LEXINGTON, Mass.--(BUSINESS WIRE)--March 3, 2006--Cubist Pharmaceuticals, Inc. (Nasdaq: CBST) today announced that briefing documents prepared by Cubist and the FDA and provided to members of the Anti-Infective Drugs Advisory Committee (AIDAC) are now available to the public. The documents posted on line today by the FDA refer to the sNDA filed by Cubist on September 21, 2005 for an expanded label for CUBICIN(R)(daptomycin for injection) as treatment for Staphylococcus aureus (S. aureus) bacteremia including those with known or suspected endocarditis. As previously announced, in a landmark Phase 3 study of S. aureus bacteremia and endocarditis, CUBICIN, as monotherapy at 6 mg/kg, met co-primary end points for non-inferiority compared with standard of care dual therapy. The CUBICIN sNDA, which has been granted Priority Review by the FDA with a PDUFA date of March 24, 2006, will be the focus of the next public meeting of the Anti-Infective Drugs Advisory Committee on Monday, March 6 at 8:30 a.m.
