Staph aureus Blood Stream Infection in End Stage Kidney Disease Associated With Substantial Illness and Increased Healthcare Costs

Pharmacoeconomic Studies Sponsored by Nabi Biopharmaceuticals

Presented at 43rd Annual ICAAC Meeting

Sep 17, 2003, 01:00 ET from Nabi Biopharmaceuticals

    CHICAGO, Sept. 17 /PRNewswire-FirstCall/ -- Substantial treatment costs
 and illness are suffered by end-stage kidney (renal) disease (ESRD) patients
 who develop Staph aureus blood stream infections (bacteremias), according to
 new pharmacoeconomic studies presented this week at the 43rd annual
 Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in
 Chicago, IL. Moreover, ESRD patients with Staph aureus bacteremia that are
 caused by bacteria that are resistant to the antibiotic methicillin (MRSA) are
 at a higher risk of dying and incur higher treatment costs than patients with
 bacteremias caused by methicillin sensitive Staph aureus (MSSA). The two
 studies, sponsored by Nabi Biopharmaceuticals, Inc. (Nasdaq:   NABI) and
 executed by Duke University Medical Center, were presented by investigators
 from Duke University Medical Center and Duke Clinical Research Institute,
 Durham, NC.
     "Staph aureus is the most common cause of serious hospital-acquired
 infections, including bloodstream infections, and their increased resistance
 to many different antibiotics is a growing source of concern in the medical
 community," said Henrik S. Rasmussen, M.D., Ph.D., Nabi Biopharmaceuticals
 senior vice president, clinical, medical and regulatory affairs. "Despite its
 clinical significance, the economic impact of Staph aureus bacteremia has not
 been fully appreciated. The two studies presented at ICAAC clearly describe
 the clinical outcomes, associated with health care resource utilization and
 infection-associated costs of Staph aureus bacteremia among a large group of
 prospectively identified, hemodialysis-dependent patients. The full data from
 these studies have been submitted for publication."
     "Clearly, these studies point out the tremendous challenges that continue
 to face healthcare professionals trying to manage Staph aureus bacteremias in
 ESRD patients," continued Dr. Rasmussen. "These results underscore the need
 for a new approach such as Nabi Biopharmaceuticals' StaphVAX(R)
 (Staphylococcus aureus Polysaccharide Conjugate Vaccine) vaccine for
 preventing these infections  with the potential to significantly reduce the
 tremendous costs associated with them."
     The first study reported on 210 hemodialysis-dependent patients with Staph
 aureus bacteremia treated at Duke University Hospital. These patients
 experienced significant complications due to their infections.  The mean
 initial hospitalization costs almost doubled for patients with
 complicated Staph aureus bacteremias such as endocarditis and osteomyelitis
 versus bacteremias without these complications ($32,462 compared to $17,011,
 p=0.002). The mean cost of treating Staph aureus bacteremia, including
 readmissions and outpatient costs, was $24,034 per episode.
     The second study reported on the resources, costs and mortality among 143
 dialysis-dependent patients hospitalized with Staph aureus bacteremia. In this
 study, ESRD patients with bacteremia caused by MRSA proved to be at a higher
 risk of dying within 12 weeks and incurred higher costs than patients with
 bacteremia caused by MSSA. MRSA infections are responsible for up to 60% of
 Staph aureus infections in the U.S. today.
     Patients with ESRD are at high-risk of developing Staph aureus bacteremias
 partly because they are immune-compromised due to their debilitating
 underlying disease and also because the need for access to the vascular system
 for dialysis puts them at increased risk of infection. This patient population
 is projected to continue to grow due to the increasing number of patients
 suffering from the complications of diabetes which can often result in the
 loss of kidney function.
     Nabi Biopharmaceuticals is planning to initiate a confirmatory Phase III
 clinical trial with StaphVAX(R) in the United States in approximately 3,000
 ESRD patients during the 4th quarter of 2003. The primary endpoint of the
 trial will be the incidence of bacteremia caused by types 5 and 8 Staph aureus
 through 8 months post-vaccination. This endpoint correlates with the peak
 efficacy point in the first StaphVAX Phase III trial which was published in
 the February 14, 2002 issue of The New England Journal of Medicine. In an
 attempt to sustain efficacy beyond 8 months in these patients at chronic risk
 for Staph aureus infections, the confirmatory Phase III trial will also
 include a booster vaccination at 8 months. The vaccine's ability to generate
