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
August
2, 2007
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
2.02. Results
of Operations and Financial Condition.
On
August
2, 2007, Discovery Laboratories, Inc. (the “Company”) issued a press release
announcing financial results for the second quarter ended June 30, 2007, and
providing selected updates on the Company’s Surfaxin® (lucinactant) replacement
therapies pipeline development. The press release is attached as Exhibit 99.1
hereto.
In
accordance with General Instruction B.2 of Form 8-K, the information in Item
2.02 of this Current Report on Form 8-K and Exhibit 99.1 attached hereto shall
not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act
of 1934, as amended (the “Exchange Act”), or otherwise subject to the
liabilities of that section, nor shall it be deemed incorporated by reference
in
any filing under the Securities Act of 1933, as amended, or the Exchange Act,
except as expressly set forth by specific reference in any such
filings.
Item
8.01. Other
Events.
On
August
2, 2007, the Company held a conference call to discuss the financial results
for
the second quarter ended June 30, 2007. On the call, the Company provided an
estimate of aggregate cash outflows from operating and investing activities
for
the third fiscal quarter of 2007 of approximately $9.0 million.
On
August
2, 2007, the Company issued a press release (attached
hereto as Exhibit 99.2) providing updates on the Company’s progress in
addressing previously-announced manufacturing and process validation stability
issues and the April 2006 Approvable Letter from the Food and Drug
Administration (FDA). Results from the three new Surfaxin process validation
batches, which were manufactured consistent with guidance obtained from the
FDA
at a December 2006 meeting, indicate that the batches demonstrated acceptable
stability through three months under the Company’s comprehensive testing
protocol. The process validation batches must demonstrate stability through
six-months before the Company can file its formal response to the Approvable
Letter.
The
Company believes that it has made significant progress in addressing the
outstanding issues identified in the Approvable Letter, which focused on the
Chemistry, Manufacturing and Controls (CMC) section of the New Drug Application
(NDA) for Surfaxin for the prevention of Respiratory Distress Syndrome (RDS)
in
premature infants. The Company is currently focused on completing the
experiments, and compiling and analyzing the data for submission to the FDA,
and
believes that it remains on track to file its formal response in the October
2007 timeframe, followed by an anticipated six-month review cycle by the FDA
for
potential approval of the Surfaxin NDA.
Item
9.01. Financial
Statements and Exhibits.
(d) Exhibits
|
99.1
|
Press
release dated August 2, 2007
|
|
99.2
|
Press
release dated August 2, 2007
|
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
Name:
Robert J. Capetola, Ph.D.
Title:
President and Chief Executive Officer
Date:
August 6, 2007
Exhibit
99.1
Discovery
Labs Reports Second Quarter 2007 Financial Results
Warrington,
PA — August 2, 2007 — Discovery Laboratories, Inc. (Nasdaq:
DSCO),
today
announced financial
results for the second quarter ended June 30, 2007. The Company will host a
conference call today at 10:00 AM EDT. The
call in number is 866-332-5218.
For
the
quarter ended June 30, 2007, the Company reported a net loss of $10.4 million
(or $0.12 per share) on 83.8 million weighted average common shares outstanding
compared to a net loss of $14.7 million (or $0.24 per share) on 61.7 million
weighted average common shares outstanding for the same period in 2006. Included
in the net loss is a charge of $1.7 million associated with stock-based
compensation as a result of our adoption of Financial Accounting Standards
No.
123(R) (“FAS 123(R)”). Additionally, the Company’s cash burn from operating
activities and debt service was $8.2 million in the second quarter of 2007.
As
of June 30, 2007, the Company had 84.6 million common shares
outstanding.
As
of
June 30, 2007, the Company had cash and marketable securities of $40.8 million.
During the second quarter of 2007, the Company completed a registered direct
offering to institutional investors resulting in gross proceeds of $30.2 million
($28.1 million net). Additionally, under its Committed Equity Financing Facility
(CEFF), the Company may, at its discretion, access capital through the issuance
of up to approximately 7.1 million shares (not to exceed aggregate proceeds
of
$40.5 million). Use of the CEFF is subject to certain conditions, including
that
the volume weighted average price of the Company’s common stock during a draw
down must be at least $2.00 per share.
