LEVAQUIN(R) Receives FDA Approval for Multi-Drug Resistant Form of Streptococcus Pneumonia in Community-Acquired Pneumonia

RARITAN, N.J. -- The U.S. Food and Drug Administration (FDA) has approved the fluoroquinolone antibiotic LEVAQUIN(R) (levofloxacin) Tablets/Injection and LEVAQUIN(R) (levofloxacin in five percent dextrose) Injection to treat multi-drug resistant strains of Streptococcus pneumoniae in community-acquired pneumonia (CAP).

Approximately four million people in the United States develop CAP each year. S. pneumoniae is one of the primary bacteria that causes CAP. Multi-drug resistant S. pneumoniae (MDRSP) are forms of bacteria resistant to two or more therapeutic classes of antibiotics including penicillin, second-generation cephalosporins, macrolides, tetracyclines and sulfonamides. The presence of multi-drug resistant S. pneumoniae has increased significantly over time and today represents up to 23 percent of all strains.

Data from Tracking Resistance in the United States Today (TRUST) demonstrated that 98 percent of MDRSP isolates are susceptible to LEVAQUIN. TRUST, the largest and most comprehensive respiratory pathogen surveillance study in the United States, has been conducted annually since 1997. In vitro activity does not necessarily correlate with clinical results.

"This approval is significant as it increases the flexibility that physicians have to treat patients with drug-resistant bacterial infections with a medication that has demonstrated proven safety and efficacy over time," said Thomas G. Slama, MD, Clinical Professor of Medicine, Indiana School of Medicine, Indianapolis.

LEVAQUIN is indicated to treat mild-to-severe community-acquired pneumonia (CAP) due to Staphylococcus aureus, Streptococcus pneumoniae, Haemophilus influenzae, Haemophilus parainfluenzae, Klebsiella pneumoniae, Moraxella catarrhalis, Chlamydia pneumoniae, Legionella pneumophila or Mycoplasma pneumoniae. LEVAQUIN may be used to treat CAP in a five-day, 750 mg once-daily dosing regimen called the Leva-pak. LEVAQUIN is also approved to treat CAP at a dose of 500 mg daily for seven to 14 days.

LEVAQUIN is dosed once daily and indicated for a wide variety of infections in addition to CAP including acute bacterial exacerbation of chronic bronchitis, acute maxillary sinusitis, nosocomial pneumonia, mild to moderate cases of complicated and uncomplicated urinary tract infections, acute pyelonephritis and chronic bacterial prostatitis.

The safety and efficacy of levofloxacin in pediatric patients, adolescents (under 18), pregnant women and nursing mothers have not been established. Levofloxacin is contraindicated in persons with a history of hypersensitivity to levofloxacin, quinolone antimicrobial agents or any other components of this product. Serious and occasionally fatal hypersensitivity and/or anaphylactic reactions have been reported in patients receiving therapy with quinolones, including levofloxacin. These reactions often occur following the first dose. The drug should be discontinued at the first appearance of a skin rash or any other sign of hypersensitivity.

Antacids containing magnesium or aluminum, as well as sucralfate, metal cations such as iron, and multivitamin preparations with zinc, or Videx(R) (didanosine) chewable/buffered tablets or the pediatric powder for oral solution should be taken at least two hours before or two hours after levofloxacin administration. For more information on warnings, precautions and additional adverse reactions that may occur, regardless of drug relationship, please see accompanying full U.S. Prescribing Information or visit www.levaquin.com or www.ortho-mcneil.com.

More than 300 million patients have been treated with levofloxacin worldwide since 1993.

Ortho-McNeil Pharmaceutical, Inc. is a Johnson & Johnson company. Ortho-McNeil Pharmaceutical, Inc. markets prescription drugs in the areas of women's health, infectious disease, central nervous system, pain treatment, urology and migraine headaches.

Videx is a registered trademark of Bristol-Myers Squibb Company.

Source: Ortho-McNeil Pharmaceutical, Inc.