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Product Development Fact Sheet *AIGIV Is an Investigational Product Currently in Development

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Product Development Fact Sheet *AIGIV Is an Investigational Product Currently in Development FOR INTERNATIONAL USE ONLY WHERE PRODUCT IS NOT LICENSED. AIGIV * [Anthrax Immune Globulin Intravenous (Human)] Product Development Fact Sheet *AIGIV is an investigational product currently in development Disease Facts Anthrax is a potentially fatal disease caused by exposure to the spore-forming bacterium Bacillus anthracis. Routes for exposure include: cutaneous (exposure of cuts or scratches in the skin to anthrax spores); gastrointestinal (through consumption of spores in infected meat); or inhalational (by breathing spores into the lungs). Inhalational anthrax is the most deadly form of the disease, which can have fatality rates of up to 90 percent if left untreated. The major virulent components of anthrax bacteria consist of a capsule and two toxins composed of three proteins known as protective antigen (PA), lethal factor (LF), and edema factor (EF). Individually these proteins are not toxic, but the combination of PA with either LF or EF results in the formation of the anthrax lethal toxin and edema toxin, respectively. Delayed initiation of antibiotics may result in toxemia and subsequent death from the Bacillus anthracis exotoxins. Available FDA-licensed Countermeasures Several antibiotics are United States Food and Drug Administration (FDA) licensed for post exposure prophylaxis for the prevention of anthrax disease. A monoclonal antibody is FDA-licensed for the treatment of inhalational anthrax in combination with antibiotics and prophylaxis when other therapies are not available. AIGIV Therapy Candidate Overview Anthrax Immune Globulin Intravenous (Human) (AIGIV) is a human immune globulin product containing neutralizing polyclonal antibodies to the anthrax virulence component, PA, and may contain antibodies against other Bacillus anthracis proteins. AIGIV product: o specifically binds to and neutralizes the PA component of the toxin produced by Bacillus anthracis bacteria; it is being developed for treatment of toxemia associated with inhalational anthrax in adult and pediatric patients. o is prepared using pooled, fractionated plasma of screened individuals immunized with BioThrax® (Anthrax Vaccine Adsorbed). o is a sterile solution of purified gamma globulin (IgG) fraction, stabilized with 10% maltose and 0.03% Polysorbate 80. Each vial contains approximately 40 to 70 mg per mL total protein. o is formulated as a liquid frozen product for storage at ≤−15°C; stability data are available for storage up to 60 months. AIGIV is manufactured in accordance with cGMP using plasma from a collection program licensed by FDA. The United States Government stockpiles AIGIV for possible use under Emergency Use Authorization. AIGIV has been administered to a limited number of patients diagnosed with active anthrax disease. Due to the unpredictable and inconsistent nature of these anthrax cases, no conclusions regarding AIGIV efficacy in humans can be made at this time. Development Status AIGIV is designated as an Investigational New Drug with FDA and has been granted both Fast Track and Orphan Drug Status. FDA licensure is being pursued. The effectiveness of the AIGIV product is based solely on efficacy studies conducted in animal models of anthrax. AIGIV was found to be efficacious in protecting rats from anthrax LT exposure. Non-clinical efficacy studies in rabbits and Cynomolgus macaques exposed to 200 x LD50 of Bacillus anthracis spores by the aerosol route have been completed; each study showed a statistically significant enhancement in survival compared to the placebo. A Phase 1 human safety and pharmacokinetic study was completed in which AIGIV was well tolerated at all doses with no serious adverse events reported. Head to head comparison in animal studies suggested no interference with antibiotic efficacy. For additional information on AIGIV clinical trials please visit http://clinicaltrials.gov/. Development of AIGIV has been funded by the Biomedical Advanced Research and Development Authority (BARDA). Emergent BioSolutions Inc. Emergent BioSolutions Inc. is a specialty pharmaceutical company seeking to protect and enhance life by offering specialized products to healthcare providers and governments to address medical needs and emerging health threats. Emergent BioSolutions Inc. AIGIV is not currently licensed by the national regulatory agency of any country. 2273 Research Blvd, Suite 400 Cangene Corporation doing business as Emergent BioSolutions. Rockville, MD 20850, USA This fact sheet is provided in response to specific information requested. 866 300 7602 © 2014 All rights reserved. BioThrax® and any and all Emergent BioSolutions Inc. brand, [email protected] product, service and feature names, logos and slogans are trademarks or registered www.emergentbiosolutions.com trademarks of Emergent BioSolutions Inc. or its subsidiaries in the United States or other www.biothrax.com countries. .
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