Also
in
the second quarter of 2007, the Company entered into a $12.5 million secured
credit facility with Merrill Lynch Capital to finance capital expenditures,
of
which $9.0 million was immediately available and up to $3.5 million will become
available when the Company raises new capital through business development
partnerships, stock offerings and other similar financings. Of the available
$9.0 million, approximately $4.0 million was applied to prepay the Company’s
existing equipment financing indebtedness.
Robert
J.
Capetola, Ph.D., President and Chief Executive Officer of Discovery, commented,
“Our top priority is to gain FDA approval of Surfaxin.
We
believe that considerable progress has been made in addressing the manufacturing
stability failure and open CMC issues from the April 2006 Approvable Letter.
Based on the progress to date, we remain confident that we are on track to
file
our formal response to the FDA in the October timeframe. With the continuing
enhancements to our manufacturing and quality operations, the expansion of
our
pipeline and improved financial resources, we have strengthened our Company
in
2007.”
Selected
Updates on SRT Pipeline Development:
· |
Recently,
the Company initiated a Phase 2 clinical trial evaluating the use
of
Surfaxin in children up to two years of age suffering from Acute
Respiratory Failure (ARF). This new trial will explore the expanded
application of surfactant therapy to pediatric critical care medicine.
This trial is intended to enroll approximately 180 patients and enrollment
is currently active.
|
· |
The
Company is presently collaborating with Chrysalis Technologies on
the
development of a prototype aerosolization system to deliver Aerosurf
to
patients in the Neonatal Intensive Care Unit (NICU). The Company
has also
met with and received guidance from the FDA with respect to the design
of
the proposed Phase 2 clinical program. The Company and Chrysalis,
together
with third-party engineers and manufacturers, are presently collaborating
on the development and optimization of this novel system as well
as next
generation drug device systems. The initial prototype development
work,
originally expected to be completed in the second half of 2007, is
now
anticipated to be completed in the first quarter of 2008. Based on
the
timing adjustment of the system development, initiation of our Phase
2
clinical program is now anticipated in the first quarter of
2008.
|
Second
Quarter 2007 Operating Expenses:
Total
operating expenses for the quarter ended June 30, 2007 were $10.3 million
compared to $14.7 million for the same period in 2006. The decrease in this
quarter compared to the same period last year is primarily due to a charge
of
$4.8 million in 2006 associated with a corporate restructuring in April 2006,
following receipt of an Approvable Letter from the FDA for Surfaxin and the
process validation stability failure. For the second quarter of 2007, the
components of the $10.3 million operating expense included:
· |
manufacturing
development expenses (included in research and development expenses)
of
$2.9 million, including: (i) costs to operate the Company’s manufacturing
facility to support production of clinical and anticipated commercial
drug
supply for the Company’s Surfactant Replacement Therapies (SRT) programs;
(ii) continued investment in the Company’s quality assurance and
analytical chemistry capabilities to ensure compliance with current
good
manufacturing practices (cGMP); (iii) activities associated with
developing data and other information necessary for the Company’s formal
response to the Surfaxin Approvable Letter; and (iv) activities to
develop
additional formulations of the Company’s
SRT;
|
· |
research
and development expenses (excluding manufacturing development activities)
of $3.9 million associated with infrastructure development, including
clinical trial management, regulatory compliance, data management
and
biostatistics, and medical and scientific affairs activities as well
as
direct program expenses to advance the Company’s SRT pipeline, including:
(i) costs associated with developing data and other information necessary
for the Company’s formal response to the Surfaxin Approvable Letter; (ii)
activities associated with the ongoing Phase 2 clinical trial to
evaluate
Surfaxin in
children up to two years of age with
ARF;
and (iii) development activities related to Aerosurf™,
the Company’s proprietary SRT in aerosolized form administered through
nasal continuous positive airway pressure (nCPAP), to address premature
infants at risk for respiratory
failure;
|
· |
general
and administrative expenses of $3.5 million, including costs associated
with executive management, evaluation of various strategic business
alternatives, financial and legal management and other administrative
costs; and
|
· |
$1.7
million (classified in the amounts above as $0.5 million in research
and
development and $1.2 million in general and administrative) associated
with stock-based employee compensation resulting from Financial Accounting
Standards No. 123(R).
