SIGA Technologies, Inc., a commercial-stage pharmaceutical company
focused on global health and infectious diseases, announced today
an agreement to expand access to TPOXX (tecovirimat) to the member
states in the Association of Southeast Asian Nations (ASEAN), a
political and economic union in the region. This agreement, which
was signed by the Ministry of Health of the Government of Brunei
Darussalam on behalf of ASEAN Health Sector, is significant as it
reflects the use of ASEAN funds to support preparedness activities
for potential public health events. The contract was coordinated by
SIGA and its international promotion partner, Meridian Medical
Technologies, LLC, a subsidiary of Kindeva Drug Delivery.
A spokesperson from the Ministry of Health, Brunei Darussalam
said, “We are pleased to support the ASEAN-wide effort to prepare
for and respond to public health events. Ensuring adequate supply
and access to countermeasures is a vital part of preparedness and
this initiative by the region strengthens our collective health
security against the Mpox threat.”
“At SIGA, we are committed to expanding our global reach and
ensuring patients around the world have access to TPOXX, our
best-in-class medicine to treat some of the world’s most
devastating diseases, including smallpox,” said Victor Gomes, Vice
President, International Markets of SIGA. “This agreement
establishes a footprint in a highly populated region and sets the
groundwork for additional activity in the future. Asia is a
strategic region for SIGA and a contract providing for the initial
procurement of TPOXX for the ASEAN region represents an important
step in growing orthopoxvirus preparedness in the region. We look
forward to working closely with our new partners at ASEAN.”
ASEAN, established in August 1967, is comprised of Brunei
Darussalam, Cambodia, Indonesia, Lao PDR, Malaysia, Myanmar,
Philippines, Singapore, Thailand, and Viet Nam. Together, its
member states represent a population of over 600 million with a GDP
of $3.6 trillion. This union was formed primarily to accelerate
economic growth, social progress, and cultural development in the
region, as well as to promote regional peace and stability among
the countries in the region.
The financial terms of the agreement were not
disclosed.
ABOUT SIGA TECHNOLOGIES,
INC.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.
ABOUT TPOXX®TPOXX is a novel
small-molecule drug and the U.S. maintains a supply of
TPOXX under Project BioShield. The oral formulation of TPOXX was
approved by the FDA for the treatment of smallpox in 2018, and the
IV formulation was approved for the same indication in 2022. The
full label is available by clicking here.
Oral tecovirimat received approval from the European Medicines
Agency (EMA) and the Medicines and Healthcare Products
Regulatory Agency (MHRA) in the United Kingdom in
2022. The EMA and UK approvals include labeling for oral
tecovirimat indicating its use for the treatment of smallpox, Mpox,
cowpox, and vaccinia complications following vaccination against
smallpox. The full label is available by clicking
here. In September 2018, SIGA signed a contract with
the Biomedical Advanced Research and Development
Authority (BARDA), part of the office of the Administration
for Strategic 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. For more information about SIGA, please
visit www.siga.com.
ABOUT ORTHOPOXVIRUSES
Orthopoxvirus, belonging to the family of poxvirus that infect
humans, include smallpox, mpox, cowpox and vaccinia. Smallpox, a
highly contagious and fatal disease, presents itself as a risk to
global health security today given fears of its release
accidentally or intentionally as a bioweapon. Mpox
virus, similar to smallpox, causes intermittent human infections,
painful lesions, and possible case fatalities. Mpox outbreaks have
been observed recently in the US, Europe, and Central
& West Africa. Whether through natural occurrence or
potential bioweapon warfare, orthopox threatens global health.
Anti-virals and vaccines serve as possible solutions to address
these threats.
FORWARD-LOOKING STATEMENTS
This press release contains “forward-looking statements” within
the meaning of the Private Securities Litigation Reform Act of
1995, as amended, including statements relating to SIGA’s future
business development and plans, including future procurement of
TPOXX in the ASEAN region. The words or phrases “can be,”
“expects,” “may affect,” “may depend,” “believes,” “estimate,”
“will”, “project” and similar words and phrases are intended to
identify such forward-looking statements. 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. SIGA’s actual results could differ
materially from those anticipated by such forward-looking
statements due to a number of factors, some of which are beyond
SIGA’s control, including, but not limited to, (i) the risk that
BARDA elects, in its sole discretion as permitted under the 19C
BARDA Contract (the “BARDA Contract”), not to exercise all, or any,
of the remaining unexercised options under those contracts, (ii)
the risk that SIGA may not complete performance under the BARDA
Contract on schedule or in accordance with contractual terms,
(iii) the risk that the BARDA Contract or U.S. Department of
Defense contracts are modified or canceled at the request or
requirement of, or SIGA is not able to enter into a new contracts
to supply TPOXX to, the U.S. Government, (iv) the risk that
the nascent international biodefense market does not develop to a
degree that allows SIGA to continue to successfully market TPOXX
internationally, (v) the risk that potential products, including
potential alternative uses or formulations of TPOXX that appear
promising to SIGA or its collaborators, cannot be shown to be
efficacious or safe in subsequent pre-clinical or clinical trials,
(vi) the risk that target timing for deliveries of product to
customers, and the recognition of related revenues, are delayed or
adversely impacted by the actions, or inaction, of contract
manufacturing organizations, or other vendors, within the supply
chain, or due to coordination activities between the customer and
supply chain vendors, (vii) the risk that SIGA or its collaborators
will not obtain appropriate or necessary governmental approvals to
market these or other potential products or uses, (viii) the risk
that SIGA may not be able to secure or enforce sufficient legal
rights in its products, including intellectual property protection,
(ix) the risk that any challenge to SIGA’s patent and other
property rights, if adversely determined, could affect SIGA’s
business and, even if determined favorably, could be costly, (x)
the risk that regulatory requirements applicable to SIGA’s products
may result in the need for further or additional testing or
documentation that will delay or prevent SIGA from seeking or
obtaining needed approvals to market these products, (xi) the risk
that the volatile and competitive nature of the biotechnology
industry may hamper SIGA’s efforts to develop or market its
products, (xii) the risk that changes in domestic or foreign
economic and market conditions may affect SIGA’s ability to advance
its research or may affect its products adversely, (xiii) the
effect of federal, state, and foreign regulation, including drug
regulation and international trade regulation, on SIGA’s
businesses, (xiv) the risk of disruptions to SIGA’s
supply chain for the manufacture of TPOXX®, causing delays in
SIGA’s research and development activities, causing delays or the
re-allocation of funding in connection with SIGA’s government
contracts, or diverting the attention of government staff
overseeing SIGA’s government contracts, (xv) risks associated with
actions or uncertainties surrounding the debt ceiling, (xvi)
the risk that the U.S. or foreign governments'
responses (including inaction) to national or global economic
conditions or infectious diseases, are ineffective and may
adversely affect SIGA’s business, and (xvii) risks associated with
responding to an mpox outbreak, as well as the risks and
uncertainties included in Item 1A “Risk Factors” of our Annual
Report on Form 10-K for the year ended December 31,
2023 and SIGA's subsequent filings with the Securities
and Exchange Commission. SIGA urges investors and security holders
to read those documents free of charge at
the SEC's website
at http://www.sec.gov. All such
forward-looking statements are current only as of the date on which
such statements were made. SIGA does not undertake any obligation
to update publicly any forward-looking statement to reflect events
or circumstances after the date on which any such statement is made
or to reflect the occurrence of unanticipated events.
Contacts |
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Investors |
Media |
Jennifer Drew-Bear, Edison
Groupjdrew-bear@edisongroup.com |
Holly Stevens, Berry &
Companyhstevens@berrypr.com |
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