Located in Washington,
D."
Belshe added, "Californians can be proud of how far we've come in
the last 15 years, but should
also remember that the battle against
tobacco addiction continues.
Progress to Date and
Next Steps
Nabi Biopharmaceuticals has completed four Phase I/II studies, totaling
close to
200 patients, for NicVAX. 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.
rwj chemically
These included 19 major public health organizations, the
Citizens' Commission to Protect
the truth, and 34 states across the country.americanlegacy.
According to the 2004 Field Research
poll:
Fifty-two percent of former smokers who quit in the past 10
years said that
having smoke-free public places made it easier
for them to quit smoking.nabi.S.perils smoking
With this
action, it is now clear that
Big Tobacco is resolute in its intent to shut down the Foundation's
truth(R)
campaign, the only national independent youth smoking prevention campaign not
directed
by the tobacco industry.
We continue to be grateful for their support, as they stand behind us in
our
very important work to extend and save the lives and health of millions of
Americans."
New
figures show that smoking among California youth has decreased
to record lows.
People who
moved to the state after the law went into effect
also overwhelmingly support the smoke-free
workplace law.D. 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. This further
demonstrates the significant advancements that have already been achieved
in
the development of Nabi Biopharmaceuticals' nicotine addiction program.smokers prevalence
Sixty-nine percent
of current smokers who attempted to quit in
the past 10 years said that smoke-free public
places helped
them reduce the number of cigarettes they smoke.Nabi Biopharmaceuticals Announces
U.S. Fast Track Designation for NicVAX(R)
S. 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
. The company is headquartered in Boca
Raton, Florida. 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.tobaccofree unfiltered
Tobacco-related disease remains
the number one cause of preventable death
in the nation and 45 million adult Americans continue to
smoke. The American Legacy Foundation was created as a
result of the November 1998 MSA reached between
attorneys general from 46
states, five US territories and the tobacco industry.
"California
's smoke-free policies are helping to protect people
from the dangers of secondhand smoke," said State
Public Health
Officer Dr. 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.grannis smokefree
The foundation's national programs include
Circle of
Friends(R), Great Start(R), a Priority Populations Initiative,
Streetheory(R) and truth(R).2 percent
of high school students in California smoked last
year, compared with 16. There are currently four
million adult
smokers in California.
For a complete list of pipeline products, please go to
http:
//www.proportion tobacco
The tobacco industry is in business to sell cigarettes.
In addition to new data on youth
smoking, CDHS also released
results from a new Field Research poll, which shows that the state's
smoke-free workplace law has had a major impact on smoking behavior
and cessation efforts, and
that the majority of Californians support
the law. 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.
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.grannis perils
Reynolds, Philip
Morris USA and Brown and
Williamson -- filed a motion for leave to appear as
Amici Curiae, literally "friends of the court
," on behalf of the Lorillard
Tobacco Company in the Delaware Supreme Court in its long-running litigation
with the American Legacy Foundation.
In September 2005, Nabi Biopharmaceuticals announced
that it had received
a $4.1 million grant by the U. The
study design will incorporate recommendations
from a newly formed scientific
advisory panel.hooked nonsmokers
This latest action by
every major tobacco company
comes on the heels of the initiation of a
comprehensive dialogue between the Foundation and states
with the largest
numbers of smokers, and tobacco control stakeholders, to begin an effort to
work
together through public education and services to drive down still
further the number of Americans
trapped by nicotine addiction. The Lorillard suit demands the return of all the
Foundation's Master
Settlement Agreement (MSA) funding, retroactive to its
signing in 1998, to the escrow agent.----Fifteen
years
after California launched its tobacco control program, and 10 years
after passage of an
unprecedented statewide smoke-free workplace law,
new data released today show that smoking among
youth continues to
decline and that Californians approve of the state's smoke-free
efforts.businesswire
. 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.com/pipeline/pipeline.unfiltered prevalence
Ironically
, if the
major cigarette manufacturers succeed, there will be only one national media
voice "advising
" America to quit smoking -- that of the tobacco industry. In this litigation, Lorillard did not
contest
the veracity of the foundation ads, but argued that any advertising
that was remotely critical of
the tobacco industry would be in violation of
the MSA's vilification clause.
