Form 8K Current Report
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): December 20, 2006
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
December 20, 2006, SIGA Technologies, Inc., a Delaware corporation (“SIGA” or
the “Company”), issued a press release pursuant to which it announced that the
Office of Orphan Products Development (OOPD) of the United States Food and
Drug
Administration (FDA) has granted Orphan Drug designation to SIGA-246, SIGA’s
smallpox drug, for the prevention and treatment of smallpox.
A
copy of
the press release is attached hereto as Exhibit 99.1, which is incorporated
by
reference in this Item 9.01.
Item
9.01. Financial Statements
and Exhibits.
(c)
Exhibits
Exhibit
No.
|
Description
|
99.1
|
Press
Release dated December 20, 2006.
|
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: Acting
Chief Executive Officer & Chief
Financial Officer
Date: December
20, 2006
Exhibit 99.1 Press Release
Exhibit
99.1
Contact:
Tom
Konatich
SIGA
Technologies, Inc.
Chief
Financial Officer & Acting CEO
(212)
672-9100
FDA
APPROVES ORPHAN DRUG DESIGNATION FOR
SIGA’S
SMALLPOX DRUG, SIGA-246
THE
DESIGNATION IS FOR BOTH TREATMENT AND PREVENTION OF
SMALLPOX
New
York,
December 20, 2006 -- SIGA
Technologies, Inc.
(NASDAQ:
SIGA) announced today that the Office of Orphan Products Development (OOPD)
of
the United States Food and Drug Administration (FDA) has granted Orphan Drug
designation to SIGA-246, SIGA’s smallpox drug, for the prevention and treatment
of smallpox. In December 2005, the FDA awarded SIGA-246 fast track status to
expedite the drug’s review.
Orphan
Drug designation will entitle SIGA to seven years of marketing exclusivity
in
the United States if SIGA-246 becomes the first drug of its kind to obtain
marketing approval from the FDA. Historically, the approval time for orphan
products as a group has been considerably shorter than the approval time for
other drugs.
“This
is
an important step in bringing SIGA-246 to market. The drug has made significant
progress since the approval of its Investigational New Drug application just
a
year ago. In July 2006, we successfully completed the first planned human
clinical safety trial, and, in October, the drug demonstrated 100% protection
against human smallpox virus in a primate trial. We believe that SIGA-246 holds
great promise and will be the first drug available to prevent and treat the
disease without significant side effects,” said Dr. Dennis E. Hruby, Chief
Scientific Officer of SIGA.
Smallpox
has been designated by the Department of Homeland Security as a “material
threat” to our national security, qualifying SIGA -246 for purchase for the
Strategic National Stockpile under Project Bioshield. Currently, there is no
effective and safe smallpox therapy available without the risk of significant
complications, and the U.S. government has expressed strong interest in the
development of novel smallpox therapies. Existing techniques to prevent or
ameliorate smallpox have unacceptably high rates of complications, including
encephalitis, myocarditis and death, and can take days or weeks to confer
protection.
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). SIGA's
product development programs also emphasize the increasingly serious problem
of
drug resistant bacteria.
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, 2005, 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.
###