SIGA Supplies TPOXX® (Tecovirimat) as Compassionate Treatment for Monkeypox Case in the United Kingdom
June 30 2021 - 7:30AM
SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage
pharmaceutical company focused on the health security market, today
announced that it provided TPOXX® (tecovirimat) to Liverpool
University Hospitals NHS Foundation Trust, in the United Kingdom
(UK). TPOXX, which is approved in the United States for the
treatment of smallpox, was delivered to Liverpool for compassionate
treatment for a patient confirmed to be infected with monkeypox.
SIGA has previously provided TPOXX on a named
patient basis for the treatment of several cases of adverse events
from vaccination with or accidental exposure to vaccinia virus, as
well as to treat several patients infected with cowpox and a recent
laboratory acquired vaccinia virus infection. One of these cases
was recently published in the New England Journal of Medicine,
where TPOXX was used to treat a patient in London, UK, infected
with cowpox1. In 2020, SIGA submitted an application for marketing
authorization to the European Medicines Agency (EMA) that includes
a broader label indication including the treatment of orthopox
indications, including monkeypox, cowpox, and vaccinia
complications in addition to smallpox. Approval is expected in late
2021 or early 2022.
“As we undergo regulatory review in the EU and
Canada for an expanded label for TPOXX, we continue to provide
TPOXX as a compassionate use treatment for monkeypox, cowpox, and
vaccinia complications,” said Phil Gomez, CEO of SIGA Technologies,
“It is becoming clear TPOXX will be an important tool to treat
these diseases throughout the world, and we are committed to
expanding our regulatory approvals and provide access for
patients.”
Monkeypox is a contagious disease caused by
infection with monkeypox virus, a virus closely related to variola
virus, which causes smallpox. Monkeypox is characterized by severe
flu-like symptoms and a rash of pus-filled pocks that may cover the
whole body. The rash may not occur until approximately two weeks
after exposure to the virus, making it difficult to diagnose
initially, and the disease may last nearly a month in total if not
fatal. Almost all infections are contracted by exposure to infected
animals, although person-to-person transmission is possible. Most
cases occur in Central and West African countries where it is
endemic, but infections have been documented outside of Africa; in
the United States in 2003, UK (2018, 2019), and Israel (2018). The
incidence of disease is likely to continue to increase, both within
Africa and elsewhere, as protective immunity in the population
decreases. This decreased immunity is due in part to cessation of
vaccination following eradication of smallpox in 1980, which had
provided some degree of cross-reactive immunity to monkeypox.
On July 2018, the U.S. Food and Drug
Administration (FDA) approved the oral formulation of TPOXX
(tecovirimat) for the treatment of smallpox. TPOXX (tecovirimat), a
small molecule, was the first therapy specifically approved for
this indication, and was developed through funding and
collaboration with Biomedical Advanced Research and Development
Authority at the U.S. Department of Health and Human Services, as
well as early stage development supported by the National
Institutes of Health, U.S. Centers for Disease Control and
Prevention, and the Department of Defense. TPOXX is stockpiled by
the U.S. Government to mitigate the impact of a potential outbreak
or bioterror attack.
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® (tecovirimat) also known
as 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
stockpile of 1.7 million courses in the Strategic National
Stockpile under Project BioShield. The oral formulation of TPOXX
was approved by the FDA for the treatment of smallpox in adults and
children weighing more than 13 kg on July 13, 2018. In September
2018, SIGA signed a new contract with Biomedical Advanced Research
and Development Authority (BARDA) for additional procurement and
development related to both oral and intravenous formulations of
TPOXX (tecovirimat). For more information about SIGA, please visit
www.siga.com.
About
Smallpox2
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 currently
routine vaccinations are not administered for people given the low
risk of exposure to the smallpox virus.
FORWARD-LOOKING STATEMENTS
This press release contains certain
"forward-looking statements" within the meaning of the Private
Securities Litigation Reform Act of 1995, as amended. 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. More detailed information about
SIGA and risk factors that may affect the realization of
forward-looking statements, including the forward-looking
statements in this press release, is set forth in SIGA's filings
with the Securities and Exchange Commission, including SIGA's
Annual Report on Form 10-K for the fiscal year ended December 31,
2020, and in other documents that SIGA has filed with the SEC. SIGA
urges investors and security holders to read those documents free
of charge at the SEC's web site at http://www.sec.gov. Interested
parties may also obtain those documents free of charge from SIGA.
Forward-looking statements are current only as of the date on which
such statements were made, and except for our ongoing obligations
under the United States of America federal securities laws, 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 Contacts
Laine Yonker, Edison
Grouplyonker@edisongroup.com
Michael Crawford, Edison
Groupmcrawford@edisongroup.com
1 Orbital Cowpox. Miles Kiernan and Nikolaos Koutroumanos. June
10, 2021, N Engl J Med 2021; 384:2241, DOI: 10.1056/NEJMicm2033620
2
http://www.mayoclinic.org/diseases-conditions/smallpox/basics/definition/con-20022769
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