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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 20
th annual meeting of the world's largest biotechnology organization.
http://photos.prnewswire.com/prnh/20130423/610748-b ) 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 targetingthe antibody for use in primary prevention of Pa-associated pneumonia in mechanically ventilated patients in hospitals and we are also interested in providing prevention of relapses and improvement of treatment outcomes in patients with an ongoing Pa infection," according to
Michel DeWilde, Ph.D., Senior Vice President, Research and Development.
"Additional indications may be considered later in the lifecycle of the product."
Under the terms of the current agreement, Sanofi Pasteur has worldwide rights to KaloBios' KB001A technology for all disease indications related to
Pa infections, except cystic fibrosis and bronchiectasis, the rights in which were retained by KaloBios, and Sanofi Pasteur has the option to obtain at a later date.
"Hospital-based pneumonias, especially those associated with mechanically ventilated patients in the ICU, are a life-threatening complication that can significantly increase mortality and morbidity as well as add tens of thousands of dollars to the cost of a hospital stay," said
David Pritchard, President and CEO, KaloBios
."KB001's novel mechanism of action againstPamay provide a unique means of fighting these infections, which are often resistant to antibiotic therapies.The FDA fast-track designation recognizes that this novel biologic could address an important unmet medical need."