September 28, 2004

IN BRIEF: OSCIENT PHARMACEUTICALS CORP.

Oscient Pharmaceuticals Corp. plans to add Factive (gemifloxacin mesylate) sales representatives in more than 150 territories "by early next year," the company said in a press release. Oscient currently has more than 100 field representatives selling the pharma name antibiotic, which has been approved by the Food and Drug Administration for the treatment of acute bacterial exacerbations of chronic bronchitis and community-acquired pneumonia of mild to moderate severity.

August 12, 2004

DATA SHOW FACTIVE AT LEAST AS EFFECTIVE AS OTHER ANTIBIOTICS FOR TREATING ACUTE EXACERBATION OF CHRONIC BRONCHITIS, PNEUMONIA

Two studies published in the August issue of Respiratory Medicine demonstrated that Oscient Pharmaceuticals Corp.'s Factive (gemifloxacin mesylate) was as effective as other commonly used antibiotics for treating acute exacerbation of chronic bronchitis (AECB) as well as community-acquired pneumonia with suspected pneumococcal origin.

During one double-blind trial, 360 adult patients with AECB were randomized to receive 320 mg of Factive each day for five days or 500 mg of Ortho-McNeil Pharmaceutical Inc.'s Levaquin (levofloxacin) once each day for seven days. A total of 335 patients completed the trial.

The primary endpoint, defined as a clinical response after 14 to 21 days, was achieved by 85.2 percent of patients treated with Factive versus 78.1 percent of those who received Levaquin in the intent-to-treat group. Between days 28 and 35 of follow-up, the clinical success rates in the per-protocol population were 83.7 percent in the Factive group and 78.4 percent in the Levaquin group.

The other double-blind study randomized 324 patients with community-acquired pneumonia of suspected pneumococcal origin to receive 320 mg of Factive each day for seven days or 1 g/125 mg of amoxicillin/clavulanate three times daily for 10 days.

At the end of therapy, the rates of clinical resolution among the 249 per-protocol patients were 95.3 percent for Factive and 90.1 percent for amoxicillin/clavulanate. Among the 228 per-protocol patients who made follow-up visits between days 24 and 30, 88.7 percent in the Factive arm and 87.6 percent in the amoxicillin/clavulanate group showed clinical resolution.

At follow-up, rates of bacteriologic response were similar: 87.2 percent for Factive-treated patients as compared with 89.1 percent for amoxicillin/clavulanate-treated patients.

Moreover, radiological response rates among the per-protocol patients at the end of therapy were 89.1 percent and 87.6 percent for the Factive and amoxicillin/clavulanate groups, respectively.

Factive is a registered trademark of LG Life Sciences Ltd.

July 30, 2003

GENESOFT'S FACTIVE GRANTED SUPPLEMENTAL APPROVAL BY FDA TO TREAT STREPTOCOCCUS PNEUMONIAE

The Food and Drug Administration granted approval to Genesoft Pharmaceuticals Inc.'s Factive (gemifloxacin) for an indication to treat mild to moderate community acquired pneumonia (CAP) due to multi-drug resistant streptococcus pneumoniae.

The pharma name Factive, originally approved in April for the treatment of mild to moderate CAP caused by other pathogens and for acute bacterial exacerbations of chronic bronchitis, is the first antibiotic with a specific indication for CAP caused by drug-resistant organisms, according to Genesoft.

Factive's supplemental approval provides physicians with a valuable option for pneumonia treatment due to the increasing rate of cross-resistance among bacteria to many current antibiotics, the company said.

"Increasingly, physicians are realizing that their prescribing decisions can not only affect the individual patient receiving a pharma brand drug, but can also have a larger societal impact," said Dr. Gary Patou, president of Genesoft.

As many as 4 million cases of CAP are reported in the United States annually, making it the leading cause of death due to infection.