HHS Awards Multiple Contracts for Anthrax Countermeasures
By Molly D'Esopo and Luciana Borio, M.D., 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.”1 Anthim is a high affinity monoclonal antibody that targets anthrax’s protective antigen. 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 Last year, a clinical phase I study revealed the therapeutic candidate was well tolerated and was associated with a favorable safety risk-profile in healthy volunteers, whether used alone or in combination with ciprofloxacin.2
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.” Valortim also targets anthrax’s protective antigen.3 Valortim was effective in the prophylaxis and treatment of rabbits exposed to aerosolized anthrax spores, and a single intramuscular injection of 1 mg/kg of body weight fully protected cynomolgus monkeys challenged with aerosolized anthrax spores.4 Last year, a clinical phase I study revealed that Valortim was safe and well tolerated.5
HHS has an interest in procuring for the Strategic National Stockpile medical countermeasures that could be used to treat patients with anthrax disease.6 Several similar, antibody-based therapeutics against anthrax are being developed by a number of companies. On June 20, 2006, HHS awarded a contract for 20,000 treatment courses of ABthrax, an anthrax therapeutic treatment from Human Genome Sciences for $165,205,217. On July 28, 2006, HHS awarded a contract for 10,000 treatment courses of Anthrax Immune Globulin (AIG) from Cangene Corporation for $143,833,719.7 Human-derived Anthrax Immune Globulin (AIG) was successfully used, under an IND, in the treatment of a patient with naturally-occurring inhalational anthrax in 2006.8 However, AIG’s clinical efficacy could not be ascertained. Although formal guidelines for use of such therapeutics have not been issued and the CDC currently states that decisions to use such therapeutics would be made on a case-by-case basis, it is generally believed that their use in the event of a bioterrorist attack employing Bacillus anthracis would be reserved for sick patients who are toxemic despite receiving antibiotics and supportive medical care.
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 “for delivery of 18.75 million doses of BioThrax® (Anthrax Vaccine Adsorbed) for inclusion in the strategic national stockpile (SNS).”
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.”9 This is a step in the right direction for ensuring a robust stockpile since anthrax vaccine will be critical in the event of a biological weapons attack employing B. anthracis.
NIAID/BARDA Awards Elusys a $12 Million Contract to Further Develop Anthim, the Company’s Anthrax Therapeutic. Elusys, Inc. Press Release. September 25, 2007. Available at: http://www.elusys.com/press_releases.php?article=1277
Elusys Therapeutics Successfully Completes Human Clinical Study of Anthrax Therapeutic, Anthim(TM). PR Newswire. March 29, 2006. Available at: http://www.prnewswire.com/cgi-bin/stories.pl?ACCT=104&STORY=/www/story/03-29-2006/0004329332&EDATE
PharmAthene Named as Contractor in $13.9 Million Award Notice Published by the Department of Health and Human Services. PharmAthene, Inc. Press Release. September 26, 2007. Available at: http://www.pharmathene.com/pdf/Press%20Release%2032.pdf
Vitale L, Blanset D, Lowy I, et al. Prophylaxis and therapy of inhalational anthrax by a novel monoclonal antibody to protective antigen that mimics vaccine-induced immunity. Infect Immun 2006;74:5840-7.
Medarex and PharmAthene Announce Phase I Results of Anthrax Therapeutic Valortim(TM). Medarex. Press Release. October 16, 2006. Available at: http://www.medarex.com/cgi-local/item.pl/20061016-916440
Department of Health and Human Services; Office of the Assistant Secretary for Preparedness and Response. HHS Public Health Emergency Medical Countermeasures Enterprise Implementation Plan for Chemical, Biological, Radiological and Nuclear Threats. April 2007. Available at: https://www.medicalcountermeasures.gov/media/2179/phemce_implplan_041607final.pdf
Department of Health and Human Services. Project BioShield: Medical Countermeasures for Anthrax. Available at: http://www.hhs.gov/aspr/barda/mcm/medcountmeas.html
Walsh JJ, Pesik N, Quinn CP, et al. A case of naturally acquired inhalation anthrax: clinical care and analyses of anti-protective antigen immunoglobulin G and lethal factor. Clin Infect Dis 2007;44:968-71.
Emergent BioSolutions Signs $448 Million Three Year Contract with Department of Health and Human Services. Emergent BioSolutions. Press Release. September 26, 2007. Available at: http://investors.emergentbiosolutions.com/phoenix.zhtml?c=202582&p=irol-newsArticle&ID=1055689&highlight