Emergent BioSolutions(US:EBS) Globenewswire·2025-09-15 12:35Core Viewpoint - Emergent BioSolutions Inc. has received a $17 million contract modification from BARDA to supply TEMBEXA® oral suspension, following FDA's approval for manufacturing scale-up, highlighting the importance of this formulation for patients with swallowing difficulties [1][2]. Group 1: Contract and Collaboration - The contract modification reinforces the need for a continuous supply of countermeasures against smallpox, particularly for vulnerable populations during potential outbreaks [2]. - This contract modification builds upon previously announced options from September 2024 and is part of Emergent's existing 10-year contract with BARDA [2]. Group 2: Product Information - TEMBEXA is an oral antiviral approved for the treatment of human smallpox disease in both adult and pediatric patients, including neonates [3][4]. - The formulation includes 100 mg tablets and a 10 mg/mL oral suspension, dosed once weekly for two weeks, which is crucial for patients who have difficulty swallowing [3]. Group 3: Safety and Efficacy - TEMBEXA is not indicated for diseases other than smallpox, and its efficacy has not been determined in humans due to ethical concerns regarding field trials [5]. - The drug may have increased mortality risks when used for longer durations and can cause elevations in hepatic transaminases and bilirubin [6][7].