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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
Date
of
Report (Date of earliest event reported): March 19, 2007
SIGA
TECHNOLOGIES, INC.
(Exact
name of registrant as specified in its charter)
|
Delaware
|
0-23047
|
13-3864870
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(Commission
file number)
|
(I.R.S.
employer
identification
no.)
|
|
420
Lexington Avenue, Suite 408
New
York, New York
(Address
of principal executive offices)
|
10170
(Zip
code)
|
Registrant’s
telephone number, including area code: (212) 672-9100
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 (see
General
Instruction A.2. below):
r
Written
communications
pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
r
Soliciting
material
pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
r
Pre-commencement
communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR
240.14d-2(b))
r
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
March
19, 2007, SIGA Technologies, Inc., a Delaware corporation (“SIGA”), issued a
press release pursuant to which it announced that a toddler who inadvertently
contracted eczema vaccinatum has been treated with ST-246, SIGA’s lead smallpox
drug candidate, pursuant to an Emergency Investigational New Drug Application
(IND) granted by the U.S. Food and Drug Administration (FDA), and is now
improving.
A
copy of
the press release is attached hereto as Exhibit 99.1, which is incorporated
into
this Item 8.01 by reference.
Item
9.01. Financial Statements and Exhibits.
(c)
Exhibits
|
Exhibit
No.
|
Description
|
|
99.1
|
Press
Release, dated March 19, 2007.
|
SIGNATURE
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.
SIGA
TECHNOLOGIES,
INC.
By:
/s/
Thomas N.
Konatich
Name:
Thomas
N.
Konatich
Title: Chief
Financial Officer
Date: March
19,
2007
Exhibit
99.1
SIGA’S
SMALLPOX DRUG CANDIDATE
ADMINISTERED
TO CRITICALLY ILL HUMAN PATIENT
New
York,
March
19, 2007--
SIGA
Technologies, Inc.
(NASDAQ:
SIGA) announced today that a toddler who inadvertently contracted eczema
vaccinatum has been treated with ST-246, SIGA’s lead smallpox drug candidate,
pursuant to an Emergency Investigational New Drug Application (IND) granted
by
the U.S. Food and Drug Administration (FDA), and is now improving.
Due
to
the absence of smallpox disease in the general human population, the efficacy
of
ST-246 has been investigated in animals to date. However, the federal Centers
for Disease Control and Prevention (CDC) was recently notified that a child
had
contracted eczema vaccinatum, a potentially deadly illness that can manifest
with a generalized skin rash similar to smallpox, following accidental contact
with an open skin lesion on a relative who had recently been vaccinated for
smallpox using a live vaccinia virus vaccine. The
patient developed late-stage manifestations of the disease, including
hemorrhagic lesions, respiratory failure, shock and high viral loads in the
blood. CDC facilitated
communication between SIGA and FDA resulting in provision of ST-246 for the
patient under an Emergency IND.
“There
is
a clear need for an effective therapeutic against smallpox and other orthopox
virus diseases,” said Dr. Eric A. Rose, Chief Executive Officer of SIGA and
Executive Vice President for Life Sciences at MacAndrews & Forbes Holdings
Inc., SIGA’s largest shareholder. “We will continue to work closely with CDC and
FDA to obtain the earliest possible approval for ST-246, so that it can be
purchased and widely available whenever needed.”
SIGA
believes that ST-246 is the most advanced-stage treatment for smallpox currently
in development. ST-246 represents
a new approach to achieve a novel, orally active, antiviral therapeutic. It
has
already demonstrated significant
antiviral activity in various animal trials, including the complete elimination
of human smallpox virus or the related monkeypox virus in several primate
studies. SIGA has not yet filed for final regulatory approval for ST-246,
although FDA has granted “fast-track” status for the development and FDA review
of this product.
Development
of ST-246 has been supported by grants from the National Institute of Allergy
and Infectious Diseases of the National Institutes of Health, the CDC and the
Department of Defense.
SIGA
Technologies, Inc. March 19, 2007 Press Release
0; Page
2
About
SIGA Technologies, Inc.
SIGA
Technologies is applying viral and bacterial genomics and sophisticated
computational modeling in the design and development of novel products for
the
prevention and treatment of serious infectious diseases, with an emphasis on
products for biological warfare defense. SIGA believes that it is a leader
in
the development of pharmaceutical agents and vaccines to fight potential
biowarfare pathogens. In
addition to smallpox, SIGA has antiviral programs targeting other Category
A
pathogens, including arenaviruses (Lassa
fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis),
dengue virus, and the filoviruses (Ebola and Marburg).
For
more
information about SIGA, please visit SIGA's Web site at www.siga.com.
Forward-looking
Statements
This
Press Release contains or implies certain "forward-looking statements'' within
the meaning of the Private Securities Litigation Reform Act of 1995, as amended,
including statements regarding the efficacy of potential products, the timelines
for bringing such products to market and the availability of funding sources
for
continued development of such products. Forward-looking statements are based
on
management's estimates, assumptions and projections, and are subject to
uncertainties, many of which are beyond the control of SIGA. Actual results
may
differ materially from those anticipated in any forward-looking statement.
Factors that may cause such differences include the risks that
(a) potential products that appear promising to SIGA or its collaborators
cannot be shown to be efficacious or safe in subsequent pre-clinical or clinical
trials, (b) SIGA or its collaborators will not obtain appropriate or
necessary governmental approvals to market these or other potential products,
(c) SIGA may not be able to obtain anticipated funding for its development
projects or other needed funding, (d) SIGA may not be able to secure
funding from anticipated government contracts and grants, (e) SIGA may not
be
able to secure or enforce adequate legal protection, including patent protection
for its products and (f) regulatory approval for SIGA’s products may
require further or additional testing that will delay or prevent approval.
More
detailed information about SIGA and risk factors that may affect the realization
of forward-looking statements, including the forward-looking statements in
this
Press Release, is set forth in SIGA's filings with the Securities and Exchange
Commission, including SIGA's Annual Report on Form 10-K for the fiscal year
ended December 31, 2006, and in other documents that SIGA has filed with the
Commission. SIGA urges investors and security holders to read those documents
free of charge at the Commission's Web site at http://www.sec.gov. Interested
parties may also obtain those documents free of charge from SIGA.
Forward-looking statements speak only as to the date they are made, and, except
for any obligation under the U.S. federal securities laws, SIGA undertakes
no
obligation to publicly update any forward-looking statement as a result of
new
information, future events or otherwise.