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SIGA Technologies Inc. (NASDAQ: SIGA) is a commercial-stage pharmaceutical company that targets the health security market. SIGA specializes in the development of antiviral therapeutics aimed at treating some of the world's most lethal pathogens including smallpox, Ebola, dengue, and Lassa fever. The company's flagship product, TPOXX® (also known as tecovirimat and ST-246®), is an oral and intravenous formulation antiviral drug approved for the treatment of human smallpox disease caused by the variola virus.
TPOXX has received approval from multiple regulatory bodies. In 2018, the U.S. Food and Drug Administration (FDA) approved the oral formulation of TPOXX, followed by approval for the intravenous formulation in 2022. The European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom also approved oral TPOXX in 2022 for treating smallpox, monkeypox, cowpox, and complications arising from vaccinia virus infections post smallpox vaccination.
In recent developments, SIGA has expanded its reach in Europe through a joint procurement mechanism, allowing multiple EU countries to access oral TPOXX. Orders under this mechanism are anticipated to generate around $164 million in 2023, with a substantial portion of deliveries expected within the year. As such, the company projects a pre-tax operating income between $90 million and $100 million for 2023. Additionally, SIGA has recently amended its international promotion agreement with Meridian Medical Technologies, Inc., granting SIGA primary responsibility for promoting oral TPOXX in various territories, including the European Union, thereby enhancing its global reach.
SIGA also maintains a strong relationship with the Biomedical Advanced Research and Development Authority (BARDA) for the procurement and development of both oral and intravenous formulations of TPOXX under Project BioShield. This partnership underscores SIGA's commitment to enhancing global health security through its innovative antiviral treatments.
With a clear focus on health security, SIGA aims to address high-priority biological threats, providing solutions that are crucial in preparing for and mitigating the impact of infectious diseases and potential bioterrorist threats.
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