Nabi Receives U.S. Patent Covering Nabi(R) NicVAX(TM) (Nicotine Conjugate Vaccine) for Treatment and Prevention of Nicotine Addiction
BOCA RATON, Fla., May 15 /PRNewswire/ -- Nabi (Nasdaq: NABI - news) today announced that the U.S. Patent and Trademark Office has issued U.S. Patent No. 6,232,082, entitled ``Hapten-Carrier Conjugates for Treating and Preventing Nicotine Addiction.'' The
Mr. David Gury, Nabi's Chairman, President and CEO, said, ``The issuance of this patent solidifies our proprietary position around NicVAX and provides further 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 for more than six months. Thus, we believe this product has the potential to meet a major healthcare need.''
The 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 be required to determine if these antibodies are effective in binding nicotine that is inhaled from smoking, absorbed from smokeless tobacco or otherwise ingested. The patent furthermore covers the method of using nicotine-protein conjugates as a vaccine to treat and prevent nicotine addiction in patients.
Nabi has demonstrated the ability of NicVAX to generate high levels of nicotine-specific antibodies in vaccinated animals and has shown that these antibodies quickly bind free nicotine in the blood. Research has further demonstrated that the nicotine-antibody complexes are too large to cross the blood/brain barrier, and thus less nicotine reaches the brain of a vaccinated animal after intravenous nicotine administration. Nabi will test clinically the possibility that the immune barricade can prevent nicotine from inducing its physiological and psychological effects in the brain. One of the potential targets of a nicotine vaccine is preventing positive feedback from nicotine should tobacco users, who are trying to break their habit, be exposed to nicotine. Nabi has also shown in animals that antibodies induced by the vaccine can significantly reduce nicotine addiction and nicotine levels in the brain compared to that seen in control animals. These studies also show that the vaccine can prevent nicotine-induced blood pressure increases, and attenuate hyperactive movement in response to nicotine injections.
Dr. Robert Naso, Sr. Vice President at Nabi, was quoted as saying, ``We await the final results of animal safety studies using NicVAX and are preparing clinical supplies of the vaccine in anticipation of the filing of an Investigational New Drug (IND) application to begin human clinical studies later this year.'' As previously announced, Nabi is receiving funding from the National Institute on Drug Abuse (NIDA) to support development of this vaccine.
Nabi, a fully integrated biopharmaceutical company, has a broad product portfolio and significant R&D capabilities focused on the development and commercialization of drugs that prevent and treat serious diseases. Nabi currently has several clinical trials underway as well as four marketed pharmaceutical products. Nabi has its corporate headquarters in Boca Raton, Florida, with principal R&D offices and laboratories in Rockville, Maryland. Additional information about Nabi 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. While these statements reflect the Company's best current judgment, they are subject to risks and uncertainties. Actual results may differ significantly from the results projected herein due to a number of factors, including, but not limited to, the need for additional financing and access to capital; the costs of research and development; dependence upon third parties to manufacture product; the impact on the Company of current industry supply and demand factors and the supply of and demand for the Company's individual products; margin pressure on the Company's non-specific antibody product line; future sales growth prospects for its biopharmaceutical products; the likelihood that any product in the research pipeline can receive regulatory approval in the U.S. or abroad or be successfully developed, manufactured and marketed; and failure to receive licensure for the Boca Raton manufacturing facility. These factors are more fully discussed in the Company's most recent Form 10-K filed with the Securities and Exchange Commission.