ROCKVILLE, Md.--(BUSINESS WIRE)--Emergent BioSolutions Inc. (NYSE: EBS) today announced the initiation of a Phase 2 study designed to evaluate non-interference of BioThrax® (Anthrax Vaccine Adsorbed) when administered in conjunction with antibiotics. This non-interference study will be used to support a supplemental Biologics License Application seeking licensure of a Post-Exposure Prophylaxis (PEP) indication for BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. Currently, BioThrax is licensed for a pre-exposure prophylaxis indication only.
"Emergent continues to advance its BioThrax Post-Exposure Prophylaxis program to enhance the clinical utility of BioThrax, the only vaccine licensed by the U.S. Food and Drug Administration for the active immunization against anthrax disease," said Adam Havey, EVP and president of the biodefense division at Emergent BioSolutions. "Inhalation anthrax is highly lethal when left untreated. Through our partnership with the Biomedical Advanced Research and Development Authority (BARDA), we are exploring how our vaccine can fit in the current PEP treatment regimen, which consists of only oral antibiotics. We remain committed to working in partnership with BARDA to advance critical countermeasures that help ensure the nation's preparedness."
The primary objective of this Phase 2, randomized, open label study is to evaluate any impact of the vaccine on ciprofloxacin by administering the antibiotic prior to and following the administration of a 3-dose series of BioThrax. The study, which will enroll 120 healthy adult volunteers and is being conducted in multiple sites within the U.S., will also provide additional safety data on the concurrent administration of ciprofloxacin and BioThrax. Preliminary data from this study are expected in the fourth quarter of 2013.
This study is fully funded under contract number HHSO100200700037C provided by BARDA within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services.
About Emergent BioSolutions
Emergent BioSolutions is a specialty pharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Additional information may be found at www.emergentbiosolutions.com. Follow us on twitter: @emergentbiosolu.
BioThrax is the only FDA-licensed vaccine for the prevention of anthrax disease. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. The safety and efficacy of BioThrax in a post-exposure setting have not been established. Individuals are not considered protected until they have completed the three-dose primary immunization series. Vaccination with BioThrax may not protect all individuals.
BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. To date, Emergent has delivered over 66 million doses of BioThrax to the U.S. government and continues to deliver additional doses under active procurement contracts. Since 1998, over 11 million doses have been administered to more than 2.9 million military personnel. For full prescribing information, please visit http://www.biothrax.com/prescribinginformation_biothrax_us.pdf.
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 strategy, future operations, prospects, plans and objectives of management, and any other statements containing the words "believes", "expects", "anticipates", "intends", "plans", "estimates" and similar expressions, 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 our ongoing and planned preclinical studies and clinical trials; the rate and degree of market acceptance and clinical utility of our products; the success of our ongoing and planned development programs; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; and our estimates regarding expenses, future revenue, capital requirements and needs for additional financing. 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.
Robert G. Burrows
Vice President, Investor Relations
Vice President, Corporate Communications
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