ROCKVILLE, Md., Jun 09, 2011 --  Emergent BioSolutions Inc. (NYSE:EBS) announced today that its investigational  anthrax vaccine, NuThraxTM (Anthrax Vaccine Adsorbed with CPG 7909 Adjuvant), has been granted Fast Track Designation by the U.S. Food and Drug Administration (FDA). The vaccine candidate, also  known as AV7909, consists of BioThrax(R) (Anthrax Vaccine Adsorbed)  in combination with a novel immunostimulatoryoligodeoxynucleotide compound, CPG  7909, and is currently being evaluated in a Phase 1b clinical trial for safety,  tolerability, and immunogenicity. The FDA's Fast Track Development Program  provides for expedited regulatory review of drugs and biologics that treat  serious or life threatening diseases and that demonstrate the potential to  address unmet medical needs. 
  "Emergent is pleased to receive  Fast Track Designation for NuThrax," said Daniel J. Abdun-Nabi, president  and chief operating officer of Emergent BioSolutions. "Expedited  regulatory review could mean more frequent communications with FDA, priority  review of Biologics License Applications (BLA) for our vaccine, and a rolling BLA submission, which allows  FDA to review sections of the BLA in advance of receiving the complete  submission." 
  The Phase 1b trial for NuThrax is  being conducted with support from a development contract that is jointly  administered under contract number HHSN272200800051C by the National Institute  of Allergy and Infectious Diseases (NIAID), a component of the National  Institutes of Health (NIH), and the Office of the Biomedical Advanced Research  and Development Authority (BARDA) of the Department of Health and Human Services  (HHS). 
  About Emergent BioSolutions Inc. 
  Emergent BioSolutions, led by  Chairman and CEO Fuad El-Hibri, protects and enhances life by developing and manufacturing  vaccines and therapeutics that are supplied to healthcare providers and  purchasers for use in preventing and treating disease. Emergent's marketed and  investigational products target infectious diseases, oncology, and autoimmune  disorders. Additional information about the company may be found at www.emergentbiosolutions.com. 
  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, future financial position, future revenues, projected costs,  prospects, plans and objectives of management, including any potential future  securities offering, our expected revenue growth and net earnings for 2011, and  any other statements containing the words "believes",  "expects", "anticipates", "plans", "estimates",  "may", "would", "will", and similar expressions,  are forward-looking statements. 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  preclinical studies and clinical trials of our product candidates and  post-approval clinical utility of our products; the rate and degree of market  acceptance 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 other product candidates; our plans to pursue label  expansions and improvements for BioThrax; our commercialization, marketing and  manufacturing capabilities and strategy; our estimates regarding expenses,  future revenue, capital requirements and needs for additional financing; and  other factors identified in the company's Quarterly Report on Form 10-Q for the  quarter ended March 31, 2011 and subsequent reports filed with the SEC. The  company disclaims any intention or obligation to update any forward-looking  statements as a result of developments occurring after the date of this press  release. 
  SOURCE: Emergent BioSolutions Inc.