SIGA Receives Approval from the FDA for Intravenous (IV) Formulation of TPOXX® (tecovirimat)
May 19 2022 - 7:30AM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced that the U.S. Food and Drug Administration (FDA) approved
the intravenous (IV) formulation of TPOXX for the treatment of
smallpox. The IV formulation is an important option for those who
are unable to swallow the oral capsules of TPOXX.
“We are grateful to the FDA for their work
leading to approval of IV TPOXX, which will provide access to a
broader patient population,” said Dr. Dennis Hruby, CSO of SIGA.
“We are also appreciative to our colleagues at BARDA who have been
working with us for many years to include oral and IV TPOXX in U.S.
preparedness efforts and look forward to continuing to work with
them on our liquid pediatric formulation.”
The oral formulation of TPOXX (tecovirimat) is
approved in the US, Canada and Europe for the treatment of
smallpox. The European approval also includes the treatment of
monkeypox, cowpox, and complications from immunization with
vaccinia. The IV formulation of TPOXX was cited in the recent U.S.
president’s budget request as being used to treat a patient in the
U.S. with monkeypox.
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. Funding and technical support for this work is provided by
the Biomedical Advanced Research and Development Authority (BARDA),
under the Assistant Secretary for Preparedness and Response (ASPR),
within the U.S. Department of Health and Human Services (HHS),
under ongoing USG Contract No. 75A50118C00019 (19C). For more
information about BARDA, refer to
https://www.medicalcountermeasures.gov/. 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. 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. For
more information about SIGA, please visit www.siga.com.
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 “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, as well as the impact of COVID-19 on
SIGA’s business. Forward-looking statements may be identified by
words or phrases such as “believes,” “estimates,” “expects,” “may,”
“will,” “would,” “can,” “could,” and similar words and phrases.
Such forward-looking statements are based on current expectations
and assumptions and 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 the U.S. Biomedical Advanced Research and Development
Authority (“BARDA”) elects, in its sole discretion as permitted
under the BARDA Contracts (as defined below), not to exercise all,
or any, of the remaining unexercised options under those contracts,
(ii) the risk that SIGA may not complete performance under its
contracts with BARDA (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 that the COVID-19
pandemic could impact SIGA’s operations by disrupting 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 affect SIGA’s business
adversely, and (xv) other risk factors discussed in Item 1A. “Risk
Factors” of SIGA’s Annual Report on Form 10-K for the
year ended December 31, 2021, and in SIGA’s
subsequent filings with the U.S. Securities and Exchange
Commission. These documents are publicly available at
the SEC’s website at http://www.sec.gov and SIGA’s
website at https://investor.siga.com. Forward-looking statements
are current only as of the date on which such statements were made,
and except as may be otherwise required by law, 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:
Investor ContactLaine Yonker, Edison
Grouplyonker@edisongroup.com
Michael Crawford, Edison
Groupmcrawford@edisongroup.com
Public RelationsDoug
Haslamdhaslam@berrypr.com
1
http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
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