UNITED
STATES
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
June
6, 2006
Date
of
Report (Date of earliest event reported)
Discovery
Laboratories, Inc.
(Exact
name of Company 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 18976-3622
(Address
of principal executive offices)
(215)
488-9300
(Company'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 Company 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
June
6, 2006, Discovery Laboratories, Inc. (the “Company”) issued a press release to
announce that it has notified the European Medicines Evaluation Agency of its
decision to voluntarily withdraw the Marketing Authorization Application for
Surfaxin®
for the
prevention and treatment of Respiratory Distress Syndrome in premature infants.
The full text of the press release is set forth in Exhibit 99.1 to this Current
Report on Form 8-K.
Item
9.01. Financial
Statements and Exhibits.
| (d) | Exhibits: |
|
99.1
|
Press
Release dated June 6, 2006.
|
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 Company 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:
June 7, 2006
|
||
3
Exhibit
99.1
Discovery
Labs Withdraws European Marketing Application for
Surfaxin®
Warrington,
PA — June 6, 2006 — Discovery Laboratories, Inc. (Nasdaq:
DSCO),
today
announced that it has notified the European Medicines Evaluation Agency (EMEA)
of its decision to voluntarily withdraw the Marketing Authorization Application
(MAA) for Surfaxin®
for the
prevention and treatment of Respiratory Distress Syndrome (RDS) in premature
infants. The decision to withdraw is based on recently announced manufacturing
issues that Discovery has now determined can not be resolved within the MAA
review timetable. Withdrawal precludes resolution of certain outstanding
clinical issues, which were the focus of a recent EMEA clinical expert meeting
and relate to the Surfaxin Phase 3 clinical trials (including the design and
lack of comparison to Curosurf®,
the
leading surfactant in Europe), that also may not have been resolvable within
the
current MAA review timetable. As a consequence, additional clinical trials
may
be required to support approval of Surfaxin for RDS in Europe through the
centralized procedure.
Discovery’s
New Drug Application to the United States Food & Drug Administration (FDA)
is supported with data from Discovery’s Phase 3 SELECT and STAR trials. The FDA
has issued Discovery a second Approvable Letter, which contains conditions
that
must be satisfied by Discovery prior to obtaining final U.S. marketing approval.
Consistent with previous review, the FDA does not have any clinical or
statistical comments.
Discovery
previously announced that certain stability parameters from the Surfaxin process
validation batches had not been achieved. As a result, additional process
validation batches will have to be produced, which will take longer than the
allotted MAA review timetable. The European centralized regulatory procedure
does not provide a mechanism for placing an application on hold at this stage
in
the review process, or allow a company to add new information to the MAA.
Discovery intends to have further discussions with the EMEA and develop a
strategy for potential Surfaxin approval in Europe.
Discovery
submitted the MAA in October 2004. The MAA submission was supported, in large
part, by data from Discovery’s two positive Phase 3 RDS clinical trials. The
SELECT study was a pivotal, landmark, adjudicated 1294 patient study that
demonstrated Surfaxin’s superiority to Exosurf®,
a
non-protein containing synthetic surfactant. Survanta®,
a
cow-derived surfactant and the leading surfactant used in the United States,
served as a reference arm in the SELECT trial. The multinational SELECT study
demonstrated that Surfaxin was significantly more effective in the prevention
of
RDS and also improved survival (continuing through at least one year of life)
and other outcomes versus comparator surfactants. Discovery also conducted
a 252
patient supportive study (STAR) that demonstrated Surfaxin’s non-inferiority to
Curosurf, a pig-derived surfactant and the leading surfactant used in Europe.
Surfaxin
is a precision-engineered, peptide-containing, synthetic surfactant that is
designed to closely mimic the function of natural human lung surfactant and
represents a potential alternative to animal-derived surfactants.
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 address respiratory
diseases where there are few or no approved therapies available.
Discovery’s
lead product, Surfaxin®,
for the
prevention of Respiratory Distress Syndrome (RDS) in premature infants, has
received two Approvable Letters from the FDA.
Discovery’s
proprietary SRT is also being developed in an aerosolized form under the name
Aerosurf™, for the treatment of neonatal respiratory disorders. Discovery is
preparing to conduct Phase 2 pilot studies with Aerosurf™, aerosolized SRT
administered through nasal continuous positive airway pressure (nCPAP). In
addition, also for premature infants, Discovery recently concluded early a
Phase
2 clinical trial of Surfaxin for the prevention and treatment of
Bronchopulmonary Dysplasia (BPD), also known as Chronic Lung Disease. Discovery
recently completed and announced preliminary results of a Phase 2 clinical
trial
to address Acute Respiratory Distress Syndrome (ARDS) in adults, and is also
developing aerosol formulations of SRT to potentially address Acute Lung Injury
(ALI), cystic fibrosis and other respiratory conditions.
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 aerosol and Surfactant Replacement
Therapies), risk that Discovery will not be able to develop or otherwise provide
for a successful sales and marketing organization in a timely manner, if at
all
risk that approval by the FDA or other health regulatory authorities of any
applications filed by Discovery may be withheld, delayed and/or limited by
indications or other label limitations, 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 that
Discovery’s CMC will not satisfy the FDA, risk in the FDA or other regulatory
agency review process generally, risks relating to the ability of Discovery
or
Discovery’s third party contract manufacturers and development partners to
manufacture or provide Discovery with adequate supplies of drug substance,
drug
products and expertise for completion of any of Discovery’s clinical studies,
risks relating to drug manufacturing by Discovery, risks relating to the
integration of manufacturing operations into Discovery’s existing operations,
other risks relating to the lack of adequate supplies of drug substance and
drug
product for completion of any of Discovery’s clinical studies, risks relating to
the ability of the Company and its collaborators to develop and successfully
commercialize products that will combine our drug products with innovative
aerosolization technologies, risks relating to the significant, time-consuming
and costly research, development, pre-clinical studies, clinical testing and
regulatory approval for any products that we may develop independently or in
connection with our collaboration arrangements, 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:
Lisa
Caperelli, Investor Relations
215-488-9413