Responding to the ongoing monkeypox outbreak worldwide, the Biomedical Advanced Research and Development Authority (BARDA) last week exercised procurement options for SIGA Technologies, Inc.’s intravenous TPOXX treatments of smallpox.
Those treatments, valued at approximately $26 million, would offer increased options for monkeypox-afflicted patients with difficulty swallowing oral treatments. Both an oral and intravenous formulation of TPOXX were previously approved by the U.S. Food and Drug Administration (FDA), the former in 2018 and then earlier this year. Both approvals allow the treatment’s use for smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox.
“These option exercises for the procurement of IV formulation of TPOXX as well as the funding of a post-marketing field study for IV TPOXX highlight the growing importance of a broad-based response to the substantial risks posed by the orthopox family of viruses, including smallpox and monkeypox,” Phil Gomez, CEO of SIGA, said. “The exercised options are among many procurement options under the 19C contract that remain to be exercised and, as such, we will continue to coordinate with the U.S. government toward future procurements of oral TPOXX and IV TPOXX.”
Product deliveries of the IV versions of TPOXX should arrive next year.
SIGA first signed a contract with BARDA for additional procurement and development of oral and IV formulations of TPOXX in September 2018. The larger project was backed with funding from the Administration for Strategic Preparedness and Response and BARDA, which aim to maintain a supply of TPOXX as part of the federal Project BioShield. BioShield was established in 2004 as an incentive to private industry to develop and provide medical countermeasures against bioterrorist attacks.