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Oscient Pharmaceuticals Completes Enrollment in Pivotal Phase III Clinical Trial of FACTIVE Tablets for Potential Five-Day Treatment of Community-Acquired Pneumonia

Posted on: Wednesday, 9 March 2005, 09:00 CST

Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) has completed enrollment in its pivotal Phase III clinical trial comparing a five-day treatment of FACTIVE(R) (gemifloxacin mesylate) tablets to the FDA-approved seven-day course of therapy for the potential treatment of community-acquired pneumonia of mild to moderate severity (CAP). The non-inferiority, double-blind study has enrolled over 460 patients at approximately 100 sites in the United States and Europe. The Company expects to complete data analysis in the coming weeks, and pending the outcome of the analyses, the Company plans to file a supplemental New Drug Application with the FDA for the indication by the end of 2005.

"Our plans to expand the labeling for FACTIVE are underway and the completion of enrollment in this trial represents another key step in our effort to broaden the use of FACTIVE," stated Steven M. Rauscher, President and CEO of Oscient Pharmaceuticals. "Pending a successful outcome, the data from this trial will be submitted to the FDA as we pursue a labeling claim for five-day therapy for mild to moderate community-acquired pneumonia. We believe that physicians and patients will benefit from an even shorter course of therapy in this indication through increased convenience and potentially improved compliance."

The five-day course would also provide physicians with the convenience of treating both CAP and AECB with the same dose. The final patients have been enrolled and are expected to complete follow-up visits in the next few weeks. The Company will examine the data comparing the two courses of therapy and, if supportive of a new drug application, will file an NDA by the end of the year. Results from the study are expected to be submitted for publication in a scientific journal or for presentation at a medical meeting this fall.

Approved for acute bacterial exacerbations of chronic bronchitis and mild to moderate CAP, Oscient began selling FACTIVE in the fall of 2004. The Company estimates that over 100,000 patients in total have been treated with FACTIVE, either via prescriptions or full course therapy samples.

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).

Important Safety Information about FACTIVE Tablets

The most common (more than 2% incidence) 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 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. 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 set forth in Exhibit 99.1 to the Company's Quarterly Report on Form 10-Q for the quarter ending September 25, 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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