, pre-clinical studies, clinical
testing and regulatory approval process for any products that Discovery Labs
may
develop independently or with Discovery Labs collaboration arrangements, risks
relating to the development by other companies of competing therapies and/or
technologies, risks relating to reimbursement and health care reform, and risks
relating to securities, product liability and other litigation. Companies in
the
pharmaceutical and biotechnology industries have suffered significant setbacks
in advanced clinical trials, even after obtaining promising earlier trial
results. Data obtained from tests are susceptible to varying interpretations,
which may delay, limit or prevent regulatory approval. Those associated 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