Healthcare Industry News:  antibiotic 

Biopharmaceuticals FDA

 News Release - August 10, 2010

Advanced Life Sciences Achieves Special Protocol Assessment Agreement With FDA for Restanza in Pneumonia

First-of-its-Kind Superiority Trial Compares Restanza to Standard of Care in antibiotic-Resistant Pneumonia Population

CHICAGO, Aug. 10 (Healthcare Sales & Marketing Network) -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board:ADLS.ob ), a biopharmaceutical company engaged in the discovery, development and commercialization of novel drugs in the therapeutic areas of infection, oncology and respiratory diseases, announced today 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 its novel once-daily oral antibiotic Restanza™ to treat community acquired bacterial pneumonia (CABP). The trial is the first prospectively designed superiority study to be conducted in CABP.

The double-blind pivotal superiority study will compare the efficacy and safety of once-daily oral administration of 300 milligrams of Restanza over seven days of treatment to azithromycin. The primary efficacy endpoint will be the clinical cure rate in a macrolide-resistant Streptococcus pneumoniae (MRSP) population. The protocol also includes several unique features, such as the inclusion of patient-reported outcome measures, which have the potential to generate a more robust demonstration of effectiveness and establish Restanza as a new standard of care in treating pneumonia.

With reported resistance rates as high as 40 percent to standard-of-care macrolide antibiotics in the U.S., there is a pressing medical need for new drugs to treat CABP. Based on the data Advanced Life Sciences has accumulated in its extensive pre-clinical and clinical program to date, coupled with a thorough review of published literature on the clinical relevance of macrolide resistance, the company believes that Restanza has the potential to show a superior efficacy advantage in patients who are resistant to marketed macrolide drugs.

"We are pleased that the FDA has agreed to a SPA which provides a clear pathway to approval for Restanza in the CABP indication, and which is designed to meet the needs of the community, industry and regulators," said Michael T. Flavin, Ph.D. CEO of Advanced Life Sciences. "We believe that the superiority-based SPA represents a precedent-setting clinical trial design for oral antibiotics and will make a significant contribution to the field of CABP and antimicrobial clinical trial design. Regulators, industry and experts in the field have long recognized the need for clinical design protocols that will help to bring innovative and important antimicrobial therapies to the market. Advanced Life Sciences welcomes the opportunity to demonstrate the broad efficacy of our unique product candidate and to play a leadership role in advancing the science and clinical practice of treating pneumonia."

Continued Dr. Flavin: "Using clinical response in the MRSP population as the primary endpoint provides the most scientifically meaningful approach to demonstrate a clinical efficacy advantage against resistant strains of Streptococcus pneumonia. Importantly, this approach will provide Advanced Life Sciences a viable path to move Restanza towards approval and commercialization."

About Special Protocol Assessments

An SPA is a written agreement between the FDA and a drug sponsor concerning the clinical trial design, clinical endpoints and other clinical trial issues that can be used to support regulatory approval of a drug candidate. The process is intended to provide assurance that if the agreed upon clinical trial protocols are followed, the clinical trial endpoints are achieved and there is a favorable risk benefit profile, the data may serve as the primary basis of an efficacy claim in support of a New Drug Application.

About Community Acquired Bacterial Pneumonia (CABP)

CABP is the sixth most common cause of death in the United States. CABP and other respiratory tract infections are caused by pathogens such as Streptococcus pneumoniae and Haemophilus influenzae. Approximately 5.6 million cases of CABP are diagnosed each year in the United States with 10 million physician visits, resulting in an estimated total annual expenditure of $2.0 billion for prescribed antibiotics to treat CABP. CABP is potentially fatal if not treated properly, and the bacteria that cause CABP are developing resistance to current standard of care treatments.

Macrolides and penicillins are currently the front-line treatments for respiratory tract infections such as CABP. As macrolide and penicillin resistance grows and has the potential to cause more clinical failures, there is a need for new antibiotics with unique mechanisms of action that can overcome this emerging resistance.

About Restanza

Restanza is a novel oral once-a-day antibiotic that is in late stage development for the treatment of CABP and biodefense pathogens. 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.

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 community acquired bacterial pneumonia (CABP) and biodefense pathogens including anthrax, plague and tularemia.

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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 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

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