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
October
21, 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
October 21, 2005, Discovery Laboratories, Inc. (the “Company”) issued a press
release to announce that the U.S. Food and Drug Administration (“FDA”) has
accepted the Company’s Response Letter, amended by a letter submitted to the FDA
on October 5, 2005, as a complete response to the Approvable Letter for
SurfaxinÒ
for the
prevention of Respiratory Distress Syndrome in premature infants. The FDA
has
established April 2006 as its target to complete its review of the Surfaxin
New
Drug Application. 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 October 21, 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.
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: October 21, 2005 | By: | /s/ Robert J. Capetola |
|
Name: Robert J. Capetola, Ph.D. |
||
| Title: President and Chief Executive Officer | ||
Exhibit
99.1
FDA
Accepts Discovery Labs’ Complete Response to
Approvable
Letter for SurfaxinÒ
Warrington,
PA, October 21, 2005 — Discovery Laboratories, Inc. (Nasdaq: DSCO), has been
informed today by the U.S. Food and Drug Administration (FDA) that the FDA
has
accepted Discovery’s resubmission of October 5, 2005 as a complete response to
the Approvable Letter for SurfaxinÒ,
for the
prevention of Respiratory Distress Syndrome (RDS) in premature infants. The
FDA
has established April 2006 as its target to complete its review of the Surfaxin
New Drug Application (NDA).
Robert
J.
Capetola, Ph.D., President and Chief Executive Officer of Discovery, commented,
“With the acceptance of our response to the Surfaxin Approvable Letter, the
FDA
six month review process has begun as of October 5, 2005, the date of our
resubmission. Discovery will work diligently with the FDA during this review,
which will include the reinspection of our Surfaxin contract manufacturing
facility, Laureate Pharma in Totowa, New Jersey. We anticipate that Surfaxin,
the first precision-engineered Surfactant Replacement Therapy, will be available
to the neonatal medical community in the second quarter of 2006.”
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 for the animal-derived and non-protein
containing synthetic surfactants. Discovery’s Surfaxin has received an
Approvable Letter from the FDA for the prevention of RDS in premature infants
and is pending approval. Surfactants are substances that are produced naturally
in the lungs and are essential to the lungs’ ability to absorb oxygen and to
maintain proper airflow through the respiratory system. Premature babies are
born with a lack of natural surfactant in their lungs. Without surfactant,
the
air sacs in the lungs collapse and are unable to absorb sufficient oxygen
resulting in RDS.
DISCLOSURE
NOTICE: The information in this press release includes certain “forward-looking”
statements relating to the timing of FDA approval of Discovery’s NDA for
Surfaxin for RDS, which assume that all of the conditions in the Approvable
Letter are timely satisfied. These conditions include, without limitation,
issues previously raised by earlier FDA inspections of the Totowa, NJ facility
of Laureate Pharma, Inc., Discovery’s contract manufacturer for Surfaxin.
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 initially focused on the most significant respiratory conditions
prevalent in the neonatal intensive care unit. The Company’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 treatment of
Chronic Lung Disease (CLD) in premature infants. Aerosurf™, aerosolized SRT
administered through nasal continuous positive airway pressure (nCPAP), is
in
development to address neonatal respiratory failures.
To
address the various respiratory conditions affecting pediatric, young adult
and
adult patients in the critical care and other hospital settings, Discovery
is
conducting a Phase 2 clinical trial to address Acute Respiratory Distress
Syndrome (ARDS) in adults, and is also developing aerosol formulations of SRT
to
address Acute Lung Injury (ALI), asthma, COPD, 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 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