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
20, 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
(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
June
20, 2006, Discovery Laboratories, Inc. (the “Company”) issued a press release
announcing that it has engaged Jefferies & Company, Inc., an investment
banking firm, to assist the Company in identifying and evaluating strategic
alternatives intended to enhance the future growth potential of the Company’s
surfactant replacement therapy pipeline and maximize shareholder value. The
press release, dated June 20, 2006, is filed as Exhibit 99.1 to this report
and
is incorporated herein by reference.
Item
9.01. Financial
Statements and Exhibits.
| |
|
99.1
|
Press
release, dated June 20, 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.
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 |
| |
Robert
J. Capetola, Ph.D. |
| |
President
and
Chief Executive Officer |
Date:
June 22, 2006
Discovery
Labs Retains Jefferies & Company to Assist in the Evaluation
of Potential
Strategic Alternatives
Warrington,
PA, June 20, 2006 — Discovery Laboratories, Inc. (Nasdaq:
DSCO),
today
announced that it has engaged Jefferies & Company, Inc., the New York-based
investment banking firm, to assist the Company in identifying and evaluating
strategic alternatives intended to enhance the future growth potential of
the
Company’s surfactant replacement therapy pipeline and maximize shareholder
value. Discovery is considering multiple alternatives including, but not
limited
to, potential business alliances, commercial and development partnerships,
financings, business combinations and other similar opportunities. No assurances
can be given that this evaluation will lead to any specific action or
transaction. Discovery does not plan to make future comments about the status
of
the evaluation of strategic alternatives unless there are material
developments.
Discovery
Laboratories, Inc. is a biotechnology company developing proprietary Surfactant
Replacement Therapies (SRT) for multiple 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 its proprietary pulmonary surfactant platform has
the
potential to address multiple respiratory diseases where there are few or
no
approved therapies available.
Robert
J.
Capetola, Ph.D. President and Chief Executive Officer of Discovery commented,
“The management and Board of Directors continuously evaluate our business
to
identify and develop opportunities for maximizing value for all shareholders.
We
look forward to working with Jefferies in this regard. While reviewing various
strategic alternatives, the Company’s immediate priorities are to address the
manufacturing and regulatory requirements for FDA approval of
Surfaxin®,
initiate Phase 2 clinical trials with Aerosurf™ and announce our next SRT
programs to enter Phase 2 clinical development.”
Discovery’s
lead product, Surfaxin, has received two Approvable Letters from the FDA
for the
prevention of Respiratory Distress Syndrome (RDS) in premature infants. In
addition, Discovery recently concluded patient enrollment for its Phase 2
Bronchopulmonary Dysplasia (BPD) clinical trial evaluating the potential
incremental benefit of Surfaxin versus standard of care. Discovery plans
to
report the top-line results for this trial in the fourth quarter of 2006.
Discovery is also developing Aerosurf, its proprietary SRT administered in
aerosolized form, for the treatment of multiple respiratory disorders. Discovery
is preparing to initiate Phase 2 clinical studies in neonates with Aerosurf
administered through nasal continuous positive airway pressure (nCPAP),
potentially obviating the need for intubation and conventional mechanical
ventilation. Discovery is also developing aerosol formulations of SRT to
potentially address Acute Lung Injury (ALI), cystic fibrosis and other
respiratory conditions.
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.
For
more information, please visit our corporate website at www.Discoverylabs.com.
Company
Contacts:
John
G.
Cooper, Executive Vice President and Chief Financial Officer
215-488-9490
