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NEW YORK, June 30, 2021 (GLOBE NEWSWIRE) – SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health safety market, today announced the provision of TPOXX ® (tecovirimat) at Liverpool University Hospitals NHS Foundation Trust, UK (UK). TPOXX, which is approved in the United States for the treatment of smallpox, has been delivered to Liverpool for compassionate treatment for a patient confirmed to be infected with monkey pox.
SIGA has previously supplied TPOXX on a nominated patient basis for the treatment of several cases of adverse events due to vaccination or accidental exposure to vaccinia virus, as well as to treat several patients infected with cowpox and infection. recent by vaccinia virus acquired in the laboratory. One such case was recently published in the New England Journal of Medicine, where TPOXX was used to treat a patient in London, UK, infected with cowpox.1. In 2020, SIGA submitted a Marketing Authorization Application to the European Medicines Agency (EMA) which includes a broader indication, including treatment of orthopox indications, including monkey pox, smallpox bovine and vaccine 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 complications of monkey pox, beef pox and vaccine, “said Phil Gomez, CEO of SIGA Technologies,” It’s becoming clear that TPOXX will be an important tool in treating these diseases worldwide, and we are committed to expanding our regulatory approvals and providing patient access. . “
Monkey pox is a contagious disease caused by infection with the monkey pox virus, a virus closely related to the smallpox virus, which causes smallpox. Monkey pox is characterized by severe flu-like symptoms and a pus-filled rash that can cover the whole body. The rash may not occur until about two weeks after exposure to the virus, making the initial diagnosis difficult, and the disease can last for almost a month in total, or even fatal. Almost all infections are acquired through exposure to infected animals, although human-to-human transmission is possible. Most cases occur in Central and West African countries where it is endemic, but infections have been documented outside Africa; in the United States in 2003, in the United Kingdom (2018, 2019) and in Israel (2018). The incidence of the disease is likely to continue to rise, both in Africa and elsewhere, as the protective immunity of the population wanes. This decrease in immunity is due in part to the cessation of vaccination after the eradication of smallpox in 1980, which had provided some degree of cross-immunity against monkey pox.
In July 2018, the United States 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 treatment specifically approved for this indication, and was developed with funding and collaboration with the Biomedical Advanced Research and Development Authority of the US Department of Health and Human Services , as well as early development supported by the National Institutes of Health, the U.S. Centers for Disease Control and Prevention, and the Department of Defense. TPOXX is stored by the US government to mitigate the impact of a potential epidemic or bioterrorist attack.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the food safety market. Health security includes countermeasures to biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies against emerging infectious diseases and health preparedness. Our flagship product is TPOXX® (tecovirimat) also known as ST-246®, an antiviral medicine given by mouth and IV for the treatment of human smallpox caused by variola virus. TPOXX is a new small molecule drug and the US is maintaining 1.7 million courses in National Strategic Stock as part of the BioShield Project. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in adults and children weighing over 13 kg on July 13, 2018. In September 2018, SIGA signed a new contract with the Biomedical Advanced Research and Development Authority (BARDA) for further supply and development related to oral and intravenous formulations of TPOXX (tecovirimat). For more information on SIGA, please visit www.siga.com.
About smallpox2
Smallpox is a contagious, disfiguring and often fatal disease that has affected humans for thousands of years. Natural smallpox was eradicated worldwide in 1980, the result of an unprecedented global vaccination campaign. Smallpox virus samples were kept for research. This has led to fears that smallpox could one day be used as a biological warfare agent. A vaccine can prevent smallpox, but currently routine vaccinations are not given to people because of 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. These 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 the risk factors that may affect the realization of forward-looking statements, including the forward-looking statements contained in this press release, are set out in the documents filed by SIGA with the Securities and Exchange Commission, including the SIGA’s annual report on Form 10. -K for the year ended December 31, 2020, and in other documents that SIGA has filed with the SEC. SIGA urges investors and security holders to read these documents for free on the SEC’s website at http://www.sec.gov. Interested parties can also obtain these documents free of charge from SIGA. Forward-looking statements are only current as of the date on which such statements are made, and except for our continued obligations under the federal securities laws of the United States of America, we do not undertake not to publicly update forward-looking statements, whether as a result of new information, future events or otherwise.
The information in this press release does not necessarily reflect the position or policy of the government and no official endorsement should be inferred.
Contacts:
Investor contacts
Laine Yonker, Edison Group
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Michael Crawford, Edison Group
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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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