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Second Phase 3 Trial Investigating Doripenem for Complicated Urinary Tract Infections Begins
According to an Arlington Medical Resources survey, there were over 2.5 million hospitalized patients diagnosed with various cUTIs and/or pyelonephritis in 2002. More than 50% of these patients received intravenously administered beta-lactam antibiotics as first line therapy.
According to IMS Health Incorporated, beta-lactam antibiotics were the most commonly prescribed antibiotics in the world based on 2002 sales. Based on sales figures reported by pharmaceutical companies, worldwide carbapenem antibiotic sales increased 13.8% to over $1 billion in 2003 compared to 2002.
"The global problem of antibiotic resistance ranks among the most challenging of medical issues facing the world today," said Matthew A. Wikler, M.D., FIDSA, Chief Medical Officer and Executive Vice President at Peninsula. "We believe that doripenem may provide a valuable alternative for treating hospitalized patients with complicated urinary tract infections and pyelonephritis, especially as resistance to currently marketed antibiotics continues to increase."
"Doripenem has the potential to address a significant unmet need for broad spectrum antibiotics to treat life threatening infections in the hospital," said Dr. Claudia Rodriguez of Hospital General de Agudos Dr. Cosme Argerich in Buenos Aires, Argentina. "As recently published studies have linked antibiotic resistance to the over use of fluoroquinolone antibiotics, there is a clear need for antibiotics with improved therapeutic profiles."
Doripenem has demonstrated in vitro activity against many aerobic and anaerobic Gram-positive and Gram-negative bacteria, including Enterobacteriaceae strains (including Escherichia coli and other extended spectrum beta-lactamase-producing strains) and Bacteroides fragilis.
Peninsula is also developing an inhaled version of doripenem to manage pulmonary infections in Cystic Fibrosis patients. Peninsula licensed North American, South American, and European rights for doripenem from Shionogi & Co. Ltd.
Source: Peninsula Pharmaceuticals, Inc.