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
'"/>
Contact: Ellen M. Martin
emm4@pacbell.net
510-832-2044
Kureczka/Martin Associates
11-Feb-2003