CHICAGO, Oct. 4 /PRNewswire/ -- 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 the company provided testimony at the U.S. Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services (HHS) Hearing on "Defending Against Public Health Threats" on September 29, 2010 in Washington, D.C.
Advanced Life Sciences chairman and chief executive officer, Michael T. Flavin, Ph.D., commented on the critical need to invest in the development of late-stage medical countermeasures that can defend against public health threats, such as emerging infectious diseases as well as bioterrorism. He commended the efforts of HHS to support development of medical countermeasures to combat public health threats, and urged the department to balance its portfolio by including late-stage products nearing FDA approval which can be efficiently and cost effectively studied and which, if approved, could rapidly be made available to protect the public.
"Advanced Life Sciences has responded to the critical threat of bioterrorism by developing its novel antibiotic, Restanza™, to protect against infection from inhaled anthrax, plague and tularemia," said Dr. Flavin. "Consistent with the priorities articulated by HHS, our company is committed to advancing Restanza through the final stage of clinical testing with the goal of gaining FDA approval and providing a safe and effective new countermeasure against lethal pathogens. We intend to continue to explore opportunities to work collaboratively with the US government to protect the public health."
Secretary of HHS Kathleen Sebelius testified at the hearing that "In today's world, the range of threats is ever-widening to include biological, chemical, nuclear, and radiological hazards in addition to conventional threats." Secretary Sebelius went on to say that "the greatest danger we may face is a microbe that we may have never seen before and for which we do not have a countermeasure. We clearly need the capacity to develop a medical countermeasure quickly." Senator Tom Harkin, Chairman of the Committee, added that the US Government "needs a stronger partnership with biotech companies that could produce next-generation countermeasures."
A link to the video archive of today's hearing can be found at the U.S. Senate Committee on Appropriations Subcommittee on Labor, Health and Human Services website at:
In advanced animal models, Restanza has demonstrated significant protection post-exposure against anthrax, plague and tularemia. Restanza has also conducted Phase 3 clinical testing to treat community acquired bacterial pneumonia (CABP). The FDA has designated Restanza as an orphan drug for the post-exposure prophylactic treatment of inhalation anthrax, plague and tularemia, but the FDA has not yet approved the drug for marketing in this or any other indication.
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.