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Advanced Life Sciences Receives FDA Guidance on Approval Pathway for Restanza in Community Acquired Bacterial Pneumonia and Biodefense Indications
Date:3/11/2010

BP, the Company should establish a special protocol assessment (SPA) using a superiority clinical trial design comparing Restanza to a marketed macrolide antibiotic in two clinical trials.

In light of this guidance, Advanced Life Sciences is working with the FDA to finalize a SPA using a superiority design for the outpatient CABP indication.  Clinical cure rate in a macrolide-resistant Streptococcus pneumoniae (MRSP) population will be the primary endpoint.

"We are pleased that the Agency provided clear guidance regarding our registration pathway for Restanza in the CABP and biodefense indications.  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 pneumoniae," said Michael T. Flavin, Ph.D., chairman and chief executive officer of Advanced Life Sciences. "Based on the data we have accumulated in our extensive pre-clinical and clinical program to date, coupled with a thorough review of published literature on the clinical relevance of macrolide resistance, we believe that Restanza can show a superior efficacy advantage in patients who are resistant to marketed macrolide drugs.  With reported macrolide resistance rates as high as 40 percent in the U.S., there is a pressing medical need for new drugs to treat CABP.  Our goal is to finalize the SPA by the end of the third quarter of this year."


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SOURCE Advanced Life Sciences Holdings, Inc.
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