Full Press Release Details
RECEIVES $16.5 MILLION FROM THE NIH TO ADVANCE
OF ITS SMALLPOX DRUG CANDIDATE, SIGA-246
Funding Awards Received by SIGA Since August 2, 2006 Now Exceeds $27
October 4, 2006-- SIGA Technologies, Inc. (NASDAQ: SIGA) today announced the
receipt of a 3 year, $16.5 million contract from the National Institute of
Allergy and Infectious Diseases (NIAID) of the National Institutes for Health
(NIH), to advance the development of SIGA-246, the company's smallpox drug
candidate. The award will support the development of SIGA-246 through the
preparation and filing of a New Drug Application with the Food and Drug
Administration. The receipt of this award brings the total amount of funding
commitments the company has received from various sources since August 2nd
grateful for the continued commitment of the NIH to the development of
SIGA-246," said Dr. Dennis E. Hruby, Chief Scientific Officer of SIGA. "The
funding we have received from the NIH, as well as their advice and guidance
been critical to the success of our smallpox drug program to date. We look
forward to continue working with the NIH as SIGA-246 advances
2006, SIGA announced the successful completion of its first human clinical
safety trial. The preliminary results indicated that SIGA-246 is safe and well
tolerated in human volunteers at all tested orally administered
believes that SIGA-246 is the most advanced smallpox treatment currently in
development. It represents a new approach to achieve a novel, orally
active, antiviral therapeutic to smallpox. The Centers for Disease Control
Prevention classified smallpox as a Category A agent. It is considered one
the most significant threats for use as a bio-warfare agent due the fact that
people in the United States have not been vaccinated against it since 1972.
Smallpox is very easily transmitted from person to person, and has high
mortality rates (30-60%) with 90% morbidity. At present there is no approved
treatment for smallpox that can be safely administered to the general population
without significant risk of adverse reactions. "We are committed to continue the
development of SIGA-246 and hope to provide a solution to this urgent
bio-security need," commented Dr. Hruby.
SIGA Technologies, Inc.
Technologies is applying viral and bacterial genomics and sophisticated
computational modeling in the design and development of novel products for
prevention and treatment of serious infectious diseases, with an emphasis on
products for biological warfare defense. SIGA has the potential to become a
significant force in the discovery of vaccine and pharmaceutical agents to
emerging pathogens. SIGA's product development programs emphasize the
increasingly serious problem of drug resistant bacteria. In addition to
smallpox, SIGA has antiviral programs targeting other Category A viral
pathogens, including arenaviruses (Lassa
fever, Junin, Machupo, Guanarito, Sabia, and lymphocytic choriomeningitis),
dengue virus, and the filoviruses (Ebola and Marburg).
information about SIGA, please visit SIGA's Web site at www.siga.com.
Press Release contains 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
management's estimates, assumptions and projections, and are subject to
uncertainties, many of which are beyond the control of SIGA. Actual results
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, and (e) SIGA may
be able to secure or enforce adequate legal protection, including patent
protection for its products. 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 and the above-mentioned
presentation, 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
obligation to publicly update any forward-looking statement as a result of
information, future events or otherwise.