Siga Technologies said today that the U.S. government has ordered $113 million of the company’s oral TPOXX treatment courses and $25 million of the intravenous version of TPOXX for the Strategic National Stockpile.
TPOXX, also known as tecovirimat, is a novel small molecule drug used to treat human smallpox disease caused by variola virus.
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A vaccine can prevent smallpox but is currently not recommended for routine vaccination.
The U.S. has tapped into the national stock of TPOXX over the past year to meet the challenges of an unprecedented mpox (formerly monkeypox) outbreak. Access to oral tecovirimat is available for mpox patients with severe disease (or at risk of severe disease) or involvement of anatomic areas that might result in serious sequelae under CDC’s expanded access Investigational New Drug (EA-IND) protocol. The National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health, is also enrolling patients in the Study of Tecovirimat for Human Mpox Virus (STOMP), designed to more thoroughly assess tecovirimat as a treatment of mpox.
SIGA expects to deliver approximately $113 million of oral TPOXX under this order in 2023 and expects to start delivering IV TPOXX in 2024. Before delivery of IV TPOXX under this order, SIGA will be focused on fulfilling delivery obligations under a prior IV TPOXX order.
The FDA approved the oral formulation of TPOXX for smallpox in 2018, and the IV formulation was approved for the same indication in 2022. Oral tecovirimat received approval from the European Medicines Agency (EMA) and the Medicines and Healthcare Products Regulatory Agency (MHRA) in the United Kingdom in 2022. The EMA and UK approvals include labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox.
This project has been supported in whole or in part with federal funds from the U.S. Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority (BARDA) and Strategic National Stockpile, under Contract No. 75A50118C00019.