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Emergent BioSolutions Initiates NIAID-Funded Phase 1b Clinical Study to Evaluate Broad-Spectrum Antiviral UV-4B for Dengue

GAITHERSBURG, Md., Feb. 01, 2017 (GLOBE NEWSWIRE) -- Emergent BioSolutions Inc. (NYSE:EBS) today announced the initiation of a Phase 1b multiple ascending dose study to evaluate the safety and tolerability of UV-4B, the company’s novel antiviral candidate being developed as a potential oral treatment for dengue viral infection. This study, which will enroll 40 healthy adults in U.S. sites, follows a successful Phase 1a single ascending dose clinical study completed in 2016. Preclinical studies have shown that UV-4B is active in vitro against all four dengue virus subtypes and in vivo studies have shown improved survival even when dosing was delayed by up to 48 hours post-infection.

Adam Havey, executive vice president and president, biodefense division of Emergent BioSolutions, stated, “Emergent is pleased to announce the initiation of our Phase 1b clinical study. With Emergent’s sharpened focus on preventing and treating public health threats and emerging infectious diseases, we will leverage our growing anti-infectives platform technologies and expertise in development and manufacturing to help find solutions to these threats.”      

UV-4B is the lead dengue virus therapeutic candidate in Emergent’s iminosugar library. Iminosugars are small molecule therapeutics that target host glycosidase enzymes leading to reduced virus infectivity in multiple viruses such as dengue, Zika, SARS, and influenza. This novel host-based mechanism of action allows the potential for broad-spectrum application and a reduced probability of developing drug resistance.

According to the Centers for Disease Control and Prevention, dengue is a leading cause of illness and death in the tropics and subtropics. There are 100 endemic countries with 400 million new infections annually. Currently, there are no available treatments for dengue.

This study is fully funded under development contract HHSN272201100030C with the National Institute of Allergy and Infectious Diseases, part of the National Institutes of Health of the U.S. Department of Health and Human Services.

About Emergent BioSolutions
Emergent BioSolutions is a global specialty biopharmaceutical company dedicated to one simple mission—to protect and enhance life. We develop, manufacture, and deliver a portfolio of medical countermeasures for biological and chemical threats as well as emerging infectious diseases. 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 @emergentbiosolu.

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, 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 availability of funding; the success of the planned development programs; the timing of and ability to obtain and maintain regulatory approvals for the product candidates; 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.

Investor Contact:
Robert G. Burrows
Vice President, Investor Relations
240-631-3280
BurrowsR@ebsi.com

Media Contact:
Tracey Schmitt Lintott
Senior Vice President, Global Public Affairs
240-631-3281
SchmittT@ebsi.com

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