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
11, 2006
Date
of
Report (Date of earliest event reported)
Discovery
Laboratories, Inc.
(Exact
name of registrant as specified in its charter)
|
Delaware
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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
October 11, 2006, Discovery Laboratories, Inc. issued a press release to
announce top-line results of its Phase 2 clinical trial of Surfaxin®
(lucinactant) for the prevention and treatment of Bronchopulmonary Dysplasia.
The press release is filed as Exhibit 99.1 to this report and is incorporated
herein by reference.
Item
9.01. Financial
Statements and Exhibits.
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(d)
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Exhibits
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99.1
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Press
release, dated October 11,
2006.
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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 | |
|
Robert
J. Capetola, Ph.D.
President
and Chief Executive Officer
|
||
Date:
October 11, 2006
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Exhibit
99.1
Discovery
Labs
Announces Topline Results of Surfaxin®
Phase 2 Clinical Trial for the Prevention and Treatment of
BPD
Improved
outcomes observed with Surfaxin including increased survival without
BPD
Warrington,
PA — October 11, 2006 — Discovery Laboratories, Inc. (Nasdaq: DSCO),
today
announced encouraging results from its recently completed Phase 2 clinical
trial
of Surfaxin®
(lucinactant) for the prevention and treatment of Bronchopulmonary Dysplasia
(BPD), a debilitating and chronic lung disease typically affecting premature
infants who have suffered Respiratory Distress Syndrome (RDS). The results
suggest that Surfaxin, administered up to five times, may represent a novel
therapeutic option for infants at risk for BPD. Presently there are no approved
therapies for this disease. Surfaxin has received an Approvable Letter from
the
United States FDA for the prevention of RDS and has Orphan Drug Status and
Fast
Track designation from the FDA for the prevention and treatment of
BPD.
Discovery
will hold a conference call on Thursday, October 12th
at 9:00 AM EST. The call in number is 866-332-5218. The audio webcast is
available at http://audioevent.mshow.com/310493.
In
Discovery’s Phase 2 clinical trial, 136 premature infants were enrolled and
received either Surfaxin standard dose (175 mg/kg), Surfaxin low dose (90
mg/kg), or sham air as a control. This clinical trial was designed as an
estimation study to evaluate the safety and potential efficacy of Surfaxin
in
infants at risk for BPD, and was not powered to determine statistically
significant differences in outcomes. The Surfaxin standard dose (175 mg/kg)
is
the dose that was administered in Discovery’s successful RDS Phase 3 clinical
trials. The key preliminary findings observed in this Phase 2 BPD trial
were:
|
·
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A
positive acute pharmacological response to Surfaxin therapy evidenced
by a
reduction in supplemental oxygen and ventilatory
support.
|
|
·
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A
lower incidence of death or BPD in patients receiving the standard
175
mg/kg Surfaxin dosing compared with controls (57.8% vs. 65.9%,
respectively).
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|
·
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A
higher survival rate through 36 weeks post-menstrual age (PMA) in
patients
receiving the standard 175 mg/kg Surfaxin dosing compared with controls
(88.9% vs. 84.1%, respectively).
|
|
·
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A
reduction in duration of mechanical ventilation (approximately four
less
days) and need for supplemental oxygen in patients receiving the
standard
175 mg/kg Surfaxin dosing compared with
controls.
|
|
·
|
Surfaxin
therapy was generally safe and well tolerated with generally no
differences between the Surfaxin treatment groups and the control
group in
common complications of prematurity. There were no differences noted
in
tolerability of drug between the Surfaxin standard dose of 175 mg/kg
(given at a volume of 5.8 ml/kg) and the Surfaxin low dose of 90
mg/kg
(given at a volume of 3.0 ml/kg).
|
1
By
chance, infants assigned to the Surfaxin low dose (90 mg/kg) treatment group
were significantly sicker with more pre-existing medical risk factors, that
typically adversely affect clinical outcomes, compared with the Surfaxin
standard dose (175 mg/kg) group or the control group. Therefore, the data from
the Surfaxin low dose treatment group cannot be easily interpreted and no
meaningful conclusions can be drawn.
Comprehensive
analysis of the data from this trial is ongoing. Following this analysis,
Discovery in collaboration with its Steering Committee and Investigators, will
present the study results to the medical community and submit these data for
publication in a peer review journal.
Robert
Segal, MD, Chief Medical Officer and Senior Vice President of Discovery,
commented, “These data are very exciting and support the further development of
Surfaxin as a potential therapy for BPD. Surfactant dysfunction is
associated with many respiratory disorders prevalent in neonatal, pediatric
and
adult patients. These data, consistent with those from our RDS and ARDS
clinical programs, continue to validate the pharmacology of our
technology. There are many unmet medical needs in pulmonary medicine.
