Investing in biodefense companies, II

and treatment are critical for successful outcome. To highlight the issue, even with aggressive antibiotic therapy five of the eleven victims of the 2001 anthrax postal attacks died.  Ciprofloxacin, doxycycline, and penicillin are FDA-approved antibiotics for the treatment of anthrax. Combination therapy with additional antibiotics is recommended for treatment of both inhalational and cutaneous anthrax.  

Vaccines: The anthrax vaccine currently available for use in the United States is anthrax vaccine adsorbed [AVA]-commercial name BioThrax, made by Emergent BioSolutions, Inc. There are approximately 10 million doses in the Strategic National Stockpile [SNS] for emergency use. Delivery of 18.75 million additional doses of AVA is part of a 3 year U.S. Department of Health and Human Services [HHS] contract with Emergent BioSolutions. According to an 23 October 2007, GAO report, SNS supplies of the previously stockpiled BioThrax will begin to expire in 2008. AVA consists of filtered proteins from a weakened strain of B. anthracis and does not contain whole bacteria. The traditional course for the vaccine is 6 injections given over an 18-month period. AVA is currently recommended only for persons who are at occupational risk of acquiring anthrax, such as laboratory personnel, livestock handlers, and members of the military.

Anti-toxins: According to testimony delivered by the HHS Deputy Assistant Secretary for Preparedness and Response  before the U.S. House of Representatives Committee on Government Reform, the SNS holds enough “anthrax antibiotics” to “provide 60-day regimens for post-exposure prophylaxis to approximately 41.5 million people,” and enough “intravenous antibiotics to treat approximately 831,000 symptomatic anthrax patients.” The U.S. government has purchased 20,000 treatment courses of ABthrax antitoxin from Human Genome Sciences and 10,000 therapeutic courses of AIG antitoxin from Emergent Biosolutions for the SNS. These countermeasures potentially could be used against drug resistant strains of B. anthracis and as adjunctive therapy in addition to antibiotics for severely ill patients. 

  • ABthrax: This is a human monoclonal antibody that blocks the binding of Bacillus anthracis protective antigen to the cell surface. This prevents the anthrax toxin from entering and killing the cells. ABthrax is developed under a contract with the U.S. government, which was secured in June 2006. In December 2007, HGS announced study results that provide the scientific evidence required to establish the efficacy of ABthrax. The Company has also demonstrated that ABthrax was generally safe and well tolerated in two clinical trials in healthy adults. HGS plans to submit the final data package to the