|
Financial
Results for the Six Months Ended June 30, 2007:
For
the
six months ended June 30, 2007, the Company reported a net loss of $18.7 million
(or $0.24 per share) on 76.9 million weighted average common shares outstanding
compared to a net loss of $30.5 million (or $0.50 per share) on 61.4 million
weighted average common shares outstanding for the same period in 2006. Included
in the net loss for the six months ended June 30, 2006 is a charge of $4.8
million (or $0.08 per share) associated with a corporate restructuring following
receipt of the Approvable Letter for Surfaxin and the process validation
stability failure.
Debt
Arrangements at June 30, 2007:
The
Company had $9.3 million outstanding under its long-term loan with PharmaBio
Development Inc., a strategic investment group of Quintiles Transnational Corp.
The outstanding principal and all accrued interest since July 1, 2006, is due
and payable on April 30, 2010. The Company may repay this loan in whole or
in
part at any time prior to April 2010 without prepayment penalty or
premium.
The
Company had $4.2 million outstanding under its secured credit facility with
Merrill Lynch Capital, of which $1.7 million is classified as a current
liability and $2.5 million is classified as a long-term liability.
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 Labs’ technology produces a
precision-engineered surfactant that is designed to closely mimic the essential
properties of natural human lung surfactant. Discovery Labs believes that its
proprietary SRT pipeline has the potential to advance respiratory medicine
and
address a variety of respiratory diseases affecting neonatal, pediatric and
adult patients.
Discovery
Labs’ 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
other neonatal and pediatric indications. Aerosurf™, Discovery Labs’ aerosolized
SRT, is being developed to potentially obviate the need for intubation and
conventional mechanical ventilation and holds
the
promise to significantly expand the use of surfactants in respiratory medicine.
For
more
information, please visit our website at www.Discoverylabs.com.
To
the extent that statements in this press release are not strictly historical,
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 Labs actual results and could cause
results to differ from those contained in these forward-looking statements
are
the risk that Discovery Labs may not profitably develop and market its products,
the risk that financial market conditions may change, the risk that Discovery
Labs will not be able to raise additional capital or enter into additional
collaboration agreements, the risk that Discovery Labs will not be able to
attract or retain qualified personnel or timely provide for a successful sales
and marketing organization, risks relating to the progress of Discovery Labs
research and development, risks in the FDA or other regulatory agency review
process generally, including that such regulatory authority will not approve
the
marketing and sale of a drug product even after acceptance of an application
or
that approval by such regulatory agency may be withheld, delayed and/or limited
by indications or other label limitations, risks that the Chemical,
Manufacturing and Controls section of Discovery Labs New Drug Application will
not satisfy the FDA, risks relating to the ability of Discovery Labs or
Discovery Labs third party manufacturers and development partners to manufacture
or provide Discovery Labs with adequate supplies of drug substances and
expertise for completion of any of Discovery Labs clinical studies, risks
related to the ability of Discovery Labs and its collaborators to develop,
manufacture and successfully commercialize products that combine Discovery
Labs
drug products with innovative aerosolization technologies, risks relating to
drug manufacturing by Discovery Labs, risks relating to the significant,
time-consuming and costly research, development, pre-clinical studies, clinical
