19. Tpoxx

FDA
(FDA)

Active ingredient: tecovirimat
Disease: smallpox
Peak sales estimate: n/a
Approved: July 13
Company: SIGA Technologies

The scoop: Is it possible to build a growing business around a disease that was eradicated nearly 40 years ago? New York City-based SIGA Technologies is doing just that, having scored an eye-catching first for its smallpox treatment Tpoxx. The FDA approved the drug in July, clearing SIGA to market the first-ever treatment for the disease. The agency approved the drug after issuing the first Material Threat Medical Countermeasure priority review voucher to SIGA, based on concerns that lost samples of the virus held in labs around the world could be turned into bioweapons. SIGA partnered on the development of Tpoxx with U.S. Department of Health and Human Services’ Biomedical Advanced Research and Development Authority (BARDA), with which it had a $472 million procurement and development contract to deliver 2 million doses of the oral formulation of the drug. In September 2018, SIGA signed a multiyear contract with BARDA to deliver both oral and intravenous formulations of Tpoxx for a national stockpile. That contract is worth up to $629 million. The peak sales potential for the drug could extend far beyond that contract, however, as the company expects further demand for Tpoxx could come from foreign governments and private organizations. — Arlene Weintraub

19. Tpoxx

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