Emergent BioSolutions Inc. (NYSE: EBS) today announced the initiation of a Phase 2 clinical trial for NuThrax TM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), also known as AV7909, with the dosing of the first subject. NuThrax, a next generation vaccine being developed as part of Emergent's anthrax franchise, consists of Anthrax Vaccine Adsorbed in combination with a novel immunostimulatory adjuvant, CPG 7909. “Emergent is pleased to initiate this Phase 2 clinical trial of NuThrax, which supports the near-term goal and priority of the U.S. Department of Health and Human Services (HHS) to develop next generation anthrax vaccines with advanced characteristics such as requiring fewer doses and generating an enhanced immune response,” said Adam Havey, EVP and president of the biodefense division at Emergent BioSolutions. “We thank HHS for their continued trust and partnership as we work together to accomplish elements of its Public Health Emergency Medical Countermeasures Enterprise Implementation Plan set forth to strengthen the nation’s biodefense capabilities.” The Phase 2 clinical trial, a randomized, parallel-group, active-controlled, double-blind study, is designed to evaluate the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using two and three dose immunization schedules and two dose levels. The study is being conducted in multiple sites within the U.S. and plans to enroll 168 healthy adult volunteers. Preliminary data from this study are expected in the fourth quarter of 2013. Emergent has submitted to the U.S. Food and Drug Administration the Clinical Study Report for the Phase 1 study, which evaluated the safety and immunogenicity of NuThrax for post-exposure prophylaxis of anthrax infection using a two dose immunization schedule and four formulations. This Phase 2 clinical trial is being conducted with support from the National Institute of Allergy and Infectious Diseases (NIAID), part of the National Institutes of Health (NIH) of HHS, under development contract number HHSN272201000035C. The Phase 1 trial was conducted with support from a development contract jointly administered under contract number HHSN272200800051C by NIAID and the Office of the Biomedical Advanced Research and Development Authority (BARDA), a component of the Office of the Assistant Secretary for Preparedness and Response (ASPR), HHS.
About Emergent BioSolutionsEmergent 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. 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.