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Advanced Life Sciences' Restanza(TM) Shows 100% Survival In Confirmatory Anthrax Study
Date:6/23/2009

CHICAGO, June 23 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), today announced that a second non-human primate study involving its novel, once-a-day, oral antibiotic Restanza(TM) (cethromycin), showed that a 14-day course of Restanza achieved a 100% survival rate against an inhaled lethal dose of anthrax. All of the animals in the study that received 16 mg/kg once-a-day (the human equivalent dose of 300 mg) of Restanza within 24 hours after exposure to anthrax survived while none of the animals that received placebo survived. The study was supported by the National Institute of Allergy and Infectious Diseases (NIAID), an institute of the National Institutes of Health (NIH), which is a component of the Department of Health and Human Services (HHS), an agency of the U.S. Government.

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"The successful outcome of the study provides strong evidence of Restanza's life saving potential and underscores its value as a potent new biodefense countermeasure," said Dr. Michael Flavin, Chairman and CEO of Advanced Life Sciences. "When coupled with the positive outcome of the pivotal primate study that we announced in May 2007, we believe that these significant findings complete the regulatory package for Restanza in the post-exposure prophylactic treatment of inhalation anthrax indication. We are looking forward to working with NIAID on the final study report and submitting our data package for regulatory review based on our NDA for Restanza, which is currently under review by the FDA for the treatment of mild-to-moderate community acquired pneumonia (CAP)."

Restanza as a Biodefense Countermeasure

Advanced Life Sciences is developing Restanza for the post-exposure prophylactic treatment of inhalation anthrax to help
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SOURCE Advanced Life Sciences Holdings, Inc.
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