-- Grant Enables Nabi Biopharmaceuticals to Advance NicVAX
To Phase III Pivotal Trials --
BOCA RATON, Fla., Sept. 12 /PRNewswire-FirstCall/ -- Nabi
Biopharmaceuticals (Nasdaq: NABI) announced today that it has been awarded a
$4.1 million grant by the U.S. National Institute on Drug Abuse (NIDA), part
of the National Institutes of Health, for partial funding of the company's
development program for NicVAX(TM) (Nicotine Conjugate Vaccine). NicVAX is
Nabi Biopharmaceuticals' novel, innovative and proprietary investigational
vaccine being developed to treat nicotine addiction and prevent smoking
relapse.
Smoking is a global healthcare problem, and The World Health Organization
estimates that there are 1.3 billion smokers worldwide and nearly 5 million
tobacco-related deaths each year. According to the U.S. Centers for Disease
Control and Prevention (CDC), tobacco use is the single leading preventable
cause of death in the United States and is responsible for more than
440,000 deaths each year. They estimate that 70 percent of smokers in the
U.S. want to quit, but less than 5 percent of those who try to quit abstain
from smoking for 3 to 12 months. In addition, they estimate that tobacco use
causes $75.5 billion in excess medical costs and $81.9 billion in illness-
related productivity losses each year in the U.S.
Dr. Frank Vocci, director, division of pharmacotherapies and medical
consequences of drug abuse, NIDA, stated, "Despite the widespread knowledge of
nicotine's dangerous health effects, smoking continues to represent a serious
public health threat in the U.S. Given nicotine's highly addictive
properties, and because other forms of smoking cessation treatments may not be
as successful in the long term, vaccines may prove to be a promising
alternative for those wishing to stop smoking."
Henrik S. Rasmussen, M.D., Ph.D., senior vice president clinical, medical
and regulatory affairs, Nabi Biopharmaceuticals, stated, "NicVAX, the only
vaccine being developed in the U.S. and Europe, is potentially advantageous in
several important, scientific and commercially strategic ways. NicVAX appears
to be very well tolerated, even at 200 mcg, the highest dose level tested,
allowing the company to explore higher and potentially even more efficacious
doses. Secondly, NicVAX is based on a proprietary and established mechanism
of action. Lastly, Nabi Biopharmaceuticals will be in a position in 2005 to
produce commercial-scale manufacturing quantities of the vaccine, making
NicVAX the most clinically advanced product candidate in development for
smoking cessation. Today's grant will enable Nabi Biopharmaceuticals to
rapidly advance NicVAX's development program into and through Phase III
pivotal trials."
By the end of 2005, Nabi Biopharmaceuticals intends to announce
preliminary safety and immunogenicity results from its European Phase II
study, be in a position to initiate a pivotal efficacy trial, and begin to
manufacture NicVAX in its own vaccine manufacturing facility in Boca Raton,
Florida.
NicVAX Development Program
U.S.
In September 2004, Nabi Biopharmaceuticals reported positive results from
its U.S. Phase II trial. This trial was a double-blinded, placebo-controlled,
randomized study in smokers, designed to assess safety and antibody response.
In addition, standard measures of anti-smoking efficacy, such as percentage of
patients who quit smoking, was included.
The results showed that, at the 200-microgram dose, 33 percent of smokers
in the treated group quit smoking (defined as no smoking for at least 30
consecutive days) versus 9 percent in the placebo group. In addition, results
showed a substantial reduction in average cigarette consumption in smokers who
received the highest dose of NicVAX versus lower doses or placebo. Smoking
cessation was confirmed by cotinine and carbon monoxide levels, which are
biochemical markers of smoking. Nicotine dependency was measured by a
questionnaire and also showed a substantial reduction at the top dose of
NicVAX as compared to placebo or the lower dose levels. NicVAX was very well
tolerated, and side effects were similar between the active dose levels and
the placebo group. The outside clinical costs for the trial were funded by a
grant from NIDA.
Europe
Nabi Biopharmaceuticals completed enrollment for its European-based NicVAX
Phase II dose-ranging study in smokers in July 2005.
The study, designed to evaluate NicVAX's safety, antibody response to
nicotine, and measure smoking cessation/nicotine dependency, is a randomized
dose-ranging study in smokers. Four different NicVAX dose levels will be
given over a six-month period, with 10 to 20 patients included per dose group.
