Emergent BioSolutions Release: New Studies Conclude BioThrax(R) Plus Antibiotics Provide 100% Protection In Animals When Administered After Anthrax Exposure

GAITHERSBURG, Md., Jan. 10 /PRNewswire/ -- Two separate government- sponsored studies demonstrated that BioThrax (Anthrax Vaccine Adsorbed), the world’s only FDA-licensed anthrax vaccine produced by Emergent BioSolutions Inc., provided 100% protection against death in anthrax-infected animals treated with BioThrax combined with antibiotics. This was a significant improvement over antibiotic treatment alone.

“These studies demonstrated that post-exposure vaccination enhanced the protection afforded by antibiotic prophylaxis alone,” said Fuad El-Hibri, Chairman and Chief Executive Officer of Emergent BioSolutions Inc. “The addition of BioThrax to antibiotic therapy protected animals against inhalational anthrax and provided evidence that post-exposure vaccination can shorten the duration of antibiotic prophylaxis required. This approach has the ability to significantly improve public health management following a bioterrorism event.”

In a study performed at USAMRIID (United States Army Medical Research Institute of Infectious Disease) and sponsored by NIAID (National Institute of Allergy and Infectious Disease) and the Medical Biological Defense Research Program, U.S. Army Medical Research and Materiel Command, Fort Detrick, MD, it was shown that in non-human primates infected by aerosol exposure with 1600 times the lethal dose of spores treated with a 14-day course of antibiotics alone, significant mortality was seen after antibiotics were discontinued. Antibiotic therapy in combination with post-infection BioThrax vaccination using the licensed schedule provided protection against death in 100% of the animals tested (10 of 10). These study results were presented in October at the 43rd Annual Meeting of the Infectious Disease Society of America.

Preliminary results from a similar study performed in rabbits, sponsored by NIAID (National Institute of Allergy and Infectious Disease) and performed at Battelle Memorial Institute, indicate the animals were protected against death when treated with BioThrax plus antibiotics after aerosol exposure to anthrax spores, under conditions where antibiotic prophylaxis alone was only partially protective.

“These studies provide the strongest evidence to date that a combination of BioThrax and antibiotics is an effective way to treat inhalational anthrax in a post-exposure setting and strengthens support for Emergency Use Authorization of BioThrax in the event of another anthrax attack,” said El-Hibri. “These results provide further supports our ongoing program to modify the licensed indication for to include post-exposure prophylaxis.”

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is dedicated to the development and manufacture of immunobiotics(TM) -- novel products that direct the immune system to prevent and treat life-threatening diseases. These include products for prophylactic and therapeutic use against common infectious diseases and against biological weapons. The company currently employs more than 400 people with facilities in Gaithersburg and Frederick, Maryland; Lansing, Michigan; Berkshire, UK, and Munich, Germany. More information about Emergent BioSolutions and its subsidiaries can be found at http://www.ebsi.com .

Emergent BioSolutions

CONTACT: Kim Brennen Root of Emergent BioSolutions, +1-517-749-3265,rootk@bioport.com

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