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
August
15, 2005
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
August
15, 2005, Discovery Laboratories, Inc., a Delaware corporation (the “Company”)
announced that it has received a preliminary communication from the U.S.
Food
and Drug Administration (FDA) indicating that the Company’s previously submitted
Response Letter is not considered complete at this time. The FDA notified
Discovery that it will provide, later this week, its official written
communication regarding select matters for which the FDA may be requesting
additional information. The Company previously submitted its Response Letter
to
the FDA’s Approvable Letter for Surfaxin® (lucinactant) for the prevention of
Respiratory Distress Syndrome (RDS) in premature infants on July 29, 2005.
The
Company issued a press release providing this information on August 15, 2005.
The full text of the press release is set forth in Exhibit 99.1.
Item
9.01 Financial
Statements, Pro Forma Financial Statements and
Exhibits
(c) Exhibits:
|
99.1
|
Press
Release dated August 15, 2005.
|
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. | ||
| |
|
|
| Date: August 15, 2005 | By: | /s/ Robert J. Capetola |
|
Name: Robert J. Capetola, Ph.D. |
||
| Title: President and Chief Executive Officer | ||
3
Exhibit
99.1
Discovery
Labs Provides Status of Previously Submitted Response to FDA Approvable Letter
for Surfaxin®
Warrington,
PA, August 15, 2005 — Discovery Laboratories, Inc. (Nasdaq: DSCO), announces
that it has received a preliminary communication from the U.S. Food and Drug
Administration (FDA) indicating that the Company’s previously submitted Response
Letter is not considered complete at this time. The FDA notified Discovery
that
it will provide, later this week, its official written communication regarding
select matters for which the FDA may be requesting additional information.
The
Company previously submitted its Response Letter to the FDA’s Approvable Letter
for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants on July 29, 2005.
Robert
J.
Capetola, Ph.D., President and CEO of Discovery, commented, “The response we
recently submitted to the FDA’s Approvable Letter for Surfaxin was encyclopedic
and comprehensive. Based upon the thoroughness of our Response Letter, we are
optimistic that the FDA’s issues will center on a few select items that are
capable of being addressed in an as timely and efficient manner as possible.
Of
course, we will have greater clarity on these matters once we have received
and
fully assessed the FDA’s official communication which we expect later this week.
At that time, we anticipate holding a conference call to communicate more
detailed information with our shareholders. We believe that our relationship
with the FDA has always been collaborative and very productive. We anticipate
prompt discussions with the FDA and moving forward to finalize a complete
response as quickly as possible.”
DISCLOSURE
NOTICE: The information in this press release includes certain “forward-looking”
statements relating to the timing of FDA matters relating to Discovery’s NDA for
Surfaxin for RDS, which assume that all of the conditions in the Approvable
Letter are timely satisfied. Any statements contained in this press release
that
do not describe historical facts are forward-looking statements that involve
risks and uncertainties that could cause actual results to differ materially
from those discussed in such forward-looking statements. Such risks and
uncertainties include the following: uncertainties relating to Discovery Labs’
ability to successfully address the comments and concerns of the FDA contained
in the approvable letter for Surfaxin, including uncertainties relating to
the
sufficiency of the additional details to be submitted to the FDA by Discovery
Labs; the timing of FDA actions regarding Surfaxin, including the timing of
its
review of the supporting data or the additional details submitted in relation
thereto; the outcome of FDA actions in response to the submissions, including
the possibility that the FDA will not consider the submissions complete or
that
the FDA will require additional information in support of the submissions;
the
possibility that even if the response is deemed complete by the FDA, the FDA
could respond to these submissions by issuing an additional approvable letter
with additional conditions for approval or the FDA could issue a not approvable
letter; the ability to resolve final labeling for Surfaxin with the FDA;
uncertainties regarding market acceptance of Surfaxin; uncertainties relating
to
third-party reimbursements; uncertainties relating to Discovery Labs’ ability to
continue to operate at commercial scale in compliance with FDA regulations
and
other applicable manufacturing requirements; uncertainties relating to patents
and proprietary rights; issues previously raised by earlier FDA inspections
of
the Totowa, NJ facility of Laureate Pharma, Inc. (Laureate), Discovery’s
contract manufacturer for Surfaxin, and other risks identified in Discovery
Labs’ Securities and Exchange Commission filings. Many
factors could cause the resolution of those or other issues to differ materially
from Discovery’s forward-looking statements, including that the timing, scope
and duration of a resolution of the issues related to the Approvable Letter
will
depend on the ability of Discovery (and Laureate) to assure the FDA of the
quality and reliability of its basic quality controls, process assurances and
documentation requirements that support the commercial production manufacturing
process under applicable cGMPs. The reader of this release should understand
that the failure to reach resolution of any issues could result in delays in
ultimate approval of Discovery’s potential products beyond the first quarter of
2006.