testing and regulatory approval process for any products that Discovery Labs
may
develop independently or with Discovery Labs collaboration arrangements, risks
relating to the development by other companies of competing therapies and/or
technologies, risks relating to reimbursement and health care reform, and risks
relating to securities, product liability and other litigation. 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 Labs 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
Condensed
Consolidated Statement of Operations
(in
thousands, except per share data)
|
|
|
|
Three
Months Ended
|
|
Six
Months Ended
|
|
|
|
June
30,
|
|
June
30,
|
|
|
|
(unaudited)
|
|
(unaudited)
|
|
|
|
2007
|
|
2006
|
|
2007
|
|
2006
|
|
|
|
|
|
|
|
|
|
|
|
Revenue
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
$
|
-
|
|
Operating
expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Research
and development (1)
|
|
|
6,794
|
|
|
5,911
|
|
|
12,216
|
|
|
13,524
|
|
General
and administrative (1)
|
|
|
3,465
|
|
|
4,024
|
|
|
6,219
|
|
|
12,706
|
|
Restructuring
charge
|
|
|
--
|
|
|
4,805
|
|
|
--
|
|
|
4,805
|
|
Total
expenses
|
|
|
10,259
|
|
|
14,740
|
|
|
18,435
|
|
|
31,035
|
|
Operating
loss
|
|
|
(10,259
|
)
|
|
(14,740
|
)
|
|
(18,435
|
)
|
|
(31,035
|
)
|
Other
income / (expense)
|
|
|
(125
|
)
|
|
45
|
|
|
(259
|
)
|
|
545
|
|
Net
loss
|
|
$
|
(10,384
|
)
|
$
|
(14,695
|
)
|
$
|
(18,694
|
)
|
$
|
(30,490
|
)
|
Net
loss per common share
|
|
$
|
(0.12
|
)
|
$
|
(0.24
|
)
|
$
|
(0.24
|
)
|
$
|
(0.50
|
)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted
average number of common shares outstanding
|
|
|
83,825
|
|
|
61,652
|
|
|
76,907
|
|
|
61,411
|
|
(1)
Expenses include a charge for stock-based employee compensation in
accordance with the provisions of FAS 123(R), which the Company adopted
on
January 1, 2006. For the three and six months ended June 30, 2007,
the
charges associated with FAS 123(R) were $1.7 million and $2.4 million,
respectively. For the three and six months ended June 30, 2006, the
charges associated with FAS 123(R) were $1.6 million and $3.2 million,
respectively.
|
Condensed
Consolidated Balance Sheets
(in
thousands)
|
|
|
June
30,
|
|
December
31,
|
|
|
|
ASSETS
|
|
2007
|
|
2006
|
|
Current
Assets:
|
|
|
|
|
|
Cash
and marketable securities
|
|
$
|
40,753
|
|
$
|
27,002
|
|
Prepaid
expenses and other current assets
|
|
|
779
|
|
|
565
|
|
Total
Current Assets
|
|
|
41,532
|
|
|
27,567
|
|
Property
and equipment, net
|
|
|
5,618
|
|
|
4,794
|
|
Other
assets
|
|
|
1,924
|
|
|
2,039
|
|
Total
Assets
|
|
$
|
49,074
|
|
$
|
34,400
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|
|
|
|
|
|
|
Current
Liabilities:
|
|
|
|
|
|
|
|
Accounts
payable and accrued expenses
|
|
$
|
6,184
|
|
$
|
5,953
|
|
Capitalized
leases and other liabilities
|
|
|
1,758
|
|
|
2,015
|
|
Total
Current Liabilities
|
|
|
7,942
|
|
|
7,968
|
|
Long-Term
Liabilities:
|
|
|
|
|
|
|
|
Loan
payable, including accrued interest
|
|
|
9,268
|
|
|
8,907
|
|
Capitalized
leases and other liabilities
|
|
|
3,453
|
|
|
3,203
|
|
Total
Liabilities
|
|
|
20,663
|
|
|
20,078
|
|
Stockholders'
Equity
|
|
|
28,411
|
|
|
14,322
|
|
Total
Liabilities and Stockholders' Equity
|
|
$
|
49,074
|
|
$
|
34,400
|
|
Exhibit
99.2
Discovery
Labs Provides Update on Progress for Surfaxin®
for RDS
Conference
Call Today at 10:00 A.M.
Warrington,
PA — August 2, 2007 — Discovery Laboratories, Inc. (Nasdaq: DSCO)
today
reports progress in addressing previously-announced manufacturing and stability
issues and the April 2006 FDA Approvable Letter (Approvable Letter), which
focused on the Chemistry, Manufacturing and Controls (CMC) section of the New
Drug Application (NDA) for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. Discovery Labs remains on track to file its formal response
to the Approvable Letter in the October 2007 timeframe, followed by an
anticipated six-month review cycle by the FDA for potential approval of the
Surfaxin NDA.
