- Patent Gives Nabi Biopharmaceuticals Protection Around Key Antigen That
Prevents Three Prevalent Staphylococcal Bacteria Strains -
ROCKVILLE, Md., Oct. 11 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) announced today that it has been granted U.S. Patent No.
6,936,258 entitled "Staphylococcus Antigen and Vaccine" by the U.S. Patent and
Trademark Office for the composition of a strategically important
glycoprotein-based antigen (GP-1) associated with three Staphylococcal
strains: S. epidermidis, S. haemolyticus and S. hominis. These strains are
part of the increasing problem of hospital-acquired infections. Addressing
them represents a strategically important component of Nabi
Biopharmaceuticals' commercial franchise focused on treating and preventing
the broadest array of Staphylococcal bacteria across the largest cross section
of patients.
The patent covers the following: the composition of the antigen, the use
of the antigen as a vaccine, and the methods for obtaining and detecting the
antigen. Nabi Biopharmaceuticals also currently holds a patent for another
S. epidermidis antigen, PS-1, which covers the use of the antigen as a
vaccine. The PS-1 antigen is found on approximately 80 percent of all S.
epidermidis strains. Nabi Biopharmaceuticals initiated a Phase I clinical
trial with this vaccine earlier in 2005.
One unique aspect of the GP-1 antigen claimed in the patent is that it
prevents adherence of S. epidermidis to catheters. Hence, this antigen will
be developed to help diminish the risk of infections associated with implanted
devices, in particular, indwelling catheters. Patients with chronic
indwelling catheters are at high risk for S. epidermidis infections, as the
catheter provides a port of entry for the bacteria, which often lives on the
skin of the patient and healthcare personnel. S. epidermidis is responsible
for 50 to 70 percent of all catheter-related infections.(1) Additionally, S.
epidermidis and other similar infections represent approximately 20 to 25
percent of all Gram-positive nosocomial (hospital-acquired) infections.(2)
Nabi Biopharmaceuticals' hospital-acquired infections franchise has the
potential to not only help the broadest range of patients, most at risk of
contracting prevalent and often deadly bacterial infections, but to also
address the growing problem of antibiotic resistance. Antibiotics have been
the traditional method for treating these infections, but are becoming less
effective against these bacteria. A vaccine such as Nabi Biopharmaceuticals'
StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate Vaccine) has the
potential to circumvent this problem because it is designed to safely empower
the body's own immune system to recognize the bacteria and destroy it before
causing harm to the patient. A vaccine based on the GP-1 antigen against
these three Staphylococcal strains would convey the same potential advantages.
"The protection afforded these antigens is an important step in advancing
the significant commercial opportunity inherent in our hospital-acquired
infections franchise," stated Thomas H. McLain, chairman, chief executive
officer and president, Nabi Biopharmaceuticals. "The award of this patent is
part of our strategy to protect and expand this franchise, and it
significantly strengthens the company's intellectual property position in this
area."
Mr. McLain added, "At Nabi Biopharmaceuticals we are building what will be
the first comprehensive and holistic approach in the prevention and treatment
of dangerous and often life-threatening hospital-acquired infections. We are
focused not only on developing this franchise to address the most prevalent
pathogens, but also to protect the greatest number of patients at risk for
those infections."
About Nabi Biopharmaceuticals' Hospital-Acquired Infections Franchise
Hospital infections add $28 billion to $30 billion to the Nation's health
costs each year.(3) Nabi Biopharmaceuticals is building a franchise of
products designed to protect the approximately five million patients who get
hospital-acquired S. aureus infections in the EU and U.S. 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, to offer patients prevention of 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, kidney
disease (nephrology), and opportunistically in nicotine addiction. We have
three products on the market today: PhosLo (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 U.S. 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 MAAs 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 U.S. may not be successful;
the possibility that we may not realize the value of our acquisition of
PhosLo; the ability of the company to prevail in patent litigation; 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 U.S. 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) Von Eiff C., Peters G., Heilman C. "Pathogenesis of infections due to
coagulase-negative staphylococci." Lancet Infect Dis. 2002 November;
2(11): 677-85.
(2) Kleeman KT, Bannerman TL, Kloos WE. "Species distribution of
coagulase-negative staphylococcal isolates at a community hospital and
implications for selection of staphylococcal identification procedures."
Journal of Clinical Microbiology. 1993 May; 31(5): 1318-21.
(3) Weingart, Saul N., Iezzonbi, Lisa I. "Looking for Medical Injuries
Where the Light is Bright." Journal of the American Medical Association.
2003 October; vol. 290, no. 14. Cassandro D. Salgado and Barry M. Farr, "MRSA
and VRE: Preventing Patient-to-Patient Spread." Infectious Medicine. 2003;
vol. 20, no. 4. (The costs are derived thus: 2,000,000 infected patients x
$14,000 to $15,000 average cost of treating an infection) Roberts, et.al.,
"Hospital-Acquired Infection Economic Modeling." Clinical Infectious Diseases.
Vol. 36, no. 11 puts the cost at $15,275; P.W. Stone, et. al., "A Systematic
Audit of Economic Evidence Linking Nosocomial Infections and Infection Control
Interventions 1990-2000," American Journal of Infection Control (2002) puts
the cost at $13,973.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
CONTACT:
Constance C. Bienfait, Vice President,
Investor Relations, Nabi Biopharmaceuticals, +1-561-989-5800
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