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U.S. FDA Grants Fast-Track Designation to Sanofi Pasteur and KaloBios' Novel Biologic Candidate for Pseudomonas aeruginosa
Date:4/23/2013

CHICAGO, April 23, 2013 /PRNewswire/ --



Sanofi Pasteur, the vaccines division of Sanofi (EURONEXT: SAN and NYSE: SNY), and KaloBios Pharmaceuticals (Nasdaq: KBIO) announced today that the U.S. Food and Drug Administration (FDA) has granted Fast Track designation to Sanofi Pasteur for the investigation of KB001A, an antibody fragment, intended for protection against bacterial pneumonia caused by Pseudomonas aeruginosa (Pa) in mechanically-ventilated patients. The Fast Track Drug Development Program of the FDA is designed to facilitate the clinical development and expedite the review of new drugs and vaccines that are intended to treat or prevent serious or life-threatening conditions and demonstrate the potential to address unmet medical needs.  The joint announcement was made on this second day of the BIO International Convention, the 20th annual meeting of the world's largest biotechnology organization.

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Most serious Pa infections occur in hospitalized and critically or chronically ill patients--primarily affecting the respiratory system in susceptible individuals--and are a serious clinical problem due to the bacteria's resistance to antibiotics. Sanofi Pasteur, which is responsible for the clinical development under the terms of the agreement with KaloBios, is currently conducting a phase I trial of the monoclonal antibody in the United States and has started the planning of a phase IIb study.  

"Sanofi Pasteur is currently targeting the antibody for use in primary prevention of Pa-associated pneumonia in mechanically ventilated patients in hospital
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SOURCE Sanofi Pasteur
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