KaloBios Pharmaceuticals, Sanofi Pasteur partner in development of KB001 biologic for Pa infections

KaloBios Pharmaceuticals, Inc. today announced an agreement with Sanofi Pasteur, the vaccines division of the sanofi-aventis Group, for the development and commercialization of KB001, an investigational new biologic for the treatment or prevention of Pseudomonas aeruginosa (Pa) infections. Sanofi Pasteur will be responsible for the development and commercialization of KB001 and initially focus on hospital indications, including the prevention of Pa pneumonias in mechanically ventilated patients. KaloBios will focus on developing and commercializing KB001 for use in treating patients with cystic fibrosis and bronchiectasis, an obstructive lung disease aggravated by bacterial infections.

“KB001’s novel mechanism of action against Pa provides a unique means of fighting these infections, which are often resistant to antibiotic therapies. We also think this novel mechanism could have a significant impact on Pseudomonas aeruginosa infections in cystic fibrosis patients as well.”

Under the terms of the agreement, KaloBios will receive an upfront payment of $35 million from Sanofi Pasteur, plus development, regulatory and commercial milestones for a potential further $255 million, as well as royalties on eventual product sales. Sanofi Pasteur also has the option to acquire commercial rights to KaloBios’ indications for KB001 outside the United States and co-promotion rights in the United States.

“Sanofi Pasteur is the world’s largest company devoted entirely to human vaccines, including those for the prevention of pneumonia,” said David Pritchard, President and Chief Executive Officer of KaloBios. “Their enormous development expertise in the field of infectious disease and worldwide commercialization capabilities make them the ideal partner for KB001, which has shown early promise in preventing Pa pneumonia and mortality in mechanically ventilated patients and in treating patients with cystic fibrosis.”

“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 Tillman Pearce, M.D., Chief Medical Officer of KaloBios. “KB001’s novel mechanism of action against Pa provides a unique means of fighting these infections, which are often resistant to antibiotic therapies. We also think this novel mechanism could have a significant impact on Pseudomonas aeruginosa infections in cystic fibrosis patients as well.”