Cubist Pharmaceuticals Announces Posting of Briefing Documents for FDA Anti-Infective Drugs Advisory Committee (AIDAC) Meeting; AIDAC Meeting to Review CUBICIN sNDA is Monday, March 6th.LEXINGTON, Mass. -- Cubist Pharmaceuticals, Inc. (Nasdaq: CBST CBST Center for Biophotonics Science and Technology CBST Congregation Beth Simcha Torah (NYC) CBST Complete Binary Search Tree ) today announced that briefing documents prepared by Cubist and the FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. 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 Staphylococcus au·re·us n. A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning. Staphylococcus aureus Staphylococcus pyogenes (S. aureus The aureus (pl. aurei) was a gold coin of ancient Rome valued at 25 silver denarii. The aureus was regularly issued from the 1st century BC to the beginning of the 4th century AD, when it was replaced by the solidus. ) bacteremia bacteremia: see septicemia. bacteremia Presence of bacteria in the blood. Short-term bacteremia follows dental or surgical procedures, especially if local infection or very high-risk surgery releases bacteria from isolated sites. including those with known or suspected endocarditis endocarditis (ĕn'dōkärdī`tĭs), bacterial or fungal infection of the endocardium (inner lining of the heart) that can be either acute or subacute. . 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 PDUFA Prescription Drug User Fee Act of 1992 (USA) 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. Both the Sponsor's Background Package, prepared by Cubist, and the FDA Briefing Document, prepared by the FDA Center for Drug Evaluation and Research The Center for Drug Evaluation and Research is a division of the FDA that deals with the approval of drugs. CDER reviews New Drug Applications to ensure that the drugs are safe and effective. It is one of five Centers at the United States Food and Drug Administration. (CDER CDER Center for Drug Evaluation and Research (US FDA) CDER Centre de Développement des Energies Renouvelables (French) CDER Client Development and Evaluation Report ), are now available at: http://www.fda.gov/ohrms/dockets/ac/cder06.html#AntiInfective. The sponsor document includes background on CUBICIN, a review of the unmet need in S. aureus bacteremia and infective endocarditis infective endocarditis n. See infectious endocarditis. infective endocarditis Acute endocarditis; bacterial endocarditis; subacute endocarditis Cardiology An infection of the endocardium which may involve the valves , an overview of regulatory guidance, and a detailed review of results from the Phase 3 study, along with conclusions. The FDA briefing document provides background information on S. aureus bacteremia and infective endocarditis, CUBICIN, regulatory history regarding bacteremia as an indication, selected analyses of the results of the trial comparing CUBICIN to standard of care in the treatment of patients with S. aureus bacteremia, including patients with known or suspected IE, and topics for discussion by the AIDAC. It is Cubist's understanding that an additional document from the FDA, with corrections and clarifications to the FDA Briefing Document, is being made available to the Advisory Committee and will be posted, although we do not know if this will happen prior to Monday's meeting. We understand that copies of the corrective document will be publicly available to those attending the Committee meeting on Monday. Details concerning access to the AIDAC meeting on Monday are available at: http://www.fda.gov/oc/advisory/accalendar/2006/cder12530d030606.html. About CUBICIN(R) (daptomycin for injection) CUBICIN is currently the only once-daily bactericidal bactericidal /bac·te·ri·ci·dal/ (bak-ter?i-si´d'l) destructive to bacteria. Bactericidal An agent that destroys bacteria (e.g. 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 Streptococcus py·og·e·nes n. A bacterium that causes the formation of pus or of fatal septicemias. Streptococcus pyogenes A common bacterium that causes strep throat and can also cause tonsillitis. , 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(R) (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 methicillin-resistant Staphylococcus aureus Methicillin-aminoglycoside resistant Staphylococcus aureus, MRSA An organism with multiple antibiotic resistances–eg, aminoglycosides, chloramphenicol, clindamycin, erythromycin, rifampin, tetracycline, (MSSA MSSA Methicillin-Sensitive Staphylococcus Aureus MSSA Microscopy Society of Southern Africa MSSA Maryland Saltwater Sportfishermen's Association MSSA Military Selective Service Act MSSA Mid-South Sociological Association MSSA Minnesota Social Service Association and MRSA MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. ) in complicated skin and skin structure infections. Cubist has filed 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 has granted this application priority review. Our product pipeline includes our lipopeptide program, the product candidate HepeX-B and our natural products screening program. Cubist is headquartered in Lexington, MA. Cubist Safe Harbor Statement Statements contained herein that are not historical fact may be forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and such statements are subject to a variety of risks and uncertainties. There are a number of important factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements made by Cubist. These factors include, but are not limited to: (i) whether we will receive, and the potential timing of, regulatory approvals or clearances to market CUBICIN in other countries and for additional indications in the United States and other countries pursuant to our currently-planned filings and any filings we determine to make in the future, which filings are subject to approval by the applicable regulatory agency or agencies, regardless of our confidence in the results of the clinical trials supporting such filings;(ii) the level of acceptance of CUBICIN by physicians, patients, third-party payors and the medical community; (iii) any changes in the current or anticipated market demand or medical need for CUBICIN; (iv) competition, particularly with respect to CUBICIN; (v) whether the FDA accepts proposed clinical trial protocols that may be achieved in a timely manner; (vi) our ability to conduct successful clinical trials in a timely manner; (vii) the ability of our third party manufacturers, including our single source provider of bulk drug substance, to manufacture sufficient quantities of CUBICIN in accordance with Good Manufacturing Practices and at an acceptable cost; (viii) our dependence upon pharmaceutical and biotechnology collaborations; (ix) our ability to finance our operations; (x) the effectiveness of our expanded sales force; (xi) potential costs resulting from product liability or other third party claims; (xii) our ability to protect our proprietary technologies; (xiii) our ability to discover or in-license drug candidates and develop and achieve commercial success for drug candidates; and (xiv) a variety of risks common to our industry, including ongoing regulatory review, litigation An action brought in court to enforce a particular right. The act or process of bringing a lawsuit in and of itself; a judicial contest; any dispute. When a person begins a civil lawsuit, the person enters into a process called litigation. relating to intellectual property, and legislative or regulatory changes. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward-looking statements are contained in Cubist's recent filings with the Securities and Exchange Commission, including those factors discussed under the caption "Risk Factors" in such filings. Cubist and CUBICIN are registered trademarks of Cubist Pharmaceuticals, Inc.; HepeX-B is a trademark of XTL XTL Crystal XTL Xpress Train Limited XTL Anything-To-Liquids (synthetic fuels) XTL XML Template Language XTL Xml Transformation Language XTL Extensible Transformation Language XTL Executable Temporal Language Biopharmaceuticals Ltd. Additional information can be found at Cubist's web site at www.cubist.com |
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