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
6, 2008
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
6, 2008, Discovery Laboratories, Inc. (the “Company”) issued a press release
announcing financial results for the quarter ended June 30, 2008. 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
6, 2008, Discovery Laboratories, Inc. (the “Company”) held a conference call to
discuss the financial results for the second quarter ended June 30, 2008. On
the
call, the Company provided an estimate of the anticipated net cash outflows
for
the third quarter of 2008 of approximately $7.0 million which includes $2.5
million received from Chrysalis Technologies (Chrysalis, a division of Philip
Morris USA, Inc.) in accordance with a modified collaboration agreement dated
May 22, 2007.
On
August
6, 2008, the Company issued a press release announcing progress in addressing
key remaining items identified in the May 1, 2008 Approvable Letter received
by
the Company from the FDA in connection with its New Drug Application (NDA)
for
Surfaxin® (lucinactant) for the prevention of Respiratory Distress Syndrome
(RDS) in premature infants. The press release, dated August 6, 2008, is filed
as
Exhibit 99.2 to this report and is incorporated herein by
reference.
Item
9.01. Financial
Statements and Exhibits.
(d) Exhibits
|
99.1
|
Press
release dated August 6, 2008
|
|
99.2
|
Press
release dated August 6, 2008
|
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. | ||
| |
|
|
| Date: August 7, 2008 | By: | /s/ Robert J. Capetola |
|
Name:
Robert J. Capetola, Ph.D.
Title:
President and Chief Executive
Officer
|
||
3
Exhibit
99.1
Discovery
Labs Reports Second Quarter 2008 Financial Results
Warrington,
PA — August 6, 2008 — Discovery Laboratories, Inc. (Nasdaq:
DSCO)
today
announced financial
results for the second quarter ended June 30, 2008. 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, 2008, the Company reported a net loss of $10.2 million
(or $0.11 per share) on 96.7 million weighted average common shares outstanding
compared to a net loss of $10.4 million (or $0.12 per share) on 83.8
million weighted average common shares outstanding for the same period in
2007.
For the six months ended June 30, 2008, the Company reported a net loss of
$19.9
million (or $0.21 per share) on 96.7 million weighted average common shares
outstanding compared to a net loss of $18.7 million (or $0.24 per share) on
76.9 million weighted average common shares outstanding for the same period
in
2007. As of June 30, 2008, the Company had 96.8 million common shares
outstanding.
As
of
June 30, 2008, the Company had cash and marketable securities of $33.4 million.
In the second quarter 2008, cash burn from operating activities, capital
expenditures and debt service was $8.2 million. The Company also has access
to
two Committed Equity Financing Facilities (CEFF). The CEFF allows the Company,
at its discretion, to raise capital (subject to certain conditions, including
price and volume limitations) to support its business plans. As of June 30,
2008, under the 2008 CEFF, approximately 19.3 million shares were available
for
issuance for future financings (not to exceed an aggregate of $60.0 million)
and, under the 2006 CEFF, approximately 5.2 million shares were available
for
issuance for future financings (not to exceed an aggregate of $35.5 million).
The 2008 CEFF expires in June 2011 and the 2006 CEFF expires in April 2009.
Under the terms of the CEFF, the Company determines the exact timing and
amount
of any CEFF financings, subject to certain conditions.
Robert
J.
Capetola, Ph.D., President and Chief Executive Officer of Discovery Labs,
commented, “The Company is focused on gaining FDA approval of Surfaxin by
providing the FDA with the additional information outlined in the May 1
Approvable Letter and clarified in our June 18 meeting. Current assessment
of
our timelines and plans continues to support the submission of our Complete
Response to the Approvable Letter and, assuming a Class 1 review period,
potential FDA approval for Surfaxin in 2008. While we work to achieve this
milestone, we are diligently managing our financial resources, planning a
cash
burn from operations, capital expenditures and debt service of $7.0 million
for
the third quarter, and have already offset a significant portion of this
burn
with the judicious use of the CEFF.”
Second
Quarter 2008 Financial Results:
The
net
loss for the quarter ended June 30, 2008 was $10.2 million compared to $10.4
million for the same period in 2007. Included in the second quarter 2008
and
2007 net loss is a charge of $1.2 million and $1.7 million, respectively,
associated with stock-based compensation expense per Financial Accounting
Standards No. 123R (FAS 123(R)).
