David J. Gury, Nabi Biopharmaceuticals chairman and chief executive officer, said, "The issuance of this second patent on NicVAX further solidifies our proprietary position around this vaccine and provides added momentum to our product development efforts. Nicotine addiction is an important health concern in the United States, and while 80 percent of smokers express a desire to quit smoking, fewer than 10 percent of those who try, succeed in quitting for more than six months. Thus, we believe this product has the potential to meet a major healthcare need."
The NicVAX patent specifically covers the composition of stable nicotine-carrier protein conjugates that preserve the natural structure and orientation of nicotine, with the result that antibodies are generated specifically to the native form of nicotine. Clinical trials will determine if these antibodies are effective in binding nicotine that is inhaled from smoking, absorbed from smokeless tobacco, or otherwise ingested.
As reported earlier, the first Phase I safety and immunogenicity trial of NicVAX in humans showed that a single dose of the vaccine resulted in a rapid immune response and generated substantial amounts of nicotine specific antibodies. Local reactions to NicVAX were generally mild to moderate, temporary and required no treatment. Antibody levels were detected within 7-14 days of vaccination and were maintained or continued to increase through 60 days post-vaccination. Additional clinical trials of NicVAX in smokers and ex-smokers are scheduled to begin in 2003.
Research in animal models has demonstrated that nicotine-antibody complexes are too large to cross the blood/brain barrier, and thus less nicotine reached the brain in animals vaccinated with NicVAX after they were challenged with nicotine. The company has also shown in animals that antibodies induced by NicVAX can significantly reduce nicotine addiction and block the physiological effects of nicotine compared to those seen in control animals. One of the potential uses of NicVAX is preventing the positive feedback from nicotine among tobacco users who are trying to break their smoking habit.
As previously announced, Nabi Biopharmaceuticals is receiving funding from the National Institute on Drug Abuse (NIDA) to support development of this vaccine.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals discovers, develops, manufactures and markets products that power the immune system to help people with serious, unmet medical needs. The company has a broad product portfolio and significant research capabilities focused on developing and commercializing novel vaccines and antibody-based therapies that prevent and treat infectious, autoimmune and addictive diseases, such as Staphylococcus aureus and hepatitis infections, ITP, and nicotine addiction. Nabi Biopharmaceuticals has several products in clinical trials, as well as four marketed products, including Nabi-HB™ [Hepatitis B Immune Globulin (Human)], for the prevention of hepatitis B infections and WinRho SDF®, [Rho(D) Immune Globulin Intravenous (Human)], for the treatment of acute, chronic and HIV-related immune thrombocytopenia purpura. The company is headquartered in Boca Raton, Florida, with principal R&D offices and laboratories in Rockville, Maryland. Additional information about Nabi Biopharmaceuticals may be obtained on the company's website at 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 costs of research and development; the company's dependence upon third parties to manufacture its products; the impact of current industry supply and demand factors on the company and its products; the future sales growth prospects for the company's biopharmaceutical products; and the likelihood that any product in the company's research pipeline can receive regulatory approval in the U.S. or abroad or be successfully developed, manufactured and marketed. These factors are more fully discussed in the company's most recent Form 10-K filed with the Securities and Exchange Commission and any subsequent filings.