ADVANCED LIFE SCIENCES TO STUDY CETHROMYCIN FOR ANTHRAX.

Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), Chicago, has announced the commencement of its collaboration with the National Institute of Allergy and Infectious Diseases (NIAID), the lead governmental institute supporting biodefense research, under which the NIAID will conduct studies to evaluate cethromycin, the company's late-stage antibiotic, as a treatment for anthrax and other high-priority biodefense agents. This collaboration is part of the U.S. Government's effort to accelerate the research and development of medical countermeasures through the crucial phase of drug development under Project BioShield. All studies conducted under this partnership will be funded by the NIAID and will be performed by its contract testing laboratories.

Project BioShield provides the Department of Health and Human Services with the authority and funding to procure promising countermeasures for addition to the Strategic National Stockpile, which is the Center for Disease Control and Prevention's store of medical supplies to protect the American public in the event of a public health emergency. Project BioShield provides the NIAID, part of the National Institutes of Health, with the authority to support development of countermeasures toward possible future procurement with Project BioShield funds.

"We are very excited about our partnership with the NIAID as it allows us to leverage the financial and scientific resources of the U.S. Government's premier research institute to develop cethromycin as a broad spectrum medical countermeasure," said Dr. Michael T. Flavin, CEO. "With the threat of growing resistance to currently available therapies, the U.S. Government is focused on procuring next-generation products with a broad spectrum of activity to complement currently-held medical countermeasures in the Strategic National Stockpile. This partnership with NIAID will expand the data on cethromycin as a biodefense application, and we expect the results to strengthen our efforts in positioning cethromycin for purchase by the U.S. Government."

In May, Advanced Life Sciences announced positive data from a primate study that showed cethromycin to be effective in preventing inhalation anthrax infection. The study, involving a 30-day course of oral dosing, demonstrated that cethromycin was 100% protective against a lethal dose of inhaled anthrax as compared to the current standard of care, Cipro(r) (ciprofloxacin), which demonstrated 90% protection. The FDA has designated cethromycin as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, but the FDA has not yet approved the drug for marketing in this or any other indication.

About Project BioShield

The Project BioShield Act of 2004 (Public Law 108-276) is aimed at accelerating the research and development of medical countermeasures by instituting a secure funding source ($5.6 Billion over 10 years) for the purchase of critical medical countermeasures, such as vaccines, therapeutics and diagnostics. Project BioShield also grants the NIAID authority to expedite and simplify the solicitation, review, and award of grants and contracts for the development of critical medical countermeasures. Finally, Project BioShield establishes the Emergency Use Authorization (EUA) to provide access to the best available medical countermeasures following a Declaration of Emergency by the Secretary of Health and Human Services.

About Advanced Life Sciences

Advanced Life Sciences is a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, cancer and inflammation. The company's lead candidate, cethromycin, is a novel once-a-day antibiotic in late-stage clinical development for the treatment of respiratory tract infections including community acquired pneumonia (CAP).

For more information, call 312/546-3508 or visit http://www.advancedlifesciences.com.

About Cethromycin

Advanced Life Sciences is developing cethromycin, a novel once-a-day antibiotic in response to the emerging bacterial resistance observed in the treatment of CAP. In addition to its utility in CAP, cethromycin was also recently shown to be effective in preventing inhalation anthrax (Bacillus anthracis) infection post-exposure in a primate study.

Cethromycin has been tested in approximately 5,000 human subjects during clinical trials. The company believes that cethromycin, if approved, would build upon the growing market opportunity in the antibiotic marketplace and address the critical need for antibiotics that overcome bacterial resistance.