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Data Presentations at the 44th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy Support Clinical Utility of FACTIVE Tablets to Treat Respiratory Infections

Posted on: Friday, 29 October 2004, 09:00 CDT

Four presentations at the 44th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) conference highlight the clinical utility of Oscient Pharmaceuticals Corporation's (Nasdaq: OSCI) potent new oral antibiotic, once-daily FACTIVE(R) (gemifloxacin mesylate) tablets (320mg). FACTIVE tablets are approved by the United States Food and Drug Administration (FDA) for the treatment of acute bacterial exacerbations of chronic bronchitis (AECB) and mild to moderate community-acquired pneumonia (CAP) due to susceptible organisms. Oscient Pharmaceuticals launched FACTIVE to physicians last month.

"These data further underscore the important role that FACTIVE plays as a new treatment option for medically important respiratory infections," stated Steven M. Rauscher, President and CEO of Oscient Pharmaceuticals. "Of particular interest is one study that examined FACTIVE's activity compared to other agents against resistant strains of Streptococcus pneumoniae, especially in light of the medical community's growing concern about antibiotic resistance."

Data on FACTIVE presented at the meeting include:

Sunday, October 31, 2004, 2:30-2:45 PM Slide Session:

A-1094: Iannini, P, et al., "Influence of Gemifloxacin on the Incidence of Blood Glucose Disturbances"

-- Results from Phase III clinical trials assessing the incidence of glucose disturbances in patients exposed to gemifloxacin or comparator agents.

Sunday, October 31, 2004, 2:45-3:00 PM Slide Session:

A-1095: Mandell, L, et al., "Safety and Tolerability of Gemifloxacin: A Review of Clinical Trial Data"

-- Overview of data from 20 Phase II and Phase III clinical studies examining safety and tolerability profile of gemifloxacin for the treatment of respiratory tract infections.

Sunday, October 31, 2004, 3:00-4:30 PM Poster Session:

B-1175: De Azavedo, J, "Gemifloxacin Is Highly Effective Against a First-Step ParC Mutant of Streptococcus Pneumoniae in a Murine Pneumonia Model"

-- Results from an in vivo study evaluating the efficacy of gemifloxacin for the treatment of pneumococcal pneumonia caused by a first-step ParC mutant in a murine pneumonia model.

Tuesday, November 2, 2004, 10:00-11:30 AM Poster Session:

E-2071: Vaughan, D.J., et al., "Comparative Activity of Gemifloxacin against Penicillin-, Macrolide- and Quinolone-Resistant Strains of Streptococcus pneumoniae"

-- Results from a study examining the in vitro activity of gemifloxacin compared to comparator agents against penicillin-, macrolide- and quinolone-resistant strains of Streptococcus pneumoniae.

Additionally, the company will present data on its novel antibiotic candidate, Ramoplanin, which is in advanced clinical development for the treatment of Clostridium difficile-associated diarrhea (CDAD).

Sunday, October 31, 2004, 1:30-3:00 Poster Session:

K-985a: Leach, T, et al., "Ramoplanin vs Vancomycin in the Treatment of Clostridium difficile Diarrhea: a Phase 2 Study"

-- Results from the recently completed Phase II study of Ramoplanin for the treatment of Clostridium difficile-associated diarrhea.

About FACTIVE Tablets

FACTIVE tablets are approved by the United States Food and Drug Administration (FDA) for the treatment of acute bacterial exacerbations of chronic bronchitis (AECB) and mild to moderate community-acquired pneumonia (CAP). Together, these conditions afflict more than 17 million individuals in the United States each year, resulting in significant illness, economic expense and, in some cases, death.

Oscient continues to develop FACTIVE tablets for the treatment of respiratory tract infections. Clinical trials for the treatment of acute bacterial sinusitis (ABS) have been completed and a regulatory submission for that indication is planned for next year, pending the outcome of planning discussions with the FDA. In addition, Oscient is conducting a Phase III trial of FACTIVE tablets for the potential treatment of CAP in five days and is developing a FACTIVE intravenous formulation for the potential treatment of patients hospitalized with severe CAP. FACTIVE is not approved for either severe CAP, a five-day course of therapy for CAP or ABS.

The safety and efficacy of FACTIVE tablets were established through a robust clinical development program involving 6,775 patients. In these studies, FACTIVE tablets demonstrated excellent clinical response rates at the test-of-cure visit for CAP and AECB as good as comparators including clarithromycin, levofloxacin, amoxicillin/clavulanate, ceftriaxone and oral cefuroxime.

Important Safety Information about FACTIVE Tablets

The most common (more than 2% incidence) side effects reported in FACTIVE clinical trials were diarrhea (3.6%), rash (2.8%) and nausea (2.7%). In clinical trials, 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 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. To reduce the development of drug-resistant bacteria and maintain the effectiveness of FACTIVE tablets and other antibacterial drugs, FACTIVE tablets should be used only to treat infections that are proven or strongly suspected to be caused by bacteria.

Patients receiving marketed fluoroquinolones have reported serious and occasionally fatal hypersensitivity and/or anaphylactic reactions, peripheral neuropathy, and tendon ruptures. These adverse events have not been reported by patients taking gemifloxacin. However, 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 measure 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.

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(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). The Company's preclinical program includes an oral peptide deformylase (PDF) inhibitor series, under preclinical development for community-based respiratory tract infections.

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 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, delays in the progress of ongoing clinical trials and safety concerns arising with respect to 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 set forth in Exhibit 99.1 to the Company's Quarterly Report on Form 10-Q for the quarter ending June 26, 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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