Cubist Pharmaceuticals Launches CORE, a CUBICIN U.S. Clinical Outcomes Registry.Business Editors/Health/Medical Writers BIOWIRE2K LEXINGTON, Mass.--(BUSINESS WIRE)--March 17, 2004 CORE Program to Provide Valuable Data to Physicians Treating Serious Gram-Positive Infections Cubist Pharmaceuticals, Inc. (Nasdaq: CBST CBST Center for Biophotonics Science and Technology CBST Congregation Beth Simcha Torah (NYC) CBST Complete Binary Search Tree ) today launched a registry program branded CORE(SM), or Cubicin Outcomes Registry & Experience. Cubicin(TM) (daptomycin for injection), a first in class 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, was launched in the U.S. by Cubist in late 2003 for the treatment of complicated skin and skin structure infections caused by certain Gram-positive organisms. CUBICIN is currently the only once-daily bactericidal antibiotic proven effective against both methicillin-resistant and methicillin-susceptible Staphylococcus aureus Staphylococcus au·re·us n. A bacterium that causes furunculosis, pyemia, osteomyelitis, suppuration of wounds, and food poisoning. Staphylococcus aureus Staphylococcus pyogenes (MRSA MRSA Methicillin-resistant Staphylococcus aureus. See MARSA. and 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 ). Debra Goff, PharmD, Clinical Associate Professor and Infectious Diseases Specialist at The Ohio State University Ohio State University, main campus at Columbus; land-grant and state supported; coeducational; chartered 1870, opened 1873 as Ohio Agricultural and Mechanical College, renamed 1878. There are also campuses at Lima, Mansfield, Marion, and Newark. Medical Center, commented on the launch of CORE: "Over the past several years, mortality rates and costs associated with the treatment of serious Gram-positive infections have risen dramatically, particularly as a result of infections caused by resistant organisms. With the creation of CORE, Cubist is helping supply valuable data to the clinical community--data that not only tracks relationships between patient demographics and clinical characteristics, but also provides outcomes data and allows sites to learn from the experiences of other participants in CORE. More importantly, CORE is expected to provide comparative data that may improve patient management strategies and quality improvement initiatives." CORE is a retrospective, longitudinal, multicenter registry program designed to collect information on patients who have received CUBICIN therapy. Cubist expects to enroll 40 sites in the U.S. by the end of 2004. By facilitating the benchmarking of regional data against national trends, the registry is intended to improve information flow on the standards of care Standards of care are medical or psychological treatment guidelines, and can be general or specific. They specify appropriate treatment protocols based on scientific evidence, and collaboration between medical and/or psychological professionals involved in the treatment of a given for patients treated for serious Gram-positive bacterial infections. Data from the registry will be published as it becomes available. For more information on the CORE program, contact Westat Clinical Trials at (888) 841-9322. The CORE program complies with all applicable HIPAA (Health Insurance Portability & Accountability Act of 1996, Public Law 104-191) Also known as the "Kennedy-Kassebaum Act," this U.S. law protects employees' health insurance coverage when they change or lose their jobs (Title I) and provides standards for patient health, requirements. To reduce the development of drug-resistant bacteria and maintain the effectiveness of CUBICIN and other antibacterial drugs, CUBICIN should be used only to treat or prevent infections that are proven or strongly suspected to be caused by susceptible bacteria. Patients receiving CUBICIN should be observed for the development of muscle pain or weakness and have creatine creatine /cre·a·tine/ (kre´ah-tin) an amino acid occurring in vertebrate tissues, particularly in muscle; phosphorylated creatine is an important storage form of high-energy phosphate. phosphokinase (CPK CPK creatine kinase. CPK creatine phosphokinase. ) levels monitored weekly if unexplained symptoms develop. CUBICIN is not indicated for the treatment of pneumonia. The most commonly reported adverse events in the cSSSI clinical trials in adults were constipation, nausea and headache. CUBICIN is 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. , Streptococcus agalactiae, Streptococcus streptococcus (strĕp'təkŏk`əs), any of a group of gram-positive bacteria, genus Streptococcus, some of which cause disease. dysgalactiae subsp. equisimilis and Enterococcus faecalis (vancomycin-susceptible strains only). For full prescribing information, visit www.Cubicin.com. Cubicin is a trademark and CORE is a service mark of Cubist Pharmaceuticals, Inc. About Cubist Cubist Pharmaceuticals, Inc. is a biopharmaceutical company focused on the research, development and commercialization of drugs that meet significant unmet medical needs. Since its founding in 1992, Cubist has been exclusively focused on exploiting business and product opportunities in the antiinfective marketplace. In the U.S., Cubist markets Cubicin(TM) (daptomycin for injection), the first antibiotic in a new class of antiinfectives called lipopeptides, for the indication of complicated skin and skin structure infections caused by Gram-positive bacteria. 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 and MRSA). Cubist's pre-clinical pipeline includes an oral version of ceftriaxone ceftriaxone /cef·tri·ax·one/ (cef?tri-ak´son) a semisynthetic, ß–resistant, third-generation cephalosporin effective against a wide range of gram-positive and gram-negative bacteria, used as the sodium salt. (OCTX), a broad-spectrum cephalosporin cephalosporin (sĕf'əlōspôr`ĭn), any of a group of more than 20 antibiotics derived from species of fungi of the genus Cephalosporium and closely related chemically to penicillin. Cephalosporins, e.g. antibiotic, and other novel members of the lipopeptide class. 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 further identify, develop, and achieve commercial success for new products and technologies; (vi) Cubist's ability to establish and maintain successful manufacturing, sales and marketing, distribution, and development collaborations; (vii) legislative or regulatory changes adversely affecting Cubist or the biopharmaceutical industry; (viii) Cubist's ability to protect its intellectual property and proprietary technologies; and (ix) 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. Additional information can be found at Cubist's web site at www.cubist.com |
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