Restanza as broad biodefense countermeasure and pneumonia treatment fits profile of novel drug to combat public health threats
CHICAGO, Aug. 24 /PRNewswire-FirstCall/ -- 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."
About the HHS Report
The HHS report recommended helping small innovator companies to develop promising countermeasures that have multi-use potential, including the establishment of an independent strategic investment firm to invest in medical countermeasure development (MCMSI). HHS would establish and sponsor an independent strategic investment firm that would partner with small innovator companies and private investors to generate novel technologies for the required medical countermeasures. Its mission would be the development of novel technologies that have the potential for sustainable commercial applications while at the same time demonstrating applicability in the medical countermeasure public health space. The first focus would help to address the lack of novel antimicrobial compounds in the pipeline that is a growing problem in the face of rapidly emerging multidrug-resistant organisms.
The MCMSI would display a higher-risk tolerance than currently exists by the US government for these products and accept a longer time horizon. The fund would operate independently and outside the government as a 501(c)(3) corporation or other similar alternative. In addition to its own investments, the MCMSI would leverage private capital, provide expert consultation, and link promising companies with potential partners in the private sector. Secretary of HHS Kathleen Sebelius noted that the MCMSI enterprise is part of a new $1.9 billion effort to ensure the U.S. has a "nimble" and "flexible" system to produce drugs and vaccines against any national medical emergency, whether from a terrorist attack or natural disaster.
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Restanza is a novel oral once-a-day antibiotic that is in late stage development for the treatment of community acquired bacterial pneumonia (CABP) and biodefense pathogens including anthrax, plague and tularemia. It has shown higher in vitro potency and a broader range of activity than macrolides against Gram-positive bacteria including CA-MRSA and pathogens associated with respiratory tract infections and appears to be effective against penicillin-, macrolide- and fluoroquinolone-resistant bacteria. Restanza's demonstrated potency and ability to overcome bacterial resistance may be due to its mechanism of action resulting in specificity for its bacterial target. In addition to its utility in CABP, Restanza is also being investigated for the prophylactic treatment of inhalation anthrax post-exposure and other high priority biodefense pathogens, including plague and tularemia. The FDA has designated Restanza as an orphan drug for the prophylactic treatment of inhalation anthrax post exposure, as well as for use in treating plague and tularemia, but the drug is not yet approved for these or any other indications.
Advanced Life Science recently announced that it has 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 of Restanza to treat CABP.
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.