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Emergent BioSolutions Initiates Development of Plasma-Derived Product Candidates for the Treatment and Prevention of Coronavirus Disease

• Human polyclonal hyperimmune with antibodies to SARS-CoV-2 (COVID-HIG) being developed as a potential treatment for severe hospitalized patients and protection for at-risk individuals
• Equine-derived polyclonal hyperimmune with antibodies to SARS-CoV-2 (COVID-EIG) being developed as a potential treatment for severe hospitalized patients

GAITHERSBURG, Md., March 11, 2020 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has initiated development of two product candidates for the treatment and prevention of coronavirus disease (COVID-19). These product candidates are being developed on Emergent’s hyperimmune platforms that have a well-established safety database. The hyperimmune platforms and related in-house manufacturing infrastructure support several products approved by the U.S. Food and Drug Administration, including the company’s treatments for smallpox vaccine complications, botulism, and anthrax, VIG [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV), BAT^® [Botulism Antitoxin Heptavalent (A, B, C, D, E, F, G) – (Equine)], and Anthrasil^® [Anthrax Immune Globulin Intravenous (Human)], respectively.

Robert G. Kramer Sr., president and chief executive officer at Emergent BioSolutions, stated, “As a company focused on public health threats, we are committed to responding to this novel coronavirus and will use our broad capabilities and platforms to advance solutions. On the heels of our collaboration with an industry partner to develop an experimental vaccine candidate for clinical testing, we are pleased to leverage our existing infrastructure to help expedite development of our product candidates for COVID-19, founded on our decades of experience in hyperimmune manufacturing.”

Hyperimmunes are polyclonal antibody therapeutics derived from plasma that leverage the immune response in humans or animals and can provide immediate protection from infection. COVID-HIG, manufactured from human plasma with antibodies to SARS-CoV-2, will be developed as a potential treatment for severe hospitalized patients as well as protection for at-risk individuals. In parallel, COVID-EIG, manufactured from plasma of immunized horses with antibodies to SARS-CoV-2, will be developed as a potential treatment for severe hospitalized patients.

“Emergent is advancing these programs based on our hyperimmune platforms and using existing infrastructure and capabilities that we deployed for our recently completed Phase 2 clinical trial for our influenza hyperimmune FLU-IGIV to treat patients hospitalized with Influenza A,” said Laura Saward, senior vice president and therapeutics business unit head at Emergent BioSolutions. “By leveraging our platform and capabilities that are already in place, Emergent is in a state of readiness to develop treatment options for COVID-19 to potentially protect healthcare workers and others on the frontline, as well as treat individuals who have fallen ill.”

Emergent has initiated plasma collection efforts for both human and equine platforms with a goal of manufacturing clinical material within the next four to five months in anticipation of beginning a clinical study as early as the third quarter of 2020.

The company’s hyperimmune specialty plasma product manufacturing platform has been used to create multiple products that have obtained FDA and Health Canada approval. Emergent’s marketed antibody therapeutics, including VIG, a treatment for smallpox vaccine complications, and Anthrasil^®, a treatment for anthrax, are based on the human hyperimmune platform, while BAT^®, the company’s botulism anti-toxin, was developed on the equine hyperimmune platform.

About Emergent BioSolutions
As a global life sciences company whose mission is to protect and enhance life, we provide solutions that target public health threats. Through our specialty products and services as well as our social responsibility efforts, we aspire to build healthier, safer communities and deliver peace of mind to our patients and customers so they can focus on what’s most important in their lives. For more information visit www.emergentbiosolutions.com. Find us on LinkedIn and follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

Safe Harbor Statement
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Any statements, other than statements of historical fact, including statements regarding our ability to advance potential solutions to combat coronavirus disease using our existing platforms and respond rapidly to a related public health emergency, as well as the anticipated production, timing, and use of COVID-19 product candidates for clinical testing are forward-looking statements. These forward-looking statements are based on our current intentions, beliefs and expectations regarding future events. We cannot guarantee that any forward-looking statement will be accurate. Investors should realize that if underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could differ materially from our expectations. Investors are, therefore, cautioned not to place undue reliance on any forward-looking statement. Any forward-looking statement speaks only as of the date of this press release, and, except as required by law, we do not undertake to update any forward-looking statement to reflect new information, events or circumstances.

There are a number of important factors that could cause the company’s actual results to differ materially from those indicated by such forward-looking statements, including the success of the planned development programs; the timing of and ability to obtain and maintain regulatory approvals for related product candidates; and our commercialization, marketing and manufacturing capabilities. The foregoing sets forth many, but not all, of the factors that could cause actual results to differ from our expectations in any forward-looking statement. Investors should consider this cautionary statement, as well as the risk factors identified in our periodic reports filed with the SEC, when evaluating our forward-looking statements.