SIGA Technologies Inc. (NASDAQ: SIGA) has received approval from Health Canada for TPOXX as an exceptional use new drug. The regulatory agency has TPOXX approved specifically for human smallpox treatment in pediatric and adult patients weighing more than 13kg.
Adverse risk of routine smallpox vaccination outweighs benefits
Smallpox is an infectious, debilitating, and often fatal disease that has afflicted people for millennia. By 1980, naturally occurring smallpox had been eradicated worldwide, thanks to a massive global vaccine campaign. However, smallpox virus samples have been retained for research purposes. This has raised fears that smallpox could be utilized as a biological warfare agent in the future. Although a vaccine can prevent smallpox, the risk of adverse effects from the present vaccine is too great to justify routine vaccination for persons who are at low risk of contracting the virus.
Dr. Phil Gomez, SIGA Technologies CEO, stated, “This is an important milestone in our partnership with the Canadian Department of National Defence (DND) that provided support to SIGA for the submission and regulatory review of its application. The approval ensures that we can continue to supply oral TPOXX to both the DND and the Public Health Agency of Canada (PHAC) for stockpiling as a key countermeasure.”
TPOXX is a novel treatment that is part of the US’s Bioshield Project
The company’s lead product candidate is TPOXX®, also known as tecovirimat and ST-246, an orally administered and IV formulation antiviral medication for the treatment of variola virus-induced human smallpox illness. TPOXX is a revolutionary small-molecule medicine that the US has on hand as part of Project BioShield. In July 2018, the FDA authorized TPOXX’s oral formulation for the treatment of smallpox.
SIGA and Pfizer’s Meridian Medical Technologies, Inc. signed an international promotion deal in June 2019. Meridian will promote the sale of oral tecovirimat for the treatment of smallpox in all worldwide markets outside of the US under the terms of the agreement. Interestingly, SIGA will retain complete ownership of the drug and its associated intellectual property.