ROCKVILLE, MD, USA I April 16, 2014 I 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.
SOURCE: Emergent BioSolutions
Post Views: 161
ROCKVILLE, MD, USA I April 16, 2014 I 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.
SOURCE: Emergent BioSolutions
Post Views: 161
