GAITHERSBURG, Md., June 01, 2020 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced that it has been issued a task order under an existing contract with 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), to deploy its contract development and manufacturing (CDMO) capacities, capabilities, and expertise to support the U.S. government’s efforts to accelerate delivery of COVID-19 vaccines.
“Emergent is proud of this expanded BARDA partnership that symbolizes confidence in our development and manufacturing capabilities that have served the U.S. government’s needs for more than two decades,” said Robert G. Kramer Sr., president and chief executive officer of Emergent BioSolutions. “Our longstanding record of delivering safe and effective medical countermeasures for public health positions us to continue to help at this critical moment by advancing COVID-19 vaccine programs of our fellow innovators in the industry.”
This task order, valued at approximately $628 million, is being issued under the company’s 2012 contract with BARDA that established Emergent’s Baltimore Bayview facility as a Center for Innovation in Advanced Development and Manufacturing (CIADM) for pandemic preparedness, and expands the partnership to include investments in Emergent’s Baltimore Camden and Rockville facilities, creating a U.S.-based manufacturing supply chain for pharmaceutical and biotechnology innovators of COVID-19 vaccine candidates.
Under the task order, Emergent will deploy its molecule-to-market CDMO offering, committing manufacturing capacity, valued at approximately $542.7 million, for production of COVID-19 vaccine candidates through 2021. This award secures, on behalf of leading COVID-19 vaccine innovators that are supported by the U.S. government, capacity for drug substance manufacturing at the company’s Baltimore Bayview facility and for drug product manufacturing at the Baltimore Camden and Rockville locations. The task order also includes an investment of approximately $85.5 million for the rapid expansion of Emergent’s viral and non-viral CDMO drug product fill/finish capacity at the Baltimore Camden and Rockville facilities.
Emergent’s Baltimore Bayview CIADM facility was established through a public-private partnership with HHS in 2012 and was designed for rapid manufacturing of large quantities of vaccines and treatments during public health emergencies. The Baltimore Bayview facility has the capacity to produce tens to hundreds of millions of doses of vaccine on an annual basis, based upon the platform technology being used. The task order extends the CIADM collaboration to include viral and non-viral drug product fill/finish capabilities at Emergent’s Rockville and Baltimore Camden facilities. Activities under this task order are in addition to the company’s previously announced collaborations for COVID-19 vaccine candidates with the Janssen Pharmaceutical Companies of Johnson & Johnson, Novavax, and Vaxart that are currently underway.
“Emergent’s landmark partnership with BARDA puts us at the forefront of CDMO collaborations, elevating us to respond to these unprecedented times,” said Syed T. Husain, SVP and CDMO business unit head at Emergent. “This innovative solution paves the way for pharmaceutical and biotechnology innovators with leading COVID-19 vaccine candidates to have an established U.S. development and manufacturing supply chain. This investment in increased capacity and capabilities will serve the industry’s expanding clinical and commercial pipelines more broadly, ultimately benefiting more patients globally.”
The company will provide an update to its 2020 financial outlook incorporating expectations related to this task order and any other relevant information when it reports its second quarter financial results.
About Emergent BioSolutions
Emergent BioSolutions is a global life sciences company whose mission is to protect and enhance life. Through our specialty products and contract development and manufacturing services, we are dedicated to providing solutions that address public health threats. Through social responsibility, we aim to build healthier and safer communities. We aspire to deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. In working together, we envision protecting or enhancing 1 billion lives by 2030. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.
Emergent’s Response to COVID-19
Emergent BioSolutions is deploying its decades of experience in vaccine and hyperimmune development and manufacturing, as well as its molecule-to-market contract development and manufacturing (CDMO) services to provide comprehensive medical countermeasure solutions in response to the COVID-19 pandemic.
Using its established hyperimmune platforms, Emergent is developing two investigational plasma-based treatments - COVID-Human Immune Globulin (COVID-HIG) and COVID-Equine Immune Globulin (COVID-EIG). COVID-HIG is being developed as a human plasma-derived therapy candidate with $14.5 million in HHS funding, and will be evaluated in at least one of the studies of the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health, for potential treatment of COVID-19 in severe hospitalized and high-risk patients. COVID-EIG is being developed as an equine plasma-derived therapy candidate for potential treatment of severe disease in humans. Both candidates are anticipated to be in Phase 2 clinical studies in Q3 2020. These investigational products are not approved by the U.S. Food and Drug Administration and their safety and effectiveness have not been established.