Biaxin XL (R) (Clarithromycin extended-release tablets) and Levaquin(R) achieve similar results for community-acquired pneumonia

San Francisco, Calif., May 23, 2001 – A new study comparing Biaxin XL(R) (clarithromycin extended-release tablets) and another leading, once-daily antibiotic, Levaquin(R) (levofloxacin tablets, Johnson & Johnson) shows that Biaxin XL and Levaquin had similar results in patients with community-acquired pneumonia (CAP). The results presented today at the 97th annual meeting of the American Thoracic Society showed that patients receiving Biaxin XL achieved a clinical cure rate of 88 percent, similar to those taking the quinolone, Levaquin, who achieved an 86 percent clinical cure rate.

Biaxin XL is the once-daily formulation of Abbott Laboratories’ widely prescribed, advanced-generation macrolide antibiotic, Biaxin(R)(clarithromycin tablets), and in March 2000 was approved by the U.S. Food and Drug Administration for the treatment of mild-to-moderate acute maxillary sinusitis and acute bacterial exacerbation of chronic bronchitis in adults. The efficacy and safety of Biaxin XL in treating other infections for which other formulations of Biaxin are approved have not been established.

“These data are of interest because as many as three million Americans are affected each year by community-acquired pneumonia,” said Dan Dattani, M.D., principal investigator, Prairie Clinical Research Group, assistant clinical professor of Family Medicine, University of Saskatchewan, Saskatoon, Saskatchewan, Canada, and lead investigator in this study. “These data show that Biaxin and Levaquin had similar results in patients with this respiratory infection.”

Study Results

Biaxin XL and Levaquin were compared in a double-blind, parallel-group, multicenter study in 299 ambulatory patients with CAP. Patients were randomized to receive either 1,000 mg of Biaxin XL (2 x 500mg tablets) once-a-day for seven days, or 500 mg of Levaquin (2 x 250mg tablets) once-a-day for seven days. Efficacy evaluations were made at the test-of-cure visit (seven to 14 days after completion of therapy). Safety was assessed throughout the study by clinical laboratory tests, physical examinations, vital signs, and adverse events monitoring.

According to the study results, similar results were seen for both drugs. A clinical cure rate of 88 percent (113 of 128 patients) was achieved for Biaxin XL, compared to 86 percent (107 of 124 patients) for Levaquin. A bacteriological cure rate of 86 percent (80 of 93 patients) was observed in patients taking Biaxin XL, in comparison to 88 percent (85 of 97 patients) taking Levaquin. In terms of an overall pathogen eradication rate, 87 percent (134 of 154 patients) was achieved for Biaxin XL, compared to 88 percent or (136 of 155 patients) for Levaquin. Finally, a 95 percent (117 of 123 patients) radiographic success rate (resolution/improvement) was seen with Biaxin XL, compared to an 88 percent (104 of 118) for Levaquin.

The most common adverse events patients in both groups experienced were diarrhea, headache, and nausea. More patients taking Biaxin XL experienced altered taste due to their medication.

“We are excited to be sharing these data for Biaxin XL,” says Carol Olson, M.D., Ph.D., medical director, Marketed Product Development, Abbott Laboratories. “According to the results, both Biaxin XL and Levaquin were similar in their eradication of target pathogens associated with CAP.”

Biaxin XL tablets are indicated for mild-to-moderate infections in adults for the treatment of acute maxillary sinusitis (AMS) caused by Haemophilus influenzae, Moraxella catarrhalis, or Streptococcus pneumoniae, and acute bacterial exacerbation of chronic bronchitis (AECB) caused by Haemophilus influenzae, Haemophilus parainfluenzae, Moraxella catarrhalis, or Streptococcus pneumoniae. In adult clinical trials, Biaxin XL tablets taken once daily resulted in clinical cure rates comparable to that of the original formulation of Biaxin taken twice daily. The efficacy and safety of Biaxin XL in treating other infections for which other formulations of Biaxin are approved have not yet been established. Biaxin XL is available in a seven-day convenience pack and should be taken with food.

In patients with a known hypersensitivity to clarithromycin or any macrolide antibiotic, Biaxin and Biaxin XL tablets are contraindicated. Concomitant administration with Propulsid(R) (cisapride), Orap(R)(pimozide), or Seldane(R) (terfenadine) is contraindicated due to the potential for cardiac arrhythmias. Biaxin and Biaxin XL tablets should not be used in pregnant women except in circumstances for which no alternative therapy is appropriate. Biaxin and Biaxin XL tablets may elevate digoxin serum concentration. Serum digoxin levels should be carefully monitored while digoxin and clarithromycin are taken concomitantly. The dose of clarithromycin should be halved or the dosing interval doubled in patients with severe renal impairment (CrCl<30mL/minute).

Pneumonia is an infection or inflammation of the lungs. Community-acquired pneumonia is the most common type of pneumonia, affecting two to three million Americans each year, and resulting in approximately 10 million physician visits annually. The most common symptoms of CAP include malaise, shaking chills, chest pain, weakness, fever, and a cough that produces rust or greenish-colored mucus. CAP is caused by pathogens acquired in the general community.

Abbott Laboratories filed for a CAP indication for Biaxin XL with the FDA in September, 2000.

Abbott Laboratories has a long history of leadership in anti-infectives dating back to the 1930s. Abbott was one of the five pioneers in the United States to start commercial production of penicillin. Years later, in conjunction with the research efforts of two other pharmaceutical companies, Abbott developed an early macrolide antibiotic. In addition, Abbott also markets a cephalosporin antibiotic and recently signed a global licensing agreement with Wakunaga Pharmaceutical Co., Ltd., of Osaka, Japan, to develop and market two investigational anti-infective compounds. Abbott's commitment continues today with extensive research to discover and develop new compounds in this area.

Abbott Laboratories is a global, diversified health care company devoted to the discovery, development, manufacture, and marketing of pharmaceuticals, nutritionals, and medical products, including devices and diagnostics. The company employs approximately 70,000 people and markets its products in more than 130 countries.

Abbott's news releases and other information including full prescribing information for Biaxin and Biaxin XL are available on the company's Web site at www.abbott.com.