SIGA Announces U.S. Government Procurement Order of $113 Million for Oral TPOXX®
19 Luglio 2024 - 2:00PM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a
commercial-stage pharmaceutical company, today announced that the
U.S. Department of Health and Human Services exercised a
procurement option for the delivery of approximately $113
million of oral TPOXX® treatment courses.
“Building on the orders received in 2023 from the
U.S. government and 15 international customers, this $113 million
order from the U.S. government will enhance orthopoxvirus
preparedness and support sizable and consistent action when needed
to help ensure public health from natural, accidental, or
intentional threats,” said Diem Nguyen, Chief Executive
Officer. “We are pleased to fulfill our responsibility to global
health security while generating attractive returns for our company
and shareholders.”
This project has been supported in whole or in part
with federal funds from the U.S. Department of Health and Human
Services; Administration for Strategic Preparedness and Response;
Biomedical Advanced Research and Development Authority (BARDA) and
Strategic National Stockpile, under contract number
75A50118C00019.
ABOUT SIGASIGA is a
commercial-stage pharmaceutical company and leader in global health
focused on the development of innovative medicines to treat and
prevent infectious diseases. With a primary focus on
orthopoxviruses, we are dedicated to protecting humanity against
the world’s most severe infectious diseases, including those that
occur naturally, accidentally, or intentionally. Through
partnerships with governments and public health agencies, we work
to build a healthier and safer world by providing essential
countermeasures against these global health threats. Our flagship
product, TPOXX® (tecovirimat), is an antiviral medicine approved in
the U.S. and Canada for the treatment of smallpox and authorized in
Europe and the UK for the treatment of smallpox, mpox (monkeypox),
cowpox, and vaccinia complications. For more information about
SIGA, visit www.siga.com.
FORWARD-LOOKING STATEMENTSThis
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 the timing of delivery of ordered
oral TPOXX courses. 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 75A50118C00019 BARDA Contract
(the “BARDA Contract”), not to exercise the remaining unexercised
option under the BARDA Contract, (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.
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.
Contact: |
Investors and Media |
Suzanne Harnett |
sharnett@siga.com |
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