SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a
commercial-stage pharmaceutical company, today announced the
exercise of procurement options under its 75A50118C00019 (19C)
contract with the U.S. Department of Health and Human Services
for the delivery to the U.S. government of intravenous (IV)
formulation of TPOXX treatment courses valued at
approximately $26 million . These option exercises
represent the first procurement option exercises for IV TPOXX under
the 19C contract. Product deliveries of IV TPOXX in connection with
these contract options are targeted for 2023. IV TPOXX is an
important option for those who are unable to swallow.
“These option exercises for the procurement of IV
formulation of TPOXX as well as the funding of a post-marketing
field study for IV TPOXX highlight the growing importance of a
broad-based response to the substantial risks posed by the orthopox
family of viruses, including smallpox and monkeypox,”
said Phil Gomez, CEO of SIGA. “The exercised options are among
many procurement options under the 19C contract that remain to be
exercised and, as such, we will continue to coordinate with the
U.S. government toward future procurements of oral TPOXX and IV
TPOXX.”
The procurement options, which were exercised by
the Biomedical Advanced Research and Development
Authority (BARDA), part of the office of the Administration
for Strategic Preparedness and Response at the U.S. Department
of Health and Human Services, include the manufacture of bulk drug
substance and the use of such substance to manufacture and deliver
final drug product of IV TPOXX.
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 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, 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 office of the Assistant Secretary
for 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. This
project has been funded in whole or in part with federal funds from
the Administration for Strategic Preparedness and Response,
Biomedical Advanced Research and Development Authority, under
contract number HHSO100201800019C. 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.
About Monkeypox
Monkeypox is a disease caused by infection with the
monkeypox virus, which is in the same family of viruses as
smallpox. Monkeypox symptoms are similar to smallpox, but not as
severe and with historical mortality of less than 1% to 10%
depending on region and clade. The first human case of monkeypox
was recorded in 1970. Since then, monkeypox has been reported in
several central and western African countries, with case numbers
greatly increasing in recent years because the virus is endemic in
those countries. Prior to the ongoing 2022 outbreak, nearly all
monkeypox cases in people outside of Africa were linked to
international travel to countries where the disease commonly
occurs, or through imported animals, including two cases in the
United States in 2021. These cases are currently occurring on
multiple continents. On July 23, 2022, the World Health
Organization (WHO) declared the monkeypox outbreak a public health
emergency of international concern. On August 4, 2022, the U.S.
government declared the monkeypox outbreak as a public health
emergency.
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 the Strategic
Stockpile, the enforceability of our procurement contracts,
such as the 19C BARDA Contract (the "BARDA Contracts"),
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 Contracts, 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 Contracts on schedule or in accordance
with contractual terms, (iii) the risk that the BARDA Contracts 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
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) 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 (xv) risks associated with responding to the current monkeypox
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, 2021 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
Michael Crawford, Edison
Groupmcrawford@edisongroup.com
Public RelationsHolly Stevens, Berry &
Companyhstevens@berrypr.com
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