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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
5, 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:
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
April
5, 2006, Discovery Laboratories, Inc. (the “Company”) announced the receipt of a
second Approvable Letter from the U.S. Food and Drug Administration (FDA) for
the Company’s lead product candidate, Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. The Approvable Letter is an official notification from the
FDA and contains conditions that must be satisfied by the Company prior to
obtaining final U.S. marketing approval. Specifically, the FDA is requesting
certain information primarily focused on the Chemistry, Manufacturing and
Controls (CMC) section of the New Drug Application (NDA). Consistent with its
previous review, the FDA does not have any clinical or statistical comments.
The
Company is in the process of arranging a meeting with the FDA regarding
conditions for final approval. The Company anticipates that this meeting will
clarify timelines with respect to its response to the FDA. This is the second
Approvable Letter received by the Company from the FDA since the Company's
NDA
for Surfaxin was filed in April 2004. The Company’s previously submitted
responses to the first Approvable Letter were accepted by the FDA as a complete
response in October 2005. 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, Pro Forma Financial Statements and
Exhibits
(d) Exhibits:
|
99.1
|
Press
Release dated April 5, 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.
By:
/s/
Robert J. Capetola
Name:
Robert J. Capetola, Ph.D.
Title:
President and Chief Executive Officer
Date:
April 5, 2006
3
Exhibit
99.1
Discovery
Labs Receives Second Approvable Letter from
FDA
for
SurfaxinÒ
for RDS
Warrington,
PA — April 5, 2006 — Discovery
Laboratories, Inc. (Nasdaq: DSCO) today announced that it has received a
second
Approvable Letter from the U.S. Food and Drug Administration (FDA) for
Discovery’s lead product candidate, Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. 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. Discovery
will hold a conference call today at 8:45 AM EDT. The call in number is
866-332-5218.
The
Approvable Letter is an official notification from the FDA and contains
conditions that must be satisfied by Discovery prior to obtaining final U.S.
marketing approval. Specifically, the FDA is requesting certain information
primarily focused on the Chemistry, Manufacturing and Controls (CMC) section
of
the NDA. The information predominately involves the further tightening of
active
ingredient and drug product specifications and related controls. Consistent
with
previous review, the FDA does not have any clinical or statistical comments.
Discovery is in the process of arranging a meeting with the FDA regarding
conditions for final approval. The Company anticipates that this meeting
will
clarify timelines with respect to its response to the FDA.
This
is
the second Approvable Letter received by the Company from the FDA since the
Company's NDA for Surfaxin was filed in April 2004. Our
previously submitted responses to the first Approvable Letter were accepted
by
the FDA as a complete response in October 2005.
Robert
J.
Capetola, Ph.D., President and Chief Executive Officer of Discovery, commented,
“Our top priority is to satisfy the FDA’s requests as soon as possible, so that
we can obtain final approval for this important life-saving therapy and make
it
available to the neonatal community. In light of today’s news, we are analyzing
all aspects of our business with an intention to conserve cash while remaining
focused on developing our NICU franchise of Surfaxin and Aerosurf™.”
RDS
is a
life-threatening and costly breathing disorder that strikes tens of thousands
of
premature infants in the United States each year, with a global at-risk
population in excess of 500,000 infants. Approximately 75,000 infants are
treated with surfactants in the United States annually. Current surfactant
treatment options are limited to animal-derived surfactants harvested from
bovine (cow) and porcine (pig) sources.
Data
from
Discovery’s pivotal, multinational SELECT study demonstrates that Surfaxin was
significantly more effective in the prevention of RDS and improved survival
and
other outcomes versus comparator surfactants. The SELECT
and STAR (a supportive Phase 3 study) trials, as well as a pooled Phase 3
analysis, have been presented at several international medical meetings and
the
results from the two studies were published in Pediatrics.
Discovery
will hold a conference call today at 8:45 AM EDT to further discuss in greater
detail the foregoing. 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/295458/
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
7560777.
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. 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 multiple
Phase
2 pilot studies with Aerosurf, aerosolized SRT administered through nasal
continuous positive airway pressure (nCPAP), for the treatment of neonatal
respiratory failure.
To
address the various respiratory conditions affecting pediatric, young adult
and
adult patients in the critical care and other hospital settings, 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), 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 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:
Lisa
Caperelli, Manager, Investor Relations
215-488-9413