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Advanced Life Sciences Submits Updated Special Protocol Assessment to FDA for Restanza in Community Acquired Bacterial Pneumonia
Date:6/30/2010

CHICAGO, June 30 /PRNewswire-FirstCall/ -- Advanced Life Sciences Holdings, Inc. (OTC Bulletin Board: ADLS), a biopharmaceutical company developing Restanza™, a novel once-a-day oral antibiotic, today announced that it has submitted a final Special Protocol Assessment (SPA) with the FDA for the proposed Phase III clinical program of Restanza in the treatment of patients with community acquired bacterial pneumonia (CABP).  The Company has been engaged in the SPA process with the FDA over the last year and just recently met with officials from the FDA to establish the clinical trial design needed to gain approval in CABP.  As filed, the updated SPA incorporates written and oral comments from the FDA's Division of Anti-Infective and Ophthalmology Products.

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Michael T. Flavin, Ph.D., Chairman and CEO of Advanced Life Sciences stated, "We would like to thank the FDA for their written comments and guidance during the SPA process.  We have incorporated the Agency's input into our final protocol design and SPA submission for FDA's final review and concurrence.  Based on the FDA's SPA review cycle, we expect a reply to our submission by mid-August of this year.  Reaching an agreement on the SPA will be the next step in the clinical development of Restanza and establish a framework for regulatory approval and commercializa
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SOURCE Advanced Life Sciences Holdings, Inc.
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