Nabi Biopharmaceuticals Significantly Enhances NicVAX Patent Portfolio
Patent Issued for Exclusive Use of NicVAX and Related Nicotine Vaccines to Treat or Prevent Nicotine Addiction
ROCKVILLE, Md., Aug 24, 2010 (GlobeNewswire via COMTEX) --
Nabi Biopharmaceuticals (Nasdaq:NABI) announced the receipt of a patent for treating and preventing nicotine addiction with NicVAX(R) and related nicotine conjugate vaccines. The United States Patent and Trademark office issued U.S. Patent No. 7,776,620 entitled "Hapten-carrier conjugates for treating and preventing nicotine addiction" for the exclusive use of methods for treating and preventing nicotine addiction with NicVAX and related nicotine vaccines. This patent runs through December 2018.
Nabi's patent portfolio for technology related to NicVAX encompasses a variety of issued and pending patents around the world including five issued U.S. patents related to both composition of matter and therapeutic methodology for treating and preventing nicotine addiction. Claims in these patents are directed to composition of matter, or conjugate vaccines that comprise a nicotine-like molecule linked to a carrier protein as well as methods for the use of these conjugate vaccines to treat and prevent nicotine addiction.
"This patent complements our already issued composition-of-matter patents by providing for the exclusive use by Nabi and/or its licensors a method to treat and prevent nicotine addiction using NicVAX as well as a wide variety of potential nicotine vaccines," said Dr. Raafat Fahim, President and Chief Executive Officer of Nabi Biopharmaceuticals. "The patent makes it more difficult for a competitor to develop a related vaccine. Furthermore, as NicVAX is the only nicotine vaccine to have demonstrated statistically significant proof-of-concept clinical results in a phase IIb smoking cessation study, Nabi's particular hapten and conjugate may prove to be an important element in developing an effective nicotine vaccine. Clearly, this patent further solidifies Nabi's intellectual property estate for treating and preventing nicotine addiction with active immmunotherapeutics."
NicVAX is currently undergoing phase III clinical testing to enable marketing authorization in the U.S. and globally. The company initiated the first clinical trial on November 3, 2009 and with enrollment complete, expects to have final data in the fourth quarter of 2011. A second Phase III trial began in March 2010 and enrollment is well under way with final data expected in early 2012.
How NicVAX Works
Nicotine is a small molecule that, upon inhalation into the lungs, quickly passes into the bloodstream and subsequently reaches the brain by crossing the blood-brain barrier. Once in the brain, the nicotine binds to specific nicotine receptors, resulting in the release of stimulants, such as dopamine, a chemical linked to pleasure and to addiction. NicVAX stimulates the immune system to produce antibodies that bind to nicotine, creating an antigen/antibody complex that is too large to cross the blood-brain barrier. In this way, NicVAX blocks nicotine from reaching these receptors in the brain, fewer stimulants are released, and the pleasurable, highly-addictive effects of nicotine are diminished, thereby making it easier to quit smoking. Pre-clinical and previous clinical data show that NicVAX's ability to block nicotine from reaching the brain could help people quit smoking. Because the nicotine antibodies circulate for long periods of time, Nabi believes NicVAX may also be effective in preventing smoking relapse and support long-term abstinence. This is a very important difference between NicVAX and existing anti-smoking treatment therapies. Relapse is a significant challenge facing smokers; with currently-available smoking cessation therapies, relapse rates can be as high as 90% in the first year after a smoker quits.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering the immune system to develop products that target serious medical conditions in the areas of nicotine addiction and gram-positive bacterial infections. Nabi Biopharmaceuticals is currently developing NicVAX(R) (Nicotine Conjugate Vaccine), an innovative and proprietary investigational vaccine for treatment of nicotine addiction and prevention of smoking relapse. The company is headquartered in Rockville, Maryland. For additional information about Nabi Biopharmaceuticals, please visit www.nabi.com.
Forward-Looking Statements
Statements in this release that are not strictly historical are forward-looking statements and include statements about products in development, results and analyses of clinical trials and studies, research and development expenses, cash expenditures, licensure applications and approvals, and alliances and partnerships, among other matters. You can identify these forward-looking statements because they involve our expectations, intentions, beliefs, plans, projections, anticipations, or other characterizations of future events or circumstances. These forward-looking statements are not guarantees of future performance and are subject to risks and uncertainties that may cause actual results to differ materially from those in the forward-looking statements as a result of any number of factors. These factors include, but are not limited to, risks relating to our ability to conduct and obtain successful results from our two Phase III clinical trials for NicVAX; GlaxoSmithKline Biologicals (GSK) failure to exercise its option for and successfully commercialize NicVAX; GSK's failure to successfully develop and commercialize any future generation candidate nicotine vaccine utilizing our intellectual property; our ability to commercialize NicVAX if GSK does not exercise its option for NicVAX; our ability to raise sufficient new capital resources to fully develop and commercialize NicVAX if GSK does not exercise the NicVAX option; our ability to attract, retain and motivate key employees; our ability to collect any further milestones and royalty payments under the PhosLo and PentaStaph agreements; the ability to obtain regulatory approval for NicVAX and any future generation candidate nicotine vaccine in the U.S. or other markets; our ability to successfully contract with contract manufacturing organizations for the manufacture and supply of NicVAX and the risk that these organizations will not fulfill their obligations to us; our ability to comply with reporting and payment obligations under government rebate and pricing programs; and loss of full use of our net operating loss carryforwards. Some of these factors are more fully discussed, as are other factors, in our Annual Report on Form 10-K for the fiscal year ended December 26, 2009 filed with the Securities and Exchange Commission. We do not undertake to update any of these forward-looking statements or to announce the results of any revisions to these forward-looking statements except as required by law.
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SOURCE: Nabi Biopharmaceuticals
CONTACT: Nabi Biopharmaceuticals
Investor Relations
301-770-3099
www.nabi.com