Post-marketing FORCE trial completed ahead of schedule
WALTHAM, Mass. — Oscient Pharmaceuticals Corporation (Nasdaq: OSCI) has completed enrollment in its Phase IV post-marketing trial for its fluoroquinolone antibiotic, FACTIVE([R]) (gemifloxacin mesylate) tablets. Known as the FORCE trial (FACTIVE Outpatient Respiratory Infection Community Experience), Oscient began enrollment coincident with the launch of FACTIVE in the fall of 2004. A commitment to complete post-marketing trials has become a condition of approval for many drugs and this trial was expected to take three to four years to complete. Patient enrollment at more than 200 clinical sites was completed nearly one year ahead of schedule, which allows for the submission of the study report to the FDA earlier than planned.

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“By meeting our commitment to the FDA ahead of schedule, we reduce the total expense of the study and, following submission, our clinical development expenditures will decrease,” stated Steven M. Rauscher, President and Chief Executive Officer of Oscient Pharmaceuticals. “With more than one million patients treated worldwide, FACTIVE is an important option for physicians treating serious lower respiratory tract infections.”
The prospective, randomized study was designed to examine the safety of FACTIVE in treating community-acquired pneumonia of mild to moderate severity (CAP) versus clarithromycin and in treating acute bacterial exacerbations of chronic bronchitis (AECB) versus amoxicillin/clavulanate in the community. Conducted in physician offices across the U.S., the trial enrolled more than 7,500 patients: approximately 5,000 in the FACTIVE treatment group and approximately 2,500 in the comparator group. The study included patients of different ethnicities to gain additional safety information on populations not substantially represented in the clinical trial program. Preliminary results observed to date are consistent with clinical trial results and pharmacovigilance data for FACTIVE and have been submitted to the FDA through interim analyses. The Company expects to submit the final study report to the FDA later this year.
FACTIVE is approved in the U.S. for the seven-day treatment of CAP and the five-day treatment of AECB. The FDA has established an action date of May 1, 2007 for the Company’s supplemental New Drug Application seeking approval for a five-day treatment of CAP.
About Oscient Pharmaceuticals
Oscient Pharmaceuticals Corporation is a commercial-stage biopharmaceutical company marketing two FDA-approved products with its national primary care sales force. ANTARA([R]) (fenofibrate) capsules is indicated for the adjunct treatment of hypercholesterolemia (high blood cholesterol) and hypertriglyceridemia (high triglycerides) in combination with diet. FACTIVE([R]) (gemifloxacin mesylate) tablets is an antibiotic approved for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity. Oscient also has a novel, late-stage antibiotic candidate, Ramoplanin, under investigation for the treatment of Clostridium difficile-associated disease (CDAD).
For important information regarding the safety and use of ANTARA, please see the full prescribing information available at www.antararx.com.
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.

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