SIGA Produces FDA Registration Batches of ST-246(r) Drug Product
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NEW YORK, March 30, 2009 (GLOBE NEWSWIRE) -- SIGA Technologies, Inc.
(Nasdaq:SIGA), a company specializing in the development of pharmaceutical
agents to fight biowarfare pathogens, today announced that it has completed the
steps needed to demonstrate its ability to manufacture commercial quantities of
ST-246(r), its smallpox antiviral. The process involved producing three batches
of ST-246 using FDA-established manufacturing practices. SIGA's work was funded
in part by the National Institute of Allergy and Infectious Diseases, part of
the National Institutes of Health, and the Biomedical Advanced Research and
Development Authority of the U.S. Department of Health & Human Services.
The FDA-mandated practices, known as "cGMP" or "Current Good Manufacturing
Practices," involve specified steps for the design, manufacture, packaging,
labeling, storage, installation, and servicing of finished drug products
intended for commercial distribution in the United States. SIGA, working with
its contract manufacturing partner, Catalent Pharma Solutions, made
approximately 350,000 ST-246 capsules in each of the three batches. In
accordance with FDA rules, these pilot batches were each one-tenth the size of
the batches that SIGA intends to produce when it moves to regular commercial
manufacture. The capsules produced in the pilot batches met the designated
specifications.
Capsules from these batches may be used for a human safety study anticipated to
start this summer. Another portion of this material will enter stability
testing, and the remainder will be available for acquisition if SIGA's response
to the pending Project Bioshield request for proposal succeeds, or following
appropriate regulatory approval. Drug product packaging is expected to be
completed by the end of April.
Dr. Eric A. Rose, SIGA's Chief Executive Officer, commented, "SIGA has achieved
another major step required by the FDA before commercializing ST-246.
Furthermore, the process provides useful information for the chemistry,
manufacturing and control sections of SIGA's eventual NDA (New Drug Application)
filing for ST-246. We remain on track with our NDA submission timeline for
ST-246 and in our response to the Department of Health and Human Services'
request for proposal to stockpile a smallpox antiviral as part of Project
BioShield."
"Many people worked hard at SIGA and Catalent to achieve this goal, and we are
thankful to everyone involved for their contributions," concluded Dr. Rose.
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 biowarfare
pathogens. In addition to small pox, 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 website at http://www.siga.com.
The SIGA Technologies, Inc. logo is available at
http://www.globenewswire.com/newsroom/prs/?pkgid=4504
Forward Looking Statement
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 (i) 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, (ii) SIGA
or its collaborators will not obtain appropriate or necessary governmental
approvals to market these or other potential products, (iii) SIGA may not be
able to obtain anticipated funding for its development projects or other needed
funding, (iv) SIGA may not be able to secure funding from anticipated government
contracts and grants, (v) SIGA may not be able to secure or enforce sufficient
legal rights in its products, including sufficient patent protection for its
products, (vi) regulatory approval for SIGA's products may require further or
additional testing that will delay or prevent approval, (vii) the Biomedical
Advanced Research & Development Authority may not complete the procurement set
forth in its solicitation for the acquisition of a smallpox antiviral for the
strategic national stockpile, or may complete it on different terms; (viii)
SIGA's proposed drug candidate for responding to any governmental solicitation
for purchase may not meet the requirements of the solicitation; (ix) the
volatile and competitive nature of the biotechnology industry may hamper SIGA's
efforts, (x) changes in domestic and foreign economic and market conditions may
adversely affect SIGA's ability to advance its research or its products, and
(xi) changing federal, state and foreign regulation on SIGA's businesses may
adversely affect SIGA's ability to advance its research or 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, 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, 2008, 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.
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CONTACT: KCSA Strategic Communications
Todd Fromer / Marybeth Csaby
212-896-1215 / 1236
Tfromer@kcsa.com / mcsaby@kcsa.com
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