HGSI Drug Under FDA Review

Recently, Human Genome Sciences Inc. (HGSI - Analyst Report) suffered a setback when the US Food and Drug Administration (FDA) questioned the efficacy of its drug ABthrax (raxibacumab), meant for treating anthrax infection. 

The FDA accepted that the medication was more effective than a placebo in treating anthrax exposure in animals. However, it was unsure as to how effective the treatment would be for humans since the reliability of human data is doubtful. Though the drug appeared to be effective when used with antibiotics in rabbits and monkeys, animal studies do not always predict success in humans. 

Later today, an advisory panel from the FDA is scheduled to meet to decide whether the benefits of the drug outweigh the risks for treating deadly infections caused by anthrax inhalation. 

As a reminder, Human Genome had filed a Biologics License Application with the FDA in May 2009. The company is slated to receive an additional $10 million from the U.S. Government on FDA approval. 

ABthrax (raxibacumab), which received Fast Track Product and Orphan Drug designations for anthrax, is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority of the Office of the Assistant Secretary for Preparedness and Response, U.S. Department of Health and Human Services (HHS). 

Human Genome is under contract to deliver doses of ABthrax to the U.S. Strategic National Stockpile, which stores huge quantities of medicine and medical supplies to be used in national emergencies such as a flu outbreak, terrorist attacks or earthquakes that are brutal enough to deplete local supplies. The company delivered 20,000 doses of the drug to the U.S. Strategic National Stockpile in the first quarter of 2009. In Jul 2009, Human Genome had secured a new purchase order for 45,000 doses of ABthrax to be delivered to the U.S. Strategic National Stockpile over a three-year period. 

Currently, we are Neutral on Human Genome.