Emergent BioSolutions Partners with U.S. Government for Comprehensive Response to Expedite Development of Plasma-Derived Therapy for COVID-19

• BARDA to provide $14.5 million in funding to support development of COVID-Human Immune Globulin (COVID-HIG), a human plasma-derived therapy candidate being developed as a potential treatment for COVID-19 in severe hospitalized and high-risk patients
  
• NIAID to include COVID-HIG product candidate in one of its clinical studies for assessment of treatments for COVID-19 upon availability of clinical material
• Emergent will seek a path forward with the FDA for the development of COVID-HIG and possible use under Emergency Use Authorization (EUA)

GAITHERSBURG, Md., April 02, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has entered into a formal partnership with the U.S. government to expedite development of a plasma-derived therapy for patients with coronavirus disease 2019 (COVID-19). Emergent has received $14.5 million from the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response (ASPR) at the U.S. Department of Health & Human Services (HHS), in support of its COVID-HIG program, one of two hyperimmune development programs announced by Emergent in March.

COVID-HIG is a candidate human hyperimmune product being developed as a potential treatment for COVID-19 in severe hospitalized patients and high-risk, acute symptomatic patients to prevent progression to severe symptoms. COVID-HIG will be manufactured using plasma donations from people who have recovered from COVID-19 with antibodies to SARS-CoV-2.

Robert G. Kramer Sr., president and CEO of Emergent BioSolutions, stated, “In the current pandemic scenario where no preventative or therapeutic options for COVID-19 are available, public-private partnerships such as this are essential to the rapid development of medical interventions. Aside from deploying our HHS-partnered Center for Innovation in Development and Manufacturing (CIADM) to help companies advance COVID-19 vaccine candidates through manufacturing, today’s announcement of BARDA’s funding is a testament to the strength and reliability of our proven hyperimmune platform, which has a successful history of enabling us to produce treatments for serious public health threats. With more than 40 years of experience with plasma-derived therapies, Emergent is committed to the goal of getting COVID-HIG to patients as early as possible, with a potential broader reach under Emergency Use Authorization, and the availability of a commercial supply.”