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Emergent BioSolutions Acquires Monoclonal Anthrax Product Candidate

Acquisition Represents Important Addition to Company’s Portfolio of Anthrax Countermeasures
ROCKVILLE, Md., Mar 06, 2008 (BUSINESS WIRE) — Emergent BioSolutions Inc. (NYSE:EBS) announced that today it completed the acquisition of a group of anthrax monoclonal antibodies from AVANIR Pharmaceuticals (NASDAQ:AVNR), including AVANIR’s lead product candidate, AVP-21D9.

AVP-21D9 is a human monoclonal antibody product candidate that is being developed as an intravenous treatment for patients who present with symptoms of anthrax disease following exposure to Bacillus anthracis. In non-clinical studies, this candidate demonstrated an ability to protect animals challenged with a lethal dose of inhaled anthrax spores. AVP-21D9 is being developed with funding support from the National Institute of Allergy and Infectious Diseases of the National Institutes of Health (NIAID), including a grant to establish a cGMP manufacturing process and to test efficacy in additional inhalation studies.

“The acquisition of AVANIR’s monoclonal anthrax antibodies rounds out our anthrax countermeasure program nicely. In addition to our FDA-approved product, BioThrax(R) (Anthrax Vaccine Adsorbed), which is indicated for pre-exposure prevention of anthrax in individuals at high risk of exposure to anthrax spores, we are developing a polyclonal anthrax immune globulin therapeutic, which is a human plasma-derived product candidate. Now, as a result of this acquisition, we have another anthrax therapeutic in our product portfolio – a new monoclonal anthrax antibody product candidate that has performed well in proof-of-concept studies,” said Fuad El-Hibri, chairman and chief executive officer of Emergent BioSolutions. “This transaction reflects our ongoing commitment to develop a full portfolio of countermeasures to strengthen our country’s preparedness in the event of future anthrax attacks.”

The U.S. government is funding the development of, and seeking to procure, two types of treatments for inhalational anthrax disease: polyclonal antibody products, also known as immune globulins, and monoclonal antibody products. Emergent BioSolutions currently is developing a polyclonal anthrax immune globulin (AIG) product, which is being manufactured by Talecris Biotherapeutics, Inc., at its FDA-approved production facilities. Two full-scale lots of this product candidate have been manufactured under current good manufacturing practices at Talecris, and we plan to conduct pivotal human and animal studies in 2008 and 2009, which could position us for a procurement contract as early as next year. NIAID has provided us grant funding of up to $13.4 million for a combination of initiatives relating to our AIG product candidate, including non-clinical efficacy studies and a human safety and pharmacokinetics study.

We intend to pursue additional NIAID development funding for both of our anthrax therapeutic product candidates, and we believe that both therapeutics would be eligible to be procured by the U.S. Department of Health and Human Service for inclusion in the SNS prior to receiving marketing approval, provided that they are deemed to be licensable under Project BioShield.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a profitable, multinational 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 products target infectious diseases and other medical conditions that have resulted in significant unmet or underserved public health needs. 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 infection. More information on the company is available 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, 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; 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.

SOURCE: Emergent BioSolutions Inc.