Protest over BARDA purchase of smallpox antiviral withdrawn

The Biomedical Advanced Research and Development Authority of the United States Department of Health and Human Services has announced that a protest filed over its contract for the purchase of a smallpox antiviral has been withdrawn.

The protest was filed over a contract for the smallpox antiviral ST-246 with SIGA Technologies, Inc. The protest was withdrawn following the execution of a contract modification by BARDA, which lead to the lifting of a stay on performance of the contract.

The contract modification removes the option for BARDA to purchase up to 12 million courses of ST-426 beyond the initial 1.7 million courses to be purchased under the base contract. No changes were made to the base contract or the other options.

BARDA, under the modified contract, does not prevent BARDA from purchasing additional courses of ST-426 or other products in the future if it desires.

ST-246 is an oral therapeutic agent that is active against orthopoxviruses, including smallpox. It is the only drug to have demonstrated efficacy in non-human primate models of orthodox virus disease - a requirement of the request for proposal that led to the BARDA contract.

ST-246 will be the first entirely new small-molecule drug to be delivered to the Strategic National Stockpile under Project Bioshield. The antiviral works by blocking the virus' ability to spread to other cells, preventing it from causing disease. It has been designated for fast-track status.