BioThrax® [Anthrax Vaccine Adsorbed], is the only vaccine approved by the US Food and Drug Administration (FDA) for the prevention of anthrax infection in individuals at high risk of exposure to B. anthracis. The company currently employs approximately 450 people with sites in Maryland, Michigan, the United Kingdom, Germany and the Republic of Singapore.

INDICATIONS AND USAGE
BioThrax is indicated for the active immunization against Bacillus anthracis of individuals between 18 and 65 years of age who come in contact with animal products such as hides, hair or bones that come from anthrax endemic areas, and that may be contaminated with Bacillus anthracis spores. BioThrax is also indicated for individuals at high risk of exposure to Bacillus anthracis spores such as veterinarians, laboratory workers and others whose occupation may involve handling potentially infected animals or other contaminated materials.

Since the risk of anthrax infection in the general population is low, routine immunization is not recommended. The safety and efficacy of BioThrax in a post-exposure setting has not been established.

CONTRAINDICATIONS
The use of BioThrax is contraindicated in subjects with a history of anaphylactic or anaphylactic-like reaction following a previous dose of BioThrax, or any of the vaccine components.

Epidemiology
Anthrax occurs globally and is most common in agricultural regions with inadequate control programs for anthrax in livestock. Anthrax is a zoonotic disease caused by the Gram-positive, spore-forming bacterium Bacillus anthracis. The spore form of Bacillus anthracis is the predominant phase of the bacterium in the environment and it is largely through the upt ake of spores that anthrax disease is contracted. Spore forms are markedly resistant to heat, cold, pH, desiccation, chemicals and irradiation. Following germination at the site of infection, the bacilli can also enter the blood and lead to septicemia. Antibiotics are effective against the germinated form of Bacillus anthracis, but are not effective against the spore form of the organism.

The disease occurs most commonly in wild and domestic animals, primarily cattle, sheep, goats and other herbivores. In humans, anthrax disease can result from contact with animal hides, leather or hair products from contaminated animals, or from other exposures to Bacillus anthracis spores. It occurs in three forms depending upon the route of infection: cutaneous anthrax, gastrointestinal anthrax and inhalation anthrax.