Delaware
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000-26422
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94-3171943
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(State
or other jurisdiction
of
incorporation)
|
(Commission
File Number)
|
(IRS
Employer
Identification
Number)
|
(d) | Exhibits | |
99.1 | Press Release dated November 8, 2006. | |
99.2 | Press Release dated November 6, 2006. |
Discovery Laboratories, Inc. | ||
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|
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Date: November 9, 2006 | By: | /s/ Robert J. Capetola |
Robert J. Capetola, Ph.D. |
||
President and Chief Executive Officer |
· |
On
September 28, 2006, the Company submitted an information package
and
requested a meeting with the U.S. Food and Drug Administration (FDA).
The
package covers items identified in the April 2006 Approvable Letter
that
the Company received from the FDA, which primarily focused on the
Chemistry, Manufacturing and Controls (CMC) portion of our new drug
application (NDA), and provides information about the Company’s
comprehensive investigation and remediation of the April 2006
Surfaxin®
process validation stability failure. The purpose of the meeting
is to
clarify the information requested by the FDA in the Approvable Letter
and
reach agreement on the appropriate path to potentially gain approval
of
Surfaxin for the prevention of Respiratory Distress Syndrome (RDS)
in
premature infants. The FDA meeting has been scheduled for December
21,
2006.
|
· |
In
October, the Company announced encouraging preliminary results from
its
Phase 2 clinical trial of Surfaxin for the prevention and treatment
of
Bronchopulmonary Dysplasia (BPD), a debilitating and chronic lung
disease
typically affecting premature infants who have suffered RDS. The
study
results suggest that Surfaxin therapy may potentially represent a
novel
therapeutic option for infants at risk for or suffering from BPD.
Improved
outcomes were observed with Surfaxin including a lower incidence
of death
or BPD in patients receiving the Surfaxin standard dose as compared
with
the control group receiving standard of care. The FDA previously
granted
Orphan Drug Status and Fast Track designations for Surfaxin for the
prevention and treatment of BPD. Presently there are no approved
therapies
for this disease.
|
· |
In
October, the Company announced that additional clinical data from
the
SELECT and STAR Phase 3 trials for Surfaxin for the prevention of
RDS in
premature infants demonstrate that Surfaxin-treated infants require
significantly less invasive re-intubation and experience improved
key
clinical outcomes compared to those treated with the current market
leading animal-derived surfactants.
|
· |
On
November 6, 2006 the Company announced that the United States District
Court for the Eastern District of Pennsylvania dismissed, without
prejudice, the Consolidated Amended Class Action Complaint filed
on August
9, 2006 against the Company and two of its executive officers and
granted
plaintiffs leave to file an amended Consolidated Amended Complaint
by
November 30, 2006.
|
(i) |
manufacturing
development expenses (included in research and development expenses)
for
the quarter ended September 30, 2006 were $2.2 million, a decrease
of $0.8
million compared to the same period in 2005. Manufacturing development
includes (1) costs associated with operating the Company’s
manufacturing facility in Totowa, New Jersey (which the Company acquired
from its then-contract manufacturer, Laureate Pharma, Inc. (Laureate),
in
December 2005), to support the production of clinical and anticipated
commercial drug supply for the Company’s SRT programs; (2) continued
investment in the Company’s quality assurance and analytical chemistry
capabilities to assure current good manufacturing practices (cGMP);
and
(3) costs associated with the ongoing comprehensive investigation
and
analysis of the April 2006 Surfaxin process validation stability
failure
and remediation of the Company’s related manufacturing issues.
Expenditures in the quarter ended September 30, 2005 primarily represented
Laureate manufacturing service charges and direct costs for the
manufacture of Surfaxin, as well as costs of improvements and enhancements
to the manufacturing operations.
|
(ii) |
research
and development expenses (excluding manufacturing development activities)
for the quarter ended September 30, 2006 were $2.7 million, no change
compared to the same period in 2005. Expenditures in the third quarter
of
2006 were primarily associated with costs incurred for (1) regulatory
activities related to the April 2006 Approvable Letter for Surfaxin
for
RDS and the process validation stability failure; (2) clinical and
data
management activities related to the Phase 2 clinical trial of Surfaxin
for the prevention and treatment of BPD; (3) engineering and development
activities (in conjunction with our strategic alliance with Chrysalis
Technologies, Inc., a division of Philip Morris USA) related to
Aerosurf™,
the Company’s proprietary SRT in aerosolized form administered through
nasal continuous positive airway pressure (nCPAP), for the prevention
and
treatment of infants at risk for respiratory failure; and (4) research
and development activities to expand the application of the Company’s
technology in other respiratory conditions and explore improved
formulations; and
|
(iii) |
general
and administrative expenses for the quarter ended September 30, 2006
were
$2.1 million, a decrease of $2.7 million compared to the same period
in
2005. Expenses in 2006 include, but are not limited to, the costs
of
executive management, cost to defend the recently dismissed Class
Action
lawsuit, evaluating various strategic business alternatives, financial
and
legal management and other administrative costs. Included in 2005
are
costs associated with building a United States commercial infrastructure.
