NicVAX® patent challenged rebuffed in Europe

By John Johnston
Managing Editor

Nabi Biopharmaceuticals has prevailed in a challenge of its European patent for the process that covers its NicVAX® vaccine. In a recent ruling, the European Patent Office (EPO) upheld the firm’s European Patent No. EP 1,135,166

NicVAX is a vaccine being developed by Nabi to treat nicotine addiction and prevent smoking relapse. The vaccine is designed to stimulate the immune system to produce antibodies that bind to nicotine. A nicotine molecule attached to an antibody is too large to cross the blood-brain barrier. Therefore, NicVAX blocks nicotine from reaching its receptors in the brain and prevents the highly-addictive pleasure sensation experienced by smokers and users of nicotine products.

Progress to Date

• In September 2005, Nabi announced that it received a $4.1 million grant from the National Institute on Drug Abuse (NIDA), which is part of the National Institutes of Health. NIDA has also funded, in part, the costs for toxicology testing and earlier clinical trials in the U.S. and contributed scientific and clinical expertise to the program overall.

• In March 2006, Nabi Biopharmaceuticals announced that NicVAX® had received Fast Track Designation from the FDA, which facilitates the development of products that treat serious diseases where an unmet medical need exists. Nabi Biopharmaceuticals' intellectual property portfolio for technology related to NicVAX® includes both issued and pending patents in the U.S.

• In addition, Nabi holds granted patents in 18 European countries, plus patents and pending patent applications in numerous other countries around the world.

And in 2007, test data from both six, nine and twelve month trial use of NicVAX revealed “statistically significant” cessation, and continued abstinence from nicotine use, NABI said.

NABI also said in 2007 that trials are expected to show that antibodies from NicVAX will last 12 months or longer.  If that proves to be true, it would support getting through the critical first year in which relapse ranges as high as 95 percent with other therapies, Nabi said.

• According to the CDC, the 440,000 deaths in the U.S. attributable to cigarette smoking are equivalent to one-fifth of all U.S. deaths.
• More deaths are caused each year by tobacco use than by alcohol use, illegal drug use, suicides, motor vehicle accidents, murders and HIV combined
• Among nonsmokers in the U.S., approximately 3,000 lung cancer deaths and 35,000 coronary heart disease deaths occur each year as a result of exposure to secondhand smoke.
• According to the 2004 Surgeon General’s Report, nearly three quarters of smokers express a desire to quit and each year approximately 15 million smokers quit for at least a day, but fewer than 5 percent are able to stay tobacco-free for 3 to 12 months.
• Smoking harms nearly every organ of the body, causing many diseases and reducing the health of smokers in general.
• Quitting smoking has immediate as well as long-term benefits, reducing risk for diseases caused by smoking and improving health in general.

The World Health Organization estimates that half of the smokers in the world today, approximately 650 million people, will die from tobacco-related disease