CHICAGO, June 9 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 that it has provided testimony at the U.S. Congress Committee on Energy and Commerce, Subcommittee on Health, hearing on "Promoting the Development of Antibiotics and Ensuring Judicious Use in Humans," on June 9, 2010, in Washington, D.C.
Advanced Life Sciences chairman and chief executive officer, Michael T. Flavin, Ph.D., commented on the growing crisis in antibiotic resistance and the challenges Advanced Life Sciences and other innovator companies have faced in the clinical development and regulatory approval of new antibiotics to improve public health. He also offered for the Committee's consideration several proposals for incentivizing the development of novel antibiotic products to address the growing public health threat of antibiotic resistance.
Due to the alarming growth in antibiotic resistance, the CDC has warned that previously treatable diseases, such as pneumonia, are again becoming untreatable. Antibiotic resistant bacteria are responsible for more deaths each year in the United States than HIV/AIDS.
Advanced Life Sciences has responded to the urgent public health need caused by antibiotic resistance by developing Restanza(TM), a novel once-a-day antibiotic to treat community acquired bacterial pneumonia (CABP). CABP is the sixth leading cause of death in the United States and is often resistant to currently available antibiotics. Advanced Life Sciences is working with the FDA to finalize a special protocol assessment (SPA) for registration trials to establish clinical cure rate superiority against azithromycin in the macrolide resistant Streptococcus pneumoniae population.
Said Dr. Flavin: "Advanced Life Sciences appreciates the sincere interest of this Committee to protect the public and ensure that products which have been proven safe and effective against drug resistant infections are introduced into the marketplace. Advanced Life Sciences appreciates Congressional support of initiatives to incentivize antibiotic research and development coupled with the FDA's progress in establishing clear guidelines for approval of safe and effective new antibiotic treatments."
A link to the full testimony can be found on the Company's website at http://www.advancedlifesciences.com/ADLS_Testimony_for_EC_Hearing_06092010.pdf
A link to the video archive of today's hearing can be found starting tomorrow, June 10, 2010 at the Committee on Energy and Commerce, Subcommittee on Health website at: http://energycommerce.house.gov/index.php?option=com_content&view=article&id=2028:hearing-on-promoting-the-development-of-antibiotics-and-ensuring-judicious-use-in-humans&catid=132:subcommittee-on-health&Itemid=72
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 respiratory diseases. The Company's lead candidate, Restanza, is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including CABP and biodefense pathogens including anthrax, plague and tularemia. For more information, please visit us on the web at www.advancedlifesciences.com or follow us on twitter at http://twitter.com/advancedlifesci.
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. 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. 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, future revenues and capital requirements; our ability to obtain financing on terms acceptable to us; 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.
SOURCE Advanced Life Sciences Holdings, Inc.