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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

s 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 against Pa may 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."

About KB001A

KB001A, a Humaneered™ antibody fragment, is designed to fight Pseudomonas aeruginosa (Pa) by blocking a virulence mechanism (the Type Three Secretion System or TTSS) on the bacterium's external surface that enables Pa to evade human immune defenses by killing white blood cells and epithelial cells, and triggering tissue-damaging inflammation. By blocking Pa's killing mechanism, KB001A is intended to reduce the damage done to the lungs by Pa and potentially enable the patie
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