Recent CAP Clinical Trial ExperienceRecent CAP Clinical Trial ExperienceMichael T. Flavin, Ph.D.Michael T. Flavin, Ph.D.

Chief Executive OfficerChief Executive Officer

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Safe Harbor StatementSafe Harbor Statement

This presentation contains forward-looking statements about Advanced Life Sciences Holdings, Inc., including statements regarding the clinical trials and regulatory pathway of cethromycin. Forward-looking statements represent our management’s judgment regarding future events. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. These and additional risks and uncertainties are detailed in the Company’s filings with the Securities and Exchange Commission.

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CAP: Unmet Medical Need CAP: Unmet Medical Need

5 million cases of CAP reported annually in US

– 80% of cases are mild-to-moderate

6th leading cause of death in the US Streptococcus pneumoniae resistance rates to

penicillin and macrolide antibiotics are currently approaching 60% and 40%, respectively

Overuse of fluoroquinolones contributing to CDAD and class cross resistance

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New Paradigm in Antibiotic DevelopmentNew Paradigm in Antibiotic Development Goals of developing new antibiotics that fill gaps in current

treatments

– Spectrum/coverage

– Emerging resistance to current treatments

– Safety issues

Large pharma refocusing drug development in favor of chronic diseases

Smaller biopharma stepping in to advance promising antibiotics

Regulatory clarity and consistency are key factors in ability to develop new antibiotics under new paradigm

FDA recognizes new paradigm

– Supportive interaction and effort to clarify regulatory path

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CethromycinCethromycin In-licensed from a large pharma in 2005 Selected CAP: most serious RTI Developing cethromycin to treat mild-to-moderate CAP Met with FDA in December 2005 to confirm NI trial

design in CAP Enrollment in two pivotal phase 3 clinical studies

initiated in 2006 Over 1,100 patients enrolled at 200 sites worldwide Two trials from start to finish: 24 months/$40 million

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ObservationsObservations Clinical trial data analysis takes into account the

complete data package including:

– Pathogen coverage

– Clinical benefits

– Safety profile

Non-inferiority trials are a practical method of capturing a wealth of information to demonstrate antimicrobial effectiveness and safety in CAP