BARDA and Chimerix, Inc. partner under Project BioShield to procure TEMBEXA, a second licensed therapeutic for smallpox

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To fortify the nation’s health security, BARDA will use its authority under Project BioShield to procure TEMBEXA, an oral antiviral approved by the U.S. Food and Drug Administration (FDA) in tablet and oral suspension formulations for the treatment of smallpox disease. This latest contract with Chimerix, Inc., of Durham, North Carolina, adds a second therapeutic to the U.S. government’s readiness for smallpox emergencies.

Naturally occurring smallpox is believed to have been eradicated worldwide by 1980, although samples of variola virus (the virus that causes smallpox) are kept at the highest biosafety and biosecurity levels for research purposes, leading to concerns it could be used as a biological warfare agent or accidentally released. The risk for an intentional or accidental release of variola virus is believed to be low, but the effects of such an incident could be devastating. These potential consequences make planning for a smallpox emergency critical.

After a 2004 Department of Homeland Security determination that smallpox is a material threat to national security, the Public Health Emergency Medical Countermeasures Enterprise (PHEMCE) recommended securing antivirals to mitigate the consequences of a large smallpox attack. An Institute of Medicine report further emphasized the need to develop multiple countermeasures against smallpox with distinct mechanisms of action as risk mitigation for the emergence of drug resistant variola virus.

With these factors in mind, in 2011, BARDA and Chimerix began collaborating and built on earlier work with other federal agencies to complete the activities — including advanced development and manufacturing of brincidofovir — required for the company to apply for FDA approval. Brincidofovir — which is now marketed as TEMBEXA — is an antiviral drug that inhibits activity of a critical viral enzyme, preventing the virus from replicating and causing disease.

Since 2009, BARDA’s investments in the development of medical countermeasures against smallpox have contributed to the 2018 FDA approval of TPOXX from SIGA Technologies Inc., the first antiviral for the treatment of smallpox, and the 2021 FDA approval of TEMBEXA from Chimerix, Inc., the second antiviral for the treatment of smallpox and the first antiviral approved to treat neonates.

Now under the new Project BioShield contract, treatment courses comprising oral tablets and suspension formulation of TEMBEXA will be purchased, thereby strengthening national preparedness against smallpox.

About Chimerix, Inc.:

The following information is provided by the company and does not indicate endorsement by the federal government of the company or its products.

Chimerix is a biopharmaceutical company with a mission to develop medicines that meaningfully improve and extend the lives of patients facing deadly diseases. In June 2021, the U.S. Food and Drug Administration granted approval of TEMBEXA for the treatment of smallpox as a medical countermeasure.

Last Updated: August 29, 2022

CBRN Portfolio

The CBRN investments support advanced research and development and national security procurement of medical countermeasures to addresses national security threats. This award is one component of BARDA's CBRN medical countermeasure portfolio; visit the CBRN Portfolio to learn more.