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SIGA Technologies, Inc. (SIGA) (NASDAQ: SIGA), a commercial-stage pharmaceutical company focused on the health security market, today announced that the U.S. Department of Defense (DoD) awarded a contract to SIGA for the procurement of up to approximately $7.5 million of oral TPOXX, of which approximately $3.6 million of oral TPOXX is targeted for delivery in 2022 and the remainder is subject to an option at the sole discretion of the DoD.
SIGA has been collaborating with the DoD’s Joint Program Executive Office for Chemical, Biological, Radiological and Nuclear Defense (JPEO-CBRND) to develop the Post Exposure Prophylaxis (PEP) indication for TPOXX, and this work is supported by a separate development contract worth approximately $26 million. As a result, the DoD has drafted an Expanded Access Protocol (EAP)1 for TPOXX, which can be used for PEP purposes in certain DoD-affiliated personnel until the FDA approves TPOXX for PEP.
“We continue to make progress in securing new customers for TPOXX,” Phil Gomez, CEO of SIGA said. “We are pleased to be partnering with DoD to provide TPOXX to support the warfighter against smallpox as we continue development of the PEP indication.”
On July 13, 2018, the FDA approved oral TPOXX for the treatment of smallpox to mitigate the impact of a potential outbreak or bioterror attack. In December 2021, oral TPOXX was approved for the same indication by Health Canada. Tecovirimat (TPOXX) was approved by the European Medicines Agency (EMA) in January 2022 with a broader label that covers the treatment of smallpox, monkeypox, cowpox, and complications from vaccination for smallpox.
