FDA grants orphan drug status to Advanced Life Sciences' Restanza

Sep 16 2009

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 for the biodefense indications of anthrax, tularemia, and plague in the first part of 2010.

"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."

The FDA's U.S. Orphan Drug Act is intended to assist and encourage companies to develop safe and effective therapies for the treatment of rare diseases and disorders. Orphan Drug designation is awarded to compounds that offer potential therapeutic value in the treatment of rare diseases, defined as those affecting fewer than 200,000 Americans. This designation provides companies with financial and regulatory benefits such as eligibility for a special seven-year period of market exclusivity upon approval for the compound and indication with orphan designation, potential tax credits for research, potential grant funding for research and development, reduced filing fees for marketing applications, and assistance with clinical trial protocol review.

Restanza as a Biodefense Countermeasure

Advanced Life Sciences is developing Restanza as a broad spectrum medical countermeasure for biodefense. The FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, but the FDA has not yet approved the drug for marketing in this or any other indication.

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.

www.advancedlifesciences.com