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Advanced Life Sciences Announces Fourth Quarter and Full Year 2007 Financial Results
Date:2/19/2008

d and met with National Advisory Board for Cethromycin consisting

of thought leaders in the area of respiratory tract infections and

antibiotic therapies;

-- Granted Orphan Drug Designation by the FDA for ALS-357 in the topical

treatment of metastatic melanoma; and

-- Advanced development of ALS-357: manufactured clinical supplies and

submitted the protocol to the Northwestern University Institutional

Review Board (IRB) for the planned Phase I/II melanoma program.

Cethromycin Objectives for 2008

-- Attend FDA Anti-Infectives Advisory Committee meeting discussing

non-inferiority margins in CAP clinical trials scheduled for

April 1 and 2, 2008 and provide management's understanding of the

Advisory Committee meeting to investors via conference call on

April 3, 2008.

-- Conduct meeting with FDA on April 7, 2008 to discuss the anticipated

NDA submission in CAP and provide summary of outcome to investors via

conference call on April 10, 2008.

-- Incorporate guidance from April 1-2 FDA Advisory Committee meeting and

April 7 Advanced Life Sciences meeting with FDA to complete NDA

submission activities for cethromycin as a treatment for CAP;

-- Finalize negotiations with potential commercial partners for

cethromycin;

-- Continue collaborations with the National Institute of Allergy and

Infectious Diseases (NIAID) and The U.S. Army Medical Research

Institute for Infectious Diseases (USAMRIID) to explore cethromycin's

activity against high-priority bioterror agents for its use as a broad

spectrum countermeasure; and

-- Present cethromycin clinical data at ICAAC in the Fall.

Financial Guidance for 2008

Advanced Life Sciences expects its 2008 cash requirements excluding milestone payments that become due upon NDA filing to f
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SOURCE Advanced Life Sciences Holdings, Inc.
Copyright©2008 PR Newswire.
All rights reserved

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