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
September
29, 2009
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.
On
September 30, 2009, Discovery Laboratories, Inc. (the “Company”) issued a press
release announcing the results of its September 29, 2009 teleconference with the
U.S. Food and Drug Administration (FDA). The meeting was convened to
discuss an approach, which had been suggested by the FDA at an earlier meeting
held on June 2, 2009 as a way for the Company to increase the likelihood of
gaining U.S. marketing approval of Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. The meeting focused on the Company’s plans
regarding optimization and final method validation of its fetal rabbit
Biological Activity Test (BAT, a quality control and stability release test) and
a proposed limited Surfaxin clinical trial design, which would simultaneously
employ the newly-optimized BAT.
At the
meeting, Discovery Labs sought clarification with respect to its plans to
further optimize and validate the BAT. As a result of the meeting,
the Company believes that it has reached an understanding with the FDA and is
confident that it will be able to optimize the BAT to the satisfaction of the
FDA. The Company intends to employ the optimized BAT in conjunction
with all of its KL4 surfactant
pipeline programs, including the potential limited Surfaxin clinical
trial. In addition, the Company received guidance from the FDA on its
proposed limited clinical trial design. The trial design is intended
to primarily assess a pharmacodynamic (PD) response following Surfaxin
administration in preterm infants with RDS. This design was selected
to address the FDA’s requirements for Surfaxin approval while attempting to
limit trial expense and duration. The FDA indicated that a PD-based approach is
consistent with their expectation for a limited clinical trial and also provided
direction regarding trial design specifics. The final clinical trial design will
be subject to FDA review following submission of a formal
protocol. Discovery Labs expects to finalize a protocol and
anticipates submitting it to the FDA in mid-fourth quarter of 2009.
The
Company’s top priority is to secure strategic alliance partners and access
capital to advance its KL4 surfactant
pipeline, including Surfaxin, Surfaxin LS™ and Aerosurf®, which
have the potential to greatly improve the management of RDS and to potentially
redefine the RDS market. Following its anticipated further interaction with the
FDA with respect to the BAT optimization and the proposed formal protocols, the
Company plans to make a strategic assessment, together with existing and
potential new partners, to determine the appropriate level and timing of future
Surfaxin investments and to maximize the value of its KL4 pipeline
for the management of RDS.
The press
release is attached as Exhibit 99.1 hereto.
Item
9.01. Financial
Statements and Exhibits.
| (d) | Exhibits | |
|
|
99.1
|
Press
release dated September 30, 2009
|
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/ W. Thomas Amick | |
| Name: | W. Thomas Amick | ||
| Title: | Chairman of the Board and Interim | ||
| Chief Executive Officer | |||
| Date: September 30, 2009 | |||
Discovery
Labs and FDA Establish Path for Potential SURFAXIN Approval
FDA
Supports Proposed BAT Optimization and Approach for Limited Clinical
Trial
Warrington, PA – September 30, 2009
- -- Discovery Laboratories, Inc. (Nasdaq:DSCO) held a teleconference on
September 29, 2009 with the U.S. Food and Drug Administration (FDA). The meeting
established an approach to potentially resolve the remaining primary issue that
Discovery Labs must address to gain U.S. marketing approval of Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. The meeting focused on Discovery Labs’ plans regarding
optimization and final method validation of its fetal rabbit Biological Activity
Test (BAT, a quality control and stability release test) and a proposed limited
Surfaxin clinical trial design, which would simultaneously employ the
newly-optimized BAT.
At the
meeting, the FDA indicated that Discovery Labs’ proposed program to optimize and
validate the BAT is reasonable. The program is intended, among other things, to
confirm that the BAT can adequately distinguish change in Surfaxin biological
activity over time. As a result of the meeting, Discovery Labs believes that it
has reached an understanding with the FDA and is confident that it will be able
to optimize the BAT to the satisfaction of the FDA. Discovery Labs
intends to employ the optimized BAT in conjunction with all of Discovery Labs’
KL4
surfactant pipeline programs, including the potential limited Surfaxin clinical
trial.
In
addition, Discovery Labs received guidance from the FDA on its proposed limited
clinical trial design. The trial design is intended to primarily assess a
pharmacodynamic (PD) response following Surfaxin administration in preterm
infants with RDS. This design was selected to address FDA requirements for
Surfaxin approval while limiting trial expense and duration. The FDA indicated
that a PD-based approach is consistent with their expectation for a limited
clinical trial and also provided direction regarding trial design specifics. The
final clinical trial design will be subject to FDA review following submission
of a formal protocol. Discovery Labs expects to finalize a protocol
and anticipates submitting it to the FDA in mid-fourth quarter of
2009.
W. Thomas
Amick, Chairman of the Board and Chief Executive Officer of Discovery Labs,
commented, “We are pleased with the guidance received and outcomes obtained from
our interaction with the FDA. This guidance provides a viable option
for Surfaxin and meaningfully supports advancing our pipeline initiatives to
potentially address a broad range of respiratory diseases such as RDS, Acute
Respiratory Failure, Acute Lung Injury and Cystic Fibrosis. We look
forward to continued productive dialogue with the FDA.
