Under the contract HGS will manufacture and deliver 20,000 treatment courses of the compound, Abthrax, to the strategic national stockpile. The company will also complete the additional laboratory and clinical testing required to support the filing of a biologics license application (BLA) with the FDA, and to support the use of Abthrax in patients with inhalational anthrax disease in the event of an emergency prior to FDA licensure.
“Today’s announcement is an important milestone in Human Genome Sciences’ progress toward commercialization, since fulfilling the terms of this award will result in our company’s first product sales,” said H. Thomas Watkins, president and CEO.
HGS last year supplied ten grams of Abthrax to the US Department of Health and Human Services (HHS) for comparative laboratory testing. The results of this comparative testing, along with the company’s own preclinical and clinical study results, formed the basis of the government’s decision to acquire the treatment courses.