Advanced Life Sciences Collaborates With U.S. Government To Study Cethromycin As Treatment For Anthrax And Other High-Priority Biodefense Agents

Main Category: Bio-terrorism / Terrorism
Also Included In: Infectious Diseases / Bacteria / Viruses;  Public Health
Article Date: 22 Aug 2007 - 0:00 PDT

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Advanced Life Sciences Holdings, Inc. (Nasdaq: ADLS), 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 between basic research and acquisition of final products under Project BioShield.

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, Chief Executive Officer. "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 study that showed cethromycin to be effective in preventing inhalation anthrax infection in primates. 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, however 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, please visit us on the web at 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.

Forward-Looking Statements

Any statements contained in this press release that relate to future plans, events or performance are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Except for historical information, the statements made in this press release are 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 and are accurate at the time they are made. The Company does not undertake any obligations to update any forward-looking statements whether as a result of new information, future events or otherwise. Our actual results could differ materially from those discussed herein due to several factors including the success and timing of our clinical trials and our ability to obtain and maintain regulatory approval and labeling of our product candidates; our plans to develop and commercialize our product candidates; the loss of key scientific or management personnel; the size and growth of potential markets for our product candidates and our ability to serve those markets; regulatory developments in the U.S. and foreign countries; the rate and degree of market acceptance of any future products; the accuracy of our estimates regarding expenses, capital requirements, and our ability to access capital through partnerships, stock offerings and future revenues; our ability to obtain and maintain intellectual property protection for our product candidates; the successful development of our sales and marketing capabilities; the success of competing drugs that become available; and the performance of third party collaborators and manufacturers. These and additional risks and uncertainties are detailed in the Company's filings with the Securities and Exchange Commission.

Advanced Life Sciences Holdings, Inc.
http://www.advancedlifesciences.com