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Emergent BioSolutions Initiates Phase 2 Clinical Study to Evaluate FLU-IGIV to Treat Serious Influenza A Infection

GAITHERSBURG, Md., Jan. 04, 2018 (GLOBE NEWSWIRE) — Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 2 dose ranging study to evaluate the safety, pharmacokinetics, and clinical benefit of FLU-IGIV, the company’s anti-influenza immune globulin being developed as an intravenous treatment for serious illness caused by influenza A infection in hospitalized patients.

“Seasonal influenza remains a significant disease burden worldwide that can result in severe disease, hospitalization, and even mortality in vulnerable populations such as the elderly. In our quest towards our mission – to protect and enhance life – Emergent has an opportunity to progress a novel therapeutic that could potentially address this unmet need,” said Dr. Laura Saward, senior vice president and antibody therapeutics business unit head at Emergent BioSolutions. “The use of immune globulins with high neutralizing titers against the influenza virus is being considered as a complementary strategy to treat influenza virus infection and improve outcomes in the hospitalized patient population. FLU-IGIV is being developed by Emergent as a polyclonal antibody therapeutic on our established hyperimmune manufacturing platform.”

This Phase 2 clinical study will enroll approximately 75 adult patients hospitalized with serious illness caused by influenza A infection in up to 50 sites within the U.S. The study will evaluate FLU-IGIV in conjunction with standard of care, including a minimum five-day course of an anti-viral drug.

FLU-IGIV is a purified immunoglobulin containing a standardized amount of antibody to influenza A virus. It is developed on the company’s hyperimmune platform, on which several marketed antibody therapeutics have been licensed, including Emergent’s Anthrasil [Anthrax Immune Globulin Intravenous (Human)] and VIG [Vaccinia Immune Globulin Intravenous (Human)] (VIGIV).

About Emergent BioSolutions
Emergent BioSolutions Inc. is a global life sciences company seeking to protect and enhance life by focusing on providing specialty products for civilian and military populations that address accidental, intentional, and naturally emerging public health threats. Through our work, we envision protecting and enhancing 50 million lives with our products by 2025. Additional information about the company may be found at www.emergentbiosolutions.com. Follow us on Twitter @emergentbiosolu and Instagram @life_at_emergent.

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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, 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 program; the timing of and ability to obtain and maintain regulatory approvals for the product candidate; and 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.