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EX-99.1 - WINDTREE THERAPEUTICS INC /DE/ | v210416_ex99-1.htm |
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
February
9, 2011
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
8.01.
|
Other
Events.
|
Conference Call Update on
Activities to Support Surfaxin® Complete Response
On
February 1, 2011, Discovery Laboratories, Inc. (the “Company”) held a
pre-announced public conference call and webcast to discuss its ongoing efforts
to conclude its comprehensive preclinical program and file a Complete Response
intended to gain U.S. Food and Drug Administration (“FDA”) marketing
authorization of Surfaxin® for the prevention of respiratory distress syndrome
(“RDS”) in premature infants.
A copy of
the conference call transcript is filed as Exhibit 99.1 to this Current
Report on Form 8-K and is incorporated herein by reference. At the
start of the call, the Company referenced certain forward-looking statements
that the Company intended to be covered by the Safe Harbor provided by the
Private Securities Litigation Reform Act and directed call participants to refer
to the factors that could cause actual results to materially differ from those
in the forward-looking statements contained in the transcript because of a
number of factors including those set forth in the Company’s Annual Report on
Form 10-K and any subsequent SEC filings, as they may have been amended. The
filing of the transcript is not intended to constitute a representation, and
shall not be deemed to be an admission, that such filing is required by
Regulation FD or that the transcript includes information that is not otherwise
publicly available. The filing of the attached information is not an
admission as to the materiality of any of the information set forth
therein. In addition, except as required by law, the Company does not
assume any obligation to update such information in the future.
Surfaxin® for the Prevention
of RDS
The
Company believes that a key remaining step to potentially gain FDA marketing
approval for Surfaxin is to satisfy the FDA as to the final validation of its
fetal rabbit biological activity test (“BAT”), an important quality control
release and stability test for Surfaxin. The Company has been
conducting a comprehensive preclinical program in this regard. The
Company has previously optimized the BAT and its final validation is intended to
satisfy the FDA with respect to the ability of the optimized BAT to adequately
reflect the biological activity of Surfaxin throughout its shelf life and to
discriminate biologically active from inactive Surfaxin drug
product. The comprehensive preclinical program will also provide data
that will be used to gain the FDA’s agreement on final acceptance criteria, with
respect to biological activity as assessed by the BAT, for release and ongoing
stability of Surfaxin drug product.
The
comprehensive preclinical program also calls for multiple Surfaxin batches to be
used to demonstrate concordance between the BAT and the well-established preterm
lamb model of RDS by performing a series of prospectively-designed, side-by-side
preclinical studies (i.e., concordance studies). Data from the
preterm lamb model and BAT concordance studies are intended to support final BAT
validation and to demonstrate comparability of drug product used in the Phase 3
clinical program with Surfaxin drug product to be manufactured for commercial
use.
2
As noted
in the Company’s recent press release of February 1, 2011 and the conference
call transcript, the Company has been interacting with the FDA throughout the
conduct of its comprehensive preclinical program to gain Surfaxin approval and
has been incorporating the FDA’s guidance into its efforts to complete the
program and file the Surfaxin Complete Response. As previously
reported, a recent communication from the FDA focused on certain technical
criteria relating to final BAT validation and directed the Company to increase
the sample size of specified data sets by testing additional Surfaxin
batches. To respond to the FDA’s direction, the Company plans to
submit data from several Surfaxin batches that have been previously manufactured
and analyzed, as well as from newly-manufactured Surfaxin batches.
Since it
acquired its manufacturing operations in Totowa, NJ, in December 2005, the
Company has a record of manufacturing in each year batches of Surfaxin drug
product, all of which met release and stability specifications. In
December 2010, the Company began manufacturing additional Surfaxin batches for
use in the comprehensive preclinical program. Since December 2010, the Company
has manufactured four Surfaxin batches for this purpose. Of these
four batches, the first has been fully tested and has met all release
specifications. Preliminary testing of the next two batches indicates
that they do not meet one of the release specifications and cannot be used in
the comprehensive preclinical program. At this time, preliminary
testing of the fourth batch indicates that it meets specifications, including
the specification that the prior two batches did not meet. In
accordance with the Company’s quality assurance procedures and pharmaceutical
manufacturing practices, the Company is conducting an investigation into the
manufacture of the Surfaxin batches that did not meet specification to determine
the probable cause. Although the investigation is ongoing, based on
its preliminary assessment, the Company presently anticipates resuming the
manufacture of Surfaxin batches for use in the comprehensive preclinical program
in February 2011.
The
Company originally anticipated manufacturing additional Surfaxin batches to
complete the comprehensive preclinical program and be in a position to file a
Surfaxin Complete Response by early third quarter 2011, which, after an
anticipated six-month FDA review cycle, could lead to potential Surfaxin
approval early in the first quarter 2012. In light of the foregoing
and assuming that the Company resumes manufacturing in February 2011 as planned,
the Company now believes that the filing of the Complete Response could occur in
the third quarter 2011 and, as a result, potential Surfaxin approval could occur
in the first quarter 2012.