The
primary components of the second quarter 2008 results included:
| · |
$2.5
million of revenue associated with completion of the technology
transfer
of the capillary aerosolization technology in accordance with the
modified
license agreement with Chrysalis. Payment of this $2.5 million
is expected
in the third quarter of 2008. Under the modified agreement, Chrysalis
agreed to pay $4.5 million to the Company to support further development
of the capillary aerosolization technology. In the second quarter
of 2008,
the Company received $2.0 million associated with the execution
of the
modified agreement in the first quarter of 2008.
|
| · |
research
and development expenses of $7.4 million associated with (a)
manufacturing
development and quality assurance and analytical activities to
support the
production of clinical and potential commercial drug requirements
for
Surfaxin and the Company’s Surfactant Replacement Therapy (SRT) pipeline,
(b) development of the Company’s capillary aerosolization technology for
the delivery of aerosolized SRT, (c) development of new formulations
of
the Company’s surfactant technology, (d) internal research and development
capabilities (scientific and clinical trial management, regulatory
compliance, data management and biostatistics), (e) medical affairs
(including medical science liaisons) to provide scientific and
medical
education support for Surfaxin and the Company’s SRT pipeline, and (f)
direct expenses to advance the Company’s SRT pipeline, including the
Aerosurf program and the Phase 2 clinical trial using Surfaxin
in children
up to the age of two with Acute Respiratory Failure (ARF).
|
| · |
general
and administrative expenses of $5.1 million, including $1.8 million
of
pre-launch commercialization activities, related to the establishment
of
the Company’s own U.S. commercial operations, in anticipation of the
approval of Surfaxin. In addition, $0.8 million is included in
general and
administrative expenses, associated with stock-based compensation
per
FAS123(R).
|
As
of
June 30, 2008, the Company had $9.9 million outstanding under its long-term
loan
with PharmaBio Development Inc. d/b/a Novaquest (a strategic investment group
of
Quintiles Transnational Corp.). The outstanding principal, together with
all
accrued and unpaid interest is due and payable on April 30, 2010.
The
Company has a secured credit facility with GE Business Financial Services
Inc.
(GE) to finance capital expenditures. Effective May 30, 2008, the facility
was
amended to extend the term an additional six months through November 30,
2008 to
provide support for the Company’s anticipated capital investments for the
remainder of 2008. As of June 30, 2008, $4.4 million was outstanding under
this
facility ($2.9 million is classified as a current liability and $1.5 million
is
classified as a long-term liability) and $300,000 remained
available.
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
peptide-containing synthetic surfactant that is structurally similar to
pulmonary surfactant. Discovery Labs believes that, with its proprietary
technology, SRT has the potential, for the first time, to address a variety
of
respiratory diseases affecting neonatal, pediatric and adult patients.
SURFAXIN®,
the
Company’s lead product from its SRT pipeline, 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,
including, without limitation, the risks that: Discovery Labs may be unable
to
respond, if at all, to the recent approvable letter for Surfaxin within
the
anticipated timeline and the response, when filed, may not satisfy the
FDA; the
FDA or other regulatory authorities may not accept, or may withhold or
delay
consideration of, any applications that Discovery Labs may file for its
products, or may not approve any such applications or may limit marketing
of
such products to particular indications or impose unanticipated label
limitations; changes in the national or international political and regulatory
environment may make it more difficult for Discovery Labs to gain FDA or
other
regulatory approval of its products; Discovery Labs may be unable to raise
additional capital or enter into additional collaboration agreements (including
strategic alliances for development or commercialization of SRT); Discovery
Labs’ lengthy and costly research and development programs, including
pre-clinical studies, clinical trials and other efforts to gain regulatory
