Emergent BioSolutions Announces Commencement Of Phase I/II Clinical Trial Of Anthrax Immune Globulin For Treating Anthrax Disease

Main Category: Bio-terrorism / Terrorism
Also Included In: Clinical Trials / Drug Trials
Article Date: 19 Mar 2009 - 2:00 PDT

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Emergent BioSolutions Inc. (NYSE:EBS) announced that the Phase I/II clinical trial for its Anthrax Immune Globulin (AIG) therapeutic candidate has commenced with the initial treatment given to the first subject. AIG, which is intended for the treatment of inhalational anthrax disease, is the company's polyclonal therapeutic candidate developed using plasma collected from healthy donors, who have been vaccinated with Emergent's BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine approved by the U.S. Food and Drug Administration (FDA) for the prevention of anthrax infection.

"The initiation of this clinical trial is a significant milestone that marks our continued commitment to the AIG program and to the expansion of our anthrax product franchise," said Dr. Stephen Lockhart, Senior Vice President Product Development of Emergent BioSolutions. "AIG is an integral component of our efforts to develop safe and effective treatments for patients to be used in the event of a biological attack."

The clinical trial will evaluate the safety and pharmacokinetics of AIG in 120 healthy adult volunteers. The study is designed to evaluate three dose levels of a single intravenous infusion of AIG compared to GAMUNEX®*, a licensed immune globulin therapy for people with primary immunodeficiency or idiopathic thrombocytopenic purpura. AIG is manufactured using the FDA-approved GAMUNEX process. In addition, a fourth cohort receiving two intravenous infusions of AIG or GAMUNEX at equivalent doses administered two days apart will be evaluated.

Emergent BioSolutions received concurrence from the FDA and approval from an Institutional Review Board on January 23, 2009 to begin this clinical trial. The clinical trial will be conducted at SNBL Clinical Pharmacology Center, a state-of-the-art clinical trial unit located in Baltimore, Maryland. This project has been funded in whole or in part with Federal funds from the Biomedical Advanced Research and Development Authority, Department of Health and Human Services, in conjunction with the National Institute of Allergy and Infectious Diseases, National Institutes of Health, Department of Health and Human Services, under Contract No HHSN272200700034.

For more information about the AIG clinical trial, visit http://www.ClinicalTrials.gov.

About Anthrax Immune Globulin

Emergent BioSolutions' Anthrax Immune Globulin (AIG) is being developed as an intravenous therapeutic for treatment of patients who present with symptoms of anthrax disease resulting from the release of anthrax toxins into the body. If successfully developed, AIG could be prescribed for administration in these circumstances in conjunction with antibiotics.

AIG is being developed using plasma collected from healthy donors who have been vaccinated with BioThrax® (Anthrax Vaccine Adsorbed), the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax infection.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and immune-related therapeutics that assist the body's immune system to prevent or treat disease. Emergent's marketed product, BioThrax® (Anthrax Vaccine Adsorbed), is the only vaccine approved by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent's development pipeline includes programs focused on anthrax, botulism, typhoid, tuberculosis, hepatitis B and chlamydia. Additional information may be found at http://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, 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 success of our clinical programs; our plans to expand our manufacturing facilities and capabilities; the rate and degree of market acceptance and clinical utility of our products; the timing of and our ability to obtain and maintain regulatory approvals for our other product candidates; 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 annual report on Form 10-K for the year ended December 31, 2008 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.

* GAMUNEX® is a registered trademark of Talecris Biotherapeutics, Inc.

Source
Emergent BioSolutions Inc.