Emergent BioSolutions initiates Phase 2 study to evaluate BioThrax Emergent BioSolutions announced the initiation of a Phase 2 study designed to evaluate non-interference of BioThrax 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 indication for BioThrax to be used in combination with antibiotics in people suspected to have been exposed to anthrax spores. The primary objective of this Phase 2 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. Preliminary data from this study are expected in the fourth quarter of 2013.
Emergent BioSolutions reaffirms outlook for 2015 Emergent BioSolutions reaffirms its previous 2015 forecast of total revenues of $510M-$540M, driven by BioThrax sales which are anticipated to be between $270M-$285M. The company also forecasts full year 2015 GAAP net income of $50M-$60M and adjusted net income of $60M-$70M.
Emergent BioSolutions resumes full manufacturing operations of BioThrax Emergent BioSolutions announced that it has resumed full manufacturing operations of BioThrax after completing its internal manufacturing investigation of foreign particles discovered in a limited number of vials in two manufactured BioThrax lots. It stated, "Following a comprehensive assessment, the company has identified a supplier component as the most probable root cause. As a result, the company is implementing certain targeted corrective and preventive actions in the operations of its suppliers and contract manufacturers, as well as its own operations. The investigation concluded that there was no impact to any BioThrax in distribution or to any of the company's other products or manufacturing operations, including the company's Building 55 operations and plans for licensure."