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Advanced Life Sciences Receives Complete Response Letter From FDA for Restanza(TM) (Cethromycin) in Community Acquired Pneumonia
Date:7/31/2009

believe that Restanza has significant therapeutic and commercial potential as a novel agent to combat CAP as well as other lethal pathogens that represent serious bioterror threats to public health, and we intend to explore all avenues that can lead to success. We expect key data to be available and reported from our ongoing pivotal studies in plague and tularemia by the end of 2009. We plan to submit an NDA amendment seeking marketing approval for the biodefense indications in the first quarter of 2010."

In addition to developing Restanza as a potential treatment for CAP, Advanced Life Sciences has received a $3.8 million contract from the Department of Defense, via the Defense Threat Reduction Agency (DTRA), to fund NDA-enabling studies to evaluate Restanza's efficacy against bioterror agents such as tularemia, plague and melioidosis. In June, the company announced that Restanza demonstrated a 100% survival rate against an inhaled lethal dose of anthrax following a 14-day course of treatment in a second non-human primate study. The study was supported by the National Institute of Allergy and Infectious Diseases (NIAID).

Conference Call to Discuss the Restanza CAP NDA

Advanced Life Sciences will host a conference call and live webcast at 8:30 a.m. Eastern Time on Monday, August 3, 2009 to discuss the Restanza CAP NDA. The conference call will be webcast simultaneously over the Internet. Please visit the Investor Relations section of the Advanced Life Sciences corporate website www.advancedlifesciences.com. Alternatively, callers may participate in the conference call by dialing 866.362.4832 (domestic) or 617.597.5364 (international). The passcode for the conference call is 61915444. A replay of the conference call will be available until August 10, 2009. Callers may access the telephone replay by dialing 888-286-8010 (domestic) or 617-801-6888 (international), passcode 67060945. Investors are advised to dia
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SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2009 PR Newswire.
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