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news.Siga Technologies has delivered first courses of smallpox antiviral drug Arestvyr under Biomedical Advanced Research and Development Authority (BARDA) contract to the US Government's Strategic National Stockpile.
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Arestvyr (Tecovirimat) is developed as a therapeutic against smallpox resulting from a terrorist attack, biowarfare or a new natural outbreak and is not yet cleared by the US Food and Drug Administration (FDA).
The company delivered around 190,000 first courses and will embark on obtaining payments upon the delivery of 500,000 of the 2,000,000 contracted-for courses of Arestvyr.
SIGA chairman and chief executive officer Dr. Eric Rose said the initial delivery symbolizes the company’s transformation from a research company to commercial biopharmaceutical enterprise.
"While SIGA continues to research and develop pharmaceutical agents to fight other lethal pathogens, and concurrently seeks approval and licensing of Arestvyr from the U.S. Food and Drug Administration, this first delivery of Arestvyr to the Stockpile is evidence of our ability to oversee the manufacture and delivery of large quantities of high-quality pharmaceutical product," Rose added.