Core 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].

Core Insights - The ongoing mpox outbreak is a significant global health threat, necessitating increased therapeutic research and innovation [1][3] - Emergent BioSolutions has published a comprehensive review on brincidofovir, highlighting its investigational use for treating mpox infections [1][5] Company Overview - Emergent BioSolutions is focused on developing protective solutions against public health threats, including mpox, and has over 25 years of experience in this field [6] Research and Development - Brincidofovir is being evaluated in a double-blind, placebo-controlled clinical trial (MOSA) in Africa, initiated in January 2025, in partnership with Africa CDC and PANTHER [4] - The trial aims to assess the safety and efficacy of brincidofovir for mpox patients, with initial funding from Horizon Europe and Africa CDC [4] Public Health Context - The World Health Organization declared the current mpox outbreak a Public Health Emergency of International Concern (PHEIC) on August 14, 2024, marking the second such declaration in two years [3] - The U.S. Centers for Disease Control and Prevention has reported a surge in mpox cases globally [3]