NEW YORK, May 12, 2022 — SIGA Technologies, Inc. (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.”- ADVERTISEMENT -https://s.yimg.com/rq/darla/4-10-1/html/r-sf-flx.html
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.
ABOUT SIGA TECHNOLOGIES, INC. and TPOXX®
SIGA Technologies, Inc. is a commercial-stage pharmaceutical company focused on the health security market. Health security comprises countermeasures for biological, chemical, radiological and nuclear attacks (biodefense market), vaccines and therapies for emerging infectious diseases, and health preparedness. Our lead product is TPOXX®, also known as tecovirimat and ST-246®, an orally administered and IV formulation antiviral drug for the treatment of human smallpox disease caused by variola virus. TPOXX is a novel small-molecule drug and the US maintains a supply of TPOXX under Project BioShield. The oral formulation of TPOXX was approved by the FDA for the treatment of smallpox in 2018. The full label is available by clicking here. Oral tecovirimat received approval from the European Medicines Agency (EMA) in 2022. The EMA approval includes labeling for oral tecovirimat indicating its use for the treatment of smallpox, monkeypox, cowpox, and vaccinia complications following vaccination against smallpox. The full label is available by clicking here. In September 2018, SIGA signed a contract with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response within the U.S. Department of Health and Human Services, for additional procurement and development related to both oral and intravenous formulations of TPOXX. For more information about SIGA, please visit www.siga.com.
Smallpox is a contagious, disfiguring and often deadly disease that has affected humans for thousands of years. Naturally-occurring smallpox was eradicated worldwide by 1980, the result of an unprecedented global immunization campaign. Samples of smallpox virus have been kept for research purposes. This has led to concerns that smallpox could someday be used as a biological warfare agent. A vaccine can prevent smallpox, but the risk of the current vaccine’s side effects is too high to justify routine vaccination for people at low risk of exposure to the smallpox virus.