NicVAX Supports Statistically Significant Point Prevalence and Continuous
Abstinence by Dose, Schedule and Antibody Response; Nabi to Host Conference
BOCA RATON, Fla., Sept. 5 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) today announced nine-month data from its
ongoing 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. These nine-month data
demonstrate NicVAX efficacy in supporting statistically significant and
continuous abstinence rates by dose as well as by antibody response. The
nine-month data also have enabled Nabi to determine what it believes is the
most effective dose and schedule for NicVAX and determine the antibody
concentration threshold for clinical efficacy. In May 2007, Nabi announced
this trial's six-month data -- a statistically significant number of patients
with a high anti-nicotine antibody response met the trial's primary endpoint
of eight weeks of continuous abstinence between weeks 19-26.
NicVAX Nine-Month Data Key Findings
-- High antibody responders (top 30%) continued to show statistically
significant abstinence at nine months:
-- 9-Month continuous abstinence rate: NicVAX=20% (12/61, p=0.0076) vs.
-- Statistically significant dose response observed for continuous
abstinence at six and nine months for Schedule 2, 200 and 400 microgram
doses in the intent to treat population:
-- 9-Month continuous abstinence: NicVAX 400 micrograms =18% (9/51,
p=0.0047), Placebo=4% (4/100)
-- 9-Month continuous abstinence: NicVAX 200 micrograms =14% (7/50,
p=0.027), Placebo=4% (4/100)
-- Most effective schedule selected: Schedule 2 (five injections over six
-- Most effective dose selected: 400 micrograms
-- Threshold antibody level identified and probability of abstinence vs.
antibody levels calculated:
-- Attainment of the antibody threshold at Target Quit Date determines
-- Subjects in the therapeutic effect window have a >50% likelihood of
-- No compensatory smoking or increase in withdrawal symptoms
-- Through the nine months of the Phase 2b trial, NicVAX continues its
attractive safety trends with a favorable adverse events profile and no
difference between placebo and each dose group.
"We are extremely pleased with the NicVAX data and the continued smoking
cessation trends we've observed through nine months of this clinical trial,"
said Dr. Leslie Hudson, Interim President and Chief Executive Officer of Nabi.
"Our latest analyses have helped us identify a NicVAX dose that achieves the
high antibody levels associated with helping smokers successfully quit smoking
and remain abstinent over long periods of time. These analyses have also
provided us with data that are extremely important for our ongoing partnering
efforts. We believe the full 12-month data will be invaluable as we determine
next steps for our clinical development program."
To gain greater perspective on these data, Nabi discussed its nine-month
findings with nationally recognized smoking cessation researchers and the
National Institute on Drug Abuse (NIDA). Nabi will use these validated and
promising nine-month data to advance its partnership discussions surrounding
"The data seen to-date for NicVAX have been extremely encouraging," said
Dr. Dorothy Hatsukami, Forster Family Professor in Cancer Prevention and
Professor of Psychiatry at the University of Minnesota Tobacco Use Research
Center. "The data show that there is an observable link between the high
antibody levels achieved with the 400 microgram NicVAX dosing regimen and the
ability of these patients to quit smoking and to remain abstinent. This key
development -- the success of a smoking cessation vaccine -- could have an
important impact on how we address smoking and smoking relapse."
Nabi will discuss and present these nine-month data in further detail at
several upcoming scientific and investor conferences. Nabi is scheduled to
participate in the Biennial Conference of the California Tobacco-Related
Disease Research Program, Oct. 8-9, 2007 in Sacramento, California.
Additionally, Dr. Dorothy Hatsukami is scheduled to present NicVAX findings at
the 9th European Society for Research on Nicotine and Tobacco (SRNT) Europe
conference, October 3-6, 2007 in Madrid, Spain. Dr. Leslie Hudson is also
slated to present on Sept. 6, 2007 at the Thomas Weisel Partners Healthcare
Conference in Boston and on Sept. 11, 2007 at the Bear Stearns Healthcare
Conference in New York. Additionally, the full twelve-month NicVAX data have
been accepted for presentation at the American Heart Association (AHA)
Scientific Sessions 2007 in Orlando, Florida on November 7, 2007.
Nabi will host a live webcast at 5:30 p.m. EDT today, September 5, to
discuss these nine-month data. Additionally, presentation slides highlighting
key data points will be made available immediately prior to today's call.
These slides can be accessed at http://www.nabi.com.
The live webcast can be accessed at:
or via the Nabi Biopharmaceuticals website at http://www.nabi.com.
If you do not have Internet access, the U.S./Canada call-in number is
(866) 713-8307 and the international call-in number is (617) 597-5307. The
participant passcode is 42339034. An audio replay will be available for
U.S./Canada callers at (888) 286-8010 and for international callers at (617)
801-6888. The participant passcode is 67358690.
An archived version of the webcast will be available at the same Internet
address through September 12, 2007. The audio replay also will be available
through September 12, 2007. The press release will be available on the
company's website at http://www.nabi.com.
About the Phase 2b Study
The Phase 2b study is 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.
NicVAX is an innovative and proprietary investigational vaccine being
developed by Nabi to treat nicotine addiction and prevent smoking relapse.
NicVAX 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. Pre-clinical
and previous clinical data, as well as the study reported here, show that
NicVAX'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 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 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 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.
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. The company is
headquartered in Boca Raton, Florida. For additional information about Nabi
Biopharmaceuticals, please visit our Web site: http://www.nabi.com.
Statements in this release that are not strictly historical are forward-
looking statements and include statements about reorganization of our current
business into two new business units, our strategic alternatives process 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 continue development of our pipeline products,
including NicVAX; obtain successful clinical trial results; successfully
partner with third parties to fund, develop, manufacture and/or distribute our
existing and pipeline products, including NicVAX and our Gram-positive
infections products; our ability to successfully complete our strategic
alternatives process; realize anticipated cost savings related to job
elimination due to greater than anticipated severance-related costs or other
factors; 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
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 quarter ended June 30, 2007 on Form 10-Q with the Securities and
SOURCE Nabi Biopharmaceuticals
301-770-3099 | www.nabi.com (NABI)