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
29, 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:
[
] Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
[
] Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
[
] Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
[
] 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
May
29, 2008, Discovery Laboratories, Inc. (the “Company”) issued a press release
announcing that it has received from the U.S. Food and Drug Administration
(FDA)
written notification that a meeting between the FDA and the Company has been
scheduled to occur by teleconference on June 18, 2008. On May 14, 2008, the
Company submitted a formal request to the FDA to schedule such a meeting. The
formal request was accompanied by an information package containing the
Company’s proposals to address a limited number of the remaining items
identified in the Approvable Letter that the Company received on May 1, 2008
for
Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome
(RDS) in premature infants. If the June 18 meeting positively confirms the
Company’s approach to filing its formal response to the Approvable Letter, the
Company plans to submit a formal response to the Approvable Letter in June
2008.
The Company believes that the response may potentially be designated by the
FDA
as a Class 1 resubmission with a review target of 60 days. The overall timeline
to gaining approval for Surfaxin may vary depending on the outcome of the
meeting and other related factors. The press release, dated May 29, 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 May 29,
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:
May
29, 2008
3
Discovery
Labs and FDA to Meet on June 18, 2008 to Clarify Limited Items in SURFAXIN
Approvable Letter
Warrington,
PA - May 29, 2008, -- Discovery Laboratories, Inc.
(Nasdaq:DSCO),
announced that it has received written notification from the U.S. Food and
Drug
Administration (FDA) that a meeting has been scheduled for June 18, 2008 via
teleconference. This meeting is intended to confirm with the FDA Discovery
Labs’
approach to address the limited key remaining items necessary to gain U.S.
marketing approval of SURFAXIN®
(lucinactant) for the prevention of RDS in premature infants. On May 1, 2008,
Discovery Labs received an Approvable Letter from the FDA for SURFAXIN that
reflected notable progress towards gaining FDA approval.
On
May
14, Discovery Labs submitted a pre-meeting information package to the FDA which
also served as a formal request to schedule the meeting. This information
package discussed Discovery Labs’ proposals for responding to select items
identified in the Approvable Letter. The Company believes that the most
important items involve justifying and finalizing one acceptance criterion
for
SURFAXIN’s biological activity and limited acceptance criteria for lipid drug
substance impurities. Discovery Labs believes it can satisfy these items with
data that are already available and wants to confirm its approach with the
FDA
prior to filing a formal response to the Approvable Letter.
The
recent Approvable Letter reflects key achievements towards gaining FDA approval
for SURFAXIN including agreeing with the FDA on the SURFAXIN package insert
and
successfully concluding a pre-approval inspection of Discovery Labs’
manufacturing operations. The Approvable Letter does not require any additional
clinical trials to gain SURFAXIN approval. If the June 18 meeting with the
FDA
positively confirms Discovery Labs’ approach to addressing the Approvable Letter
items, Discovery Labs anticipates submitting a formal response to the Approvable
Letter in June 2008. Discovery Labs continues to believe that this response
may
potentially be designated by the FDA as a Class 1 resubmission with a review
target of 60 days. The overall timeline to gain SURFAXIN approval may be
shortened or extended depending on the outcome of the meeting and other related
factors.
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 related to Discovery Labs’ plans to meet with the FDA and
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 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 outcome are subject to a variety of risks, including but not limited
to
risks that (i) the FDA may not accept Discovery Labs’ proposals outlined in the
information package, (ii) if Discovery Labs cannot reach agreement with the
FDA on the acceptance criteria for SURFAXIN’s biological activity and lipid drug
substance impurities, Discovery Labs may be unable to file a formal response
to
the Approvable Letter, if at all, within the timeline outlined in this press
release, (iii) the FDA may require that Discovery Labs perform additional
studies or undertake other activities that are presently not contemplated before
Discovery Labs will be in a position to file a formal response to the Approvable
Letter, which could significantly extend the anticipated timeline, (iv)
Discovery Labs may not succeed in adequately responding to other items
identified in the Approvable Letter, and (v) 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 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
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