Biotech Values

[DewDiligence]

Cubist Pharmaceuticals Has Submitted Response to FDA Approvable Letter Received on Friday

[That was fast work: CBST received the approvable letter on Friday and submitted a response on Monday. The action is expected to be treated by the FDA as a “Class 1” complete response letter, which starts a 60-day clock for the FDA to reply. CBST insisted on their Friday CC that the only outstanding matter is the label.]

http://biz.yahoo.com/bw/060327/20060327005976.html?.v=1

>>
Monday March 27, 3:16 pm ET

FDA Action Anticipated by Late May

LEXINGTON, Mass.--(BUSINESS WIRE)--March 27, 2006--Cubist Pharmaceuticals, Inc. (Nasdaq: CBST ) today announced that the Company has submitted to the Food & Drug Administration (FDA) an amendment to the sNDA for CUBICIN® (daptomycin for injection), in complete response to the FDA Approvable Letter of March 24, 2006. The sNDA seeks a label expansion for CUBICIN based on the results of the company's landmark Phase 3 study of CUBICIN once-a-day at 6 mg/kg for the treatment of Staphylococcus aureus (S. aureus) bacteremia and endocarditis. This trial was the first prospective, randomized and controlled registration study of these serious infections. The submission of the amendment will establish a new action date for the sNDA that is approximately 60 days after submission. The new action date will be confirmed once the FDA determines that the submitted amendment is a complete response.

About CUBICIN® (daptomycin for injection)

CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. indicated for the treatment of complicated skin and skin structure infections caused by susceptible strains of the following Gram-positive microorganisms: Staphylococcus aureus (including methicillin-resistant strains), Streptococcus pyogenes, S. agalactiae, S. dysgalactiae subsp equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). CUBICIN is not indicated for the treatment of pneumonia. Most adverse events reported in the skin infection clinical trials were mild or moderate in intensity and the most common were constipation, nausea, injection site reactions, and headache. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by bacteria susceptible to CUBICIN. For full prescribing information, visit www.cubicin.com.

About Cubist

Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development and commercialization of antiinfective products that address unmet medical needs in the acute care environment. In the U.S., Cubist markets CUBICIN® (daptomycin for injection), the first antibiotic in a new class of antiinfectives called lipopeptides. CUBICIN is currently the only once-daily bactericidal antibiotic approved in the U.S. with activity against both methicillin-susceptible and methicillin-resistant Staphylococcus aureus (MSSA and MRSA) in complicated skin and skin structure infections. In September, 2005, Cubist submitted a supplemental New Drug Application (sNDA) for approval to add S. aureus bacteremia with known or suspected endocarditis to the indication statement for CUBICIN. The FDA granted this application priority review. On March 6, the Anti-Infective Drugs Advisory Committee recommended approval of an expanded label for CUBICIN. On March 24th, the FDA issued an approvable letter, with action on a label expected by late May. The Cubist product pipeline includes our lipopeptide program, the product candidate HepeX-B and our natural products screening program. Cubist is headquartered in Lexington, MA.
<<