State health officials
and public health advocates joined
Sacramento middle-school students, members of the first generation
to
benefit from California's tobacco-free policies, to celebrate the
success of Proposition 99
, the landmark Tobacco Tax and Health
Protection Act of 1988, and California's smoke-free workplace
law that
took effect in 1995. "The latest Field Research poll
provides evidence that these policies
also help smokers quit their
deadly addiction. ROCKVILLE, Md. Food and Drug Administration
(FDA).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.lungs nonsmokers
J. Rasmussen
, M. "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.S.S.tobacco unfiltered
It serves as the
national public health foundation
devoted to building a world where young people reject tobacco and
anyone can
quit. That process has resulted in ground
breaking advertising which resonates with
the campaign's 12-17- year-old
target audience.
The foundation will vigorously oppose the tobacco
companies' efforts to
insinuate themselves into this ongoing litigation, at this very late stage
of
the dispute.
Click here for caption
Click here for caption
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here for caption
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Click here for caption
News
Editors/Health Editors
MULTIMEDIA AVAILABLE:
http://www.
"With aggressive tobacco education
and prevention activities, we
have taught our youth to be more aware of the tobacco industry's
marketing
tactics and to reject tobacco," said CDHS Director Sandra
Shewry.
MULTIMEDIA AVAILABLE:
http:
//www. 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. 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. 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.tobaccofree addicting
Now, it is public record that the tobacco industry will
do everything in
its power to shut down truth(R) -- a campaign that has been proven very
effective
, is popular with teens, and most importantly, is saving thousands of
teenagers from a life of potential
disease and premature death. "Today we celebrate 15
years of reducing adult and youth smoking, exposure
to secondhand
smoke and tobacco-related diseases and deaths. Fast Track regulations are also designed
to expedite the review
process for designated products, including the potential for companies to
ask
for priority review.Teen and child smoking; initiation of smoking; causes and influences.
prevalence thirds
Statement
by Dr. Cheryl Healton President and CEO American Legacy Foundation(R)
The American
Legacy
Foundation is in the business of saving lives.
The tobacco industry spends $41. Visit
http:
//www. Jackson. You can
identify these forward-looking statements because they involve our
expectations
, beliefs, projections, or other characterizations of future
events or circumstances.
nicotine hooked
The MSA provides
restrictions for the foundation's advertising that
prohibit it from "vilification" or "personal attack
.org.4 percent in 2002
and 6.
"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. Unlike current therapies, such as
nicotine
patches and gums, smokers will not be able to eliminate the effects
of NicVAX by stopping their treatment
.5 billion in excess medical costs and $81.S. To learn more about NicVAX
and how it works, please
visit our website at:
http://www.php .prevalence rwj
"California's youth have grown up enjoying the benefits
of living
in America's smoke-free zone," said Kim Belshe, secretary of the
California Health and
Human Services Agency.com/cgi-bin/mmg., 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."
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. Partnering remains Nabi Biopharmaceuticals' strategic goal
for NicVAX.
Cigarette
Smoking: A Growing Global Health Challenge
Smoking is a global healthcare problem, and The World
Health Organization
estimates that there are 1. In addition, they estimate that tobacco use
causes
$75.
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.marlboro smokefree
While this action occurs four years into the foundation's litigation with
the
Lorillard Tobacco Company, it comes as no surprise. The campaign allows teens to make informed choices
about tobacco use by giving them the facts about the industry and its
products.,
the foundation
develops programs that address the health effects of tobacco
use through grants, technical assistance
and training, youth activism,
strategic partnerships, counter-marketing and grassroots marketing
campaigns,
research, public relations, and outreach to populations disproportionately
affected
by the toll of tobacco.
Among middle school students in grades six through eight, 3. Richard J.cgi?eid=4807323
According to the U.cigarettes thirds
If
successful, the tobacco industry's efforts will result in hundreds
of
thousands of young people being consigned to a future of addiction, disease
and premature death
from tobacco.
Equally important is the fact that it will also seriously jeopardize the
Foundation
's other innovative programs and campaigns designed to prevent youth
from smoking and help those who
want to quit, succeed. This translates to
300,000 fewer youth smokers in 2002 due to truth(R). According
to the 2004 California Student Tobacco
Survey released today by the California Department of Health
Services
(CDHS), 13.7 in 2000.
