FDA Approves Expanded Label for IV Antibiotic Cubicin

FDA Approves Expanded Label for IV Antibiotic Cubicin to Add Bloodstream Infections Including Right-Sided Infective Endocarditis Caused by MSSA and MRSA

LEXINGTON, Mass., May 25, 2006 - Cubist Pharmaceuticals, Inc. today announced that the U.S. Food & Drug Administration (FDA) has approved the supplemental new drug application (sNDA) for Cubicin (daptomycin for injection) as once-a-day therapy at 6 mg/kg for the treatment of Staphylococcus aureus (S. aureus) bloodstream infections (bacteremia) including right-sided endocarditis caused by MSSA (methicillin-susceptible S. aureus) and MRSA (methicillin-resistant S. aureus). Cubist estimates that these infections account for 30,000 deaths in the U.S. alone each year. Cubicin will be the only IV antibiotic approved for this indication based on the results of a prospective, randomized, controlled registration trial. Cubist will commence marketing of Cubicin for the new indication immediately to acute care infectious disease doctors and specialists who treat S. aureus bloodstream infections.

The FDA decision today follows the positive recommendations of the Anti-infective Drugs Advisory Committee, which at its March 6th meeting reviewed data from a landmark Phase 3 trial conducted by Cubist, a study of the efficacy and safety of Cubicin at 6 mg /kg once-a-day as monotherapy vs. dual therapy standard of care therapy (semi synthetic penicillin plus initial gentamicin for infections caused by MSSA or vancomycin plus initial gentamicin for infections caused by MRSA) for the treatment of S. aureus bacteremia and endocarditis.

Cubicin was originally approved on September 12, 2003, at 4 mg/kg intravenously once daily for the treatment of complicated skin and skin structure infections (cSSSI) caused by Gram-positive organisms, including both susceptible and resistant strains of S. aureus (MSSA and MRSA respectively). In September of 2005, Cubist submitted to the FDA a sNDA for an expanded label. The file was accepted and given Priority Review designation by the FDA on November 25th, followed by an FDA Approvable Letter on March 24th. The results of the Phase 3 trial on which the sNDA is based were presented at the Interscience Conference on Antimicrobial Agents and Chemotherapy in December, 2005. The trial results showed that, for the treatment of S. aureus bacteremia and endocarditis, Cubicin at 6 mg/kg intravenously once daily met both primary end points for non-inferiority vs. comparator consisting of dual therapy (semi synthetic penicillin plus initial gentamicin for infections caused by MSSA or vancomycin plus initial gentamicin for infections caused by MRSA.)

About Cubicin (daptomycin for injection)

Cubicin is currently the only once-daily bactericidal antibiotic approved in the U.S. for the following infections:

Complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: S. aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). S. aureus bloodstream infections (bacteremia), including those with right-sided infective endocarditis, caused by methicillin-susceptible and methicillin-resistant S. aureus. Cubicin is not indicated for the treatment of pneumonia. Patients with persisting or relapsing S. aureus infection or poor clinical response should have repeat blood cultures. If a culture is positive for S. aureus, MIC susceptibility testing of the isolate should be performed using a standardized procedure, as well as diagnostic evaluation to rule out sequestered foci of infection. Most adverse events reported in clinical trials were mild to moderate in intensity. The most common were anemia, constipation, diarrhea, nausea, vomiting, injection site reactions, and headache. For full prescribing information, visit www.cubicin.com.

Source: Cubist Pharmaceuticals, Inc.

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