kl09003.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
Date of
Report (Date of earliest event reported): September 3,
2008
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
September 3, 2008, SIGA Technologies, Inc., a Delaware corporation (“SIGA”),
issued a press release announcing that it has been awarded a contract of $55
million from the National Institute of Allergy and Infectious Diseases, a
component of the National Institutes of Health, and The Office of the Biomedical
Advance Research and Development Authority, within the Department of Health and
Human Services, to support development of additional formulations and
smallpox-related indications for ST-246, SIGA’s lead drug
candidate. ST-246 is a potent, non-toxic inhibitor of orthopoxviruses
that is in advanced development efforts to obtain regulatory
approval.
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 September 3, 2008.
|
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: September
4, 2008
kl09003_ex99-1.htm
Exhibit 99.1
SIGA
Technologies Awarded $55 Million by Federal Government to
Develop
Broader Applications for its Lead Drug Candidate ST-246
New York, New York,
September 3, 2008 - SIGA Technologies, Inc. (NASDAQ: SIGA), a company
specializing in the development of pharmaceutical agents to fight bio-warfare
pathogens, today announced that it has been awarded a contract of $55 million
from the National Institute of Allergy and Infectious Diseases (NIAID), a
component of the National Institutes of Health (NIH), and The Office of the
Biomedical Advance Research and Development Authority (BARDA), within the
Department of Health and Human Services, to support development of additional
formulations and smallpox-related indications for ST-246, SIGA’s lead drug
candidate. ST-246 is a potent, non-toxic inhibitor of orthopoxviruses
that is in advanced development efforts to obtain regulatory
approval.
In
contrast to SIGA’s previously awarded and ongoing $16.5 million ST-246
development contract, this new funding enables the formulation and advanced
development of a new ST-246 parenteral drug product as well as new ways to use
the existing oral formulation of ST-246 to combat smallpox. Success
would significantly enhance the utility of ST-246 and substantially expand the
biodefense indications for SIGA’s original oral formulation.
Commenting
on the contract, Dr. Dennis E. Hruby, SIGA’s Chief Scientific Officer and
Principal Investigator on the award, stated, “These funds will support all the
studies needed to gain regulatory approval for these new
indications. Formulation development, animal efficacy, human safety
evaluations, and manufacturing are among the activities needed. We
have already developed extensive evidence with respect to the safety and
efficacy of ST-246 as a treatment for exposed individuals, and we are excited to
see this project advance to include other indications and
formulations."
Commenting
on the contract, SIGA’s Chief Executive Officer Eric Rose stated, “This new
contract will broaden the use and utility of ST-246 as an orthopoxvirus (e.g., smallpox)
countermeasure. It paves the way for ST-246 to provide protection to a much
larger portion of the population in the event of a smallpox
attack.”
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 to fight potential bio-warfare
pathogens. SIGA has antiviral programs targeting smallpox and 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 http://www.siga.com/.
SIGA 420 Lexington Ave.
Suite 408, New York, NY 10170
0; Tel 212.672.9100 Fax
212.697.3130 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 continued development and possible
eventual approval 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 SIGA’s control. 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 sufficient
legal rights in its products, including sufficient 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, 2007, 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.
Contact:
KCSA
Strategic Communications
Todd
Fromer / Marybeth Csaby / David Burke
212-896-1215
/ 1236 / 1258
Tfromer@kcsa.com
/ mcsaby@kcsa.com / dburke@kcsa.com
SIGA 420 Lexington Ave.
Suite 408, New York, NY 10170
Tel
212.672.9100 Fax 212.697.3130 siga.com