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
15, 2010
Date of
Report (Date of earliest event reported)
Discovery
Laboratories, Inc.
(Exact
name of registrant as specified in its charter)
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Delaware
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000-26422
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94-3171943
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(State
or other jurisdiction
of
incorporation)
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(Commission
File Number)
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(IRS
Employer
Identification
Number)
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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:
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o
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Written
communications pursuant to Rule 425 under the Securities Act (17 CFR
230.425)
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o
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Soliciting
material pursuant to Rule 14a-12 under the Exchange Act (17 CFR
240.14a-12)
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o
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Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
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o
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Pre-commencement
communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR
240.13e-4(c))
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Item
1.02.
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Termination of a
Material Definitive
Agreement.
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On
September 15, 2010, Charles F. Katzer submitted his resignation as Senior Vice
President and Chief Technology Officer of Discovery Laboratories, Inc. (the
“Company”) effective September 24, 2010. As a result, Mr. Katzer’s
employment agreement with the Company will terminate on that
date. The agreement was filed with the SEC on March 10, 2010 as
Exhibits 10.24 – 10.26 to the Company’s Annual Report on Form 10-K for the
fiscal year ended December 31, 2009.
On
September 21, 2010, the Company issued a press release announcing the
resignation of Mr. Katzer and the hiring of Thomas C. Hoy, who will serve as
Vice President, Manufacturing Operations. Mr. Hoy has significant
experience in product manufacturing, including over 20 years at Johnson &
Johnson. He will join the Company effective September 30,
2010. The press release is attached as Exhibit 99.1.
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Item
9.01.
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Financial Statements
and Exhibits.
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(d)
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Exhibits
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99.1
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Press
Release dated September 21, 2010.
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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.
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Discovery
Laboratories, Inc.
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By:
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/s/ W. Thomas Amick | |
| Name: W. Thomas Amick | |||
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Title: Chairman
of the Board and Interim
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Chief
Executive Officer
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Date: September
21, 2010
3
Discovery
Labs Appoints Thomas C. Hoy as Vice President of Manufacturing
Operations
Warrington, PA, September 21,
2010 — Discovery Laboratories, Inc. (Nasdaq: DSCO), has today announced the
appointment of Thomas C. Hoy as Vice President, Manufacturing
Operations. Mr. Hoy will be directly responsible for leadership and
management of all Discovery Labs’ KL4 surfactant
product manufacturing, global supply chain, and pharmaceutical development of
Discovery Labs’ surfactant replacement therapy products, Surfaxin®,
Surfaxin LSTM and
Aerosurf®. In
a related matter, on September 15, 2010, Charles F. Katzer, Senior Vice
President, Chief Technical Officer, resigned to pursue another
opportunity.
Mr. Hoy
brings significant experience in product manufacturing, including over 20 years
at Johnson & Johnson (J&J). He has particular experience in
sterile pharmaceutical manufacturing of complex biologic molecules, both
in-house and at Contract Manufacturing Organizations (CMOs), and has
successfully lead teams through facility regulatory inspections by both the U.S.
Food and Drug Administration (FDA) and the European Medicines Agency
(EMA). At J&J, Mr. Hoy served as General Manager, Global
Biologics Supply Chain, where he was responsible for a 400-person bulk biologic
production facility for the manufacturing of a finished product that produced
over $1 billion in sales, and as General Manager, Contract Operations for Global
Biologics Supply. Prior to his appointment as General Manager, Mr.
Hoy held positions of increasing responsibility within the manufacturing
organizations of J&J. Earlier in his career, Mr. Hoy was involved in
pharmaceutical development and aseptic manufacturing. Mr. Hoy is a
registered pharmacist and received his pharmacy degree from the Philadelphia
College of Pharmacy and Science and a MBA degree from Drexel
University.
Thomas
Hoy commented, “I am excited to be joining the team at Discovery Labs at this
time. The KL4 surfactant
technology platform has the potential to meaningfully impact the standard of
respiratory critical care. I am impressed with the manufacturing team
and their accomplishments and look forward to working with management towards
the goal of an FDA approval of Surfaxin for the prevention of respiratory
distress syndrome (RDS) in premature infants in 2011.”
Mr. W.
Thomas Amick, Chairman of the Board and Interim Chief Executive Officer of
Discovery Labs commented, “We are at an important inflection point at Discovery
Labs, as we prepare for a potential filing in the first quarter 2011 of our
Surfaxin Complete Response, the potential US approval for Surfaxin and
initiation of Surfaxin product supply later in the year. I have
extensive, direct experience working with Tom in senior manufacturing roles at
J&J, and I am confident that he will successfully lead Discovery Labs’
manufacturing team through these pending milestones. I also would
like to thank Chuck Katzer for his contributions throughout his tenure at
Discovery Labs, including the development of an in-house KL4 surfactant
manufacturing capability, oversight of prior successful FDA facility
inspections, establishment of our surfactant aerosolization technology
development competency and recent initiation of a technology transfer to our CMO
for Surfaxin LS production.”
About
Discovery Labs
Discovery Laboratories, Inc. is a
biotechnology company developing KL4 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 with respect to the potential approval in
the United States of Surfaxin for the prevention of RDS in premature infants and
the potential of Discovery Labs’ KL4 surfactant
technology platform to meaningfully impact the standard of respiratory critical
care, 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 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:
Media
relations:
Michelle
Linn, Linnden Communications
508-362-3087
Investor
relations:
John G.
Cooper, President and Chief Financial Officer
215-488-9490