Oral doses of SIGA Technologies’ antiviral drug Tpoxx will help the U.S. maintain its reserves of the vaccine in preparation for future potential outbreaks, according to the company.
New York-based SIGA Technologies on Friday announced that it has signed a $113 million procurement option under an existing contract with the U.S. Department of Health and Human Services for its oral antiviral drug Tpoxx (tecovirimat).
Friday’s deal helps SIGA “fulfill our responsibility to global health security” while also “generating attractive returns for our company and shareholders,” CEO Diem Nguyen said in a statement.
“This $113 million order from the U.S. government will enhance orthopoxvirus preparedness and support sizable and consistent action when needed to help ensure public health from natural, accidental, or intentional threats,” Nguyen said.
Administered either orally or intravenously, Tpoxx is an antiviral agent approved for the treatment of smallpox and was largely used off-label for mpox amid the outbreak in 2022. The drug works by blocking the VP37 envelope wrapping protein, which is found on the surface of orthopoxviruses and is crucial for their reproduction.
In September 2022, as cases of mpox (which at the time was still known as monkeypox) were rapidly rising across the U.S., research from the University of California-Davis Health showed that Tpoxx was safe and effective for the treatment of the infection.
Results, published at the time in the Journal of the American Medical Association, showed that Tpoxx could completely resolve skin lesions in 40% of patients by day 7 and in 92% of patients by day 21. Tpoxx was also generally safe in this indication. The most common side effects were fatigue, headaches and nausea.
In November 2022, the FDA announced that it was looking into running clinical trials to more thoroughly evaluate Tpoxx in mpox. The EU and the U.K. have already approved the use of Tpoxx for the treatment of adults with mpox.
SIGA’s procurement agreement on Friday follows a prior contract, signed last week, to provide Tpoxx access to the Association of Southeast Asian Nations—a regional bloc that together encompasses more than 600 million people.
The New York biotech has also previously delivered $113 million worth of oral Tpoxx doses to the U.S. under a July 2023 contract. The agreement also includes a $25 million delivery of intravenous courses.
