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Emergent BioSolutions Completes Clinical Study in Support of a Post-Exposure Prophylaxis Indication for BioThrax(R) (Anthrax Vaccine Adsorbed)

Milestone triggers $8.8 million payment from Department of Health and Human Services under recently announced $448 million contract

ROCKVILLE, Md.--(BUSINESS WIRE)--Nov. 5, 2007--Emergent BioSolutions Inc. (NYSE:EBS) announced today that it has completed a human clinical study that will be used to support expanding the indication for BioThrax(R) (Anthrax Vaccine Adsorbed) to include post-exposure prophylaxis (PEP) for the treatment of individuals exposed to anthrax. The company has also submitted a final study report for this clinical trial to the Department of Health and Human Services (HHS) which triggers a payment of $8.8 million from HHS under the terms of the $448 million dollar contract announced on September 26th of this year. This clinical trial focused on the immunogenicity of a three-dose BioThrax regimen when used for post-exposure prophylaxis in adults.

"We are very pleased to have reached this contract milestone in our pursuit of achieving a PEP indication for BioThrax. We recognize how significant the development of a post-exposure prophylaxis indication is to fulfilling our mission to protect life. HHS shares our commitment to this important project and we are grateful for their support as we continue to make progress on this critical program," said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions.

The primary objective of the clinical trial was to determine the timing and peak of the immune response following three doses of BioThrax for PEP. This study, together with non-clinical and clinical studies planned during 2008, is intended to support a proposed application to the U.S. Food and Drug Administration to expand the approved indication for BioThrax to include PEP.

About BioThrax(R) (Anthrax Vaccine Adsorbed)

BioThrax is the only FDA-approved vaccine for the prevention of anthrax infection. It is approved 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 subcutaneous injection in three initial doses followed by three additional doses, with an annual booster dose recommended thereafter. Since 1998, approximately 20 million doses of BioThrax have been procured by the U.S. government. During that time period, over 6.5 million doses have been administered to over 1.6 million military personnel. BioThrax cannot cause anthrax infection.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company dedicated to one simple mission -- to protect life. We develop, manufacture and commercialize immunobiotics, consisting of vaccines and therapeutics that assist the body's immune system to prevent or treat disease. Our biodefense business focuses on immunobiotics for use against biological agents that are potential weapons of bioterrorism and biowarfare. Our 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 disease. Our commercial business focuses on immunobiotics for use against infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. More information on the company is available at

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, prospects, plans and objectives of management, including clinical trial results and development plans, and any other statements containing the words "believes", "expects", "anticipates", "plans", "estimates" 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 rate and degree of market acceptance and clinical utility of our products; our ongoing and planned development programs, preclinical studies and clinical trials, including future clinical data for our typhoid vaccine candidate; our ability to identify and acquire or in-license products and product candidates that satisfy our selection criteria; the potential benefits of our existing collaboration agreements and our ability to enter into selective additional collaboration arrangements; the timing of and our ability to obtain and maintain regulatory approvals for our product candidates; our commercialization, marketing and manufacturing capabilities and strategy; our intellectual property portfolio; 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 September 30, 2007 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.

CONTACT: Emergent BioSolutions Inc.
Investors Contact:
Robert G. Burrows
Vice President, Investor Relations
Media Contact:
Tracey Schmitt
Director, Corporate Communications

SOURCE: Emergent BioSolutions Inc.