Discovery’s unique pipeline of precision-engineered Surfactant Replacement
Therapies is potentially capable of transforming the treatment of numerous
pulmonary diseases.”
Carl
Bose, MD, Chairman of the BPD Clinical Study Steering Committee and Professor
of
Pediatrics at University of North Carolina, commented, “The data from this Phase
2 estimation trial are encouraging. The medical community would embrace a
medical therapy such as a surfactant treatment if it were proven to increase
the
odds for survival while improving the chances for a healthy future. These data
support the continued evaluation of Surfaxin as a therapeutic option for the
prevention of BPD.”
BPD
is
associated with surfactant deficiency and is diagnosed when premature infants
require mechanical ventilation or supplemental oxygen either at the
28th
day of
life or 36 weeks PMA. Premature babies are often born with a lack of natural
lung surfactant and are unable to absorb sufficient oxygen, resulting in RDS.
These infants often require endotracheal intubation to administer one of the
currently available animal derived surfactants (usually within the first hours
of birth), and to provide respiratory support via mechanical ventilation.
Unfortunately, many infants relapse following initial therapy and require
reintubation and prolonged mechanical ventilation as well as supplemental oxygen
which increases their risk of developing BPD. Discovery believes that BPD may
be
treated with repeated doses, beyond the initial RDS treatment, of a
non-immunogenic, precision-engineered synthetic surfactant (Surfaxin) to improve
the clinical outcome of these infants.
Judy
Aschner, MD, Professor of Pediatrics at the Vanderbilt University Medical Center
and a member of the BPD Clinical Study Steering Committee, commented, “BPD
represents one of the most challenging clinical problems we face in neonatology.
All extremely low birth weight infants that require mechanical ventilation
are at risk for this debilitating disorder and, unfortunately, there are no
approved therapies that effectively prevent or treat this significant medical
problem.”
2
Discovery’s
Phase 2 BPD study was a randomized, double-blind, placebo-controlled trial
that
enrolled 136 extremely low birth weight (600-900 grams) premature infants at
risk for developing BPD. The purpose of the trial was to determine the safety
and tolerability of administering Surfaxin as a therapeutic approach for the
prevention and treatment of BPD. All enrolled infants were initially supported
by mechanical ventilation and most had received a currently available animal
derived surfactant on the first day of life for treatment of RDS. Subsequently,
per protocol, infants treated with Surfaxin received up to five doses, with
the
initial dose being administered between the third and tenth day of
life.
Bronchopulmonary
Dysplasia (BPD)
BPD
is a
costly complication of prematurity that affects approximately 30-40% of infants
who survive RDS and require prolonged use
of
mechanical ventilation and oxygen supplementation. Presently there are no
approved therapies for the treatment or prevention of BPD. Infants diagnosed
with BPD have abnormal lung function and typically need respiratory support,
often requiring comprehensive care for several years. Infants with BPD also
have
longer hospital stays and higher rates of other complications of prematurity,
including cerebral palsy. More than 50,000 infants develop BPD in the United
States and Europe, combined, each year. The cost of treating an infant with
BPD
in the United States can exceed $250,000.
Surfaxin®
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. Surfaxin’s
precision-engineered and non-immunogenic nature allows it to be further
developed as a therapeutic addressing other pulmonary conditions in neonatal
and
pediatric medicine. Data from Discovery’s pivotal, multinational SELECT study
demonstrate that Surfaxin is significantly more effective in the prevention
of
RDS and improved survival (continuing through at least one year of life) 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.
Conference
Call Details
Discovery
Labs will hold a conference call on Thursday, October 12th
at 9:00
AM EST 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/310493
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
8268400.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing 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 its
proprietary SRT pipeline has the potential to advance respiratory medicine
and
address a variety of respiratory diseases affecting premature infants, children
and adults.
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Discovery’s
lead product candidate, Surfaxin, is the subject of an Approvable Letter from
the FDA for the prevention of Respiratory Distress Syndrome in premature
infants. Surfaxin® is also being developed for the prevention and treatment of
Bronchopulmonary Dysplasia in premature infants. Aerosurf™, Discovery’s
aerosolized SRT, is being developed initially to treat premature infants
suffering from respiratory disorders and is intended to obviate the need for
intubation and conventional mechanical ventilation. Discovery’s SRT pipeline
also includes programs addressing Acute Lung Injury, Acute Respiratory Failure,
Cystic Fibrosis, Acute Respiratory Distress Syndrome, 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), the 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, the 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, the risk 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 the Chemistry, Manufacturing and Controls (CMC) section of
Discovery’s
New Drug Application 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 Discovery and its collaborators to
develop, manufacture and successfully commercialize products that combine
Discovery’s 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 Discovery’s
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
Contact:
Lisa
Caperelli, Investor Relations
215-488-9413
4