SIGA Awarded Department of Defense Contract to Develop Expanded Indication for TPOXX® as Post-Exposure Prophylactic for Smal...
July 08 2019 - 7:30AM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced that it has been awarded a multi-year contract from the
United States Department of Defense (DoD) to support work necessary
to gain a potential label expansion for TPOXX® (tecovirimat) that
would include Post-Exposure Prophylaxis (PEP) of smallpox.
The contract is valued at up to $19.5 million, with an initial
award of $12.4 million. The initial funding will support
several activities, including manufacturing material for clinical
trials, initial preparation for a human clinical safety study, and
assembling regulatory filings that SIGA has designed with input
from the U.S. Food and Drug Administration (FDA) to evaluate the
use of TPOXX for PEP. As previously announced, SIGA is already
working with the U.S. Army Medical Research Institute of Infectious
Disease on animal studies to evaluate the efficacy of TPOXX as a
potential PEP therapy for smallpox.
The use of TPOXX for PEP could provide
significant potential benefit in the event of a smallpox
outbreak. While vaccines would play an important role in
containing the spread of smallpox, the vaccines are only effective
if administered prior to infection or no later than four days after
infection. However, symptoms of smallpox do not typically appear
until approximately 14 days post-infection, and there is currently
no diagnostic test to determine infection prior to symptom onset.
Given the uncertainty of an individual’s infection status in that
two-week period, and the highly contagious nature of smallpox, the
administration of vaccine in combination with TPOXX could
potentially be an important strategy for reducing morbidity and
mortality in a smallpox outbreak.
“During our FDA Advisory Committee meeting in
May 2018, several committee members emphasized the importance of
evaluating the potential use of TPOXX not only to treat smallpox
symptomatic infection, but also to treat patients with known
smallpox exposure who have not yet developed symptoms,” said Phil
Gomez, CEO of SIGA Technologies. “An expansion of the TPOXX label
to include its use for PEP would provide greater flexibility to
deliver TPOXX to those who might benefit from treatment during a
potential outbreak. We have successfully collaborated with a number
of U.S. government agencies in the development and approval of
TPOXX for the treatment of smallpox, and are pleased to be working
with DoD on these important studies.”
On July 13, 2018, the FDA approved oral TPOXX
for the treatment of smallpox to mitigate the impact of a potential
outbreak or bioterror attack. TPOXX, a small-molecule antiviral
treatment for smallpox, is the first therapy specifically approved
for this indication, and was developed through funding and
collaboration with Biomedical Advanced Research and Development
Authority at the U.S. Department of Health and Human Services, as
well as early stage development supported by the National
Institutes of Health, U.S. Centers for Disease Control and
Prevention, and DoD.
ABOUT SIGA TECHNOLOGIES, INC. and
TPOXX®
SIGA Technologies, Inc. is a commercial-stage
pharmaceutical company focused on the health security market.
Health security comprises countermeasures for biological, chemical,
radiological and nuclear attacks (biodefense market), vaccines and
therapies for emerging infectious diseases, and health
preparedness. Our lead product is TPOXX®, also known as tecovirimat
and ST-246®, an orally administered and IV formulation antiviral
drug for the treatment of human smallpox disease caused by variola
virus. TPOXX is a novel small-molecule drug of which 2 million oral
courses have been delivered to the Strategic National Stockpile
under Project BioShield. The oral formulation of TPOXX was approved
by the FDA for the treatment of smallpox on July 13, 2018. The full
label is here:
https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/208627s000lbl.pdf.
In September 2018, SIGA signed a new contract with Biomedical
Advanced Research and Development Authority (BARDA) for additional
procurement and development related to both oral and intravenous
formulations of TPOXX. For more information about SIGA, please
visit www.siga.com.
About Smallpox1
Smallpox is a contagious, disfiguring and often
deadly disease that has affected humans for thousands of years.
Naturally occurring smallpox was eradicated worldwide by 1980, the
result of an unprecedented global immunization campaign. Samples of
smallpox virus have been kept for research purposes. This has led
to concerns that smallpox could someday be used as a biological
warfare agent. A vaccine can prevent smallpox, but the risk of the
current vaccine's side effects is too high to justify routine
vaccination for people at low risk of exposure to the smallpox
virus.
FORWARD-LOOKING STATEMENTS
This press release contains certain
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended. Such
forward-looking statements are subject to various known and unknown
risks and uncertainties, and SIGA cautions you that any
forward-looking information provided by or on behalf of SIGA is not
a guarantee of future performance. 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,
2018, and in other documents that SIGA has filed with the SEC. SIGA
urges investors and security holders to read those documents free
of charge at the SEC's web site at http://www.sec.gov. Interested
parties may also obtain those documents free of charge from SIGA.
Forward-looking statements are current only as of the date on which
such statements were made, and except for our ongoing obligations
under the United States of America federal securities laws, we
undertake no obligation to update publicly any forward-looking
statements whether as a result of new information, future events,
or otherwise.
The information contained in this press release
does not necessarily reflect the position or the policy of the
Government and no official endorsement should be inferred.
Contacts:
InvestorsDavid Carey 212-867-1768dcarey@lazarpartners.com
MediaStephanie Seiler206-713-0124sseiler@lazarpartners.com
1
http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
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