Emergent BioSolutions Inc. has secured a $17 million contract modification from the Biomedical Advanced Research and Development Authority (BARDA) to supply TEMBEXA® (brincidofovir) oral suspension, strengthening the U.S. strategic preparedness against potential smallpox outbreaks. The contract follows the U.S. Food and Drug Administration's recent approval of manufacturing scale-up for the oral suspension formulation.
Strategic Supply Chain Enhancement
The newly exercised contract modification (CLIN0004B) builds upon previously announced options from September 2024 and operates under Emergent's existing 10-year contract with the federal government. Paul Williams, senior vice president, head of products business, global government & public affairs at Emergent, emphasized the critical nature of maintaining continuous countermeasure supplies.
"Our newly secured contract modification and ongoing collaboration with BARDA and its procurement of TEMBEXA® (brincidofovir) oral suspension formulation reinforces the critical need for a continuous supply of countermeasures to help address smallpox disease among vulnerable patient populations during a potential outbreak," Williams stated.
Clinical Profile and Formulation Advantages
TEMBEXA® is an orthopoxvirus nucleotide analog DNA polymerase inhibitor approved by the FDA in June 2021 for treating human smallpox disease caused by variola virus in adult and pediatric patients, including neonates. The drug is formulated as 100 mg tablets and 10 mg/mL oral suspension, administered once weekly for two weeks.
The oral suspension formulation addresses a critical clinical need for patients who have difficulty swallowing due to age or medical status, making it particularly important for vulnerable populations including pediatric and elderly patients.
Safety Profile and Limitations
TEMBEXA carries a boxed warning regarding increased risk for mortality when used for longer duration, based on findings from a 24-week clinical trial in another disease indication. The most common adverse reactions, occurring in at least 2% of treated subjects, include diarrhea, nausea, vomiting, and abdominal pain.
The drug's effectiveness for smallpox treatment has not been determined in humans due to the ethical impossibility of conducting controlled field trials. Additionally, TEMBEXA efficacy may be reduced in immunocompromised patients based on studies in immune deficient animals.
Manufacturing and Supply Chain Impact
Williams highlighted the company's commitment to scaling manufacturing capabilities to meet immediate customer needs while strengthening U.S. manufacturing and supply chain processes. The contract modification represents part of Emergent's broader mission to serve as a trusted partner supporting U.S. government efforts to address serious national health security threats.
The project has been funded with federal funds from the U.S. Department of Health and Human Services, Administration for Strategic Preparedness and Response, and BARDA under contract number 75A50122C00047.
