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
April
24, 2006
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 18976-3622
(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
April
24, 2006, Discovery Laboratories, Inc. issued a press release, the full text
of
which 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 April 24, 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 registrant
has
duly caused this report to be signed on its behalf by the undersigned hereunto
duly authorized.
| Discovery Laboratories, Inc. | ||
| |
|
|
| Date: April 26, 2006 | By: | /s/ Robert J. Capetola, Ph.D. |
|
Robert J. Capetola, Ph.D. |
||
| President and Chief Executive Officer | ||
3
Exhibit
99.1
Discovery
Labs Reports Surfaxin Manufacturing Issue
Warrington,
PA — April 24, 2006 — Discovery Laboratories, Inc. (Nasdaq:
DSCO),
today is
announcing that analysis of ongoing stability data from Surfaxin®
process
validation batches indicates that certain stability parameters have not been
achieved and, therefore, additional process validation batches will likely
have
to be produced. These process validation batches were previously manufactured
as
a requirement for Discovery’s U.S. NDA regulatory approval and have been
undergoing periodic stability testing. Discovery anticipates a potentially
significant delay in the U.S. regulatory approval process for Surfaxin for
the
prevention of Respiratory Distress Syndrome (RDS) in premature infants. At
this
time, it is not known whether this issue will have any impact on the Surfaxin
European regulatory approval process.
Discovery
will be hosting a conference call on Tuesday, April 25 at 10:00 AM EDT. Details
are provided below.
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. This recent
development does not call into question the established pharmacology and highly
statistically significant clinical outcomes demonstrated in the Company’s
Surfaxin Phase 3 clinical program. Data from Discovery’s pivotal multinational
SELECT Study demonstrates 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
previously reported the results of two recently completed pre-approval site
inspections, conducted separately by the FDA and the EMEA, of the Company’s drug
product sterile manufacturing facility. The Surfaxin clinical drug product
that
is currently in use in Discovery’s ongoing Phase 2 clinical trial of Surfaxin
for the prevention and treatment of Bronchopulmonary Dysplasia in premature
infants is unaffected.
The
major
focus of Discovery’s development programs are aerosolized Surfactant Replacement
Therapies to address serious respiratory conditions such as Neonatal Respiratory
Disorders and Acute Lung Injury. Discovery’s lead aerosol product candidate is
Aerosurf™ for Neonatal Respiratory Disorders. The development of an aerosolized
surfactant administered via nasal continuous positive airway pressure (nCPAP)
has the potential to revolutionize neonatal medicine for the treatment of
infants with a wide array of respiratory disorders that typically would require
mechanical ventilation. This recent development currently does not affect the
aerosolized drug product supply for its Phase 2 Aerosurf clinical development
program.
Discovery
is analyzing all aspects of its business with an immediate intention to conserve
cash. The establishment of a commercial infrastructure is no longer in
Discovery’s near-term plans. The Company’s focus will be on remediating these
manufacturing issues, developing its Surfactant Replacement Therapy pipeline
and
potentially entering into strategic partnerships.
Conference
Call Details
The
call
in number is 866-332-5218. The international call in number is 706-679-3237.
This
audio webcast will be available to shareholders and interested parties through
a
live broadcast on the Internet at http://audioevent.mshow.com/296693/ and
www.discoverylabs.com.
It is
recommended that participants log onto one of these sites at least 15 minutes
prior to the call. The Internet broadcast will be available for up to 30 days
after the call at both website addresses. The replay number to hear the
conference call is 800-642-1687 or 706-645-9291. The passcode is
8158896.
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
SRT pipeline is focused on significant respiratory conditions prevalent in
the
neonatal intensive care unit, critical care and other hospital settings.
Discovery’s lead product, Surfaxin®,
for the
prevention of Respiratory Distress Syndrome (RDS) in premature infants, has
received an Approvable Letter from the FDA and is under review for approval
in
Europe by the EMEA. Surfaxin is also being developed for the prevention and
treatment of Bronchopulmonary Dysplasia (BPD, also known as Chronic Lung
Disease) in premature infants. Discovery is preparing to conduct Phase 2 pilot
studies with Aerosurf, aerosolized SRT administered through nasal continuous
positive airway pressure (nCPAP), for the treatment of neonatal respiratory
disorders. Discovery has completed a Phase 2 clinical trial to address Acute
Respiratory Distress Syndrome (ARDS) in adults, and is developing aerosol
formulations of SRT to 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 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 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 review process
generally, risks relating to the ability of Discovery’s third party contract
manufacturers and development partners to 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:
John
G.
Cooper, EVP, CFO
215-488-9490
Lisa
Caperelli, Manager, Investor Relations
215-488-9413