Who We Are

SIGA Technologies, Inc. is a public, commercial-stage pharmaceutical company focused on providing solutions for unmet needs in the health security market that comprises medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) threats, as well as emerging infectious diseases. The company is headquartered in New York City, with research and development facilities in Corvallis, Oregon.

Our product, TPOXX® (tecovirimat) that is available in oral and intravenous formulations, is approved by the U.S. Food and Drug Administration (FDA) for the treatment of smallpox. The European Medicine Agency (EMA) has approved oral TPOXX (under the name Tecovirimat SIGA) for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox.

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More than $1 billion in contract value awarded by the U.S. government

SIGA’s most recent contract with the Biomedical Advanced Research and Development Authority (BARDA), primarily for the maintenance of a strategic stockpile of smallpox antiviral therapy, was awarded in September 2018 and has a value in excess of $600 million (if all options are exercised). To date approximately $240 million of TPOXX® has been delivered under this contract. In 2011, SIGA was awarded a contract with BARDA which led to the delivery of $460 million of oral TPOXX® to the strategic stockpile.

SIGA has worked closely with the U.S. Government during the development of TPOXX® and has cultivated relationships with key health security constituencies in the U.S. government, including the Biodefense Advanced Research Development Authority (BARDA), the National Institute of Allergy and Infectious Diseases (NIAID)/National Institutes of Health (NIH), the Defense Threat Reduction Agency (DTRA), U.S. Army Medical Research Institute of Infectious Diseases (USAMRIID), and the Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRN). These relationships have generated consistent, long-term mutual benefits that have helped to advance the development of TPOXX® while enhancing U.S. national health security and preparedness against a potential smallpox threat.

Proven drug development capability including development under the Animal Rule

SIGA has established an end-to-end network with over 20 partners across discovery, pre-clinical, clinical, manufacturing and supply chain that supported development of TPOXX® and successful delivery of approximately $200 million of courses to the Strategic National Stockpile. In addition, development and approval of TPOXX®, the first drug approved to treat a disease that no longer exists in the human population, required a unique regulatory approach based on the FDA’s Animal Rule. We have developed a robust drug development capability supported through U.S government investment in Biodefense, and our highly externalized cost structure minimizes fixed costs and provides scalability. SIGA intends to leverage the unparalleled expertise, infrastructure, and relationships amassed in support of the TPOXX® program in additional health security opportunities.

Our Product

Smallpox is one of the deadliest threats and cannot be addressed with vaccines alone

Oral TPOXX® (tecovirimat) is the first drug approved by the U.S. Food and Drug Administration (FDA) that is specifically indicated for the treatment of smallpox disease in adults and pediatric patients weighing at least 13 kg. (Prescription Label) TPOXX® inhibits viral maturation of variola virus (the virus that causes smallpox) and other poxviruses by preventing the formation of a secondary viral envelope. In the absence of this envelope, viral particles remain inside the cell and cannot spread to and infect other cells. The most frequently reported adverse reactions were headache and nausea.

TPOXX® Injection, the intravenous (IV) formulation of TPOXX, has also been approved by the FDA for the treatment of smallpox in patients weighing at least 3 kg. This important option will allow patients who are too sick to swallow oral capsules to receive treatment.

TPOXX® is among the first novel small molecule therapies delivered to the Strategic National Stockpile (SNS) under Project BioShield, a U.S. government program designed to accelerate the research, development, purchase, and availability of effective medical countermeasures against chemical, biological, radiological, and nuclear (CBRN) agents. As the first antiviral agent specifically indicated for the treatment of smallpox, TPOXX® would play a critical role in responding to a smallpox bioterror attack.

Following U.S. approval, Health Canada also authorized the use of oral TPOXX® for the treatment of human smallpox disease in adults and pediatric patients weighing at least 13 kg. Oral TPOXX® is supplied to both the Canadian Department of National Defence (DND) and the Public Health Agency of Canada (PHAC) for stockpiling as a key countermeasure. (Prescription Label)

Oral tecovirimat was later approved by the European Medicines Agency (EMA) (Prescription Label), the Norwegian Medicines Agency, and the Medicines and Healthcare products Regulatory Agency (MHRA – UK) (Prescription Label) for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox in adults and children with body weight at least 13kg.

TPOXX® Fact Sheet >

Our Pipeline

Our Partners

We have a rich history of successful partnerships to support our portfolio and fulfill our mission.

Partner with Us

We are seeking to expand our portfolio in health security through strategic partnerships and in-licensing opportunities. We would also like to hear from small businesses with capabilities across drug development, formulation, commercial manufacturing, clinical, and regulatory services.

Contact

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