Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application

Emergent BioSolutions Receives FDA Approval for BioThrax Supplemental Biologics License Application

Reduced Dosage and Intramuscular Administration Approved

ROCKVILLE, Md., Dec 19, 2008 — Emergent BioSolutions Inc. (NYSE:EBS) announced today that the U.S. Food and Drug Administration (FDA) has approved Emergent's supplemental Biologics License Application (sBLA) for Anthrax Vaccine Adsorbed (BioThrax(R)), the only FDA-licensed vaccine to prevent disease caused by Bacillus anthracis. The supplement provides for a change in the route of administration and a reduction in the total number of vaccinations. The new schedule for BioThrax is five intramuscular (IM) doses at 0, 1, 6, 12 and 18 months, compared with the former schedule of six subcutaneous (SC) doses at 0, 2 weeks and 1, 6, 12, 18 months. The sBLA was based on results from a planned interim analysis of data from a large multicenter study initiated by CDC in 2002. This study is designed to evaluate whether as few as three doses of BioThrax administered over six months, with booster doses up to three years apart, will confer an adequate immune response. CDC will complete further data analysis in 2009, and Emergent may submit a new sBLA to allow for further reduction in the number of required doses if supported by the data.

Daniel Abdun-Nabi, chief operating officer and president of Emergent BioSolutions said, "Today's announcement is an exciting milestone in our continued mission to advance BioThrax. We are pleased that the U.S. Government shares our commitment to enhancing this critical countermeasure. The CDC is to be applauded for their hard work and diligence throughout this important effort."

About BioThrax(R) (Anthrax Vaccine Adsorbed)

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is licensed by the FDA as a pre-exposure prophylaxis for use in adults who are at high risk of exposure to anthrax spores. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Baccillus anthracis and contains no dead or live bacteria. BioThrax is administered by intramuscular injection in five doses, with an annual booster dose recommended thereafter. Since 1998, the U.S. government has procured nearly 32 million doses of BioThrax. During that time period, nearly 7.9 million doses have been administered to more than two million military personnel. BioThrax cannot cause anthrax infection. Please visit http://www.emergentbiosolutions.com/pdf/emergent_biothrax_us.pdf for full prescribing information.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of immune-related biologic products, consisting of vaccines and therapeutics that assist the body's immune system to prevent or treat disease. Emergent's marketed product, BioThrax(R) (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection. Emergent's clinical pipeline includes programs focused on anthrax, botulism, typhoid, tuberculosis, hepatitis B and chlamydia.