Our most
advanced programs from our KL4 surfactant
pipeline, Surfaxin, Surfaxin LS™ and Aerosurf®, have
the potential to greatly improve the management of RDS and to redefine the RDS
market. Our top priority is to secure strategic alliance partners and access
capital to advance our pipeline and build shareholder value. As we move forward,
we will take into account further interaction with the FDA and make strategic
assessment, together with existing and potential new partners to determine the
appropriate level and timing of Surfaxin investment and to maximize the value of
our KL4
pipeline for RDS.”
Background
On April
17, 2009, Discovery Labs received a Complete Response letter from the FDA for
Surfaxin for RDS and on June 2, 2009, conducted a related meeting focusing
primarily on certain aspects of the BAT, specifically whether preclinical data
generated using both the BAT and a well-established preterm lamb model of RDS
adequately supports the comparability of Surfaxin clinical drug product to the
to-be-manufactured Surfaxin, and whether the BAT can adequately distinguish
change in Surfaxin biological activity over time.
During
the conduct of Phase 3 clinical trials for Surfaxin, Discovery Labs employed an
array of quality control tests, but did not employ the BAT to evaluate
biological activity of the Surfaxin clinical drug product. After completing the
Phase 3 clinical trials, in accordance with discussions with the FDA, Discovery
Labs validated and implemented the BAT as a recurring quality control test to
confirm biological activity for Surfaxin release and stability
testing. Based on guidance received from the FDA in meetings with the
FDA in 2006 and 2008, Discovery Labs conducted a series of preclinical
experiments to establish comparability between Surfaxin drug product used in
Phase 3 clinical trials and the Surfaxin drug product intended to be
manufactured for commercial use. Accordingly, Discovery Labs initiated a series
of side-by-side studies employing both the preterm lamb model of RDS and the BAT
and believes that the correlated results demonstrate comparability and support
approval of Surfaxin.
At the
June 2 meeting with the FDA, Discovery Labs presented data from the preterm lamb
model and BAT studies, together with a comprehensive statistical evaluation of
such data, intended to establish the comparability of clinical drug product to
Surfaxin drug product to be manufactured for commercial use. The
comprehensive statistical evaluation was a comparative regression analysis using
an accepted FDA statistical method. Discovery Labs believes that the
data and related statistical evaluation are highly supportive of the
comparability of clinical drug product to commercial Surfaxin.
However,
the FDA stated at the June 2 meeting that data generated from the preterm lamb
model and BAT studies must demonstrate, in a point-to-point analysis, the same
relative changes in respiratory compliance between both models over time. Based
on this standard, Discovery Labs believes that establishment of comparability in
this manner would be an extremely high hurdle and that, from the FDA’s
perspective, the data analysis provided by Discovery Labs did not meet that
standard.
In
addition, the FDA suggested that the comparability studies in the preterm lamb
model and the BAT would not be necessary if the BAT had been implemented to
assess Surfaxin drug product used in the Phase 3 clinical trials. The FDA also
suggested that, to increase the likelihood of gaining Surfaxin approval and as
an alternative to demonstrating comparability using the preterm lamb model and
BAT, Discovery Labs could consider conducting a limited clinical trial, while
simultaneously employing the BAT, as a path forward to Surfaxin
approval.
DISCLOSURE NOTICE: The
information in this press release includes certain “forward-looking” statements
relating, among other things, to Discovery Labs’ understanding of the remaining
questions identified in the April 2009 Complete Response Letter that must be
addressed to gain FDA approval of Surfaxin and the outcomes of a teleconference
held with the FDA on September 29, 2009. Although Discovery Labs
currently believes that it may still succeed in gaining approval of its NDA for
Surfaxin for the prevention of RDS in premature infants, these activities 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) although Discovery Labs is hopeful that it will be able to optimize and
validate the BAT method to the FDA’s satisfaction, and finalize acceptance
criteria for the BAT, as a precursor to potentially using the BAT in a limited
Surfaxin clinical trial,, the FDA may not be satisfied with the results of
Discovery Labs optimization and validation activities and Discovery
Labs and the FDA may not reach agreement with respect to any or all of these
issues; (ii) if Discovery Labs and the FDA do not reach agreement on the details
of a formal protocol for a limited clinical trial, Discovery Labs may be unable
to gain approval of Surfaxin; (iii) even if Discovery Labs and the FDA reach
agreement on the matters discussed above and Discovery Labs does complete the
additional activities to the FDA’s satisfaction, the FDA may not approve
Surfaxin or may subject the marketing of Surfaxin to onerous requirements that
significantly impair marketing activities; (iv) although Discovery Labs thinks
it unlikely, the FDA may not be satisfied with Discovery Labs’ responses to
other items identified in the April 17, 2009 Complete Response letter and
Discovery Labs may be unable to gain approval of Surfaxin; (v) Discovery Labs
may identify unforeseen problems that have not yet been discovered; and
(vi) the FDA could in the future impose additional requirements to gain
approval of Surfaxin. Any failure to satisfy the issues raised by the
FDA in the Complete Response letter could significantly delay, or preclude
outright, gaining approval of Surfaxin, which could potentially delay or prevent
the approval of Discovery Labs’ other products.