Nabi Biopharmaceuticals has observed no significant toxicity through the
200 mcg dose level in previous trials, hence the current study is designed to
evaluate whether higher doses of NicVAX could further increase anti-nicotine
antibody levels without increasing toxicity.
Unique Mechanism of Action
NicVAX is a nicotine derivative bound chemically to a specially selected
carrier protein using Nabi Biopharmaceuticals' proprietary vaccine technology.
NicVAX is designed to cause the immune system to produce antibodies that
bind to nicotine and prevent it from entering the brain. It is believed that
these nicotine antibodies will act like a "sponge" soaking up nicotine as it
circulates in the bloodstream and preventing it from reaching the brain. The
positive stimulus in the brain that is normally caused by nicotine would then
no longer be present, thereby eliminating the addictive properties of nicotine
and, consequently, helping people to quit and not relapse.
Studies in animal models have shown that vaccination with NicVAX can
prevent nicotine from reaching the brain and block the effects of nicotine,
including effects that can lead to addiction or can reinforce and maintain
addiction.
About Nabi Biopharmaceuticals
Nabi Biopharmaceuticals leverages its experience and knowledge in powering
the immune system to develop and market products that fight serious medical
conditions. We are poised to capture large commercial opportunities in our
core business areas: Gram-positive bacterial infections, hepatitis, and kidney
disease (nephrology), and opportunistically in nicotine addiction. We have
three products on the market today: PhosLo(R) (calcium acetate), Nabi-HB(R)
[Hepatitis B Immune Globulin (Human)], and Aloprim(TM) [Allopurinol sodium
(for injection)] and a number of products in various stages of clinical and
preclinical development. The company filed its Marketing Authorization
Application (MAA) in Europe for its product candidate, StaphVAX(R)
[Staphylococcus aureus Polysaccharide Conjugate Vaccine], in December 2004.
The application was accepted for review in January 2005. StaphVAX is
currently in a confirmatory Phase III clinical trial in the United States.
StaphVAX is designed to prevent the most dangerous and prevalent strains of
S. aureus bacterial infections. S. aureus bacteria are a major cause of
hospital-acquired infections and are becoming increasingly resistant to
antibiotics. The company also filed MAA's in Europe to market Nabi-HB(R)
Intravenous [Hepatitis B Immune Globulin (Human) Intravenous] under the trade
name HEBIG(TM) for the prevention of hepatitis B disease in HBV-positive liver
transplant patients; and for PhosLo(R) (calcium acetate), which is already
marketed in the U.S. The company's other products in development include
Altastaph(TM) [Staphylococcus aureus Immune Globulin Intravenous (Human)], an
antibody for prevention and treatment of S. aureus infections, NicVAX(TM)
[Nicotine Conjugate Vaccine], a vaccine to treat nicotine addiction, and
Civacir(TM) [Hepatitis C Immune Globulin (Human)], an antibody for preventing
hepatitis C virus re-infection in liver transplant patients. For additional
information on Nabi Biopharmaceuticals, please visit our website at
http://www.nabi.com .
This press release contains forward-looking statements that reflect the
company's current expectations regarding future events. Any such forward-
looking statements are not guarantees of future performance and involve
significant risks and uncertainties. Actual results may differ significantly
from those in the forward-looking statements as a result of any number of
factors, including, but not limited to, risks relating to the possibility that
our confirmatory Phase III clinical trial for StaphVAX or our plans to
commercialize StaphVAX in the European Union and United States may not be
successful; the possibility that we may not realize the value of our
acquisition of PhosLo; the company's ability to raise additional capital on
acceptable terms; the company's dependence upon third parties to manufacture
its products; the company's ability to utilize the full capacity of its
manufacturing facility; the impact on sales of Nabi-HB from patient treatment
protocols and the number of liver transplants performed in HBV-positive
patients; reliance on a small number of customers; the future sales growth
prospects for the company's biopharmaceutical products; and the company's
ability to obtain regulatory approval for its products in the United States or
abroad or to successfully develop, manufacture and market its products. These
factors are more fully discussed in the company's Annual Report on Form 10-K
for the fiscal year ended December 25, 2004 filed with the Securities and
Exchange Commission.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
CONTACT:
Constance C. Bienfait, Vice President,
Investor Relations, Nabi Biopharmaceuticals, +1-561-989-5800
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