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Biosecurity Briefing
HHS Awards Multiple Contracts for Anthrax Countermeasures By Molly D’Esopo, September 28, 2007 On September 25, 2007, the biopharmaceutical company, Elusys Therapeutics, Inc., issued a press release announcing the award of a $12 million contract from the Department of Health and Human Services’ Biodefense Advanced Research and Development Authority and the National Institute of Allergy and Infectious Diseases (BARDA/NIAID) for advanced development of Anthim™, Elusys’ late-stage anthrax therapeutic which is “being developed for prophylaxis and post-exposure treatment of inhalation anthrax.” In an effort to speed development, the FDA has granted Anthim Fast Track Status and Orphan Drug Designation and has allowed the therapeutic to be developed under the agency’s Animal Rule.1 Elusys is employing its Heteropolymer Antibody™ Technology to target “a unique immune receptor” to “enhance a natural clearance mechanism, and direct the rapid removal of pathogens from the circulation to tissue macrophages.” In the press release, Elusys President and CEO Elizabeth Posillico, PhD, commented that “Anthim represents a ‘just-in-time anthrax therapeutic’ that in relevant models has demonstrated complete protection against an anthrax spore challenge with a single prophylactic dose, and has shown significant protection when administered up to two days after a lethal spore challenge, with or without an antibiotic.”1 In related news, on September 26, 2007, PharmAthene, Inc., announced that it had been awarded $13.9 million from NIAID/BARDA in a joint venture with Medarex, Inc., for late-stage development of Valortim, “a fully human monoclonal antibody generated by Medarex’s UltiMAb® technology that is being developed by the two companies.” The press release reports that Valortim was developed to target anthrax protective antigen (PA), a protein component of the toxin produced by anthrax bacterium. Anthrax protective antigen is “believed to initiate the onset of the illness by attaching to cells in the infected person, and then is believed to facilitate the entry of additional destructive toxins into the cells.” Valortim targets the protective antigen and also provides the cells with protection from anthrax toxin. This contract begins September 28, 2007, and runs through 2009. According to PharmAthene Vice President and Medical Director Valerie Riddle, MD, “The latest contract from NIAID/BARDA brings the total amount of government funding allocated to Valortim to date to over $24 million.”2 On the vaccine front, Emergent BioSolutions—maker of BioThrax®, the only FDA-approved anthrax vaccine—issued a press release on September 26, 2007, indicating that it had entered into a 3-year, $448 million contract through BARDA. The release noted that the provisions of the contract include:
BioThrax is derived from an inactive strain of Bacillus anthracis, and it is currently approved for pre-exposure prophylaxis in adults. The vaccine is administered via injection—three doses are administered initially with an additional three doses administered subsequently; annual booster doses are recommended. Emergent BioSolutions has provided the U.S. government with “approximately 20 million doses of BioThrax” since 1998. The press release notes that “over 6.5 million doses have been administered to over 1.6 million military personnel.”3 The day after announcing its award for BioThrax, Emergent BioSolutions announced that it had received a $9.5 million development contract through BARDA/NIAID for non-clinical and clinical studies of Anthrax Immune Globulin (AIG). According to the release, the AIG product will be administered as “an intravenous therapeutic” for anthrax patients “for whom the use of vaccine is no longer an effective option.” The press release states that the AIG is “being developed using plasma collected from healthy donors who have been vaccinated with BioThrax®. . .,” employing a process which is already validated and approved under current Good Manufacturing Practice (cGMP) regulations. The contract period is for 24 months, and the funding will support efficacy studies and “a Phase I/II study to evaluate pharmacokinetics and safety.”4 References
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