approval for any of its products, including Surfaxin, may not progress
or may be
subject to potentially significant delays or regulatory holds, or fail;
Discovery Labs or its contract manufacturers or materials suppliers may
be
unable to successfully manufacture adequate supplies of its drug product
or drug
substances when needed or in amounts sufficient to meet demand; Discovery
Labs
may be unable to develop, manufacture and successfully commercialize products
that combine Discovery Labs’ drug products with innovative aerosolization
technologies; Discovery Labs may be unable to profitably develop and market
its
products; Discovery Labs may be unable to maintain and protect the patents
and
licenses related to its SRT; other companies may develop competing therapies
and/or technologies or health care reform may adversely affect Discovery
Labs;
and Discovery Labs may become involved in securities, product liability
and
other litigation. The foregoing 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)
|
||||||||||||
|
2008
|
2007
|
2008
|
2007
|
||||||||||
|
Revenue
|
$
|
2,500
|
$
|
-
|
$
|
4,550
|
$
|
-
|
|||||
|
Operating
expenses: (1)
|
|||||||||||||
|
Research
and development
|
7,439
|
6,794
|
14,670
|
12,216
|
|||||||||
|
General
and administrative
|
5,076
|
3,465
|
9,582
|
6,219
|
|||||||||
|
Total
expenses
|
12,515
|
10,259
|
24,252
|
18,435
|
|||||||||
|
Operating
loss
|
(10,015
|
)
|
(10,259
|
)
|
(19,702
|
)
|
(18,435
|
)
|
|||||
|
Other
income / (expense)
|
(200
|
)
|
(125
|
)
|
(227
|
)
|
(259
|
)
|
|||||
|
Net
loss
|
$
|
(10,215
|
)
|
$
|
(10,384
|
)
|
$
|
(19,929
|
)
|
$
|
(18,694
|
)
|
|
|
Net
loss per common share
|
$
|
(0.11
|
)
|
$
|
(0.12
|
)
|
$
|
(0.21
|
)
|
$
|
(0.24
|
)
|
|
|
Weighted
average number of common shares outstanding
|
96,691
|
83,825
|
96,670
|
76,907
|
|||||||||
| (1) |
Expenses
include a charge for stock-based employee compensation in accordance
with
the provisions of FAS 123(R). For the three and six months ended
June 30,
2008, the charges associated with FAS 123(R) were $1.2 million
($0.4
million in R&D and $0.8 million in G&A) and $2.2 million ($0.7
million in R&D and $1.5 million in G&A), respectively. For the
three and six months ended June 30, 2007, the charges associated
with FAS
123(R) were $1.7 million ($0.5 million in R&D and $1.2 million in
G&A) and $2.4 million ($0.8 million in R&D and $1.6 million in
G&A), respectively.
|
Condensed
Consolidated Balance Sheets
(in
thousands)
|
June
30,
|
December
31,
|
||||||
|
2008
|
2007
|
||||||
|
ASSETS
|
(unaudited)
|
||||||
|
Current
Assets:
|
|||||||
|
Cash
and marketable securities
|
$
|
33,364
|
$
|
53,007
|
|||
|
Receivables,
prepaid expenses and other current assets
|
2,857
|
611
|
|||||
|
Total
Current Assets
|
36,221
|
53,618
|
|||||
|
Property
and equipment, net
|
6,616
|
7,069
|
|||||
|
Restricted
Cash
|
600
|
600
|
|||||
|
Other
assets
|
1,182
|
1,457
|
|||||
|
Total
Assets
|
$
|
44,619
|
$
|
62,744
|
|||
|
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
|||||||
|
Current
Liabilities:
|
|||||||
|
Accounts
payable
|
$
|
3,001
|
$
|
757
|
|||
|
Accrued
expenses
|
5,079
|
7,087
|
|||||
|
Equipment
loan and other liabilities
|
2,875
|
2,625
|
|||||
|
Total
Current Liabilities
|
10,955
|
10,469
|
|||||
|
Long-Term
Liabilities:
|
|||||||
|
Loan
payable, including accrued interest
|
9,903
|
9,633
|
|||||
|
Equipment
loan and other liabilities
|
2,442
|
3,861
|
|||||
|
Total
Liabilities
|
23,300
|
23,963
|
|||||
|
Stockholders'
Equity
|
21,319
|
38,781
|
|||||
|
Total
Liabilities and Stockholders' Equity
|
$
|
44,619
|
$
|
62,744
|
|||
Exhibit
99.2
Discovery
Labs Reports Progress in Responding to Surfaxin
FDA
Approvable Letter
Warrington,
PA - August 6, 2008, -- Discovery Laboratories, Inc. (Nasdaq:DSCO)
announces
that it has made significant progress in addressing key remaining requirements
identified by the U.S. Food and Drug Administration (FDA) to gain marketing
approval of Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. Over the upcoming weeks, Discovery Labs will continue
to
conduct and finalize activities necessary to submit a Complete Response to
the
May 1, 2008 FDA Approvable Letter. Discovery Labs anticipates submitting
a
Complete Response in September 2008 and believes the response may be designated
by the FDA as a Class 1 resubmission with a target review period of 60
days.
