-- Study Marks Key Milestone in Company's Commercial Strategy to Broaden the
Clinical Application of StaphVAX(R) --
ROCKVILLE, Md., Sept. 20 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) today initiated a repeated dosing study designed to evaluate
the ability of StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate
Vaccine) to provide continuous protection in patient populations who are at
high chronic risk for S. aureus infections. The trial will evaluate StaphVAX
in end-stage renal disease (ESRD) patients on dialysis who are at high risk of
contracting a S. aureus infection during their invasive and long-term
treatment.
Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals, stated, "Nabi Biopharmaceuticals is developing what has
the potential to be an innovative and holistic approach to combating
life-threatening staph infections. We are developing both prevention and
treatment approaches for a broad array of patients who are most at risk of
these infections. Today's announcement about this new trial is important to
us because it is aligned with our focus as a company to commercialize an
industry-leading, end-to-end solution that could solve all aspects of the
problem of staph infections -- improving patient outcomes, while also reducing
the cost of care."
The clinical need for such an approach is significant:
-- Over 20 million patients in the U.S. and Europe will be put at risk for
contracting a life-threatening S. aureus infection this year.
-- S. aureus infections keep patients in the hospital longer, increasing
the economic burden on the healthcare system and extending patient
suffering.
-- "Smart" bugs have learned to evade current antibiotic treatments,
thereby overwhelming patients' immune systems and causing harm.
-- As high as 30% of patients treated for a methicillin-resistant S.
aureus infections suffer a recurrence in a short amount of time.(1)
About the Study
The study is a randomized, placebo-controlled study with two arms, and is
comprised of a subset of 460 ESRD patients participating in Nabi
Biopharmaceuticals' ongoing Phase III StaphVAX trials. One arm of the study
will be comprised of 230 patients: 115 patients will receive two injections of
the placebo eight months apart; and 115 patients will receive two injections
of the placebo 12 months apart. The second arm will be comprised of another
230 patients: 115 patients will receive two injections of StaphVAX eight
months apart; and 115 patients will receive two injections of StaphVAX 12
months apart. The goal of the study is to determine, after an initial booster
dose at eight months, at which future time points repeat doses of StaphVAX
would need to be given to achieve the optimal antibody levels in ESRD
patients.
Henrik S. Rasmussen, MD, Ph.D., senior vice president, clinical, medical
and regulatory affairs, Nabi Biopharmaceuticals, stated, "This study will
determine the optimal time to administer additional StaphVAX injections in
order to best protect patients who are at chronic risk from contracting a S.
aureus infection.
Dr. Rasmussen continued, "The results of the study, although conducted
specifically in ESRD patients, may also provide the basis for extrapolation
into other high-risk patients who can benefit from ongoing protection from
staph infections."
About ESRD Patients and S. aureus Infections
There are over 300,000 dialysis patients in the U.S., and the number of
new patients beginning dialysis has increased 139 percent since 1988.(2)
ESRD patients are at high-risk of contracting life-threatening S. aureus
infections due to their compromised immune systems and the invasive nature of
dialysis treatments. S. aureus infections remain the second leading cause of
mortality (death) in ESRD patients, accounting for close to 20 percent of all
deaths in 2001.(3) Based on current projections indicating that the number of
ESRD patients in the U.S. will reach 2 million by 2030(4) and the growing
resistance of S. aureus to antibiotics, infections in this patient population
are a major healthcare concern. In addition to the patient burden, the costs
associated with treating S. aureus infections are significant. According to
studies conducted by Duke University, the cost of treating
Methicillin-resistant S. aureus bacteremia in hospitalized ESRD patients
totals $44,000 per case.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering
the immune system to develop and market products that fight serious medical
conditions. We are poised to capture large commercial opportunities in our
core business areas: Gram-positive bacterial infections, hepatitis, and kidney
disease (nephrology), and opportunistically in nicotine addiction. We have
three products on the market today: PhosLo(R) (calcium acetate), Nabi-HB(R)
[Hepatitis B Immune Globulin (Human)], and Aloprim(TM) [Allopurinol sodium
(for injection)] and a number of products in various stages of clinical and
preclinical development. The company filed its Marketing Authorization
Application (MAA) in Europe for its product candidate, StaphVAX(R)
[Staphylococcus aureus Polysaccharide Conjugate Vaccine], in December 2004.
The application was accepted for review in January 2005. StaphVAX is
currently in a confirmatory Phase III clinical trial in the United States.
StaphVAX is designed to prevent the most dangerous and prevalent strains of S.
aureus bacterial infections. S. aureus bacteria are a major cause of
hospital-acquired infections and are becoming increasingly resistant to
antibiotics. The company also filed MAA's in Europe to market Nabi-HB(R)
Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] under the trade
name HEBIG(TM) for the prevention of hepatitis B disease in HBV-positive liver
transplant patients; and for PhosLo(R) (calcium acetate), which is already
marketed in the U.S. The company's other products in development include
Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)], an
antibody for prevention and treatment of S. aureus infections, NicVAX(TM)
[Nicotine Conjugate Vaccine], a vaccine to treat nicotine addiction, and
Civacir(TM) [Hepatitis C Immune Globulin (Human)], an antibody for preventing
hepatitis C virus re-infection in liver transplant patients. For additional
information on Nabi Biopharmaceuticals, please visit our website at
http://www.nabi.com.
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 possibility that
our confirmatory Phase III clinical trial for StaphVAX or our plans to
commercialize StaphVAX in the European Union and United States may not be
successful; the possibility that we may not realize the value of our
acquisition of PhosLo; the company's ability to raise additional capital on
acceptable terms; the company's dependence upon third parties to manufacture
its products; the company's ability to utilize the full capacity of its
manufacturing facility; the impact on sales of Nabi-HB from patient treatment
protocols and the number of liver transplants performed in HBV-positive
patients; reliance on a small number of customers; 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 United States or
abroad or to successfully develop, manufacture and market its products. These
factors are more fully discussed in the company's Annual Report on Form 10-K
for the fiscal year ended December 25, 2004 filed with the Securities and
Exchange Commission.
(1) Brigham and Women's Hospital (Clinical Infectious Diseases, 2003; 36:
281-285
(2) U.S. Renal Data System, USRDS 2004 Annual Data Report: Atlas of End-
Stage Renal Disease in the United States, National Institutes of
Health, National Institute of Diabetes and Digestive and Kidney
Diseases, Bethesda, MD, 2004
(3) U.S. Renal Data System, USRDS 2003 Annual Data Report: Atlas of End-
Stage Renal Disease in the United States, National Institutes of
Health, National Institute of Diabetes and Digestive and Kidney
Diseases, Bethesda, MD, 2003.
(4) Szczech, LA, Lazar, IL. Projecting the United States ESRD population:
Issues regarding treatment of patients with ESRD. Kidney
International; Vol. 66 (Supplement 90):S3-7, September 2004.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
CONTACT:
Constance C. Bienfait, Vice President,
Investor Relations, +1-561-989-5800
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