Biomedical Advanced Research and Development Authority (BARDA) and Siga Tech signed a contract valued at roughly $629m (€535m).
TPOXX is Siga’s antiviral, approved by the US Food and Drug Administration (FDA) in July of 2018, for the treatment of smallpox to mitigate the impact of a potential outbreak.
Per the contract, Siga will develop intravenous (IV) formulation of the drug and make post-marketing advances of the oral treatment. The agreement states that Siga will deliver 1.7m courses of treatment to the stockpile after development, with 212,000 courses of IV treatment and the rest of the order made up of oral treatments.
The contract consists of a five-year base pay and a total contract period of up to ten years. Base period activities of the contract are valued at roughly $52m but, if all options of the contract are exercised, the deal could be worth a total $629m.
BARDA is a division of the US Department of Health and Human Services’ Office of the Assistant Secretary for Preparedness and Response.
The contract is to supply TPOXX, tecovirimat, in different formulations for the Strategic National Stockpile, which holds pharmaceuticals and supplies in case of a public health emergency, should local supplies run out.
Phil Gomez, CEO of Siga, told us that one of the objectives of the contract is to sustain the stockpile that currently holds 1.7m courses after the courses currently held expire.
Siga is still in late-stage development of an IV formulation of TPOXX, which will provide a treatment option for patients who may be too sick to take an oral formulation of the drug, according to the company.
Smallpox: A public health concern
Smallpox was eradicated by 1980 after an immunization campaign initiated by the World Health Organization (WHO) in 1959, yet, small samples of smallpox remain for research purposes. The small amount of smallpox that exists poses concerns for its possible use as a biological warfare agent.
Since there is a low risk of smallpox, immunization is more of a risk than a benefit for the public, therefore, having the ability to treat the virus if an outbreak does occur is crucial.
