Cubist Pharmaceuticals Announces the Completion of Patient Enrollment in Cubicin's Phase 3 Endocarditis/Bacteremia Trial.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 ), following consultation with the U.S. Food and Drug Administration (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. ), today announced that it has completed enrollment of patients in its international Phase 3 clinical trial phase 3 clinical trial Phase 3 study. See Phase study. of Cubicin(R) (daptomycin for injection) for the treatment of 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 and 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. caused by Staphylococcus aureus Staphylococcus au·re·us n. A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning. Staphylococcus aureus Staphylococcus pyogenes . The FDA had previously requested that Cubist amend the original protocol to include patients with left-sided endocarditis endocarditis (ĕn'dōkärdī`tĭs), bacterial or fungal infection of the endocardium (inner lining of the heart) that can be either acute or subacute. . Based on the challenges of enrolling these seriously ill patients, the FDA has agreed that the inclusion of these patients would not be a requirement for a possible expansion of the CUBICIN label to include right-sided endocarditis and/or complicated bacteremia due to 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. . As a result, with more than 230 patients enrolled in this trial at centers in the U.S. and Western Europe, Cubist has met its overall enrollment target. Michael W. Bonney, President and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Cubist commented, "This news confirms that we are well on our way to completing this precedent-setting study, which has the potential of obtaining a new indication for CUBICIN." Cubist expects to conclude the trial with last patient/last visit in 2Q 2005 and anticipates releasing data in mid 2005. Key points from the meeting with the FDA are highlighted below: --Further enrollment of patients with left-sided endocarditis is not required. --Data from this study, if positive, could support an expansion of the current label to include right-sided endocarditis and/or complicated bacteremia due to S. aureus. --The FDA indicated that it plans to review the data from the overall population, as well as from clinically relevant subpopulations, to support the additional indication. As a result of its meeting with the FDA, Cubist today is notifying investigators involved in the trial that they should complete the enrollment of all patients in process, but not seek additional patients. 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 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 meet unmet medical needs. In the U.S., Cubist markets Cubicin(R) (daptomycin for injection), the first antibiotic in a new class of antiinfectives called lipopeptides. Cubist's pipeline includes HepeX-B(TM), a monoclonal antibody monoclonal antibody, an antibody that is mass produced in the laboratory from a single clone and that recognizes only one antigen. Monoclonal antibodies are typically made by fusing a normally short-lived, antibody-producing B cell (see immunity) to a fast-growing biologic currently in the second of two Phase 2 trials to determine its potential for the prevention of infection by the Hepatitis B virus (HBV HBV hepatitis B virus. HBV abbr. hepatitis B virus ) in liver transplant patients, and research efforts focused on novel members of the lipopeptide class of molecules. 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) the level of acceptance of CUBICIN by physicians, patients, third-party payors, and the medical community generally; (ii) Cubist's ability to continue to develop, secure additional regulatory approvals for, and successfully market, CUBICIN; (iii) Cubist's ability to manufacture CUBICIN on a commercial scale; (iv) commercialization of products that are competitive with CUBICIN; (v) Cubist's ability to discover or in-license drug candidates; (vi) Cubist's ability to successfully develop drug candidates in its pipeline, including HepeX-B; (vii) Cubist's ability to successfully commercialize any product or technology developed by Cubist; (viii) Cubist's ability to establish and maintain successful manufacturing, sales and marketing, distribution, and development collaborations; (ix) legislative or regulatory changes adversely affecting Cubist or the biopharmaceutical industry; (x) Cubist's ability to protect its intellectual property and proprietary technologies; and (xi) Cubist's ability to finance its operations. 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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