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Nabi Biopharmaceuticals Announces Successful Completion of NicVAX(R) Phase 2b Trial; Drug Shows Statistically Significant Rates of Smoking Cessation and Continuous Long-Term Smoking Abstinence at 12 Months

 Data Presented Today at the American Heart Association Scientific Sessions
                          2007 in Orlando, Florida

    BOCA RATON, Fla., Nov. 7 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced the successful completion
of its Phase 2b trial of NicVAX(R) (Nicotine Conjugate Vaccine), the
company's innovative and proprietary investigational vaccine being
developed to treat nicotine addiction and prevent smoking relapse. The
final 12-month data confirm the highly significant trends seen in the
previous data at six and nine months for both smoking cessation and
long-term smoking abstinence. These data were presented at 9:45 a.m., EST
today at the American Heart Association (AHA) Scientific Sessions 2007 in
Orlando, Florida by one of the trial's lead investigators, Dr. Stephen
Rennard, Larson Professor of Medicine, University of Nebraska Medical
Center.
    "I believe data from this trial are very encouraging - for smokers who
are trying to quit as well as for the field of smoking cessation vaccines,"
said Dr. Rennard. "Only a short time ago, it was difficult to find
convincing evidence to link anti-nicotine antibody with smoking cessation.
This double- blind, placebo-controlled trial has demonstrated a clinical
proof of concept. The data show there is a correlation between antibody
level and the ability of patients to quit smoking and remain abstinent over
long periods of time. This development is key for the field of smoking
cessation research and could have a significant impact on how we treat
patients with nicotine addiction."
    NicVAX(R) Phase 2b Trial: Key Findings in Final 12 Month Data Set
    Optimal NicVAX(R) Dose and Schedule Identified for Smoking Cessation
and Long-Term Abstinence
    A statistically significant number of patients treated with the
NicVAX(R) optimal dose (400 micrograms) and schedule (Schedule 2) were able
to quit smoking and remained abstinent over the long-term:
    *  12-Month continuous abstinence: NicVAX(R) 400 micrograms, Schedule 2 =
       16% (8/51), Placebo=6% (6/100), p<0.038 (intent to treat population)
    *  12-Month continuous abstinence: NicVAX(R) 200 micrograms, Schedule 2 =
       14% (7/50), Placebo=6% (6/100), p<0.056 (intent to treat population)
       *  For the final 12-month data analysis, this response was calculated
          using total time after the Target Quit Date, rather than the general
          study week (which was used in interim data analyses).  This
          conservative and stringent statistical approach yielded
          statistically significant findings even after a full year.

