SIGA Announces Canadian Department of National Defence Intent to Purchase Up To 15,325 Courses of Oral TPOXX®
December 05 2019 - 11:10AM
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 the CDND intends to purchase up to 15,325 courses of oral
TPOXX (tecovirimat) over four years as specified in the ACAN, with
an initial purchase of 2,500 courses. The ACAN is required to
remain open for at least 15 days, during which time a potential
alternative supplier may submit a competing Statement of
Capabilities. The contract would represent the first international
order for TPOXX. As SIGA previously announced, the CDND intends to
award a contract to support regulatory approval for TPOXX by Heath
Canada. The Company is currently targeting a Canadian regulatory
filing in the second half of 2020, with regulatory approval
anticipated in 2021.
“This type of initial procurement by the
Canadian military, in advance of Canadian regulatory approval,
would be a natural first step in our efforts to build an
international business for oral TPOXX. We are pleased that the
value of TPOXX as an important component of smallpox preparedness
is being recognized outside the United States,” said Dr. Phil
Gomez, CEO of SIGA Technologies. “Historically, the military is
often the first governmental department to acquire a medical
countermeasure for national preparedness, with health departments
often following at a later date with significantly larger contract
awards. Specifically with respect to Canada, we are working
collaboratively with our partner, Meridian Medical Technologies,
Inc., and both the Department of Defence and Health Ministries to
support procurement needs for TPOXX to protect Canada’s military
and civilian population.”
The value of courses to be sold to Canada will
be disclosed upon any final award by the Canadian government. In
any contract issued by Canada, Meridian will be the counterparty to
the contract and SIGA will be responsible for the manufacture and
delivery of product.
The ACAN notice can be found at:
https://buyandsell.gc.ca/procurement-data/tender-notice/PW-PH-893-78161
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 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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