April
2006 Surfaxin
Process Validation Stability Failure
Immediately
following the April 2006 process validation stability failure, Discovery Labs
conducted a comprehensive investigation into the stability failure, including
identifying a most probable root cause, and remediated by executing a
comprehensive corrective action and preventative action (CAPA) plan. As part
of
the investigation, Discovery Labs manufactured a series of investigational
batches that supported the manufacture of three new process validation batches.
These investigational batches are monitored using Discovery’s most predictive
stability-indicating method and continue to demonstrate acceptable stability,
with the earliest manufactured batches continuing to demonstrate acceptable
stability through twelve months, and the most-recently manufactured, through
six
months.
In
February 2007, Discovery Labs completed the manufacture of the three new
Surfaxin process validation batches that are a requirement for approval of
the
Surfaxin NDA. These process validation batches are subjected to comprehensive
stability testing on pre-specified testing dates, in accordance with an
established protocol that complies with ICH guidelines. Under the comprehensive
testing protocol, these process validation batches have demonstrated acceptable
stability through three months and continue to be monitored. The process
validation batches must demonstrate acceptable stability through six-months
under the comprehensive testing protocol before Discovery Labs can file its
formal response to the Approvable Letter. Discovery Labs anticipates that
six-month stability data will be available in October for inclusion in the
formal response.
The
new
Surfaxin process validation batches were manufactured consistent with guidance
obtained from the FDA at the December 2006 meeting. At that meeting, Discovery
Labs presented information to the FDA regarding its comprehensive investigation
and remediation of the April 2006 process validation stability failure. Included
was information associated with the manufacture of the series of investigational
batches, using a process consistent with that used to produce Surfaxin for
Discovery Labs’ successful RDS clinical trials. Discovery Labs applied the
manufacturing process used to produce the investigational batches to produce
the
three new process validation batches.
April
2006 FDA Approvable Letter - Chemistry, Manufacturing and Controls
Discovery
received an Approvable Letter for Surfaxin in April 2006 that primarily focused
on the CMC section of the Surfaxin NDA. The Approvable Letter did not require
any additional clinical trials, but requested additional information
predominantly involving drug product specifications and stability, analytical
methods and related controls. The CMC section of an NDA contains information
to
demonstrate that the drug product can be manufactured consistently to meet
appropriate product quality requirements.
In
December 2006, Discovery Labs met with the FDA to gain the clarity necessary
to
address key remaining CMC issues identified in the Approvable Letter. The FDA’s
guidance provided a defined pathway for Discovery Labs to generate additional
data from selected experiments that are essential for approval of Surfaxin
for
the prevention of RDS in premature infants.
Discovery
Labs believes it has made significant progress in addressing the outstanding
issues identified in the Approvable Letter and is currently focused on
completing the experiments, and compiling and analyzing the data for submission
to the FDA. Discovery Labs believes that its progress to date supports the
filing of the formal response to the Approvable Letter in the October 2007
timeframe.
DISCLOSURE
NOTICE: The information in this press release includes certain “forward-looking”
statements relating to, among other things, the remaining steps necessary for
FDA approval of Surfaxin for the prevention of RDS in premature infants,
including information being prepared for inclusion in Discovery Labs’ formal
response to the Approvable Letter and the potential results of both Discovery
Labs’ comprehensive manufacturing investigation and the ongoing release and
stability testing of the investigational batches and the new process validation
batches. Although Discovery Labs is encouraged by the progress that it believes
it has made to date, the development of data and other relevant information
for
the formal response to the Approvable Letter, including the release and
stability testing of the investigational batches and the new process validation
batches, are ongoing and the final results of these efforts could vary
materially from the observations and results obtained to date. Discovery Labs
currently believes that it will succeed in submitting its formal response to
the
Approvable Letter, with six months of successful stability data for the new
process validation batches, within the timeframe indicated above, subject,
however, to a variety of risks, including that (i) Discovery Labs may not
succeed in completing its experiments or developing the data and other
information necessary for the formal response, (ii) the new process validation
batches may in the future fail to meet designated stability or other release
parameters, and (iii) Discovery Labs may identify unforeseen problems that
have
not yet been discovered. The reader of this release should understand that
the
failure to develop all necessary information required to respond to the
Approvable Letter, including at least six months of stability data for the
new
process validation batches, could result in significant delays or additional
requirements and potentially prevent the approval of Surfaxin or other Discovery
Labs products.
