SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced that the United States Department of
Defense (DoD), via the Joint Program Executive Office for
Chemical, Biological, Radiological, and Nuclear Defense’s
(JPEO-CBRND) Joint Project Manager for Chemical, Biological,
Radiological, and Nuclear Medical (JPM CBRN Medical), has increased
research and development funding to approximately $23 million in
connection with the DoD contract to support work necessary to gain
a potential label expansion from the U.S. Food and Drug
Administration (FDA) for TPOXX® (tecovirimat) for
Post-Exposure Prophylaxis (PEP) in addition to the current approved
labeling for the treatment of smallpox.
The use of TPOXX for PEP could provide
significant potential benefit in the event of a smallpox pandemic
or outbreak. While vaccines would play an important role in
containing the spread of smallpox, they 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 a vaccine in combination with TPOXX could be an
important strategy for reducing morbidity and mortality in a
smallpox outbreak. Dosing of TPOXX in the PEP indication is
expected to be 28 days rather than the 14-day dosing currently
recommended for its use in treating patients with active smallpox
infections. This would increase the amount of TPOXX used for each
exposed person compared with each infected person.
“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 Dr. Phil Gomez, CEO of SIGA. “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. The recent
search for prophylactic agents that could be used for PEP in
patients with known exposure to the virus that causes COVID-19
underscores the importance of being able to prevent infection in
at-risk individuals. We are pleased to be working with DoD on
important studies for a PEP indication that could address similar
situations that would arise in the event of a smallpox
outbreak.”
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 and the US government
maintains a stockpile of 1.7 million courses in the Strategic
National Stockpile under Project BioShield. The oral formulation of
TPOXX was approved by the FDA for the treatment of smallpox in
2018. The full label is here:
https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fce826ab-4d6a-4139-a2ee-a304a913a253.
In September 2018, SIGA signed a contract potentially worth more
than $600 million with the Biomedical Advanced Research and
Development Authority (BARDA), part of the office of the Assistant
Secretary for Preparedness and Response within the U.S. Department
of Health and Human Services, for additional procurement and
development related to both oral and intravenous formulations of
TPOXX.
Recently, SIGA announced in May 2020 that BARDA
exercised an option under the 2018 Contract for delivery of
approximately 363,000 courses or oral TPOXX as SIGA continues to
replenish the U.S. government’s stockpile of its smallpox antiviral
treatment.
For more information about SIGA, please visit
www.siga.com.
About the JPEO-CBRND
The Joint Program Executive Office for Chemical,
Biological, Radiological and Nuclear Defense is the Joint Service’s
lead for development, acquisition, fielding and life-cycle support
of chemical, biological, radiological, and nuclear defense
equipment and medical countermeasures. As an effective acquisition
program, the JPEO-CBRND puts capable and supportable systems in the
hands of the service members and first responders, when and where
it is needed, at an affordable price. Our vision is a resilient
Joint Force, enabled to fight and win unencumbered by a chemical,
biological, radiological, or nuclear environment, championed by
innovative and state-of-the-art solutions.
About the JPM CBRN Medical
The Joint Project Manager for Chemical,
Biological, Radiological, and Nuclear Medical (JPM CBRN Medical), a
component of the U.S. Department of Defense’s Joint Program
Executive Office for Chemical, Biological, Radiological, and
Nuclear Defense (JPEO-CBRND), aims to provide U.S. military forces
and the nation with safe, effective, and innovative medical
solutions to counter chemical, biological, radiological, and
nuclear threats. The JPM CBRN Medical facilitates the advanced
development and acquisition of medical countermeasures and systems
to enhance the nation’s biodefense response capability.
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 year ended December 31, 2019, 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
212-867-1768david.carey@finnpartners.com
MediaStephanie
Seiler206-713-0124stephanie.seiler@finnpartners.com
1
http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
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