The
Surfaxin Complete Response, in addition to including the results of the
comprehensive preclinical program, will also require that the Company provide
other routine regulatory submissions, such as an updated clinical trial safety
report for Surfaxin. In April 2008, the FDA completed a
pre-approval inspection (“PAI”) of the Company’s manufacturing facility in
Totowa, NJ and issued an Establishment Inspection Report (“EIR”) reflecting a
successful inspection. Following the filing of the Complete Response
and prior to gaining potential FDA marketing authorization, the Company believes
that the FDA will likely conduct another PAI of its Totowa, NJ manufacturing
facility and assess the quality assurance/quality control facilities for
Surfaxin including those of third-party raw material suppliers and testing
laboratories. Although the Company and the FDA have previously
discussed the principal content of the Surfaxin package insert, the Company
presently anticipates that the FDA may want to update the format and content of
the package insert in connection with a potential Surfaxin approval to comply
with mandated format changes as well as to reflect updated information regarding
Surfaxin.
3
Other RDS
Programs
With
respect to the Company’s development program for Surfaxin LS™, a lyophilized
formulation of Surfaxin, the Company is in the process of conducting a
technology transfer of its manufacturing process to a cGMP-compliant,
third-party contract manufacturer with expertise in lyophilized
formulations. The Company also presently plans to seek regulatory and
scientific guidance with respect to its planned Surfaxin LS development program
with the FDA and the European Medicines Agency (“EMA”) in 2011.
Aerosurf®
is the Company’s drug/device combination development program for noninvasive
administration of aerosolized KL4 surfactant
to address neonatal RDS. Aerosurf combines the Company’s KL4 drug
product technology with the Company’s novel capillary aerosolization
technology. The Company, with the assistance of third-party medical
device engineers, is presently optimizing the design of the capillary
aerosolization device for anticipated clinical development use. The
Company presently anticipates that 2011 activities will include finalizing the
Aerosurf clinical device design, producing devices for design verification
testing, and seeking regulatory guidance from the FDA and EMA for the planned
Aerosurf development program.
Disclosure
Notice
The
information in this Form 8-K includes certain "forward-looking" statements
relating, among other things, to the Company's understanding of
recently-received written guidance from the FDA and the remaining questions
identified in the FDA's April 2009 Complete Response Letter that must be
addressed to gain FDA approval of Surfaxin. The Company has
interacted and plans to further interact with the FDA on certain technical
aspects of the comprehensive preclinical program. Such potential
interactions with the FDA could affect the ultimate timing, conduct and outcomes
of remaining steps necessary to gain Surfaxin approval, including the potential
filing of the Complete Response. In addition, the Company is
conducting an investigation into the probable cause of two batches that did not
meet one of the release specifications, and is planning to resume manufacture of
a number of Surfaxin batches that are needed to support the filing of the
Complete Response. All of the foregoing activities are subject to
potential delays or outcomes that may materially impact the Company’s present
plans. In any event, there can be no assurance that the Company will
be successful in completing the comprehensive preclinical program within the
timeline outlined above, or that the FDA will be satisfied with the
comprehensive preclinical program and the Complete Response. In
addition to uncertainties related to the FDA's review of the Complete Response,
the Company presently anticipates that the FDA will likely inspect and otherwise
assess the manufacturing and quality assurance facilities for Surfaxin including
those of third-party raw material suppliers and testing
laboratories. The outcomes of such FDA activities could also affect
the ultimate timing and remaining steps necessary to gain Surfaxin
approval.
4
The
completion of the comprehensive preclinical program and other related activities
will require the Company to raise significant amounts of additional capital and
the ultimate outcomes remain subject to a variety of risks and uncertainties
that could cause actual results to be materially different. These risks and
uncertainties include, but are not limited to, risks that (i) the FDA may
not approve Surfaxin or may subject the marketing of Surfaxin to onerous
requirements that significantly impair marketing activities; (ii) the
Company may be unable to resume or complete the manufacture of a sufficient
number of additional Surfaxin batches within the time frame set forth above,
(iii) the Company may identify unforeseen problems that have not yet been
discovered or the FDA could in the future impose additional requirements to gain
approval of Surfaxin; and (iv) the Company may be unable to raise sufficient
additional capital, through financings, strategic collaborations, or
otherwise. Any failure to satisfy the issues raised by the FDA, in
the Complete Response letter or in related discussions, could significantly
delay, or preclude outright, gaining approval of Surfaxin, which could
potentially delay or prevent the approval of the Company' other
products.
Item
9.01.
|
Financial Statements
and Exhibits.
|
(d)
|
Exhibits
|
|
99.1
|
Conference
call transcript dated February 1,
2011
|
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.
5
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/ W. Thomas Amick | |
Name: | W. Thomas Amick | ||
Title:
|
Chairman of the Board and Chief Executive Officer | ||
Date: February
9, 2011
6