Advanced Life Sciences (ADLS) Restanze Granted Fast-Track Designation from U.S. FDA

July 28, 2010 9:11 AM EDT

Advanced Life Sciences Holdings, Inc. (OTCBB: ADLS) today 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.

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