Human Genome Sciences Inc has submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its human monoclonal antibody drug ABthrax (raxibacumab) for the treatment of inhalation anthrax.
The BLA submission includes the results of two randomized placebo-controlled studies conducted in rabbits and monkeys to evaluate the efficacy of raxibacumab. These studies showed a survival benefit in two relevant animal species, which is the requirement for establishing the efficacy of new drugs used to counter bioterrorism. The submission also includes the results of safety studies of raxibacumab conducted in healthy human volunteers.
"Based on the results of our efficacy and safety studies, we believe raxibacumab has the potential to be an important new treatment for inhalation anthrax," said Sally D Bolmer, senior vice president, Development and Regulatory Affairs, HGS. "In addition, the raxibacumab BLA is the first HGS has submitted, so it represents a significant milestone for our company."
Raxibacumab is a first-in-class treatment for anthrax, and is being developed under a contract entered into in 2006 with the Biomedical Advanced Research and Development Authority (BARDA) of the Office of the Assistant Secretary for Preparedness and Response (ASPR), US Department of Health and Human Services (HHS).
In the first quarter of 2009, under the BARDA contract, HGS achieved its first product sales by initiating the delivery of 20,000 doses of raxibacumab to the U.S. Strategic National Stockpile for emergency use in the treatment of inhalation anthrax. HGS recognized $153.8 million in raxibacumab revenue in the first quarter, including $127.8 million in product sales. The company has now completed delivery and expects to recognize at least $8.0 million in additional raxibacumab revenue in the second quarter of 2009. The BLA is also being filed under the BARDA contract, and HGS will receive $10 million from the US Government upon FDA licensure of raxibacumab.
The mission of HGS is to apply great science and great medicine to bring innovative drugs to patients with unmet medical needs. The HGS clinical development pipeline includes novel drugs to treat hepatitis C, lupus, inhalation anthrax and cancer.