- Company Continues to Drive Strategic Direction of Portfolio and Convenes
Scientific Advisory Board of Leading Immunologists, Infectious Disease
Specialists and Nephrologists -
BOCA RATON, Fla., Dec. 20 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced that it has formed a panel
of outside experts in immunology, vaccines, bacterial infections and
nephrology to help assess the future development of its Gram-positive
infections programs. On December 15, 2005, the first in a series of advisory
board meetings with these experts was held. The advisory board's initial
goals are to:
1) Conduct a complete review of the preclinical and clinical data from the
company's S. aureus vaccine and antibody programs, focusing on the different
results from two StaphVAX(R) [Staphylococcus aureus Polysaccharide Conjugate
Vaccine] Phase III studies.
2) Share the latest developments in understanding S. aureus bloodstream
infections and the patients at risk for these infections.
3) Advise the company on the most appropriate steps to advance the
clinical development of the company's Gram-positive infections portfolio,
which includes its S. aureus, S. epidermidis and Enterococcus vaccine and
antibody product candidates.
The company expects that these objectives will be accomplished during the
first six months of 2006.
Nabi Biopharmaceuticals began an internal assessment of its S. aureus
infections program immediately after announcing results from its confirmatory
Phase III StaphVAX trial on November 1, 2005. Those efforts include a review
of the design and conduct of the clinical trial and the initiation of a series
of scientific experiments to help interpret the trial results. The company
has also completed a series of individual consultations with external experts
in the United States and Europe, including some members of the advisory panel.
Thomas H. McLain, chairman, chief executive officer and president, Nabi
Biopharmaceuticals, stated, "We are pleased to have assembled an accomplished
panel of scientists and clinicians in a relatively short period of time. The
advisory panel will work with us as we develop plans to advance our Gram-
positive infections programs. The results of the StaphVAX assessment,
combined with data from the Phase I clinical trials of our S. aureus Type 336
vaccine and our S. epidermidis vaccine, will be important factors in defining
our plans for 2006 and beyond. We anticipate announcing the results of these
Phase I clinical studies in early 2006, and the results of the assessment and
our future plans for our Gram-positive infections program in the first half of
next year. At the same time, we will also define what activities can be
supported by internal resources and those activities that can best be
accomplished through outside collaborations, including research, licensing and
partnering relationships."
Mr. McLain added, "Nabi Biopharmaceuticals remains committed to developing
products that enable the immune system to prevent significant medical
problems, such as staph infections, before they can cause harm to patients.
The increasing focus of thought leaders and public policy makers on products
that combine clear, demonstrated patient advantages with cost of care
benefits, will continue to drive interest in effective prevention approaches.
Based on our knowledge and expertise in the fields of immunology and
infectious diseases, we believe we will play an important role in bringing
such products to the market."
Mr. McLain concluded, "Aligned with our business strategy that leverages
our core technologies and expertise, we also plan to provide important updates
and our development plans for our Civacir and NicVAX programs in early 2006."
About the Advisory Board
The advisory board, which is comprised of leading scientists and
clinicians in the fields of immunology, vaccines, infectious disease and
nephrology, will engage in a complete and thorough assessment of the trial
results in concert with the company's efforts. This assessment will include
the identification and analysis of factors that may have contributed to the
trial's outcome, including, but not limited to: the patient population studied
(ESRD patients who are immune compromised); the vaccine target (S. aureus
polysaccharide capsule); the quality of the antibody generated by the vaccine;
and the design and conduct of the clinical trial.
Among others, the scientific advisory board members working with Nabi
Biopharmaceuticals include:
Michael M. Frank, M.D.
Former Chairman of the Department of Pediatrics and the Samuel L. Katz
Professor of Pediatrics
Duke University Medical Center-Department of Pediatrics
Dan M. Granoff, M.D.
Senior Scientist
Children's Hospital Oakland Research Institute (CHORI)
Harry Jennings, Ph.D.
Group Leader, Glycoconjugates and Tumor Immunology
National Research Council (NRC) Institute of Biological Sciences
Richard M. Krause, M.D.
Senior Investigator, Lab of Human Bacterial Pathogenesist
National Institutes of Allergy and Infectious Diseases, The National
Institutes of Health
Frank Lowy, M.D.
Professor of Medicine and Pathology
Columbia University, College of Physicians and Surgeons
John Robbins, M.D.
Chief, LDMI
National Institute of Child Health and Human Development (NICHO), The
National Institutes of Health
Ravi Thadhani, M.D., M.P.H.
Associate Professor of Medicine
Harvard Medical School
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 focusing on developing products addressing commercial
opportunities in our core business areas: Gram-positive bacterial infections,
hepatitis, kidney disease (nephrology), and 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
pre-clinical development. The company also filed Marketing Authorization
Applications (MAA) 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, which is already marketed in the United States. The company's
products in development include NicVAX, a vaccine to treat nicotine addiction,
and Civacir, an antibody for preventing hepatitis C virus re-infection in
liver transplant patients. For additional information on Nabi
Biopharmaceuticals, please visit our Website: 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 company's ability
to: advance the development of products currently in the pipeline or in
clinical trials; complete the assessment of the StaphVAX Phase III clinical
trials during the first half of 2006; maintain the human and financial
resources to commercialize current products and bring to market products in
development; obtain regulatory approval for its products in the U.S. or other
markets; successfully develop manufacture and market its products; utilize the
full capacity of its manufacturing facility; announce preliminary safety and
immunogenicity results from its Phase IIb NicVAX study by early 2006;
manufacture NicVAX in its own vaccine facility; realize the value of its
acquisition of PhosLo; realize sales from Nabi-HB due to patient treatment
protocols and the number of liver transplants performed in HBV-positive
patients; realize the value from its vaccine manufacturing facility; realize
future sales growth for its biopharmaceutical products; prevail in patent
litigation; raise additional capital on acceptable terms; re-pay its
outstanding convertible senior notes when due; and the company's dependence
upon: third parties to manufacture its products and a small number of
customers. Many of these factors are more fully discussed, as are other
factors, 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 C. Bienfait, Vice President,
Investor Relations, Nabi Biopharmaceuticals, +1-561-989-5800
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