SIGA Announces U.S. Government Procurement Orders of Approximately $138 Million for Oral and IV TPOXX®
27 Luglio 2023 - 10:45PM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a
commercial-stage pharmaceutical company, today announced that the
U.S. Department of Health and Human Services exercised procurement
options for the delivery of approximately $113 million worth
of oral TPOXX® treatment courses and approximately $25 million
worth of IV TPOXX® treatment courses.
“Building on the orders SIGA received for TPOXX
from 13 international customers and the U.S. Department of Defense
in 2022, these most recent procurement orders further highlight
that many global leaders in public heath recognize the importance
of orthopoxvirus preparedness and the need to take action to keep
people safe,” said Phil Gomez, CEO of SIGA. “We are pleased
that we are able to consistently meet demand for oral TPOXX, which
is driving substantial and increasingly diversified global revenue
opportunities at SIGA.”
SIGA expects to fully deliver approximately $113
million of oral TPOXX under this order in 2023 and expects to start
delivering IV TPOXX under this order in 2024. Prior to delivery of
IV TPOXX under this order, SIGA will be focused on fulfilling
delivery obligations under a prior IV TPOXX order.
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 No.
75A50118C00019.
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
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, monkeypox, 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 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 Smallpox
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 is currently not
recommended for routine vaccination.
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
the progress of SIGA’s development programs and timelines for
bringing products to market, delivering products to ASPR, the
enforceability of our procurement contracts, such as the
19C BARDA Contract (the "BARDA Contract"), with BARDA, the
impact of the COVID pandemic and responding to the global outbreak
of monkeypox. The words or phrases “can be,” “expects,” “may
affect,” “may depend,” “believes,” “estimate,” “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 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, DoD
Contract #2 or PEP Label Expansion R&D Contract
are modified or canceled at the request or requirement of 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 SIGA
or its collaborators will not obtain appropriate or necessary
governmental approvals to market these or other potential products
or uses, (vii) the risk that SIGA may not be able to secure or
enforce sufficient legal rights in its products, including
intellectual property protection, (viii) 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, (ix) 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, (x) the risk that the volatile and
competitive nature of the biotechnology industry may hamper SIGA’s
efforts to develop or market its products, (xi) 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, (xii) the effect of federal, state, and foreign
regulation, including drug regulation and international trade
regulation, on SIGA’s businesses, (xiii) 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, (xiv) risks associated with actions or
uncertainties surrounding the debt ceiling, (xv) the risk that the
U.S. or foreign governments' responses (including inaction)
to national or global economic conditions or infectious
diseases, such as COVID-19, are ineffective and may adversely
affect SIGA’s business, and (xvi) risks associated with responding
to the current 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,
2022 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.
Contacts:
Investor ContactLaine Yonker, Edison
Grouplyonker@edisongroup.com
Public RelationsHolly Stevens, Berry &
Companyhstevens@berrypr.com
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