- Company Continues to Grow Gram-Positive Infections Franchise With Vaccine to
Prevent the Third Most Prevalent Serotype of S. aureus Infections -
BOCA RATON, Fla., July 21 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) announced today the initiation of the first
human clinical study for its vaccine being developed to prevent Staphylococcus
aureus type 336 infections in at-risk patients. Patients at the highest risk
for S. aureus infections include dialysis patients, patients undergoing
certain types of invasive surgery, patients in intensive care or shock-trauma
units, patients receiving cancer chemotherapy or other immune suppressive
treatments, and patients in long-term care facilities. This is a Phase I
study that will evaluate safety and immune response of the vaccine in healthy
volunteers.
While there are numerous species of Staphylococci, three species are
responsible for almost all S. aureus infections. S. aureus types 5 and 8
account for approximately 80-85 percent of all Gram-positive hospital-acquired
infections, with type 336 accounting for the other 15-20 percent. Type 336,
like other S. aureus bacteria, often lives transiently or permanently in the
nasal passages or on the skin of humans. It is estimated that approximately
20-30 percent of the adult population at any given time is colonized with one
of the three serotypes of S. aureus.
"Hospital-acquired S. aureus infections, including type 336, pose a
rapidly growing challenge for healthcare globally," said Thomas H. McLain,
chairman, chief executive officer, and president. "Nabi Biopharmaceuticals'
Gram-positive infections franchise is being developed to target a broad array
of hospital-acquired bacterial infections through both prevention and
treatment approaches. These Gram-positive products, once approved, have the
potential to significantly reduce hospital stays and costs, and ease patient
burden. As with the S. epidermidis trial that we recently announced, we hope
to advance the type 336 trial rapidly, while we prepare to launch our flagship
product, StaphVAX, designed to prevent S. aureus types 5 and 8 in end-stage
renal disease patients."
"Type 336, much like the other types, is becoming increasingly resistant
to current treatment approaches," said Henrik S. Rasmussen, M.D., Ph.D.,
senior vice president, clinical, medical and regulatory affairs. "Immune-
compromised patients face an elevated risk of contracting Staph infections. In
these patient groups, S. aureus type 336 infections often result in increased
illness and death. We are excited about taking a vaccine against type 336
into clinical trials. When combined with StaphVAX, it should allow us to
provide protection against almost all S. aureus infections."
About the Type 336 Study
The type 336 Phase I study is a double-blinded, placebo-controlled study
to evaluate safety and antibody responses of the vaccine in up to 48 patients
at four different dosage levels. Within each of these four dose groups there
will be 12 patients, nine receiving the type 336 vaccine and three receiving
placebo. The doses will be administered in an escalating manner. Nabi
Biopharmaceuticals expects to announce results from this trial in the second
half of 2005.
About Nabi Biopharmaceuticals' Hospital-Acquired Infections Franchise
The annual economic cost of hospital-acquired infections totals
approximately $30 billion in the United States. Nabi Biopharmaceuticals is
building a franchise of products designed to prevent and treat the infections
in approximately two million patients who contract these infections each year.
The company's strategy to advance this franchise is three-fold:
Prevent and Treat the Clinical Problem:
Infections keep patients in the hospital longer and greatly increase
illness, death and cost. Nabi Biopharmaceuticals is pursuing a combination
approach, starting with Altastaph(TM) [Staphylococcus aureus Immune Globulin
Intravenous (Human)] and StaphVAX(R) [Staphylococcus aureus Polysaccharide
Conjugate Vaccine], with the potential to offer patients prevention and
treatment for hospital-acquired bacterial infections and, upon hospital
discharge, prevention of longer-term relapse after an infection. This
innovative approach, initially focused on S. aureus infections, will be
expanded to include S. epidermidis, Enterococcus and Gram-negative infections.
Leverage the Technology:
Nabi Biopharmaceuticals believes it has a core, patented technology that
will overcome the resistance challenges associated with current antibiotics.
Build a Risk-balanced Platform:
Nabi Biopharmaceuticals is developing a portfolio of products to address
the most prevalent and dangerous hospital-acquired infections, including S.
aureus, S. epidermidis, Enterococcus, Pseudomonas and other Gram-negative
bacteria and fungi, for the broadest array of at-risk patients.
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 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'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 in the United States may not
be successful; 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; 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.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
CONTACT:
Constance Bienfait, Vice President, Investor
Relations of Nabi, +1-561-989-5800
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