The
May
1, 2008 Approvable Letter did not require any additional clinical trials
to gain
Surfaxin approval. Prior to receiving that Approvable Letter, Discovery Labs
and
the FDA had agreed to a proposed Surfaxin package insert setting forth
prescribing information. Also, the FDA had successfully conducted a pre-approval
inspection (PAI) of Discovery Labs’ manufacturing operations. On June 18, 2008,
Discovery Labs met with the FDA to clarify and reach agreement on addressing
the
key remaining requirements necessary to gain Surfaxin approval. These key
requirements are:
Surfaxin
Biological Activity Test
Based
on
discussions with the FDA several years ago, Discovery Labs qualified and
validated a biological activity test in accordance with current Good
Manufacturing Practices (cGMP) and successfully implemented this test for
Surfaxin release and stability testing. In addition, as agreed to at a December
2006 Clarification Meeting with the FDA, Discovery Labs generated data in
a
well-characterized RDS animal model at a Surfaxin dose of 5.8 mL/kg (the
2007
Preclinical Study), which is the same dose that was used in the Phase 3 clinical
studies of Surfaxin.
The
2007
Preclinical Study results, together with data generated from the biological
activity test described above, support the comparability of Surfaxin drug
product used in Discovery Labs Phase 3 clinical studies to the commercial
manufacturing process for Surfaxin. In addition, these data were intended
to
establish final acceptance criteria for the biological activity test. The
data
from the biological activity test and the 2007 Preclinical Study were provided
to and reviewed by the FDA during the Surfaxin review cycle that concluded
with
the May 1, 2008 Approvable Letter.
At
the
June 18, 2008 meeting, the FDA requested and Discovery Labs agreed to augment
the previously-generated data by conducting additional Surfaxin biological
activity tests at a dose of 5.8 mL/kg, which is different than the dose of
8.0
mL/kg historically employed for Surfaxin release and stability testing. In
addition, Discovery Labs is contemporaneously conducting a related preclinical
study using the same RDS animal model and dose (5.8 mL/kg) as that used in
the
2007 Preclinical Study.
The
data
generated from these additional studies will be used to determine the final
acceptance criteria for the biological activity test and to further confirm
the
comparability of Surfaxin drug product used in Discovery Labs’ Phase 3 clinical
trials to the commercial manufacturing process for Surfaxin. These additional
studies are ongoing and are being conducted at the same laboratories previously
used by Discovery Labs. Although these activities must be successfully
concluded, Discovery Labs believes that the preliminary results achieved
to date
are encouraging and are expected to support Surfaxin approval.
Specifications
for Lipid-Related Impurities in Surfaxin Active Pharmaceutical Ingredients
(APIs)
Surfaxin
is comprised of four active pharmaceutical ingredients (APIs); a novel peptide,
a fatty acid and two phospholipids. To gain final marketing authorization
by the
FDA, Discovery Labs must satisfy International Conference of Harmonization
(ICH)
guidelines for the proposed specifications for certain lipid-related impurities
in the two phospholipids.
At
the
June 18 meeting with the FDA, Discovery Labs discussed its approach to justify
the levels of certain of the lipid-related impurities given their presence
in
the human lung at levels equal to or greater than those that exist in Surfaxin.
At that meeting, the FDA requested additional information about the levels
of
these lipid-related impurities specific to the neonatal lung. In addition
to
reviewing scientific literature to satisfy the requirement that lipid-related
impurities in Surfaxin’s two phospholipids meet ICH guidelines, Discovery Labs
has consulted with lipid-experts and has been working closely with its
phospholipid suppliers to reduce lipid-related impurity levels to the ICH
threshold limit.
To
date,
notable progress has been made. Based on recent analyses, Discovery Labs
believes that it can satisfy the FDA requirements by either accepting the
ICH
threshold limits for certain lipid-related impurities and/or working with
its
phospholipid suppliers to further reduce impurity levels to the ICH threshold
limits. Discovery Labs and its phospholipid suppliers are focused on
successfully completing this approach over the upcoming weeks and obtaining
all
information necessary to support a September submission of a Complete Response.
Robert
J.
