CHICAGO, Aug. 13 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. , today announced that the Defense Threat Reduction Agency (DTRA) of the U.S. Department of Defense has awarded the Company a two-year contract worth up to $3.8 million to further study cethromycin as a potential broad-spectrum medical countermeasure. The contract, part of the agency's Transformational Medical Technologies Initiative (TMTI), will fund NDA-enabling studies evaluating cethromycin's efficacy in combating Category A and B bioterror agents such as Fransicella tularensis (tularemia), Yersinia pestis (plague) and Burkholderia pseudomallei (melioidosis).
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"We are very excited to partner with DTRA and share its mission to reduce the threat of biological warfare and bioterrorism," stated Dr. Michael T. Flavin, chairman and chief executive officer of Advanced Life Sciences. "We believe this government contract further validates the potential of cethromycin as a biodefense agent, and it enables us to conduct pivotal studies to expand cethromycin's potential spectrum of activity beyond the success that was demonstrated in preventing inhalation anthrax."
Dr. Herbert Schweizer, Professor and Associate Program Director, Rocky Mountain Regional Center of Excellence for Biodefense and Emerging Infectious Diseases Research, Colorado State University stated, "Our initial evaluation of cethromycin against Burkholderia pseudomallei shows that it is very active and may have a more favorable resistance profile than other approved antibiotics in treating melioidosis." Dr. Schweizer added, "This government funding from DTRA for the advanced development of cethromycin to treat bioterror pathogens serves as a critical step that may result in advances for both national security and public health."
Under the terms of the contract, $1.8 million of DTRA funds are available over a nine-month base period to initiate NDA-enabling studies measuring cethromycin's efficacy in treating tularemia and plague as well as studies to measure cethromycin's efficacy in treating melioidosis. The remaining $2.0 million may be awarded over the ensuing 15 months to complete the project.
Dr. Michael Flavin went on to say, "The U.S. Government is committed to identifying and acquiring a next-generation antibiotic that has activity against more that one Category A and B bioterror pathogen. If cethromycin can demonstrate potent activity through the studies funded by this contract, we believe it will be well positioned to compete for revenues from a potential stockpile contract."
About the Defense Threat Reduction Agency
The Defense Threat Reduction Agency (DTRA) is the intellectual, technical and operational leader for the Department of Defense (DoD) and the U.S. Strategic Command in the national effort to combat the weapons of mass destruction (WMD) threat. Under DTRA, DoD resources, expertise and capabilities are combined to ensure the United States remains ready and able to address the present and future WMD threat. DTRA performs four essential functions to accomplish its mission: combat support, technology development, threat control and threat reduction. These functions form the basis for how it is organized and its daily activities.
About Cethromycin
Cethromycin is a novel once-a-day oral antibiotic in late-stage development for the treatment of respiratory tract infections including community acquired pneumonia (CAP). In addition to its utility in CAP, cethromycin is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure. In May of 2007, cethromycin completed a non-human primate study in which it was determined that a 30-day course of oral cethromycin was 100% protective against a lethal dose of inhaled anthrax as compared to the 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, 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. For more information, please visit us on the web at http://www.advancedlifesciences.com.
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. 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 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.
CONTACT: company, Joe Camp of Advanced Life Sciences Holdings, Inc.,
+1-630-754-4352, jcamp@advancedlifesciences.com; or media, Melanie Nimrodi,
+1-312-546-3508, mnimrodi@frbir.com, or investors, Kathy Price,
+1-213-486-6547, kprice@frbir.com, both of Financial Relations Board, for
Advanced Life Sciences Holdings, Inc.
Web site: http://www.advancedlifesciences.com/
