Pfizer Inc. (NYSE:PFE) announced today results from a Phase 4 study evaluating the efficacy and safety of CHANTIX^®/CHAMPIX^® (varenicline) for smoking cessation in nicotine dependent adolescents 12-19 years of age. The study did not meet its primary endpoint of the four-week continuous abstinence rate at weeks 9 through 12 for CHANTIX/CHAMPIX compared to placebo. The study is a regulatory post marketing commitment for CHANTIX/CHAMPIX in the U.S. and EU for adolescents 12-16 years and 12-17 years of age, respectively.

The adverse event profile of CHANTIX/CHAMPIX observed in this study of adolescent smokers was similar to that seen in studies of adults. The most common adverse events that occurred in at least 5 percent of patients were nausea, headache, vomiting, agitation, and abnormal dreams (high dose group); and nausea, dizziness, agitation, abnormal dreams, and upper respiratory tract infection (low dose group).

This randomized, double-blind, placebo-controlled, parallel-group, dose-ranging multicenter study examined the safety and efficacy of varenicline, along with age-appropriate counseling, for smoking cessation in nicotine dependent adolescents (n=312). Patients were stratified into two cohorts by body weight (≤55 kg and >55 kg). Following two-week titration, patients randomized to varenicline with a body weight >55 kg received varenicline 1 mg twice daily (high dose group) or 0.5 mg twice daily (low dose group), while patients with a body weight ≤55 kg received 0.5 mg twice daily (high dose group) or 0.5 mg once daily (low dose group). Patients received treatment for 12 weeks, followed by a non-treatment period of 40 weeks. The study was not powered to assess efficacy in adolescent smokers aged 17-19 and in this group conclusions cannot be drawn.

CHANTIX^® (also known as CHAMPIX^® in the EU and other countries) was approved by the FDA in May 2006 as a prescription medication that, along with support, helps adults aged 18 and over stop smoking. CHANTIX is approved in more than 100 countries for adults aged 18 and over and has been prescribed to more than 24 million patients worldwide.

Some people have had new or worse mental health problems, such as changes in behavior or thinking, aggression, hostility, agitation, depressed mood, or suicidal thoughts or actions while taking or after stopping CHANTIX. These symptoms happened more often in people who had a history of mental health problems. Patients should stop taking CHANTIX and call their healthcare provider right away if they, their family, or caregiver notice any of these symptoms. Before starting CHANTIX, patients should tell their healthcare provider if they ever had depression or other mental health problems.

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This release contains forward-looking information about CHANTIX/CHAMPIX (varenicline), including its potential benefits, that involves substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. Risks and uncertainties include, among other things, uncertainties regarding the commercial impact of the Phase 4 study; the risk that clinical trial data are subject to differing interpretations, including by regulatory authorities; the uncertainties inherent in research and development; decisions by regulatory authorities regarding labeling and other matters that could affect the availability or commercial potential of CHANTIX/CHAMPIX; uncertainties regarding whether Chantix will be granted pediatric exclusivity in the U.S.; and competitive developments.

A further description of risks and uncertainties can be found in Pfizer's Annual Report on Form 10-K for the fiscal year ended December 31, 2017, including in the sections thereof captioned "Risk Factors" and "Forward-Looking Information and Factors That May Affect Future Results", as well as in its subsequent reports on Form 10-Q and Form 8-K, all of which are filed with the U.S. Securities and Exchange Commission and available at www.sec.gov and www.pfizer.com.