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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

d that, to assess the approvability for Restanza to treat CABP, the Company should establish a 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 has been working with the FDA to finalize a SPA using a superiority design for the outpatient CABP indication. Clinical cure rate in the macrolide-resistant Streptococcus pneumoniae (MRSP) population will be the primary endpoint.  

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 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
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SOURCE Advanced Life Sciences Holdings, Inc.
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