SIGA Technologies, Inc. is an American

pharmaceutical company The pharmaceutical industry is a Medicine, medical industry that discovers, develops, produces, and markets pharmaceutical goods such as medications and medical devices. Medications are then administered to (or Self-medicate, self-administered b ...

founded in 1995, based in

New York City New York, often called New York City (NYC), is the most populous city in the United States, located at the southern tip of New York State on one of the world's largest natural harbors. The city comprises five boroughs, each coextensive w ...

, which develops and sells pharmaceutical solutions for the antiviral treatment of

smallpox Smallpox was an infectious disease caused by Variola virus (often called Smallpox virus), which belongs to the genus '' Orthopoxvirus''. The last naturally occurring case was diagnosed in October 1977, and the World Health Organization (W ...

monkeypox Mpox (, ; formerly known as monkeypox) is an infectious viral disease that can occur in humans and other animals. Symptoms include a rash that forms blisters and then crusts over, fever, and lymphadenopathy, swollen lymph nodes. The illness ...

cowpox Cowpox is an infectious disease caused by Cowpox virus (CPXV). It presents with large blisters in the skin, a fever and swollen glands, historically typically following contact with an infected cow, though in the last several decades more often ...

, and vaccinia complications.

History

In September 2009, SIGA Technologies received a $1.6 million research fund from the

National Institutes of Health The National Institutes of Health (NIH) is the primary agency of the United States government responsible for biomedical and public health research. It was founded in 1887 and is part of the United States Department of Health and Human Service ...

("NIH") for its broad-spectrum antiviral candidates. In August 2011, SIGA Technologies was awarded a $7.7 million grant from the

(NIH) to develop an antiviral drug for treating and preventing Lassa fever and others of

arenavirus An arenavirus is a bi- or trisegmented ambisense RNA virus that is a member of the family ''Arenaviridae''. These viruses infect rodents and occasionally humans. A class of novel, highly divergent arenaviruses, properly known as reptarenavirus ...

origin. That year, it sealed a contract worth over $400 million to sell its antiviral drug Tpoxx to the United States

Biomedical Advanced Research and Development Authority The Biomedical Advanced Research and Development Authority (BARDA) is a center within the Administration for Strategic Preparedness and Response (ASPR) located within the U.S. Department of Health and Human Services (HHS) responsible for the p ...

(BARDA) for the purpose of its development and distribution. Also in 2011, it was ordered to pay $232 million in damages in a legal dispute with PharmAthene over rights to the smallpox drug tecovirimat. In July 2013, SIGA Technologies delivered about 590,000 courses of its smallpox antiviral drug

tecovirimat Tecovirimat, sold under the brand name Tpoxx among others, is an Antiviral drug, antiviral medication with activity against orthopoxviruses such as smallpox and monkeypox, mpox. In 2018 it was the first antipoxviral drug approved in the United S ...

(Arestvy) to the United States Government's Strategic National Stockpile (SNS), meeting the requirement of Government's

(BARDA). In May 2018, a US

Food and Drug Administration The United States Food and Drug Administration (FDA or US FDA) is a List of United States federal agencies, federal agency of the United States Department of Health and Human Services, Department of Health and Human Services. The FDA is respo ...

(FDA) advisory committee decided that the benefits of SIGA's small molecule antiviral treatment, Tpoxx, outweigh its potential risks. Later in July, FDA granted the approval of Tpoxx to SIGA after the drug was evaluated in 359 healthy human volunteers. In July 2019, SIGA signed a $23 million contract with the United States Department of Defense to create Tpoxx's post-exposure prophylaxis. Tecovirimat was approved for medical use in the

European Union The European Union (EU) is a supranational union, supranational political union, political and economic union of Member state of the European Union, member states that are Geography of the European Union, located primarily in Europe. The u ...

in January 2022. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged. In 2021, SIGA submitted an intravenous version of Tpoxx to the FDA for approval, which was approved in May 2022. In December 2021,

Health Canada Health Canada (HC; )Health Canada is the applied title under the Federal Identity Program; the legal title is Department of Health (). is the Structure of the Canadian federal government#Departments, with subsidiary units, department of the Gove ...

approved oral Tpoxx for the treatment of smallpox in adults and pediatric patients weighing at least 13kg. In January 2022, the

European Medicines Agency The European Medicines Agency (EMA) is an agency of the European Union (EU) in charge of the evaluation and supervision of pharmaceutical products. Prior to 2004, it was known as the European Agency for the Evaluation of Medicinal Products ...

approved oral tecovirimat for smallpox, monkeypox, cowpox and vaccinia complications in adults and children with a body weight of at least 13kg. Intravenous (IV) Tpoxx has no lower weight cap and can be used in

infant In common terminology, a baby is the very young offspring of adult human beings, while infant (from the Latin word ''infans'', meaning 'baby' or 'child') is a formal or specialised synonym. The terms may also be used to refer to juveniles of ...

s under the

Investigational New Drug The United States Food and Drug Administration's Investigational New Drug (IND) program is the means by which a pharmaceutical industry, pharmaceutical company obtains permission to start human clinical trials and to ship an experimental drug inte ...

protocol. The Centers for Disease Control and Prevention and the FDA have relaxed regulations to make it easier for doctors in the United States to prescribe Tpoxx to treat people with monkeypox.

Operations

SIGA has a well established cooperation with US federal agencies for its research and development activities. It provides countermeasures to the

Strategic National Stockpile The Strategic National Stockpile (SNS), originally called the National Pharmaceutical Stockpile (NPS), is the United States' national repository of antibiotics, vaccines, chemical antidotes, antitoxins, and other critical medical supplies. Its ...

(SNS) and the

Department of Defense The United States Department of Defense (DoD, USDOD, or DOD) is an executive department of the U.S. federal government charged with coordinating and supervising the six U.S. armed services: the Army, Navy, Marines, Air Force, Space Force, ...

(DoD), such as Category A pathogens using BSL-3 or -4 work. In September 2018, it signed a contract with BARDA for the delivery of oral and IV formulations of Tpoxx to the Strategic National Stockpile, effective for the following years.

Products and services

SIGA's products include

, sold under the brand name Tpoxx, the first drug approved by the FDA to treat adults and children for smallpox.

Recognition

In 2008, SIGA won its fourth listing on the Deloitte Tri-State Area Technology Fast 50, then at #44.

References

External links

* * {{Authority control Pharmaceutical companies established in 1995 Pharmaceutical companies of the United States Companies listed on the Nasdaq Publicly traded companies based in New York City