A Case Study of Developing Smallpox Antiviral TPOXX and an Overview of the Biodefense Industry
Presented by Phil Gomez, chief executive officer, SIGA Pharmaceuticals
SIGA is a company specializing in the development and commercialization of solutions for serious unmet medical needs and biothreats. SIGA’s lead product is TPOXX (USAN tecovirimat, ST-246), an orally administered antiviral drug that targets orthopoxvirus infections. While TPOXX is not yet approved as safe or effective by the U.S. Food & Drug Administration, it is a novel small-molecule drug that is being delivered to the U.S. Strategic National Stockpile (“SNS”) under the Project BioShield Act of 2004 (“Project Bioshield”).
SIGA believes that TPOXX is among the first new small-molecule drugs delivered to the Strategic Stockpile under Project BioShield. There could be several potential uses for an effective antiviral drug to treat orthopoxvirus infections: to reduce mortality and morbidity in those infected with the smallpox (or another orthopoxvirus) virus, to protect the non-immune who risk developing smallpox following virus exposure, and as an adjunct to the smallpox vaccine in order to reduce the frequency of serious adverse events due to the live virus used for vaccination.