CHICAGO, Sept. 15 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS) today announced that the United States Food and Drug Administration (FDA) has granted Orphan Drug Designation to Restanza(TM) (cethromycin), its novel, once daily oral antibiotic, for the prophylactic treatment of plague and tularemia. Both tularemia and plague are classified by the Centers for Disease Control as Category A Bioterrorism Agents, which is the highest priority classification. High-priority agents include organisms that pose a risk to national security because they can be easily disseminated or transmitted, result in high mortality rates and have the potential for major public health impact, might cause public panic and social disruption, and require special action for public health preparedness.
Advanced Life Sciences is currently conducting pivotal studies of Restanza under FDA's "Animal Rule" as a broad countermeasure against bioterror agents including plague and tularemia under a contract with the US Department of Defense. Additionally, the Company has previously reported that Restanza demonstrated significant efficacy in preventing anthrax infection post-exposure as well as in treating inhalation anthrax after symptoms of infection had developed.
The Company expects key data to be available and reported from its pivotal animal studies in plague and tularemia by the end of 2009. If these studies continue to confirm the product profile of Restanza as a potent broad spectrum medical countermeasure for biodefense, Advanced Life Sciences plans to meet with the FDA to finalize the biodefense regulatory plan for Restanza, with the goal of submitting an NDA amendment seeking marketing approval fo
|SOURCE Advanced Life Sciences Holdings, Inc.|
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