SIGA Announces Award of First International Contract for Oral TPOXX® with Purchase by the Canadian Department of National De...
April 03 2020 - 10:15AM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced that the Canadian Department of National Defence (CDND)
has awarded a contract to Meridian Medical Technologies, Inc.
(“Meridian”, a Pfizer Company) (Canadian Contract), in which it
will purchase up to 15,325 courses of oral TPOXX (tecovirimat) over
four years for a total value of $14.3 million, with an initial
purchase of 2,500 courses for $2.3 million.
“The current COVID-19 pandemic has reminded us
all that preparedness with medical countermeasures is critical for
responding effectively to any infectious disease outbreak,” said
Dr. Phil Gomez, CEO of SIGA Technologies. “Smallpox remains a key
threat, and TPOXX is an important component of any smallpox
response plan. This procurement by the Canadian military is
an important first step, and we look forward to continuing to work
with Meridian to support potential future procurements with both
the CDND and Health Canada to protect Canada’s military and
civilian population.”
SIGA expects delivery of up to an additional
12,825 courses under the Canadian Contract to occur after
regulatory approval in Canada. SIGA previously received a
contract from the CDND to fund this regulatory
submission. The Company is currently targeting a Canadian
regulatory filing in the second half of 2020, with regulatory
approval anticipated in 2021. This contract represents the
first international order for TPOXX. As part of a previously
announced promotion agreement, Meridian is the counterparty to the
Canadian Contract and SIGA is responsible for the manufacture and
delivery of product.
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 the 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 Department of Defense. The US currently
maintains a stockpile of 1.7 million courses of TPOXX.
In June 2019, SIGA entered into an international
promotion agreement with Meridian. Under the agreement,
Meridian will promote the sale of oral TPOXX for the treatment of
smallpox in all international markets, except the United States and
South Korea. SIGA will continue to own all rights to the
product and its related intellectual property.
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 maintains a
stockpile of 1.7 million oral courses in 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. In September 2018, SIGA signed a 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 MERIDIAN MEDICAL TECHNOLOGIES,
INC.
Meridian Medical Technologies, Inc., a Pfizer
company, has been putting emergency care treatment options into the
hands of military and civilian defenders for more than 50 years.
Meridian is committed to help defend against critical,
time-sensitive, life-or-death situations by providing medical
countermeasures to the United States Department of Defense,
Emergency Medical Services, Homeland Security, and more than 30
nations around the world.
Meridian holds a federal SAFETY Act designation
and certification from the Department of Homeland Security for its
portfolio of auto-injectors. The SAFETY Act is intended to provide
critical incentives for the development and deployment of
anti-terrorism technologies by providing liability protections for
sellers of qualified anti-terrorism technologies.
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,
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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