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NABI BIOPHARMACEUTICALS DEDICATES ITS NEW VACCINE MANUFACTURING FACILITY
June 2, 2005
Dr. Walter Karakawa Recognized for His Work in S. aureus Infections
BOCA RATON, Fla., -- Nabi Biopharmaceuticals (Nasdaq: NABI - News) announced today that it has officially opened its new
vaccine manufacturing facility in Boca Raton, Florida. The company completed construction in just eight months, a significant
accomplishment for a facility that will be uniquely able to produce commercial quantities of StaphVAX®
[Staphylococcus aureus Polysaccharide Conjugate Vaccine] to meet global demand. StaphVAX is currently in Phase III
development to prevent S. aureus infections in end-stage renal (kidney) disease (ESRD) patients.
The facility will be dedicated to the late Walter Karakawa, Ph.D., a pioneer in immunology and biochemistry, who
discovered that S. aureus bacteria are covered by capsular polysaccharides (complex sugar molecules). This finding
was critical to understanding the make-up and "typing" of S. aureus, which led to the genesis and later development
of the company's StaphVAX vaccine. Dr. Karakawa, who built his long career in research at Pennsylvania State
University, died in 1993 at the age of 62.
The production facility, approximately 12,000 square feet, will initially be used to support the U.S. commercialization
of StaphVAX. The scalable facility is designed specifically for the manufacture of StaphVAX, NicVAX(TM) [Nicotine
Conjugate Vaccine], the company's vaccine being developed to prevent and treat nicotine addiction, as well as its next
generation of Gram-positive pipeline vaccine products.
In addition to the Dedication ceremony, today's events will also include a Scientific Forum and a Business Forum.
Featured speakers will include The Honorable Lieutenant Governor of Florida, Toni Jennings; Scott Whitaker, Chief
Operating Officer of the Biotechnology Industry Organization; Frank Brogan, President, Florida Atlantic University;
and representatives from The National Institutes of Health, Scripps Florida and others in academia and industry. A full
agenda of the Day's events follows.
Raafat E.F. Fahim, Ph.D., senior vice president, research, technical and production operations, Nabi Biopharmaceuticals,
stated, "More than ever before patient health depends on safe, compliant, efficient and effective manufacturing processes,
practices and facilities. At Nabi Biopharmaceuticals, we have constructed a world-class, state-of-the-art manufacturing
facility to prepare for the global commercialization of StaphVAX, as well as the steady stream of products being developed
as a result of our aggressive R&D efforts."
Dr. Fahim continued, "To ensure a smooth transition to the marketplace, the company has employed a dual sourcing strategy
for StaphVAX. In addition to the Florida facility, Cambrex Bio Science Baltimore, Inc. has partnered with Nabi Biopharmaceuticals
and is already manufacturing commercial quantities of StaphVAX in preparation for launch of the product. We believe that in
today's vaccine manufacturing environment, a dual sourcing strategy is a prudent and necessary approach."
Thomas H. McLain, chairman, chief executive officer and president, Nabi Biopharmaceuticals, stated, "Nabi Biopharmaceuticals'
focus in the areas of Gram-positive bacterial infections, hepatitis, kidney disease and nicotine addiction can help solve global
unmet medical needs, save lives and reduce the financial burden on the healthcare system.
"We are very pleased to dedicate this facility to the late Dr. Karakawa, a seminal figure in immunology and biochemical research.
This year, in the U.S. alone, 12 million patients will be at risk of contracting a life-threatening staph infection. At Nabi
Biopharmaceuticals, we are building an industry- leading franchise to address all of the Gram-positive bacterial infections
that plague patients worldwide every day."
Mr. McLain continued, "Furthermore, we are currently able to leverage our expertise and resources in manufacturing since
we are already licensed to manufacture and produce biologics, including Nabi-HB®, in Boca Raton. Moving forward and given
StaphVAX's commercial promise, we expect to greatly expand our workforce in the manufacturing area, creating important,
high-end jobs for the state of Florida."
Management also noted that it has just received notification that a grant through Enterprise Florida, in support of the cost of
constructing the vaccine facility, has been approved. When specified employment targets are met, the grant will repay the
cost of the facility in tax credits.
About StaphVAX
StaphVAX is designed to prevent the most dangerous and prevalent strains of Staphylococcus aureus bacterial infections.
S. aureus bacteria are a major cause of hospital-acquired infections and are becoming increasingly resistant to
antibiotics. The company filed its Marketing Authorization Application in Europe for StaphVAX in December 2004. The
application was accepted for review in January 2005. In the U.S., StaphVAX is currently in a confirmatory Phase III clinical trial.
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 four core
business areas: Gram-positive bacterial infections, hepatitis, kidney disease (nephrology), and nicotine addiction. We have
three products on the market today: PhosLo® (calcium acetate), Nabi-HB® [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 StaphVAX® [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 Staphylococcus 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 web site: 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.
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