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
June
8, 2010
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))
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Item
8.01. Other
Events.
On June
8, 2010, Discovery Laboratories, Inc. (the “Company”) announced the receipt of
FDA guidance regarding its preclinical program to gain Surfaxin®
approval. The full text of the press release is set forth in Exhibit
99.1 to this Current Report on Form 8-K and is incorporated herein by
reference.
Item
9.01. Financial Statements and
Exhibits.
(d) Exhibits
|
|
99.1
|
Press
Release dated June 8, 2010.
|
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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: June
8, 2010
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Discovery Labs Receives FDA Guidance
Regarding Preclinical Program to
Gain SURFAXIN® Approval
On-Track
for Q1 2011 SURFAXIN Complete Response Filing
Warrington, PA – June 8, 2010 —
Discovery Laboratories, Inc. (Nasdaq:DSCO) announces today that it has
received written guidance from the U.S. Food and Drug Administration (FDA) that
is consistent with its ongoing, comprehensive preclinical program to resolve the
sole remaining chemistry, manufacturing & control (CMC) issue necessary to
potentially gain FDA marketing approval for Surfaxin®
(lucinactant) for the prevention of Respiratory Distress Syndrome (RDS) in
premature infants. The safety and efficacy of Surfaxin for neonatal
RDS has been previously demonstrated in a Phase 3 clinical
program. If approved, Surfaxin would be the first synthetic,
peptide-containing surfactant for commercial use in neonatal
medicine. Discovery Labs believes it remains on track to complete the
preclinical program and submit its Complete Response to the FDA in the first
quarter of 2011.
Discovery
Labs is now conducting a series of prospectively-designed, side-by-side
preclinical studies employing both the newly-optimized and revalidated fetal
rabbit Biological Activity Test (BAT, an important quality control release and
stability test) and the well-established preterm lamb model of
RDS. Discovery Labs plans to complete the preclinical program and
submit a Complete Response taking into account the recently-received FDA
comments. Multiple Surfaxin batches will be employed in the
side-by-side preclinical studies to assess the short-term physiologic response
following Surfaxin administration (via measurement of respiratory compliance) in
both the preterm lamb model and the optimized BAT.
The
resulting data will be examined to evaluate the relative changes in biologic
activity of Surfaxin at several different time points over intended shelf life
to determine the degree of comparability between the optimized BAT and the
preterm lamb model. The FDA has indicated that, to satisfactorily
establish comparability between the optimized BAT and the preterm lamb model,
these data must demonstrate the same relative changes in respiratory compliance
between both models over time. These studies are intended to also
satisfy the FDA regarding the ability of the BAT to adequately discriminate
biologically active from inactive Surfaxin drug product and establish the
Surfaxin drug product’s final acceptance criteria (with respect to biologic
activity as assessed by the BAT) for release and ongoing stability.
Dr.
Russell Clayton, Vice President, Research and Development, Preclinical and
Regulatory Affairs commented, “Discovery’s plan for the potential approval of
Surfaxin continues to benefit from the FDA’s direction and their recent
suggestions have been incorporated into our plan. Another positive
aspect of the most recent communication is the FDA’s indicated willingness to
continue to interact on our approach to gain potential Surfaxin
approval.”
In May
2010, Discovery Labs completed a key component of the comprehensive preclinical
program, the optimization and revalidation of the BAT, having met all
pre-specified acceptance criteria. Prior to optimizing and
revalidating the BAT, Discovery Labs had several interactions with the FDA and
submitted a proposed revalidation protocol, which also included pre-specified
acceptance criteria. Within the next few weeks, Discovery Labs
anticipates submitting to the FDA data and analysis from the recently
completed optimization and revalidation of the BAT. This information,
together with results from the ongoing side-by-side preclinical studies, is
expected to be used by the FDA in its review of the planned Complete Response
and its ultimate determination on whether to grant marketing approval for
Surfaxin.
Discovery
Labs believes that it is advantageously positioned to successfully complete the
comprehensive preclinical program taking into consideration (i) the revalidation
of its optimized BAT (meeting all pre-specified acceptance criteria), (ii)
Discovery Labs’ experience and relationships with well-recognized academic
centers of excellence who routinely measure respiratory compliance in both the
BAT and preterm lamb model, and (iii) the FDA’s willingness to date to provide
continued guidance regarding the Company’s plans to resolve the remaining CMC
matter.
Surfaxin
is an investigational drug candidate that has not been approved by the FDA or
any other world health regulatory authority.
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 the June 2, 2009
end-of-review meeting, the September 29, 2009 teleconference held with the FDA,
and the recently-received written guidance from the FDA. Although
Discovery Labs currently believes that it is on track to submit the Complete
Response in the first quarter of 2011 and 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) the FDA may not approve Surfaxin or may subject the
marketing of Surfaxin to onerous requirements that significantly impair
marketing activities; and (ii) Discovery Labs 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. 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
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 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.
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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 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; the risk that Discovery
Labs may be unable to identify potential strategic partners or collaborators to
develop and commercialize its products, if approved, in a timely manner, if at
all; 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 (CEFFs), or that the minimum share price at which Discovery Labs may
access the CEFFs from time to time will prevent Discovery Labs from accessing
the full dollar amount potentially available under the CEFFs; the risk that
Discovery Labs or its strategic partners or collaborators will not be able to
retain, or attract, qualified personnel; the risk that Discovery Labs will be
unable to regain compliance with The Nasdaq Capital Market listing requirements
prior to the expiration of the additional grace period currently in effect,
which could cause 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 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:
John G.
Cooper, EVP and Chief Financial Officer
215-488-9300
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