Conference
Call Details
Discovery
Labs will hold a conference call today at 10:00 AM EDT to further discuss 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 through a live broadcast
on the Internet at http://investor.shareholder.com/media/eventdetail.cfm?mediaid=26687&c=DSCO&mediakey=50596D7D4BE16CECBA5B9FD9E893B75A&e=0 and
www.discoverylabs.com.
The
replay number to hear the conference call is 800-642-1687 or 706-645-9291.
The
passcode is 10288727.
About
Surfaxin
Surfaxin,
is a precision-engineered version of natural human lung surfactant and contains
Discovery Labs’ novel KL-4 peptide. Surfaxin, administered as a
liquid-instillate, represents a potential alternative to the commercially
available animal-derived surfactants. Data from Discovery Labs’ pivotal,
multinational SELECT study demonstrate that Surfaxin is significantly more
effective in the prevention of RDS and results in 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.
In
addition, top-line results from Discovery Labs’ Phase 2 clinical trial for the
prevention and treatment of BPD suggested that infants treated with up to five
incremental standard doses of Surfaxin tended to have a lower incidence of
death
or BPD, a higher survival rate through 36 weeks post-menstrual age, and fewer
days on mechanical ventilation. Discovery Labs recently initiated a
Phase 2
clinical trial evaluating the use of Surfaxin in
children up to two years of age suffering from Acute Respiratory Failure (ARF).
This new trial will explore the expanded application of surfactant therapy
to
pediatric critical care medicine.
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 Labs’ technology produces a
precision-engineered surfactant that is designed to closely mimic the essential
properties of natural human lung surfactant. Discovery Labs believes that its
proprietary SRT pipeline has the potential to advance respiratory medicine
and
address a variety of respiratory diseases affecting neonatal, pediatric and
adult patients.
Discovery
Labs’ 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
other neonatal and pediatric indications. Aerosurf™, Discovery Labs’ aerosolized
SRT, is being developed to potentially obviate the need for intubation and
conventional mechanical ventilation and holds
the
promise to significantly expand the use of surfactants in respiratory medicine.
For
more
information, please visit our website at www.Discoverylabs.com.
To
the extent that statements in this press release are not strictly historical,
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 Labs actual results and could cause
results to differ from those contained in these forward-looking statements
are
the risk that Discovery Labs may not profitably develop and market its products,
the risk that financial market conditions may change, the risk that Discovery
Labs will not be able to raise additional capital or enter into additional
collaboration agreements, the risk that Discovery Labs will not be able to
attract or retain qualified personnel or timely provide for a successful sales
and marketing organization, risks relating to the progress of Discovery Labs
research and development, risks in the FDA or other regulatory agency review
process generally, including that such regulatory authority will not approve
the
marketing and sale of a drug product even after acceptance of an application
or
that approval by such regulatory agency may be withheld, delayed and/or limited
by indications or other label limitations, risks that the Chemical,
Manufacturing and Controls section of Discovery Labs New Drug Application will
not satisfy the FDA, risks relating to the ability of Discovery Labs or
Discovery Labs third party manufacturers and development partners to manufacture
or provide Discovery Labs with adequate supplies of drug substances and
expertise for completion of any of Discovery Labs clinical studies, risks
related to the ability of Discovery Labs and its collaborators to develop,
manufacture and successfully commercialize products that combine Discovery
Labs
drug products with innovative aerosolization technologies, risks relating to
drug manufacturing by Discovery Labs, risks relating to the significant,
time-consuming and costly research, development, pre-clinical studies, clinical
testing and regulatory approval process for any products that Discovery Labs
may
develop independently or with Discovery Labs collaboration arrangements, risks
relating to the development by other companies of competing therapies and/or
technologies, risks relating to reimbursement and health care reform, and risks
relating to securities, product liability and other litigation. 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 Labs 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