    Anti-Nicotine Antibody Levels Drive Long-Term Smoking Abstinence
    *  The rate of smoking cessation and ability to achieve long-term
       abstinence in treated patients was correlated with level of anti-
       nicotine antibodies at critical time points: The high antibody
       responder group (top 30% of antibody responders) showed continuous
       abstinence rates almost three times those of placebo at 12 months.
    *  These high antibody responders continued to show statistically
       significant abstinence at 12 months:
       *  NicVAX(R)= 16% (10/61) vs. Placebo= 6% (6/100), p<0.032
    *  Subjects in the therapeutic effect window show a >30% likelihood of
       achieving at least four months of smoking abstinence and remaining
       entirely abstinent through 12 months following the first administration
       of NicVAX(R).
    Overall Health Benefit - High Antibody Responders Smoked Fewer
Cigarettes
    Those patients in the NicVAX(R) group who continued to smoke but who
also showed a high antibody response (top third) showed a statistically
significant reduction in cigarettes smoked over the full 12 months compared
to placebo (p<0.022):
    *  Using a repeated measures model, vaccinated smokers who failed to quit
       but showed a high antibody response smoked a median of only 10
       cigarettes per day while in the study, compared to their own baseline
       values of 20 cigarettes per day before treatment.
    Safety Trends Continue - NicVAX(R) Shows No Compensatory Smoking, No
Increased Withdrawal
    Importantly, there was no evidence of compensatory smoking or increase
in withdrawal symptoms observed in NicVAX(R) patients at any stage of the
12- month trial. NicVAX(R) continued to be well-tolerated with the placebo
and NicVAX(R) dose groups showing comparable adverse event profiles at each
stage of the clinical study.
    "We are excited and greatly encouraged by the significant learning
which has come from this first efficacy trial of NicVAX." said Dr. Leslie
Hudson, Interim President and Chief Executive Officer of Nabi. "It is
important to note that we have seen success in each of the critical
parameters of this trial; we know the dimensions of the therapeutic
antibody window which will drive continuous abstinence out to a full year,
we know the relationship between the psychological and biochemical drives
to quit and remain abstinent and, most importantly, we believe we now have
the insight to drive a higher rate of response. We will use these
encouraging final data to advance our NicVAX partnership discussions and to
determine the optimal design for the next step in our clinical trial
efforts for this important primary care product candidate."
    About the Phase 2b Study
    The Phase 2b study was a double-blind, placebo-controlled and
dose-ranging study comprised of 301 patients designed to establish proof of
concept and the optimal dose for the Phase 3 program. This study was
designed in collaboration with the U.S. Food and Drug Administration and
other global regulatory agencies and incorporates the most current clinical
trial standards and prevailing protocol design for smoking cessation
studies. The trial's primary endpoint is the rate of carbon monoxide
(CO)-confirmed, continuous abstinence from smoking during weeks 19-26 after
first vaccination. In May 2007, Nabi announced this trial's six-month data,
which showed that a statistically significant number of patients with in
the high anti-nicotine antibody responder group met the trial's primary
endpoint of eight weeks of continuous abstinence between weeks 19-26.
    About NicVAX(R)
    NicVAX(R) is an innovative and proprietary investigational vaccine
being developed by Nabi to treat nicotine addiction and prevent smoking
relapse. NicVAX(R) 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(R) blocks nicotine from reaching its receptors in the brain and
prevents the highly-addictive pleasure sensation experienced by smokers and
users of nicotine products. Pre-clinical and previous clinical data, as
well as the study reported here, show that NicVAX(R)'s ability to block
nicotine from reaching the brain could help people quit smoking. Because
the body's immune system can be boosted to produce long-lasting antibodies,
Nabi believes NicVAX(R) also could be effective in preventing smoking
relapse. Relapse is a significant challenge facing smokers and, with
currently-available smoking cessation therapies, relapse rates can be as
high as 90% in the first year after a smoker quits.
    NicVAX(R) Development 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(R) 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(R) 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.
    About Nabi Biopharmaceuticals
    Nabi Biopharmaceuticals leverages its experience and knowledge in
powering the immune system to develop and, in certain areas, market
products that target serious medical conditions in the areas of hepatitis
and transplants, gram positive bacterial infections and nicotine addiction.
We are a vertically integrated company with sales of antibodies and other
biologics, including Nabi-HB(R) [Hepatitis B Immune Globulin (Human)], a
pipeline of products in various stages of development and a
state-of-the-art manufacturing capability. The company operates through two
strategic business units: Nabi Biologics and Nabi Pharmaceuticals. Nabi
Biologics has responsibility for the company's protein and immunological
products and development pipeline, including Nabi- HB. Nabi Pharmaceuticals
is responsible for the NicVAX(R) (Nicotine Conjugate Vaccine) and
StaphVAX(R) (Staphylococcus aureus Polysaccharide Conjugate Vaccine)
development programs. For a complete list of pipeline products, please go
to: http://www.nabi.com/pipeline/index.php. In September 2007, Nabi
announced that it had entered into a definitive agreement with Biotest AG
to sell the Nabi Biologics strategic business unit to Biotest
Pharmaceuticals Corporation, including Nabi-HB(R) [Hepatitis B Immune
Globulin (Human)], and other plasma business assets, including Nabi's
state-of-the-art plasma protein production plant, and nine FDA-certified
plasma collection centers across the U.S. The acquisition also will include
certain of Nabi's Corporate Shared Services group assets and the company's
Boca Raton, Florida headquarters and other facilities, as well as the
assumption of certain liabilities. This transaction is expected to close by
the end of the year. The company is headquartered in Boca Raton, Florida.
For additional information about Nabi Biopharmaceuticals, please visit our
Web site: http://www.nabi.com.
    Forward-Looking Statements
    Statements in this release that are not strictly historical are
forward- looking statements and include statements about the closing of the
sale of Nabi Biologics and clinical trials and studies. You can identify
these forward-looking statements because they involve our expectations,
beliefs, 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:
successfully close the sale of the Nabi Biologics SBU to Biotest AG;
successfully partner with third parties to fund, develop, manufacture
and/or distribute our existing and pipeline products, including NicVAX(R)
and our Gram-positive infections products; obtain successful clinical trial
results; our ability to successfully complete our strategic alternatives
process; generate sufficient cash flow from sales of products or from
milestone or royalty payments to fund our development and commercialization
activities; attract and maintain the human and financial resources to
commercialize current products and bring to market products in development;
depend upon third parties to manufacture or fill our products; achieve
approval and market acceptance of our products; expand our sales and
marketing capabilities or enter into and maintain arrangements with third
parties to market and sell our products; effectively and/or profitability
use, or utilize the full capacity of, our vaccine manufacturing facility;
manufacture NicVAX(R) or other products in our own vaccine manufacturing
facility; comply with reporting and payment obligations under government
rebate and pricing programs; raise additional capital on acceptable terms,
or at all; and re-pay our outstanding convertible senior notes when due.
Many of these factors are more fully discussed, as are other factors, in
the company's Annual Report on Form 10-K for the fiscal year ended December
31, 2006 and our Quarterly Report for the quarters ended June 30, 2007 and
March 31, 2007 on Form 10-Q with the Securities and Exchange Commission.


SOURCE Nabi Biopharmaceuticals




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