Biotech success, 2002 Message Board

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Biotech / Medical : Biotech success, 2002

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To: Miljenko Zuanic who wrote (31)	3/7/2002 8:28:21 PM
From: Miljenko Zuanic	of 117

Good for CBST! Thursday March 7, 7:49 am Eastern Time Press Release SOURCE: Cubist Pharmaceuticals Cubist Pharmaceuticals Announces Plan to File CIDECIN NDA by End of 2002 FDA Indicates that Proposed NDA Package is Acceptable for Filing LEXINGTON, Mass.--(BW HealthWire)--March 7, 2002--Cubist Pharmaceuticals, Inc. (Nasdaq: CBST - news) today announced its intention to proceed as planned with a 2002 New Drug Application (NDA) filing to the U.S. Food & Drug Administration (FDA) for its investigational antibiotic Cidecin® (daptomycin for injection) for the indication of complicated skin and soft tissue (cSST) infections involving both susceptible and resistant Gram-positive organisms. This decision comes following the receipt of correspondence from the FDA indicating that the CIDECIN NDA package as proposed would be acceptable for filing. CIDECIN is the first in a new class of antibiotics called lipopeptides. Its safety and efficacy are currently being evaluated in multiple Phase III studies at Cubist. Cubist has previously announced results from two pivotal Phase III clinical trials assessing the safety and efficacy of CIDECIN in the treatment of cSST infections. The primary endpoint of demonstrating equivalency to comparator agents was achieved in both studies. In addition, the incidence of total adverse events in the studies was similar in both the CIDECIN and comparator agent arms. Scott M. Rocklage, Ph.D., Chairman and CEO of Cubist commented on the news. ``We are extremely pleased to be in a position to file the U.S. NDA on CIDECIN by the end of 2002. We are also encouraged by data emerging from ongoing market research assessing physician and formulary acceptance of CIDECIN with the existing data package. Based on our current timeline and market feedback, we are now preparing for the U.S. launch of CIDECIN during 2003, assuming final FDA approval.''

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