CHICAGO, Sept. 15 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. 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.
“We believe that Restanza is a major advance in biodefense preparedness against lethal pathogens, given its novel mechanism of action, demonstrated broad spectrum of activity against multiple bioterror agents and favorable safety profile,” said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. “Pathogens such as anthrax, plague and tularemia represent extreme public health threats of potentially epidemic proportion as they are highly infectious and fatal diseases particularly if aerosolized, they can be deployed and spread quickly especially in densely populated areas. We look forward to continuing to work with the US government on the development of this promising new antibiotic and to meeting with the FDA to determine the regulatory pathway to approval for Restanza in the biodefense indications.”
Restanza as a Biodefense Countermeasure
In addition to its development in anthrax, Restanza is also being developed to combat other high priority bioterror agents such as Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis) under a two year, $3.8 million contract with the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense.
Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and respiratory diseases. For more information, please visit us on the web at www.advancedlifesciences.com
SOURCE Advanced Life Sciences Holdings, Inc.
CONTACT: Joe Camp of Advanced Life Sciences, +1-630-754-4352,
jcamp@advancedlifesciences.com
Web site: http://www.advancedlifesciences.com/
