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Second Phase 3 Trial Investigating Doripenem for Complicated Urinary Tract Infections Begins

Alameda, Calif., April 15, 2004 - Peninsula Pharmaceuticals, Inc., a privately-held biopharmaceutical company, announced today that patient enrollment has begun in the fourth pivotal phase III trial of its lead product candidate, doripenem (also known as S-4661). This is the second pivotal trial of doripenem for complicated urinary tract infections (cUTI) including pyelonephritis. Doripenem, a broad-spectrum antibiotic, is a new member of the carbapenem class of beta-lactam antibiotics. The multicenter, open label, pivotal phase III trial will evaluate the safety and efficacy of intravenous doripenem in patients with complicated urinary tract infections. In accordance with FDA guidelines, the primary endpoint of the trial is microbiological response at the test of cure visit (five to nine days following completion of therapy) in those patients who have been enrolled in the clinical study with a confirmed bacterial pathogen. Patients will be enrolled in various countries around the world.

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.

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