About
Discovery Labs
Discovery
Laboratories, Inc. is a biotechnology company developing Surfactant Therapies
for respiratory diseases. Surfactants are produced naturally in the lungs
and are essential for breathing. Discovery Labs’ novel proprietary KL4 Surfactant
Technology produces a synthetic, peptide-containing surfactant that is
structurally similar to pulmonary surfactant and is being developed in liquid,
aerosol or lyophilized formulations. In addition, Discovery Labs’
proprietary Capillary Aerosolization Technology produces a dense aerosol, with a
defined particle size that is capable of potentially delivering aerosolized
KL4
surfactant to the deep lung without the complications currently associated with
liquid surfactant administration. Discovery Labs believes that its
proprietary technology platform makes it possible, for the first time, to
develop a significant pipeline of surfactant products to address a variety of
respiratory diseases for which there frequently are few or no approved
therapies. For more information, please visit our website at www.Discoverylabs.com.
Forward
Looking Statements
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, including without limitation, any relating to the
second half of the Company’s fiscal year, are subject to certain risks and
uncertainties that could cause actual results to differ materially from the
statements made. Examples of such risks and uncertainties are: risks
relating to the rigorous regulatory requirements required for approval of any
drug or drug-device combination products that Discovery Labs may develop,
including that: (a) Discovery Labs and the U.S. Food and Drug Administration
(FDA) or other regulatory authorities will not be able to agree on the matters
raised during regulatory reviews, or Discovery Labs may be required to conduct
significant additional activities to potentially gain approval of its product
candidates, if ever, (b) the FDA or other regulatory authorities may not
accept or may withhold or delay consideration of any of Discovery Labs’
applications, or may not approve or may limit approval of Discovery Labs’
products to particular indications or impose unanticipated label
limitations, and (c) changes in the national or
international political and regulatory environment may make it more difficult to
gain FDA or other regulatory approval; risks relating to Discovery Labs’
research and development activities, including (i) time-consuming and expensive
pre-clinical studies, clinical trials and other efforts, which may be subject to
potentially significant delays or regulatory holds, or fail, and (ii) the need
for sophisticated and extensive analytical methodologies, including an
acceptable biological activity test, if required, as well as other quality
control release and stability tests to satisfy the requirements of the
regulatory authorities; risks relating to Discovery Labs’ ability to develop and
manufacture drug products and capillary aerosolization systems for clinical
studies, and, if approved, for commercialization of drug and combination
drug-device products, including risks of technology transfers to contract
manufacturers and problems or delays encountered by Discovery Labs, its contract
manufacturers or suppliers in manufacturing drug products, drug substances and
capillary aerosolization systems on a timely basis or in an amount sufficient to
support Discovery Labs’ development efforts and, if approved, commercialization;
risks that (A) market conditions, the competitive landscape or otherwise, may
make it difficult to launch and profitably sell products, (B) Discovery Labs may
be unable to identify potential strategic partners or collaborators to market
its products, if approved, in a timely manner, if at all, and (C) Discovery
Labs’ products will not gain market acceptance by physicians, patients,
healthcare payers and others in the medical community; the risk that Discovery
Labs or its strategic partners or collaborators will not be able to attract or
maintain qualified personnel; the risk that Discovery Labs will not be able in a
changing financial market to raise additional capital or enter into strategic
alliances or collaboration agreements, or that the ongoing credit crisis will
adversely affect the ability of Discovery Labs to fund its activities, or that
additional financings could result in substantial equity dilution; the risk that
Discovery Labs will not be able to access credit from its committed equity
financing facilities, or that the share price at which Discovery Labs may access
the facilities from time to time will not enable Discovery Labs to access the
full dollar amount potentially available under the facilities; the risk that
Discovery Labs will be unable to maintain The Nasdaq Global Market listing
requirements, causing the price of Discovery Labs’ common stock to decline; the
risk that recurring losses, negative cash flows and the inability to raise
additional capital could threaten Discovery Labs’ ability to continue as a going
concern; the risks that Discovery Labs may be unable to maintain and
protect the patents and licenses related to its products, or other companies may
develop competing therapies and/or technologies, or health care reform may
adversely affect Discovery Labs; risks of legal proceedings, including
securities actions and product liability claims; risks relating to reimbursement
and health care reform; and other risks and uncertainties 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.
Contact
Information:
Lisa
Caperelli, Investor Relations
215-488-9413