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Emergent BioSolutions Launches BioThrax.com, an Educational Website about BioThrax (Anthrax Vaccine Adsorbed) and Anthrax Disease

Website is a central resource for published data and updates to prescribing information relating to BioThrax, such as the new 5-dose schedule and intramuscular route of administration approved by FDA in December 2008ROCKVILLE, Md.–(BUSINESS WIRE)–May. 8, 2009– Emergent BioSolutions Inc. (NYSE:EBS) announced today the launch of www.biothrax.com, a website that provides information about BioThrax^® (Anthrax Vaccine Adsorbed), the only vaccine licensed by the U.S. Food and Drug Administration (FDA) for the prevention of anthrax infection. This new website educates visitors about key information on BioThrax, including published data and updates to prescribing information. In December 2008, the FDA approved the five-dose schedule and intramuscular route of administration for BioThrax.

“Information about recent product enhancements such as the five-dose schedule and intramuscular route of administration is made readily available on BioThrax.com,” said Dr. James Jackson, chief scientific officer of Emergent BioSolutions. “Emergent has developed this website to provide information about the threat of anthrax and to help individuals make informed decisions. BioThrax, the only FDA-licensed anthrax vaccine, is commercially available in the United States and in certain international markets. BioThrax.com provides a portal of information about the risk of infection and about protection through prevention,” he added.

BioThrax.com is designed to be a central resource for government entities, health professionals and vaccinees, including military personnel, emergency responders, and other individuals at high risk of exposure to anthrax. The website also provides facts on anthrax disease and the use of anthrax as a potential weapon of bioterrorism.

About BioThrax^®

BioThrax is the only FDA-licensed vaccine for the prevention of anthrax infection. It is indicated for the active immunization of adults who are at high risk of exposure to anthrax. BioThrax is manufactured from a culture filtrate, made from a non-virulent strain of Bacillus anthracis. Since 1998, the U.S. government has procured nearly 33.5 million doses of BioThrax. During that time period, more than 8.4 million doses have been administered to more than 2.1 million military personnel. For full FDA-approved prescribing information, please visit www.biothrax.com/prescribinginformation_biothrax_us.pdf.

Important Safety Information for BioThrax^®

The most common (>10%) local (injection-site) adverse reactions observed in clinical studies were tenderness, pain, erythema and arm motion limitation. The most common (>5%) systemic adverse reactions were muscle aches, fatigue and headache. Serious allergic reactions, including anaphylactic shock, have been observed during post-marketing surveillance in individuals receiving BioThrax.

Pregnant women should not be vaccinated unless the potential benefits of vaccination have been determined to outweigh the potential risk to the fetus. If BioThrax is used during pregnancy, or if the patient becomes pregnant during the immunization series, the patient should be apprised of the potential hazard to the fetus. This product should be administered with caution to persons with a possible history of latex sensitivity since the vial stopper contains dry natural rubber.

Vaccination with BioThrax should be avoided by individuals with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax.

About Emergent BioSolutions Inc.

Emergent BioSolutions Inc. is a biopharmaceutical company focused on the development, manufacture and commercialization of vaccines and 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 licensed by the U.S. Food and Drug Administration for the prevention of anthrax. Emergent’s development pipeline includes programs focused on anthrax, botulism, tuberculosis, typhoid, hepatitis B and chlamydia. Additional information may be found at www.emergentbiosolutions.com.

 

 

Source: Emergent BioSolutions Inc.