View printer-friendly version

Download PDF

Emergent BioSolutions Successfully Completes Pivotal Clinical Study to Support Expanded Indication for BioThrax

ROCKVILLE, Md.–(BUSINESS WIRE)–Apr. 16, 2014– Emergent BioSolutions Inc. (NYSE:EBS) today announced successful completion of the last licensure-enabling study in its BioThrax^® (Anthrax Vaccine Adsorbed) Post-Exposure Prophylaxis (PEP) program. This clinical study, also known as the non-interference study, was designed to evaluate the pharmacokinetic profile of the antimicrobial ciprofloxacin when administered prior to and following the administration of a three-dose series of BioThrax. It was also designed to evaluate the immune response to BioThrax when administered with or without ciprofloxacin. The primary endpoints were the ratio of the maximum concentration (Cmax) and area under the curve (AUC) for ciprofloxacin and the secondary endpoint was the ratio of the geometric mean titer of the antibody response to BioThrax two weeks following the last dose. The study met the prospectively defined success criteria for both the primary and secondary endpoints. Data from this study show no interaction between ciprofloxacin and BioThrax.

Emergent has submitted the final clinical study report to the Biomedical Advanced Research and Development Authority (BARDA) and the U.S. Food and Drug Administration (FDA). Results from this study will be used to support a supplemental Biologics License Application (sBLA) seeking licensure of a PEP indication for BioThrax to be used in combination with antibiotics in people with suspected or confirmed exposure to anthrax spores. BioThrax is currently licensed for a pre-exposure prophylaxis indication only.

“Emergent is pleased with the positive results of this non-interference study and BARDA’s approval of the final clinical study report, which is a contractual milestone in our BioThrax PEP program,” said Adam Havey, executive vice president and president, biodefense division at Emergent BioSolutions. “We look forward to having a pre-BLA meeting with FDA this quarter and submitting the supplemental application for a PEP indication for BioThrax in the fourth quarter.”

The BioThrax PEP program is a multi-year effort aimed at completing animal and human studies and seeking licensure under FDA’s Animal Rule. In 2013, Emergent’s pivotal clinical study evaluating the immunogenicity and safety of a three-dose BioThrax regimen for PEP met its primary and key secondary endpoints. Results from this pivotal study, published in the April 17, 2014 issue of the journal Vaccine, will also be used to support Emergent’s sBLA submission.

Both studies are 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.

About BioThrax

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 12 million doses have been administered to more than 3 million military personnel. For full prescribing information, please visit http://www.biothrax.com/prescribinginformation_biothrax_us.pdf.

BioThrax^® and any and all Emergent BioSolutions Inc. brand, product, service and feature names, logos and slogans are trademarks or registered trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other countries. All rights reserved.

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.

Source: Emergent BioSolutions Inc.