SIGA Announces Canadian Release of the Advanced Contract Award Notice to Support Regulatory Filing for Oral TPOXX®
November 18 2019 - 7:30AM
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 issued an advanced contract award notice (ACAN), indicating
that it intends to award a contract to fund regulatory filing with
Health Canada for approval of oral TPOXX®. The ACAN is
required to remain open for approximately 15 days, during which
time a potential alternative supplier who meets the ACAN
requirements for a smallpox anti-viral therapy that has been
approved by national regulatory authority may submit a competing
Statement of Capabilities. SIGA is the only company currently able
to fulfill this requirement.
“The ACAN represents an important first step by
the Canadian military, to ultimately provide TPOXX as a medical
countermeasure for smallpox. In the past, Canada has pursued
initial procurement of medical countermeasures prior to full
regulatory approval and pursuant to emergency use authorization as
a strategy for protecting its citizens from potential bio-threats,
with additional, larger procurements typically following such
approval,” said Dr. Phil Gomez, CEO of SIGA Technologies. “As a
result, this ACAN is an important first step in Canada’s efforts to
enhance its smallpox preparedness with an anti-viral product. We
are pleased that the CDND has identified TPOXX as the only smallpox
treatment qualified to fulfill its requirements. We look forward to
working with the appropriate Canadian authorities on the next steps
in preparation of a regulatory filing for oral TPOXX, which is
initially targeted for 2020, and ultimate delivery of this
important smallpox antiviral therapy to help protect the people of
Canada.”
The ACAN notice can be found at:
https://buyandsell.gc.ca/procurement-data/tender-notice/PW-19-00896089.
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 Medical
Technologies, Inc. (“Meridian”, a Pfizer Company). 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 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 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,
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
212-867-1768david.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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