The decrease compared to last year primarily reflects the Company’s
decision, in response to the April 2006 Approvable Letter and the
Surfaxin
process validation stability failure, to discontinue this capability.
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Condensed
Consolidated Statement of Operations
(in
thousands, except per share data)
|
||||||||||||||||
Three
Months Ended
|
Nine
Months Ended
|
|||||||||||||||
September
30,
|
September
30,
|
|||||||||||||||
(unaudited)
|
(unaudited)
|
|||||||||||||||
2006
|
2005
|
2006
|
2005
|
|||||||||||||
Revenues
from collaborative agreements
|
$
|
-
|
$
|
20
|
$
|
-
|
$
|
105
|
||||||||
Operating
expenses:
|
||||||||||||||||
Research
and development (1)
|
5,204
|
5,676
|
18,728
|
16,660
|
||||||||||||
General
and administrative (1)
|
2,723
|
4,817
|
15,429
|
13,182
|
||||||||||||
Restructuring
charge
|
--
|
--
|
4,805
|
--
|
||||||||||||
Total
operating expenses
|
7,927
|
10,493
|
38,962
|
29,842
|
||||||||||||
Operating
loss
|
(7,927
|
)
|
(10,473
|
)
|
(38,962
|
)
|
(29,737
|
)
|
||||||||
Other
income / (expense)
|
(71
|
)
|
67
|
474
|
189
|
|||||||||||
Net
loss
|
$
|
(7,998
|
)
|
$
|
(10,406
|
)
|
$
|
(38,488
|
)
|
$
|
(29,548
|
)
|
||||
Net
loss per common share
|
$
|
(0.13
|
)
|
$
|
(0.19
|
)
|
$
|
(0.62
|
)
|
$
|
(0.56
|
)
|
||||
Weighted
average number of common shares outstanding
|
62,312
|
54,476
|
61,703
|
52,844
|
||||||||||||
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||||||||||||||||
(1) Included
in expenses for the three and nine months ended September 30, 2006
are
charges of $0.9 million ($0.3 million classified as research and
development and $0.6 million classified as general and administrative)
(or
$0.02 per share) and $4.1 million ($1.2 million classified as research
and
development and $2.9 million classified as general and administrative)
(or
$0.06 per share), respectively, associated with stock-based employee
compensation in accordance with the provisions of SFAS No. 123(R),
which
the Company adopted on January 1,
2006.
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Condensed
Consolidated Balance Sheets
(in
thousands)
|
|||||||||||||||||||
September
30,
|
December
31,
|
||||||||||||||||||
2006
|
2005
|
||||||||||||||||||
ASSETS
|
(unaudited)
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||||||||||||||||||
Current
Assets:
|
|||||||||||||||||||
Cash
and marketable securities
|
$
19,723
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$
50,908
|
|||||||||||||||||
Prepaid
expenses and other current assets
|
278
|
560
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|||||||||||||||||
Total
Current Assets
|
20,001
|
51,468
|
|||||||||||||||||
Property
and equipment, net
|
4,604
|
4,322
|
|||||||||||||||||
Other
assets
|
216
|
218
|
|||||||||||||||||
Total Assets
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$
24,821
|
$
56,008
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|||||||||||||||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
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|||||||||||||||||||
Current
Liabilities:
|
|||||||||||||||||||
Accounts
payable and accrued expenses
|
$
6,867
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$
7,540
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|||||||||||||||||
Credit
facility (2)
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8,500
|
8,500
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|||||||||||||||||
Capitalized
leases and other liabilities
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1,922
|
1,568
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|||||||||||||||||
Total
Current Liabilities
|
17,289
|
17,608
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|||||||||||||||||
Long-Term
Liabilities:
|
|||||||||||||||||||
Capitalized
leases and other liabilities
|
3,489
|
3,562
|
|||||||||||||||||
Total
Liabilities
|
20,778
|
21,170
|
|||||||||||||||||
Stockholders'
Equity
|
4,043
|
34,838
|
|||||||||||||||||
Total
Liabilities and Stockholders' Equity
|
$
24,821
|
$
56,008
|
|||||||||||||||||
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(2) |
In
October 2006, the Company restructured its $8.5 million loan with
Quintiles Transnational Corp. Payment of the $8.5 million loan
principal,
originally due December 31, 2006, has now been extended as a lump
sum
payment due on April 30, 2010.
|