New Analysis Shows Significantly Higher Cure Rates in Hospital-Acquired Pneumonia for ZYVOX Compared to Vancomycin.

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CHICAGO--(BUSINESS WIRE)--Oct. 24, 2002

Embargoed until 8 a.m. Central, Friday, Oct. 25

Cure rates in patients with nosocomial (hospital-acquired) pneumonia were significantly higher in those treated with ZYVOX(TM) (linezolid injection, tablets and for oral suspension, marketed by Pharmacia Corporation) compared to vancomycin, according to a logistical regression analysis of two global Phase III studies. The analysis was presented today at the Infectious Diseases Society of America (IDSA) annual meeting in Chicago by researchers from Methodist Healthcare.

Data from two double-blind, multi-center studies of a total of 1,019 patients were analyzed using logistical regression to assess how treatment and baseline variables relate to outcome in nosocomial pneumonia (NP) due to methicillin-resistant Staphyloccocus aureus (MRSA). 153 patients were identified with MRSA and 116 were included in the analysis. The analysis showed that when controlling for patient differences and the severity of illness ZYVOX was superior to vancomycin in MRSA NP, with an overall cure rate of 63% vs. 35.5% for vancomycin (p=0.003). Patients with single lobe involvement, not on a ventilator, or without renal or oncologic comorbidities had better outcomes regardless of treatment group.

"With MRSA rates on the rise, this research gives physicians more information on the best way to treat nosocomial pneumonia," said Richard Wunderink, MD, FCCP, Director, Research Department, Methodist Healthcare in Memphis, Tenn. "The regression analysis indicated that patients in the vancomycin arms of these studies were more likely to have sub optimal outcomes and more likely to die. This analysis is the only one in the literature which actually shows a survival advantage of one drug over another in nosocomial pneumonia."

The results also demonstrated higher cure rates for ZYVOX in patients with ventilator-associated MRSA NP (62.2%) than for vancomycin (21.0%, p=0.001). Intubation and mechanical ventilation greatly increases the risk of nosocomial pneumonia.

According to the American Thoracic Society, ventilator-associated pneumonia (VAP) occurs in 9% to 24% of all patients intubated for longer than 48 hours. Each day a patient receives intubation or mechanical ventilation, the crude rate of VAP increases by 1% to 3%(1). In addition, VAP can dramatically increase length of hospital stay and total hospital costs(2).

"Because ventilator-associated pneumonia is associated with significant morbidity and mortality, physicians need to make appropriate decisions quickly," said Dr. Wunderink. "ZYVOX's tissue penetration combined with its activity against all strains of staphylococci may explain its superiority."

About Nosocomial Pneumonia and MRSA

According to the Centers for Disease Control and Prevention (CDC), nosocomial pneumonia is the second most common hospital-acquired infection in the US and is associated with high levels of morbidity and mortality. There are approximately 350,000 cases of NP each year and death occurs in almost half of them(3). Patients who acquire these infections are often immuno-compromised due to severe underlying disease or surgery, and at a higher risk of infection while intubated or on a ventilator. Hospital-acquired pneumonia is further complicated by the possible involvement of antibiotic-resistant pathogens.

Currently, more than 50 percent of Staphylococcus aureus isolates that cause infections in hospital ICUs are resistant to methicillin treatment, and in other hospital settings more than 40 percent of Staph infections are caused by MRSA. Recently, the first Staph infection due to vancomycin-resistant Staphlycoccus aureus (VRSA) was reported by a U.S. hospital.

Methods

1,019 patients were treated and 116 patients with MRSA NP were included in the intent-to-treat analysis. Patients received IV ZYVOX(TM) 600mg or IV vancomycin 1g for seven to 21 days and were evaluated 15 to 21 days after completion of therapy. Patients were assessed using logistic regression based on treatment, organ infection, lobar involvement, kidney failure or presence of cancer as significant predictors of outcome. After the severity of illness variables were evaluated, ZYVOX was found to be statistically superior to vancomycin.

ZYVOX is indicated for the treatment of adult patients with susceptible strains of designated organisms, including patients with nosocomial pneumonia caused by Staphylococcus aureus (both methicillin resistant and susceptible strains), and Streptococcus pnemonia (pencillin-susceptible strains only).

Patients receiving ZYVOX should have complete blood counts monitored weekly, since myelosuppression has been reported. This applies particularly to those who received ZYVOX for longer than two weeks, have pre-existing myelosuppression; are receiving concomitant drugs that produce bone marrow suppression; or have a chronic infection and have received previous or concomitant antibiotic therapy.

About Methodist Healthcare

Methodist Healthcare (MH) is an integrated health delivery system based in Memphis, Tennessee, primarily serving the communities of Eastern Arkansas, West Tennessee and North Mississippi. MH currently owns and operates 14 hospitals in Memphis and throughout West Tennessee, as well as rural clinics and home health agencies. The largest component of MH, Methodist Healthcare - Memphis Hospitals (MH-MH), is the third largest hospital in the country and the second largest private employer in Memphis. MH operates nearly 2,500 beds and employs approximately 11,000.

(1) American College of Chest Physicians: "Nosocomial Pneumonia in

the Critically Ill Patient."

www.macmcm.com/accpchest/accp2000_07.htm:1-6

(2) American College of Chest Physicians: "Nosocomial Pneumonia in

the Critically Ill Patient."

www.macmcm.com/accpchest/accp2000_07.htm:1-6

(3) American College of Chest Physicians: "Nosocomial Pneumonia in

the Critically Ill Patient."

www.macmcm.com/accpchest/accp2000_07.htm:1-6