Broad Access Program for Patients with Limited Available Treatment Options

    NEW YORK, Dec. 1 /PRNewswire-FirstCall/ -- Pfizer announced today that
it plans to establish a multi-national Expanded Access Program (EAP) to
make the investigational CCR5 antagonist maraviroc, currently in ongoing
phase 3 clinical trials, available to HIV/AIDS patients with CCR5-tropic
HIV-1 who have limited or no approved treatment options due to resistance
or intolerance. Pending regulatory review and approvals of the EAP study
protocol, the program will begin enrolling patients in the next few months,
with a target to enroll patients from over 30 countries.
    Maraviroc is in a new class of investigational HIV drugs known as CCR5
antagonists, designed to work differently from currently available HIV/AIDS
antiretroviral medicines. Rather than fighting HIV inside white blood
cells, CCR5 antagonists prevent the virus from entering cells by blocking
its predominant entry route, the CCR5 co-receptor.
    The EAP is designed to provide access to maraviroc for patients who, in
the opinion of the program investigators, need it to create a viable
regimen. "People living with HIV whose virus is resistant to available
therapies have an urgent need for novel medicines," said John LaMattina,
president, Pfizer Global Research and Development. "It is our hope that
maraviroc, now in final stages of clinical development, may help those
patients who have exhausted treatment options and are not already
participating in our clinical studies."
    Pfizer confirmed plans to submit applications for marketing approval in
both the U.S. and EU following review of the data from the two Phase 3
maraviroc registrational trials. These are 24-week studies of Optimized
Background Therapy (OBT), with or without maraviroc, in highly treatment
experienced patients with CCR5-tropic HIV-1. Pfizer will submit these
results expeditiously for presentation at an upcoming HIV conference.
    To broaden the program's reach, Pfizer is recruiting many investigators
with previous EAP experience as well as HIV clinical experts at centers
which have not previously engaged in expanded access initiatives. Study
patients will receive open-label maraviroc twice daily in addition to OBT.
In some circumstances, the study allows the use of OBT that may contain
other investigational antiretroviral agents in Phase 3 clinical
development.
    Health care professionals interested in enrollment should contact their
local Pfizer office.
    Maraviroc Expanded Access Study Design
    Investigators will follow patients in the EAP according to their local
standard of care. The study will continue in each country until marketing
approval and reimbursement is obtained in that country and the patient can
obtain drug through local commercial distribution channels.
    Pending regulatory review, preliminary program eligibility criteria
include patients who are, clinically stable with documented CCR5- tropic
HIV-1 infection; at least 16 years of age (or minimum adult age as
determined by local regulatory authorities or as legal requirements
dictate); have limited or no treatment options available to them due to
resistance or treatment intolerance; and they must be failing to achieve
adequate virologic suppression on their current regimen. The study cannot
include patients who have failed prior treatment with any CCR5 antagonist
in a clinical trial; have evidence of dual/mixed-tropic or X4-tropic HIV;
require any medications prohibited by the EAP protocol; have a condition
which the study investigator deems will interfere with the patient's
adherence and safety; or who are pregnant or lactating. Investigators will
select the OBT based on the patient's prior treatment history and
antiretroviral resistance testing conducted according to local practice.
Pfizer will not provide OBT. Pfizer will monitor safety and tolerability of
maraviroc throughout the course of the study.

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CONTACT:
Kate Robins, +1-860-732-9684, or Joel Morris,
+44-1304-648922, both of Pfizer

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