Advanced Life Sciences Applies For FDA Fast-Track Designation For Restanza In CABP

Main Category: Respiratory / Asthma
Also Included In: Infectious Diseases / Bacteria / Viruses;  Regulatory Affairs / Drug Approvals;  Pharma Industry / Biotech Industry
Article Date: 29 Jul 2010 - 2:00 PDT

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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, announced that the Company has applied to the U.S. Food and Drug Administration for Fast-Track designation for Restanza™, a novel once-daily oral antibiotic, for the treatment of community acquired bacterial pneumonia (CABP).

Fast Track designation by the FDA is a process designed to expedite the review of new drugs that treat serious diseases and fill an unmet medical need. If there are existing therapies, a fast track drug must show some advantage over available treatment, such as superior effectiveness or avoiding serious side effects of an available treatment. A drug that receives Fast Track designation is eligible for benefits that include:

-- More frequent meetings with FDA to discuss the drug's development plan and ensure collection of appropriate data needed to support drug approval

-- Eligibility for FDA Accelerated Approval, i.e., approval on an effect on a surrogate, or substitute endpoint reasonably likely to predict clinical benefit

-- Rolling Review, which means that a drug company can submit completed sections of its New Drug Application (NDA) for review by FDA, rather than waiting until every section of the application is completed before the entire application can be reviewed. NDA review usually does not begin until the drug company has submitted the entire application to the FDA.

In addition, most drugs that are eligible for Fast Track designation are likely to be considered appropriate to receive a Priority Review.

According to recent mortality data from the Centers for Disease Control and Prevention (CDC), pneumonia remains the leading cause of death for infectious disease in the U.S., accounting for over 55,000 deaths annually. Treatment of the disease is compounded by increasing rates of resistance to currently prescribed antibiotics. Recent surveillance data demonstrate that the primary etiologic pathogen, Streptococcus pneumoniae, has resistance rates approaching 40% for macrolides.

The Company believes that Restanza fulfills an unmet medical need in that it displays superior in vitro and in vivo efficacy against macrolide-resistant Streptococcus pneumoniae (MRSP) compared to macrolides, that it is also active against fluoroquinolone-resistant S. pneumoniae; and that it possesses a potentially better safety profile compared to existing oral antibiotics that may be used to treat MRSP infection in patients with CABP.

A clinical trial protocol using a superiority design to assess the safety and efficacy of Restanza compared to azithromycin in CABP patients with MRSP is currently being finalized in close collaboration with FDA under the Special Protocol Assessment (SPA) process.

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 Holdings, Inc