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HHS Purchases Anthrax Therapeutic for the SNS; Development of Additional Candidate Anthrax Therapeutics Continues

By Michael Mair, June 23, 2006

On June 20, the U.S. Department of Health and Human Services (HHS) announced that it has exercised the option under its contract with Human Genome Sciences, Inc. (HGS) to purchase ABthrax^TM for the Strategic National Stockpile (SNS).[1] ABthrax^TM (raxibacumab) is a human monoclonal antibody that specifically recognizes and neutralizes protective antigen, which is one of the 3 essential components of the anthrax toxin.[2] In “multiple preclinical studies in relevant animal models” HGS has “demonstrate[d] the dose-related efficacy of ABthrax in both prevention and treatment of the deadly effects of the anthrax toxins."[2]

In September 2005, HHS awarded contracts to HGS and Cangene Corporation for 10 grams of their respective candidate anthrax therapeutics for independent comparative testing. The contracts contained options to purchase additional doses for the SNS based on the results of the testing. Under the second phase of its contract, worth $165 million, HGS will deliver 20,000 treatment courses of ABthrax^TM to the SNS and will “complete the additional laboratory and clinical studies required to support the filing of a Biologics License Application (BLA) with the FDA, and to support the use of ABthrax in patients with inhalation anthrax disease in the event of an emergency prior to FDA licensure."[2]

Full payment to HGS is contingent on ABthrax^TM receiving licensure from the U.S. Food and Drug Administration (FDA). According to HGS, more than 90% of the total payment is “expected in 2008 upon delivery, and the remainder to be received when ABthrax is licensed by the FDA."[2] HHS noted that delivery is “expected to begin in 2009."[1]

On June 21, Elusys Therapeutics Inc., (Elusys) announced that FDA has granted Orphan Drug Designation to its candidate anthrax therapeutic, Anthim™ (ETI-204).[3] Anthim™ is a “monoclonal antibody with strong neutralizing activity against Protective Antigen (PA)” that Elusys is developing for pre- and post-exposure treatment of anthrax infection.[4] In March 2006, Valortim™ (MDX-1303)—a fully human monoclonal antibody that targets Protective Antigen—also was granted Orphan Drug Designation by FDA. Valortim™ is being developed by Medarex, Inc. and PharmAthene, Inc.

References

1. HHS to acquire new anthrax therapeutic treatment for stockpile. U.S. Department of Health and Human Services. June 20, 2006. Available at: http://www.hhs.gov/news/press/2006pres/20060620.html. Accessed June 22, 2006.
2. ABthrax™ (human monoclonal antibody to Bacillus anthracis protective antigen). Human Genome Sciences, Inc. June 20, 2006. Available at: http://www.hgsi.com/products/ABthrax.html. Accessed June 22, 2006.
3. Elusys' anthrax therapeutic, Anthim™, granted FDA Orphan Drug Designation. Elusys Therapeutics Inc. June 21, 2006. Available at: http://www.elusys.com/press_releases.php?article=1258. Accessed June 22, 2006.
4. Anthim™ - anthrax antibody. Elusys Therapeutics, Inc. Available at: http://www.elusys.com/product_development_anthim.php. Accessed June 22, 2006.