SIGA Technologies, Inc. is referred to throughout this report as "SIGA," "the Company," "we" or "us."
We are a commercial-stage pharmaceutical company. The Company sells its lead product, TPOXX ("oral TPOXX ," also known as "tecovirimat," "Tecovirimat-SIGA," or "TEPOXX (tecovirimat)" in certain international markets), to the U.S. Government and international governments (including government affiliated entities). In certain international markets, the Company may sell TPOXX through a distributor. Additionally, the Company sells the intravenous formulation of TPOXX ("IV TPOXX ") to the U.S. Government.
TPOXX is an antiviral drug for the treatment of human smallpox disease caused by variola virus. On July 13, 2018, the United States Food & Drug Administration ("FDA") approved the oral formulation of TPOXX for the treatment of smallpox. The Company has been delivering oral TPOXX to the U.S. Strategic National Stockpile ("Strategic Stockpile") since 2013.
In addition to being approved by the FDA, oral TPOXX (tecovirimat) has received regulatory approval from the European Medicines Agency ("EMA"), Health Canada, the Medicines and Healthcare Products Regulatory Agency ("MHRA") of the United Kingdom, and the Japanese Pharmaceuticals and Medical Devices Agency ("PMDA"). The EMA, MHRA and PMDA approved oral TPOXX for the treatment of smallpox, monkeypox ("mpox"), cowpox, and vaccinia complications following vaccination against smallpox. Health Canada approved TPOXX for the treatment of smallpox.