FDAnews
www.fdanews.com/articles/85262-fda-grants-fast-track-designation-for-ppi-0903

FDA GRANTS FAST -TRACK DESIGNATION FOR PPI-0903

March 14, 2006

Cerexa has announced that the FDA has granted fast-track designation for PPI-0903, a next-generation, broad-spectrum, cephalosporin antibiotic, for the treatment of complicated skin and skin structure infections (cSSSI) caused by methicillin-resistant Staphylococcus aureus (MRSA). The company initiated a Phase 2 trial of PPI-0903 for the treatment of cSSSI in October 2005.

PPI-0903 combines the advantages of an enhanced gram-positive spectrum, including bactericidal anti-MRSA activity, with broad gram-negative activity, while maintaining the favorable safety profile of cephalosporins. Cephalosporins are the most frequently prescribed class of antibiotics in the world. Unlike currently marketed cephalosporins, PPI-0903 has demonstrated bactericidal activity against the most resistant strains of Gram-positive bacteria, including MRSA.