Discovery
Labs further cautions readers not to place undue reliance on any forward-looking
statements which speak only as of the date they are made. Discovery Labs
disclaims any obligation to publicly update or revise any such statements to
reflect any change in expectations or in events, conditions or circumstances
on
which any such statements may be based, or that may affect the likelihood that
actual results will differ from those set forth in the forward-looking
statements.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing its proprietary
surfactant technology as Surfactant Replacement Therapies (SRT) for respiratory
diseases. Surfactants are produced naturally in the lungs and are essential
for
breathing. Discovery’s technology produces a precision-engineered surfactant
that is designed to closely mimic the essential properties of natural human
lung
surfactant. Discovery believes that through its technology, pulmonary
surfactants have the potential, for the first time, to be developed into a
series of respiratory therapies for patients in the neonatal intensive care
unit, critical care unit and other hospital settings, where there are few or
no
approved therapies available.
Discovery
has received an Approvable Letter from the FDA for Surfaxin, the Company’s lead
product, for the prevention of Respiratory Distress Syndrome (RDS) in premature
infants, and has filed a Marketing Authorization Application with the EMEA
for
clearance to market Surfaxin in Europe. Discovery is also conducting various
clinical programs to address Acute Respiratory Distress Syndrome (ARDS) in
adults, Bronchopulmonary Dysplasia (BPD) in premature infants, Neonatal
Respiratory Failures in premature infants, severe asthma in adults, and Meconium
Aspiration Syndrome (MAS) in full-term infants.
For
more
information, please visit our corporate website at
www.Discoverylabs.com.
To
the extent that statements in this press release 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 Discovery’s product development, events
conditioned on stockholder or other approval, or otherwise as to future events,
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’s actual results and could cause
results to differ from those contained in these forward-looking statements
are
the risk that financial conditions may change, risks relating to the progress
of
Discovery’s research and development, the risk that Discovery will not be able
to raise additional capital or enter into additional collaboration agreements
(including strategic alliances for our aerosol and Surfactant Replacement
Therapies), risk that Discovery will not be able to develop a successful sales
and marketing organization in a timely manner, if at all, risk that Discovery’s
internal sales and marketing organization will not succeed in developing market
awareness of Discovery’s products, risk that Discovery’s internal sales and
marketing organization will not be able to attract or maintain qualified
personnel, risk of delay in the FDA’s or other health regulatory authorities’
approval of any applications filed by Discovery, risks that any such regulatory
authority will not approve the marketing and sale of a drug product even after
acceptance of an application filed by Discovery for any such drug product,
risks
relating to the ability of Discovery’s third party contract manufacturers to
provide Discovery with adequate supplies of drug substance and drug products
for
completion of any of Discovery’s clinical studies, other risks relating to the
lack of adequate supplies of drug substance and drug product for completion
of
any of Discovery’s clinical studies, and risks relating to the development of
competing therapies and/or technologies by other companies. 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’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.
Company
Contacts:
John
G.
Cooper, EVP and CFO
215-488-9490
Lisa
Caperelli, Investor Relations
215-488-9413