Pfizer Japan to Launch Champix(R) the First Prescription Oral Smoking Cessation Aid in Japan



    Inhibits A Sense Of Satisfaction Associated With Smoking And Relieves Tobacco Craving

    Pfizer Inc announced today that on May 8, 2008, it will launch
    Champix(R) Tablet 0.5mg/1mg (varenicline tartrate), a novel smoking
    cessation aid for smokers with nicotine dependence in Japan, which has
    one of the highest rates of smoking among developed nations.

    Champix was developed as the first non-nicotine drug designed for
    smoking cessation in the United States and will be the first oral
    smoking cessation aid available in Japan. The currently available
    smoking cessation aids such as ´Nicotine Replacement Therapy´ (NRT)
    relieve withdrawal symptoms associated with smoking cessation by
    replacing tobacco use through delivering nicotine. In contrast

    Champix brings about a smoking cessation effect through a new
    mechanism of action which works by selectively targeting the
    alpha4beta2 nicotine receptors in the brain to reduce both craving and
    withdrawal symptoms and reduce the pleasure associated with smoking.

    Champix reduces withdrawal symptoms and tobacco craving associated
    with smoking cessation by acting on the same receptor in the brain as
    nicotine (the alpha4beta2 nicotine receptor) but with higher affinity.
    Champix partially stimulates the receptor and triggers a reduced
    dopamine response, which helps to relieve the craving and withdrawal
    symptoms associated with stopping smoking. At the same time, Champix
    prevents nicotine from binding at the receptor, so if a smoker slips
    and smokes a cigarette, Champix reduces the reward and sense of
    pleasure associated with smoking.

    "Pfizer is delighted to be able to provide patients and physicians
    in Japan with Champix, a breakthrough medicine for smoking cessation
    that has helped millions of smokers who want to quit," said Jeff
    Kindler, chairman and chief executive officer of Pfizer. "Furthermore

    we are gratified that health authorities in Japan recognize the
    benefits of therapies such as Champix that address a major unmet
    medical need."

    Champix´s approval in Japan was based on a 12-week, randomized

    double-blind, placebo-controlled study in Japanese smokers who wanted
    to quit smoking. The primary endpoint, the percentage of subjects who
    did not smoke at all during the four consecutive weeks between Week 9
    and Week 12 was 65.4 percent (85/130 cases) in the Champix 1mg
    twice-daily group and 39.5 percent (51/129 cases) in the placebo
    group, a statistically significant difference between the two groups.
    The most common side effects of Champix were nausea, headache, and
    constipation, but most of them were mild.

    As of April 1, 2006, medical service providers under the Japanese
    national health insurance (NHI) system which meet certain registration
    criteria are designated as ´smoking cessation treatment facilities´
    and can fully reimburse the cost of smoking cessation treatments to
    patients with nicotine dependence. In order for a patient to receive
    NHI treatment, he or she must meet certain requirements.

    "Smoking is a chronic, relapsing medical condition and one of the
    leading causes of preventable disease, death and disability in the
    world," said Hiromitsu Iwasaki, president and chief executive officer
    of Pfizer Japan. "Champix represents a major clinical advance for
    smoking cessation which we hope, together with counseling, will help
    patients end their addiction to the nicotine in tobacco."

    With the launch of Champix, Pfizer Japan will introduce a website
    for patients with nicotine dependence called "SUGU KIN-EN (Smoking
    Cessation Now) at www.sugu-kinen.jp" as of May 8, 2008. This website
    provides easy-to-understand guidance on smoking cessation and
    treatment options. The website also offers a list of medical
    institutions that provide smoking cessation treatment throughout
    Japan.

    Japan has one of the highest rates of smoking among developed
    nations, with approximately 26 million smokers. Although many smokers
    want to quit, studies show that withdrawing from nicotine dependence
    using willpower alone is very difficult because smoking is a chronic
    relapsing medical condition that typically involves a physical and
    psychological addiction to nicotine. In light of this information, the
    NHI approved coverage for smoking cessation treatments in April 2006

    thereby enabling patients to receive treatment for nicotine addiction
    by physicians. Approved in more than 60 countries, Champix has been
    used by more than 5 million people around the world. The launch of
    Champix in Japan will bring another medical option for smoking
    cessation treatment, and it will contribute to more effective smoking
    cessation treatment for patients with nicotine dependence.