Capetola, Ph.D., President and Chief Executive Officer of Discovery Labs,
commented, “I am extremely pleased with the results achieved to date and am
confident that the upcoming Complete Response will satisfy the remaining
FDA
requirements to gain Surfaxin approval. We are positioning Surfaxin, the
first
peptide-containing, synthetic surfactant, to be the highest quality surfactant
replacement therapy available. The state-of-the-art advancements made to
our
manufacturing operations, quality systems, analytical methods, and regulatory
capabilities should favorably impact Surfaxin’s acceptance by the medical
community and meaningfully support the advancement of Discovery Labs’
surfactant-based development pipeline.”
Discovery
Labs believes that it will be in a position to complete the activities related
to satisfying all remaining FDA requirements and submit a Complete Response
to
this Approvable Letter in the September 2008 timeframe. Based on its
understanding of FDA guidelines, and in consultation with outside experts,
Discovery Labs believes that the FDA may designate the Complete Response
to this
Approvable Letter as a Class 1 resubmission, which would result in a target
review period of 60 days (whereas a Class 2 resubmission would result in
a
6-month target review period). If Discovery Labs’ understanding of the timeline
is correct, the potential approval of Surfaxin is anticipated in
2008.
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 and
Discovery Labs’ plans and expected timing to respond to the May 1, 2008
Approvable Letter. Although Discovery Labs believes that it has made significant
progress towards gaining approval of Surfaxin, gaining approval of Surfaxin
involves ongoing activities, the final results of which could vary materially
from Discovery Labs’ expectations and the results obtained to date. Discovery
Labs currently believes that it will succeed in gaining approval of its NDA
for
Surfaxin for the prevention of RDS in premature infants within the timeline
outlined above; however, these activities and the ultimate outcomes are subject
to a variety of risks, including but not limited to risks that (i) even if
Discovery Labs is able to generate the additional data requested by the FDA
and
file its Complete Response to the Approvable letter within the timeline
indicated above, the FDA may not be satisfied with the new data and may require
Discovery Labs to perform further studies or undertake other activities that
are
presently not contemplated by Discovery Labs, (ii) Discovery Labs may not
succeed in adequately addressing other items identified in the Approvable
Letter
and be unable to gain approval of Surfaxin within the timeline indicated
above,
(iii) Discovery Labs, in the process of preparing its response to the Approvable
Letter, may identify unforeseen problems that have not yet been discovered,
and
(iv) the FDA could impose additional requirements to gain approval of Surfaxin.
Any failure to provide information requested by the FDA or to adequately
address
the items raised in the Approvable Letter in Discovery Labs’ formal response to
the Approvable Letter could significantly delay, or preclude outright, gaining
approval of Surfaxin, which could potentially prevent the approval of Discovery
Labs’ other products.
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
peptide-containing synthetic surfactant that is structurally similar to
pulmonary surfactant. Discovery Labs believes that, with its proprietary
technology, SRT has the potential, for the first time, to address a variety
of
respiratory diseases affecting neonatal, pediatric and adult patients.
SURFAXIN®,
the
Company’s lead product from its SRT pipeline, 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,
including, without limitation, the risks that: Discovery Labs may be unable
to
respond, if at all, to the recent approvable letter for Surfaxin within the
anticipated timeline and the response, when filed, may not satisfy the FDA;
the
FDA or other regulatory authorities may not accept, or may withhold or delay
consideration of, any applications that Discovery Labs may file for its
products, or may not approve any such applications or may limit marketing
of
such products to particular indications or impose unanticipated label
limitations; changes in the national or international political and regulatory
environment may make it more difficult for Discovery Labs to gain FDA or
other
regulatory approval of its products; Discovery Labs may be unable to raise
additional capital or enter into additional collaboration agreements (including
strategic alliances for development or commercialization of SRT); Discovery
Labs’ lengthy and costly research and development programs, including
pre-clinical studies, clinical trials and other efforts to gain regulatory
approval for any of its products, including Surfaxin, may not progress or
may be
subject to potentially significant delays or regulatory holds, or fail;
Discovery Labs or its contract manufacturers or materials suppliers may be
unable to successfully manufacture adequate supplies of its drug product
or drug
substances when needed or in amounts sufficient to meet demand; Discovery
Labs
may be unable to develop, manufacture and successfully commercialize products
that combine Discovery Labs’ drug products with innovative aerosolization
technologies; Discovery Labs may be unable to profitably develop and market
its
products; Discovery Labs may be unable to maintain and protect the patents
and
licenses related to its SRT; other companies may develop competing therapies
and/or technologies or health care reform may adversely affect Discovery
Labs;
and Discovery Labs may become involved in securities, product liability and
other litigation. The foregoing 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