Pfizer Canada announced today that it has
received Health Canada approval for Revatio(TM) (sildenafil citrate), an
important new treatment for pulmonary arterial hypertension (PAH), a rare and
incurable vascular disease. Sildenafil citrate is also the active ingredient
in Viagra(R), Pfizer's revolutionary treatment for erectile dysfunction, which
has been used by more than 27 million men worldwide since it was first
introduced in 1998.
    PAH is characterized by dangerously high blood pressure in the vessels
that lead from the heart to the lungs. Symptoms include difficulty breathing,
dizziness and fatigue. Left untreated, patients have an average survival time
of less than three years from the time of diagnosis. The disease occurs on its
own (primary pulmonary arterial hypertension) or may be associated with other
diseases including scleroderma, congenital heart disease and HIV (secondary
pulmonary arterial hypertension).
    It is estimated that fewer than 100,000 people worldwide and
approximately 650 people in Canada - most of them women between the ages of 20
and 40 - suffer from PAH.
    Revatio is a significant advance in the treatment of PAH as there are few
effective options currently available and it is the only therapy approved to
treat an earlier stage of the disease (Class II PAH). Patients with Class II
PAH are defined as having mild limitation of physical activity and treating
them early improves quality of life and significantly delays the progression
to later stages of the disease, which are characterized by much more severe
limitations on physical activity to the point where patients are unable to
perform routine tasks without experiencing fatigue and chest pain.
    "The major benefits of Revatio really relate to its high level of
effectiveness and low level of side effects," explains Dr. Robert Levy,
Professor, Department of Medicine, University of British Columbia. "By
effectiveness, we are referring to a decrease in a patient's symptoms,
improving his or her exercise capacity and decreasing the strain on the
heart."

    Clinical Studies Show Revatio Helps Relax Pulmonary Vessels
    -----------------------------------------------------------
    Revatio has a unique mode of action that works differently than other
approved PAH therapies. By inhibiting the enzyme phosphodiesterase (PDE)
type 5, Revatio helps to relax the pulmonary vessels and improve blood flow.
    During six years of global clinical studies Revatio has been shown to
reduce mean pulmonary arterial pressure and improve exercise capacity and
cardiac function. A large randomized, double-blind, placebo-controlled study
involving 277 patients with PAH published in the New England Journal of
Medicine in November 2005 measured the exercise capability of patients after
12 weeks of treatment. Patients were randomized to receive Revatio 20 mg,
40 mg, or 80 mg three times a day or placebo.
    All three treatment groups showed highly significant improvements in the
six-minute walk distance, the standard measure of efficacy in PAH trials,
compared to patients who received placebo. No differences were observed among
the Revatio doses studied - therefore, the approved dosage is 20 mg three
times daily.
    "Pfizer is committed to researching and developing new treatments to
address unmet medical needs, including rare disorders that affect small
numbers of patients," said Dr. Bernard Prigent, Vice President and Medical
Director, Pfizer Canada Inc. "Revatio is an important new treatment option for
a disease where patients have few alternatives."
    Pfizer Canada has developed the Revatio Reimbursement Support Program
(RRSP), a comprehensive program for those needing Revatio. The program is
designed to simplify the insurance and reimbursement process, and provide
access to Revatio for uninsured or underinsured patients. Patients can learn
more about Pfizer's program by calling 1-866-424-8051.
    Revatio was generally well tolerated at all doses. The most common side
effects were headache, upset stomach, facial flushing, back and limb pain,
diarrhea and epistaxis (nosebleeds). The use of Revatio and organic nitrates
in any form, at any time, is contraindicated.
    Revatio is currently available in Canadian pharmacies in a round white
20 mg pill to distinguish it from Viagra's blue diamond-shaped pill for
erectile dysfunction. Revatio was approved in Europe and the United States in
2005.

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