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New Data Illustrate Geographic Variance in Rates of Drug Resistant Streptococcus Pneumoniae in the United States

Posted on: Tuesday, 5 April 2005, 18:00 CDT

FACTIVE (R) (gemifloxacin mesylate) tablets demonstrate highest degree of activity among fluoroquinolones

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, Ph.D., 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 (Nasdaq: OSCI) is a biopharmaceutical company committed to the clinical development and commercialization of novel therapeutics to address unmet medical needs. The Company is marketing FACTIVE (R) (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% incidence) drug-related side effects reported in FACTIVE clinical trials were diarrhea (3.6%), rash (2.8%) and nausea (2.7%). In clinical trials, drug-related rash was reported in 2.8% 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% versus 2.1%, 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.

Forward-Looking Statement

This news release may contain forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements represent our management's judgment regarding future events. Forward-looking statements typically are identified by use of terms such as "may,""will,""should,""plan,""expect,""intend,""anticipate,""estimate," and similar words, although some forward-looking statements are expressed differently. We do not plan to update these forward-looking statements. You should be aware that our actual results could differ materially from those contained in the forward-looking statements due to a number of risks affecting our business. Our business is significantly dependent upon our ability to launch the commercial sale of FACTIVE (R) tablets, and, due to the limitations on our resources and experience in commercializing products, there can be no assurance that we will be able to successfully launch FACTIVE tablets. Even if we succeed in launching FACTIVE tablets, a number of factors could negatively affect the success of FACTIVE tablets, including lack of acceptance by physicians, patients and third party payors, unanticipated safety, efficacy, or other regulatory issues, problems relating to manufacturing or supply, inadequate distribution of our products by wholesalers, pharmacies, hospitals and other customers and competition from other products. It is also uncertain whether we will be able to expand the indications for which FACTIVE tablets are approved or obtain approval to sell our lead product candidate, Ramoplanin. Factors which may prevent or delay us in obtaining additional regulatory approvals of our products and product candidates include, negative, inconclusive or insufficient results in ongoing or future clinical trials, the FDA requiring additional information or data, delays in the progress of ongoing clinical trials, safety concerns arising with respect to our products or product candidates and disputes with the third parties from whom we license our products or product candidates. We are also subject to the risk that our business and the business of GeneSoft Pharmaceuticals will not be integrated successfully and the significant costs related to the integration. Our business could also be negatively affected due to our inability or the inability of our alliance partners to successfully develop and commercialize products based on our discoveries. Additional factors that could cause actual results to differ materially from those projected or suggested in any forward looking statement are described under the heading "Risk Factors" in "Management's Discussion and Analysis of Financial Condition and Results of Operations" in the Company's Annual Report on Form 10-K for the year ending December 31, 2004 and in other filings that we may make with the Securities and Exchange Commission from time to time.

Source: Business Wire

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