BOCA RATON, Fla., Dec. 20 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals 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.
Nabi Biopharmaceuticals
CONTACT: Constance C. Bienfait, Vice President, Investor Relations, NabiBiopharmaceuticals, +1-561-989-5800
Web site: http://www.nabi.com/
