Advanced Life Sciences seeks government funding for development of Restanza antibiotic

Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, today announced plans to seek additional government funding for development of its novel, once-daily antibiotic, Restanza™ (cethromycin) based on a new, high-profile report from the Department of Health and Human Services (HHS) Office of the Assistant Secretary for Preparedness and Response recommending independent investment in small innovator companies developing potentially life-saving medical countermeasures. Advanced Life Sciences believes that Restanza meets the mandated criteria for investment and support detailed in the government report, which follows a Presidential directive to launch "a new initiative that will give us the capacity to respond faster and more effectively to bioterrorism or an infectious disease -- a plan that will counter threats at home, and strengthen public health abroad."  The report, issued last week, is titled, "The Public Health Emergency Medical Countermeasure Enterprise Review: Transforming the Enterprise to Meet Long Range National Needs.

Advanced Life Sciences is embarking upon a Phase 3 program with Restanza as a potential treatment for community acquired bacterial pneumonia (CABP). Earlier this month, the company reached agreement with the United States Food and Drug Administration (FDA), under the Special Protocol Assessment (SPA) process, on the design of its planned Phase 3 study. The trial is the first prospectively designed superiority study to be conducted in CABP, a precedent-setting clinical trial design for oral antibiotics that the company believes will make a significant contribution to the field of CABP and antimicrobial clinical trial design.

Advanced Life Sciences Chief Executive Officer, Dr. Michael T. Flavin, said: "Given Restanza's demonstrated effectiveness as a broad biodefense countermeasure against such bioterror agents as anthrax, plague and tularemia, as well as its value as a potential treatment for community acquired bacterial pneumonia, we intend to pursue all opportunities to expand our relationship with the US government and seek additional funding that could help complete development of Restanza, support regulatory filings and gain FDA approval. Our recently completed special protocol assessment with the agency should also help to position Restanza favorably for government consideration. The establishment of a strategic investment firm to help fund the development of novel antibiotics to overcome bacterial resistance represents a major step forward in the U.S. government's commitment to counter bioterrorism and infectious disease."