* First new prescription treatment approved for smoking cessation in nearly
           a decade, received priority review designation by FDA
 * Addiction to nicotine is a chronic medical condition that makes quitting
    smoking difficult; Chantix is a breakthrough treatment specifically
  developed to block nicotine's effect in the brain * Chantix (1 mg twice
  daily) nearly doubles the likelihood of quitting versus Zyban(R) (150 mg
       twice daily) and nearly quadruples the likelihood over placebo

    NEW YORK, May 11 /PRNewswire-FirstCall/ -- Pfizer Inc said today that
the U.S. Food and Drug Administration (FDA) has approved Pfizer's
anti-smoking pill, Chantix(TM) (varenicline). Chantix, the first new
prescription medication approved for smoking cessation in nearly a decade,
received priority review designation by the FDA because of its potential to
be a significant therapeutic advance over existing therapies.
    Addiction to nicotine is a habit that is very difficult for many
smokers to quit. When smokers inhale smoke from a cigarette, nicotine
reaches the brain within seconds and binds to nicotinic receptors, which
activates the reward pathway in brain circuitry. This stimulates the
pleasure center in the brain. The initial effects recede quickly and a
cycle of craving and withdrawal takes hold.
    Chantix is unique because it is specifically designed to partially
activate the nicotinic receptor and reduce the severity of the smoker's
craving and the withdrawal symptoms from nicotine. Moreover, if a person
smokes a cigarette while receiving treatment, Chantix has the potential to
diminish the sense of satisfaction associated with smoking. This may help
to prevent the cycle of nicotine addiction.
    "I tried to quit smoking so many times but could not until Chantix,"
said Joe Maloof, a former smoker and Chantix clinical trial participant.
"The cravings went down and I finally stopped."
    "Pfizer's discovery and development of Chantix demonstrates
groundbreaking science leading to the first prescription treatment aimed
directly at smoking cessation in nearly a decade," said Hank McKinnell,
chairman and chief executive officer of Pfizer. "Smoking harms nearly every
organ in the body. It is responsible for approximately one in five deaths
in the U.S. and costs the U.S. health care system about $167 billion
annually. This medical advance from Pfizer will now help many smokers end
their addiction."
    Chantix is the fourth new Pfizer medicine to receive FDA approval in
2006.
    The other medicines approved are Exubera for diabetes, Eraxis for the
treatment of candidemia infections, and Sutent for the treatment of
advanced kidney cancer and gastrointestinal stromal tumors.
    Chantix's approval was based on a comprehensive clinical trial program
including four pivotal trials involving more than 2,000 cigarette smokers.
Subjects on average had smoked about 21 cigarettes per day for an average
of approximately 25 years. In two identically designed studies, patients
receiving a 12-week course of Chantix therapy (1 mg twice daily) nearly
quadrupled the likelihood of quitting than those taking placebo and had
nearly twice the likelihood of quitting than those patients taking
buproprion (150 mg twice daily), after the 12-week course of therapy.
Enrolled patients were provided with educational materials. Patients were
followed for an additional 40 weeks without treatment. After one year,
approximately one-in-five patients who received the 12-week course of
Chantix remained smoke-free. For those patients who quit at the end of 12
weeks, an additional course of 12 weeks treatment with Chantix resulted in
a greater likelihood of long-term success in quitting smoking.
    "These results suggest Chantix is a significant advancement," said Dr.
Cheryl Oncken, a Chantix clinical investigator and associate professor of
Medicine at the University of Connecticut Health Center. "It is never too
late to quit smoking. People who quit smoking before the age of 50 have
one- half the risk of dying of a smoking-related illness in the next 15
years compared to those who continue smoking. Patients who are unable to
quit on their own should consider seeking medical support and treatment."
    In trials, Chantix was generally well tolerated, with overall
discontinuation rates similar to placebo. The most common side effects
included nausea, changes in dreaming, constipation, gas and vomiting.
    Pfizer's Commitment to Smoking Cessation
    "As everyone knows, it is extremely difficult to quit smoking," said
Karen Katen, Pfizer vice chairman and president of Pfizer Human Health.
"For example, less than 7 percent of smokers who try to quit on their own
achieve more than one year of abstinence. In fact, most smokers begin
smoking again within a few days of attempting to quit. It takes about 10
attempts -- with or without treatment -- before the average smoker is able
to quit."
    Because smokers need considerable support to successfully quit, Chantix
will be available to patients with a support program designed to help
address behavioral components of smoking dependence. This personalized
program will be free and easy to use.
    "Chantix is an excellent example of Pfizer's focus on combating the
human and economic cost of disease through prevention and wellness based on
scientific innovation and patient support initiatives," said Ms. Katen.
    In November 2005, Pfizer submitted a European marketing authorization
application for varenicline for smoking cessation.
    Patients and health care providers can visit http://www.chantix.com or call
1-877-CHANTIX and register to receive more information about Chantix.
    To preview and request free broadcast-standard video about this
announcement digitally or by tape please log onto
http://www.thenewsmarket.com/pfizer.
    Zyban is a registered trademark of Glaxo Group Limited.
    DISCLOSURE NOTICE: The information contained in this release is as of
May 11, 2006. The Company assumes no obligation to update any
forward-looking statements contained in this release as a result of new
information or future events or developments.
    This release contains forward-looking information about Chantix that
involves substantial risks and uncertainties. A description of these risks
and uncertainties can be found in the Company's Annual Report on Form 10-K
for the fiscal year ended December 31, 2005 and in its reports on Forms
10-Q and 8-K.

Link to this page:

  

http://www.prnewswire.com/comp/688250.html/
CONTACT:
Shreya Prudlo of Pfizer Inc, +1-212-733-4889

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