New Data Illustrate Geographic Variance in Rates of Drug-Resistant Streptococcus Pneumoniae in U.S.

COPENHAGEN, Denmark -- Data presented at the 15th European Congress of Clinical Microbiology and Infectious Diseases (ECCMID) in Copenhagen, Denmark, confirmed a continued increase in multi-drug resistant Streptococcus pneumoniae (MDRSP) rates throughout the U.S. The study provides current MDRSP data and is the first to evaluate resistance rates for specific geographic communities in the U.S.

In this study, a total of 1,479 Streptococcus pneumoniae (S. pneumoniae) isolates were collected during 2003-4 from patients seen at 60 hospitals in 17 major metropolitan areas with high antibiotic prescription volume. The S. pneumoniae isolates were then analyzed by Focus Bio-Inova, a global research laboratory, to further define the incidence of MDRSP in specific regions. Nationally, the rate of MDRSP among clinical isolates was determined to be 22 percent, with regional rates ranging from 13.5 percent to 37.5 percent. The U.S. Food and Drug Administration defines MDRSP as S. pneumoniae strains resistant to two or more of the following antibiotics: penicillin, second generation cephalosporins (e.g. cefuroxime), macrolides, tetracyclines and trimethoprim/sulfamethoxazole.

In addition to examining regional MDRSP rates, the study, funded by Oscient Pharmaceuticals, also evaluated in vitro activity of fluoroquinolone antibiotics against MDRSP. To compare the in vitro activity and potency of the drugs, the study measured the minimum inhibitory concentration (MIC), which is the lowest concentration of antibiotic needed to inhibit the growth of the bacteria. Among the fluoroquinolones tested against 326 MDRSP isolates, gemifloxacin showed the highest degree of in vitro activity (MIC ranges of less than or equal to 0.004 to 4.0 mg/L) followed by moxifloxacin (MIC ranges of 0.03 to 16.0 mg/L) and levofloxacin (MIC ranges of 0.25 to greater than or equal to 32 mg/L).

"The data showed that resistance associated with older treatments like penicillin and erythromycin is high, demonstrating the importance of prescribing a potent or active drug first in order to quickly eradicate difficult-to-treat bacteria like MDRSP," said Mark E. Jones, PhD, Scientific Director at Focus Bio-Inova, Inc.

Copies of the poster presented at ECCMID are available upon request.

About Focus Bio-Inova, Inc.
Focus Bio-Inova is a research and development laboratory focused on providing global central laboratory and customer microbiology services to help biopharmaceutical researchers expedite the discovery and development of new therapeutics. Built on a foundation of 14 years experience, Focus Bio-Inova has world-respected scientific accomplishments in supporting clinical trials of any size or complexity with specialties in cardiology, infectious disease, immunology and oncology.

About Oscient Pharmaceuticals
Oscient Pharmaceuticals Corporation is a biopharmaceutical company committed to the clinical development and commercialization of novel therapeutics to address unmet medical needs. The company is marketing FACTIVE® (gemifloxacin mesylate) tablets, approved by the FDA for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. In addition to the oral tablet form, Oscient Pharmaceuticals is developing an investigational FACTIVE intravenous formulation for use in hospitalized patients. The company has a novel antibiotic candidate, Ramoplanin, in advanced clinical development for the treatment of Clostridium difficile-associated diarrhea (CDAD).

Important Safety Information about FACTIVE Tablets
The most common (more than 2 percent incidence) drug-related side effects reported in FACTIVE clinical trials were diarrhea (3.6 percent), rash (2.8 percent) and nausea (2.7 percent). In clinical trials, drug-related rash was reported in 2.8 percent of patients receiving gemifloxacin and was more commonly observed in patients less than 40 years of age, especially females. The incidence of rash increases with treatment longer than the maximum-labeled duration of 7 days. In clinical trials, the discontinuation rate due to drug-related adverse events was similar for FACTIVE tablets and comparators (2.2 percent versus 2.1 percent, respectively).

Gemifloxacin is contraindicated in patients with a history of hypersensitivity to gemifloxacin, fluoroquinolone antibiotic agents, or any of the product components.

Patients receiving marketed fluoroquinolones have reported serious and occasionally fatal hypersensitivity and/or anaphylactic reactions, peripheral neuropathy, antibiotic-associated colitis and tendon ruptures. Gemifloxacin should be discontinued immediately at the first sign of any of these events.

Fluoroquinolones may prolong the QT interval in some patients. Gemifloxacin should be avoided in patients with a history of prolongation of the QTc interval, patients with uncorrected electrolyte disorders (hypokalemia or hypomagnesemia), and patients receiving Class IA or Class III antiarrhythmic agents.

In clinical studies with gemifloxacin, CNS effects have been reported infrequently. As with other fluoroquinolones, gemifloxacin should be used with caution in patients with known or suspected CNS diseases. If CNS reactions occur, gemifloxacin should be discontinued and appropriate measures instituted.

No significant drug-drug interactions were seen with theophylline, digoxin, oral contraceptives, cimetidine, omeprazole, and warfarin, although patients receiving a fluoroquinolone concomitantly with warfarin should be monitored closely. Drug-drug interactions include probenicid, sucralfate, antacids containing aluminum or magnesium, iron, multivitamins containing metal cations, and didanosine.

The safety and effectiveness of gemifloxacin in children, adolescents (less than 18 years of age), pregnant women, and lactating women have not been established. For complete safety and efficacy information, please see the full prescribing information available at www.factive.com.

Source: Business Wire