Seventy-four percent of Californians surveyed, including
nearly half of those who were smokers, agreed that smoking
should be prohibited in
the outdoor dining areas of
restaurants."
In November 1988, Proposition 99 was approved
by California voters
and instituted a 25-cent tax on cigarettes and earmarked 5 cents of
every
cigarette pack sold to fund the California Tobacco Control
Program, the nation's longest running
and most emulated comprehensive
anti-tobacco program.D. The panel will also provide input to the
company on other
aspects of the NicVAX development program.php?id=3 .proportion smokefree
The American
Journal of
Public Health published findings in February 2005 crediting
truth(R) with contributing to the overall
decline in youth smoking by 22
percent in the campaign's first two years, 2000-2002.com/cgi-bin/mmg
. For additional information about Nabi Biopharmaceuticals,
please visit our website at http://www
.com .addicting proportion
The Honorable William Sorrell, Attorney General of Vermont,
Chair, American
Legacy Foundation Board of Directors
WASHINGTON, The following is a statement by Dr. The
companies took a
similar position last year when they launched an attack against the truth(R)
campaign
in connection with the Department of Justice's racketeering lawsuit
against the tobacco industry
.
The American Legacy Foundation was established in 1999 as a result of the
MSA, reached between
attorneys general from 46 states, five US territories and
the tobacco industry.
In its dispute
with the foundation, Lorillard has maintained that the
truth(R) campaign violates the restrictions
of the MSA.9
percent reported smoking last year, compared with 4. With rising health care costs,
preventive
health programs are vital to the state's efforts to ensure a healthy
and prosperous
California.addicting proportion
The Foundation was
gratified last year when the Delaware Chancery Court twice ruled in
our favor.
The foundation's Board of Directors and staff follow a rigorous approval
process
to ensure compliance with the MSA.
, senior vice president, clinical, medical and
regulatory
affairs, Nabi Biopharmaceuticals. National Institute on Drug Abuse (NIDA), part
of the National Institutes
of Health, for partial funding of the development
program for NicVAX. They estimate that approximately
70 - 80 percent of smokers
in the U. want to quit, but less than five percent of those who try to
quit
remain smoke-free at 12 months.com/pipeline/index. 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.nonsmokers slugfest
Cheryl Healton, President and CEO, American Legacy Foundation(R):
On Friday
, March 3, three tobacco companies -- R."
The truth(R) campaign launched in February 2000, is
the largest national
youth smoking prevention campaign and the only national campaign not directed
by the tobacco industry.5 million a day on domestic advertising
and promotional expenditures of
its products.0 percent in 2002 and 21.6 in 2000.
Ninety percent of Californians surveyed, including
the
majority of smokers, said they approve of the smoke-free
workplace law. We
believe the vaccine approach inherent to NicVAX will provide clear patient
advantages and a strong
differentiation from currently marketed and
development-stage products.9 billion in illness-
related
productivity losses each year in the U.lorillard thirds
Lorillard's demand includes funds
provided by all of the
MSA signatories.
The Court fully vindicated the Foundation's position that none of our
advertisements
have vilified or personally attacked the tobacco industry or
its employees.
Many truth(R)
campaign ads are developed directly from actual tobacco
industry documents for the purpose of providing
teens with a window into
cigarette advertising aimed at them.
Ninety-three percent said
they approve of the law and 91
percent said they would recommend that other communities adopt
a similar smoke-free policy.
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.3 billion smokers worldwide and nearly five million
tobacco-related deaths each year.lorillard chemically
Effective
national campaigns
like the truth(R) campaign are essential to give Americans needed information
about the health effects, addictive nature and social costs of tobacco use.California's 15-Year-Old
Tobacco Control Program Keeps Promise to California Voters; New Data Confirm Aggressive Program Works
nabi.tobacco proportion
Just this past February, a host of public health and other leaders across
the country
filed friend of the court briefs on behalf of the Foundation --
supporting our position in this case
, and our important work on behalf of
America's children.
The American Legacy Foundation
(R) is dedicated to building a world where
young people reject tobacco and anyone can quit.C.businesswire
.cgi?eid=4807323
SACRAMENTO, Calif., Ph.
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 panel is comprised of scientific and clinical experts in
smoking cessation.
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.nabi.thirds hooked
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