Factive® faster than Biaxin® in eradicating the leading cause of airway infections in patients with chronic bronchitis

September 17, 2000

Comparative study shows 5-day treatment with Factive® more effective than 7-day treatment with Biaxin®

TORONTO, September 18, 2000 - SmithKline Beecham's (NYSE: SBH) investigational antibiotic Factive® (gemifloxacin mesylate) eradicated the bacterium, H. influenzae, after one day of treatment in airway infections in patients with chronic bronchitis, according to data presented at the 40th Interscience Conference of Antimicrobial Agents and Chemotherapy (ICAAC) in Toronto. Factive®is a highly active antibiotic with broad-spectrum activity against key respiratory pathogens.

"Impressively, the bacteria were eradicated after just one day of treatment with just one dose of Factive," said Thomas File, MD, Professor of Internal Medicine at Northeastern University College of Medicine and Chief of Infectious Disease at Summa Health System (Akron, Ohio). "These results support the efficacy of 5-day treatment with Factive® compared to seven-day treatment with Biaxin® in treating bacterial respiratory tract infections in patients with chronic bronchitis."

Superior efficacy of Factive® compared to Biaxin® in treating chronic bronchitis
A double blind, active-controlled study involving 709 patients compared the efficacy of 5-day treatment with Factive® (320 mg once daily) to 7-day treatment with Biaxin® (clarithromycin) (500 mg twice daily) in patients with airway infections due to chronic bronchitis. For all patients with documented bacterial infections at study entry, the success rates with Factive® were significantly better than the success rates with Biaxin® in follow-up evaluation at week five (81.8% as compared to 62.0%, respectively).

Bacterial eradication occurred on day one of treatment following one dose of Factive. In contrast, Biaxin-treated patients demonstrated evidence of H. influenzae persistence in patients through day seven. The results indicate that once-daily Factive® taken for five days has significantly better bacteriological success rates and faster eradication of H. influenzae than Biaxin® taken twice daily for seven days.

"It is important to treat respiratory tract infections with an effective therapy that can eradicate bacteria quickly," commented Dr. File. "This study confirms that shorter treatment durations with Factive® are effective in patients with chronic bronchitis."

The most commonly reported adverse events were diarrhea (6.6% for Factive® and 8.4% for Biaxin®) and headache (6.3% for Factive® and 8.7% for Biaxin®).

Activity of Factive® against resistant bacteria
In vitro studies also presented at ICAAC demonstrate the high activity of Factive® against resistant S. pneumoniae, H. influenzae and M. catarrhalis bacteria,* which are the leading causes of respiratory tract infections. In one of these studies, Factive® was found to be the most active antibiotic with broad-spectrum coverage compared to other antibiotics such as Levaquin® (levofloxacin) and Tequin® (gatifloxacin) against the multi drug-resistant bacteria S. pneumoniae, H. influenzae and M. catarrhalis.

A separate study evaluated the activity of Factive®, Levaquin®, Avelox® (moxifloxacin) and Tequin, among others, against penicillin-resistant and multiple antibiotic-resistant S. pneumoniae. Factive®retained activity against greater than 90% of isolates when the other drugs demonstrated reduced activity (71% for Avelox®, 64% for Tequin® and 16% for Levaquin®).

*In the study, the isolates were penicillin-resistant and multidrug-resistant S. pneumoniae, ampicillin- and TMP/SMX-resistant H. influenzae, and ampicillin-resistant M. catarrhalis

Chronic Bronchitis
Community-acquired respiratory tract infections, such as bronchitis, pneumonia and sinusitis, are highly prevalent. In the United States, more than 15-20 million people are estimated to have chronic bronchitis, and patients with chronic bronchitis may have several cases of acute exacerbations of chronic bronchitis (AECB) per year. The American Lung Association (ALA) ranks chronic bronchitis among the top 10 most prevalent conditions in the United States.

Respiratory tract infections are caused by several respiratory pathogens and are the most commonly treated infections in the United States. In fact, infections of the respiratory tract are some of the most common causes of morbidity and mortality globally and are the underlying cause of 30 out of every 100,000 deaths in the United States.

The Factive®New Drug Application was submitted in December of 1999 and is currently under review by the U.S. Food and Drug Administration. Factive®had an extensive clinical trial program involving more than 9,000 patients to evaluate clinical efficacy and safety.
SmithKline Beecham- one of the world's leading healthcare companies- discovers, develops, manufactures and markets pharmaceuticals, vaccines, over-the-counter medicines and health-related consumer products. For company information, visit SmithKline Beecham on the World Wide Web at http://www.sb.com.

Editor's note: Levaquin® is a registered trademark of Ortho-McNeil Pharmaceutical, Avelox® is a registered trademark of Bayer Corporation, Tequin® is a registered trademark of Bristol-Myers Squibb Company and Biaxin® is a registered trademark of Abbott Laboratories.

Add'l contact: Jennifer Armstrong
(215) 751-5664

Cohn & Wolfe

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