CHICAGO, Aug. 21 Advanced Life SciencesHoldings, Inc. (Nasdaq: ADLS), today announced the commencement of itscollaboration with the National Institute of Allergy and Infectious Diseases(NIAID), the lead governmental institute supporting biodefense research, underwhich the NIAID will conduct studies to evaluate cethromycin, the Company'slate-stage antibiotic, as a treatment for anthrax and other high-prioritybiodefense agents. This collaboration is part of the U.S. Government's effortto accelerate the research and development of medical countermeasures throughthe crucial phase of drug development between basic research and acquisitionof final products under Project BioShield.
Project BioShield provides the Department of Health and Human Serviceswith the authority and funding to procure promising countermeasures foraddition to the Strategic National Stockpile, which is the Center for DiseaseControl and Prevention's store of medical supplies to protect the Americanpublic in the event of a public health emergency. Project BioShield providesthe NIAID, part of the National Institutes of Health, with the authority tosupport development of countermeasures toward possible future procurement withProject BioShield funds.
"We are very excited about our partnership with the NIAID as it allows usto leverage the financial and scientific resources of the U.S. Government'spremier research institute to develop cethromycin as a broad spectrum medicalcountermeasure," said Dr. Michael T. Flavin, Chief Executive Officer. "Withthe threat of growing resistance to currently available therapies, the U.S.Government is focused on procuring next-generation products with a broadspectrum of activity to complement currently-held medical countermeasures inthe Strategic National Stockpile. This partnership with NIAID will expand thedata on cethromycin as a biodefense application, and we expect the results tostrengthen our efforts in positioning cethromycin for purchase by the U.S.Government."
In May, Advanced Life Sciences announced positive data from a study thatshowed cethromycin to be effective in preventing inhalation anthrax infectionin primates. The study, involving a 30-day course of oral dosing,demonstrated that cethromycin was 100% protective against a lethal dose ofinhaled anthrax as compared to the current standard of care, Cipro(R)(ciprofloxacin), which demonstrated 90% protection. The FDA has designatedcethromycin as an orphan drug for the prophylactic treatment of inhalationanthrax post-exposure, however the FDA has not yet approved the drug formarketing in this or any other indication.
About Project BioShield
The Project BioShield Act of 2004 (Public Law 108-276) is aimed ataccelerating the research and development of medical countermeasures byinstituting a secure funding source ($5.6 Billion over 10 years) for thepurchase of critical medical countermeasures, such as vaccines, therapeuticsand diagnostics. Project BioShield also grants the NIAID authority to expediteand simplify the solicitation, review, and award of grants and contracts forthe development of critical medical countermeasures. Finally, ProjectBioShield establishes the Emergency Use Authorization (EUA) to provide accessto the best available medical countermeasures following a Declaration ofEmergency by the Secretary of Health and Human Services.
About Advanced Life Sciences
Advanced Life Sciences is a biopharmaceutical company engaged in thediscovery, development and commercialization of novel drugs in the therapeuticareas of infection, cancer and inflammation. The Company's lead candidate,cethromycin, is a novel once-a-day antibiotic in late-stage clinicaldevelopment for the treatment of respiratory tract infections includingcommunity acquired pneumonia (CAP). For more information, pleas