US FDA fast-track for Sanofi Pasteur's KB001A; orphan status for Teva/Xenon's XEN402; second BD Simplist product approved

Among a flurry of news items from the US Food and Drug Administration, was notification that Sanofi Pasteur, the vaccines division of French drug major Sanofi (Euronext: SAN), and KaloBios Pharmaceuticals (Nasdaq: KBIO) had been granted fast track designation for the investigation of KB001A, an antibody fragment, intended for protection against bacterial pneumonia caused by Pseudomonas aeruginosa (Pa) in mechanically-ventilated patients.

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 USA and has started the planning of a Phase IIb study.

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.