Advanced Life Sciences Holdings announced that the FDA has granted orphan drug designation to Restanza (cethromycin), its once daily oral antibiotic, for the prophylactic treatment of plague and tularemia. 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. Key data is expected 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 for the biodefense indications of anthrax, tularemia, and plague in the first part of 2010.
Restanza is a once daily oral antibiotic being developed as a post-exposure prophylactic treatment of inhalation anthrax and other high priority bioterror agents such as Francisella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis).
For more information call (630) 739-6744 or visit www.advancedlifesciences.com.