 antibodies, efficacy and safety will continue to be followed for up to six
 months following the booster dose. Secondary endpoints for this trial will
 also include the cost of Staph aureus bacteremia infections that occur during
 the study.
     About Staph aureus Infections
     Staph aureus is the most common cause of serious hospital-acquired
 infections, including bloodstream infections. Community-acquired staph
 infections are also of growing concern as they continue to increase in
 prevalence. Hospitals and other healthcare settings worldwide face
 unprecedented crises from the rapid emergence and dissemination of antibiotic-
 resistant bacteria, according to the National Institutes of Health and the
 Center for Disease Control. Strains of drug-resistant staph are found in most
 hospitals, often leaving vancomycin as the antibiotic of last resort for
 treating patients with these infections. With vancomycin-resistant strains of
 Staph aureus now appearing globally, many experts believe that a vaccine to
 prevent these infections may offer the best long-term solution.
      According to the U.S. Centers for Disease Control and Prevention (CDC),
 more than two million patients in the U.S. each year contract an infection as
 a result of exposure while receiving healthcare in a hospital. Staph aureus is
 among the most common causes of these hospital-acquired infections and is
 reportedly associated with a death rate of 10 percent to 30 percent because of
 its capacity to cause serious complications and its resistance to many
 different antibiotics. Staph aureus can spread from the blood (bacteremia), to
 the bones (osteomyelitis), or the inner lining of the heart and its valves
 (endocarditis), or cause abscesses in internal organs such as the lungs, liver
 and kidneys. People most at risk for these infections are surgical patients,
 trauma or burn victims, newborns whose immune systems are not yet developed,
 and patients with chronic illnesses such as diabetes, cancer, or lung or
 kidney diseases. People whose immune systems are suppressed due to disease,
 chemotherapy, or radiation therapy are generally more susceptible to these
 bacterial infections. ESRD patients on hemodialysis represent a particular
 high-risk group due to a combination of their compromised immune system and
 the need for repeated access to their blood system several times a week.
     About Nabi Biopharmaceuticals
     Nabi Biopharmaceuticals discovers, develops, manufactures and markets
 products that power the immune system to help people with serious, unmet
 medical needs.  The company has a broad product portfolio and significant
 research capabilities focused on developing and commercializing novel vaccines
 and antibody-based therapies that prevent and treat infectious, autoimmune and
 addictive diseases, such as Staphylococcus aureus and hepatitis infections,
 immune thrombocytopenia purpura ("ITP"), and nicotine addiction.  Nabi
 Biopharmaceuticals has several products in clinical trials, as well as five
 marketed products, including Nabi-HB(R) [Hepatitis B Immune Globulin (Human)],
 for the prevention of hepatitis B infections upon acute exposure; WinRho
 SDF(R) [Rho (D) Immune Globulin Intravenous (Human)], for the treatment of
 acute, chronic and HIV-related ITP; and PhosLo(R) (Calcium Acetate) for the
 control of hyperphosphatemia in end stage renal (kidney) failure patients.
 The company is headquartered in Boca Raton, Florida, with principal R&D
 offices and laboratories in Rockville, Maryland. Additional information about
 Nabi Biopharmaceuticals may be obtained on the company's web site at
     This press release contains forward-looking statements that reflect the
 company's current expectations regarding future events. Any such forward-
 looking statements are not guarantees of future performance and involve
 significant risks and uncertainties. Actual results may differ significantly
 from those in the forward-looking statements as a result of any number of
 factors, including, but not limited to, risks relating to the costs of
 research and development; the company's dependence upon third parties to
 manufacture its products; the impact of current industry supply and demand
 factors on the company and its products; the ability of the company to meet
 its contractual obligations; the future sales growth prospects for the
 company's biopharmaceutical products; and the company's ability to obtain
 regulatory approval for its products in the U.S. or abroad or to successfully
 develop, manufacture and market its products. These factors are more fully
 discussed in the company's most recent Form 10-K filed with the Securities and
 Exchange Commission and any subsequent filings.

SOURCE Nabi Biopharmaceuticals