ROCKVILLE, Md., March 9 /PRNewswire-FirstCall/ -- Nabi Biopharmaceuticals
(Nasdaq: NABI) today announced that NicVAX(R) (Nicotine Conjugate Vaccine),
the company's novel, innovative and proprietary investigational vaccine being
developed to treat nicotine addiction and prevent smoking relapse, has
received Fast Track Designation from the U.S. Food and Drug Administration
(FDA).
Under the FDA Modernization Act of 1997, Fast Track regulations facilitate
the development of products that treat serious diseases where an unmet medical
need exists. Fast Track regulations are also designed to expedite the review
process for designated products, including the potential for companies to ask
for priority review.
"We believe this is the first Fast Track Designation for a smoking
cessation product candidate, which is unprecedented, and provides further
validation for our unique approach to addressing nicotine addiction," stated
Henrik S. Rasmussen, M.D., Ph.D., senior vice president, clinical, medical and
regulatory affairs, Nabi Biopharmaceuticals. "Smoking is the number one
preventable cause of death in the western world, yet current smoking cessation
therapies do not effectively treat the root cause of the addiction. We
believe the vaccine approach inherent to NicVAX will provide clear patient
advantages and a strong differentiation from currently marketed and
development-stage products."
How NicVAX is Designed to Work
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 is no
longer present, thereby eliminating the addictive properties of smoking and,
consequently, helping people to quit. Unlike current therapies, such as
nicotine patches and gums, smokers will not be able to eliminate the effects
of NicVAX by stopping their treatment. In addition, because these antibodies
are expected to be long lasting, it is believed NicVAX will also be effective
in preventing smoking relapse, a significant challenge with existing smoking
cessation therapies.
Progress to Date and Next Steps
Nabi Biopharmaceuticals has completed four Phase I/II studies, totaling
close to 200 patients, for NicVAX. These studies demonstrated that NicVAX is
well tolerated, highly immunogenic, produced dose-dependent increases in
antibody titers, and showed a good indication of efficacy at the 200 ug dose
with a 33 to 40 percent quit rate versus nine percent for smokers dosed with a
placebo.
In September 2005, Nabi Biopharmaceuticals announced that it had received
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 development
program for NicVAX. Partnering remains Nabi Biopharmaceuticals' strategic goal
for NicVAX.
Nabi Biopharmaceuticals will next conduct a Phase II "proof-of-concept"
study for NicVAX, which is expected to commence during the second quarter of
2006. The study will be comprised of approximately 300 patients, a large
enough sample size to establish both proof-of-concept and optimal dose
identification for the company's Phase III program. The study results are
anticipated in the second half of 2007.
Importantly, the vaccine manufactured for this Phase II study has been
manufactured at commercial scale in an optimized formulation at the company's
vaccine manufacturing facility in Boca Raton, Florida. This further
demonstrates the significant advancements that have already been achieved in
the development of Nabi Biopharmaceuticals' nicotine addiction program. The
study design will incorporate recommendations from a newly formed scientific
advisory panel. The panel is comprised of scientific and clinical experts in
smoking cessation. The panel will also provide input to the company on other
aspects of the NicVAX development program.
Nabi Biopharmaceuticals has also met with the FDA, as well as the European
Medicines Agency (EMEA), to ensure all key regulatory requirements are built
into the NicVAX Phase II trial design and overall development program.
Cigarette Smoking: A Growing Global Health Challenge
Smoking is a global healthcare problem, and The World Health Organization
estimates that there are 1.3 billion smokers worldwide and nearly five 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 approximately 70 - 80 percent of smokers
in the U.S. want to quit, but less than five percent of those who try to quit
remain smoke-free at 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. To learn more about NicVAX
and how it works, please visit our website at:
http://www.nabi.com/pipeline/pipeline.php?id=3 .
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. The company has 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. Nabi Biopharmaceuticals is
focused on developing products that address unmet medical needs and offer
commercial opportunities in our core business areas: Gram-positive bacterial
infections, hepatitis, kidney disease (nephrology) and nicotine addiction.
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 website at http://www.nabi.com .
Forward-Looking Statement
Statements in this press release about the company that are not strictly
historical are forward-looking statements and include statements about our
marketed products, products in development, demand for our products, clinical
trials and studies, licensure applications and approvals, assessment of the
StaphVAX Phase III trial results, and alliances and partnerships. You can
identify these forward-looking statements because they involve our
expectations, beliefs, projections, 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 the company's ability to advance the
development of products currently in the pipeline or in clinical trials;
complete the assessment of the StaphVAX Phase III clinical trials during the
first half of 2006; maintain the human and financial resources to
commercialize current products and bring to market products in development;
obtain regulatory approval for its products in the U.S., Europe or other
markets; successfully develop, manufacture and market its products; realize
future sales growth for its biopharmaceutical products; prevail in patent
litigation; raise additional capital on acceptable terms; re-pay its
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, 2005 filed with the Securities and
Exchange Commission.
SOURCE Nabi Biopharmaceuticals
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Related links:
http://www.nabi.com
http://www.nabi.com/pipeline/pipeline.php?id=3
http://www.nabi.com/pipeline/index.php
CONTACT:
Thomas E. Rathjen, Vice President, Investor
Relations, Nabi Biopharmaceuticals, +1-561-989-5800
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