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Pfizer's Celsentri(R) Approved in the European Union, Providing a Novel Treatment Option for Treatment-Experienced HIV Patients


    First in a New Oral Class of HIV Medicines in 10 Years

    Pfizer Inc announced today that the European Commission (EC) has
    approved Celsentri(R) (maraviroc). Treatment-experienced HIV patients
    in the EU can soon benefit from the first CCR5 antagonist and only
    oral entry inhibitor. Maraviroc, in combination with other
    antiretroviral medicinal products, is indicated for
    treatment-experienced adult patients infected with only CCR5-tropic
    HIV-1 virus detectable.

    Maraviroc is the first member of a new class of oral HIV medicines
    in more than a decade (CCR5-antagonists). Discovered and developed by
    Pfizer scientists in Sandwich, UK, since 1997, maraviroc works by
    blocking viral entry into human cells. Rather than fighting HIV inside
    white blood cells, maraviroc prevents the virus from entering white
    blood cells by blocking its predominant entry route, the CCR5
    co-receptor.

    "HIV is a significant health concern in Europe and infection rates
    are still increasing. Without new medicines, resistance to current
    treatments is one of the biggest challenges facing HIV care today,"
    said Filippo von Schloesser, president of Italian HIV patient
    organization, Fondazione Nadir Onlus. "The approval of maraviroc will
    offer a new option to many people living with HIV in Europe."

    The EC approval of maraviroc is based on 48-week data from the two
    ongoing double-blind, placebo-controlled MOTIVATE clinical trials. The
    data of the MOTIVATE trials show that:

    -- Maraviroc and optimized background therapy (OBT) provided
    substantially greater viral load reduction compared to
    patients receiving OBT alone.

    -- More than twice as many patients receiving maraviroc plus
    optimized background therapy (OBT) achieved undetectable viral
    load at 48 weeks compared with those receiving OBT alone.

    -- The group receiving maraviroc and OBT in the MOTIVATE trials
    demonstrated significantly greater increases in CD4 white
    cells compared to the group receiving OBT alone.

    -- The rates of most frequently reported adverse reactions
    (diarrhoea, nausea and headache) were similar in patients
    receiving maraviroc and OBT compared with those receiving OBT
    alone.

    -- Patients treated with maraviroc and OBT had low
    discontinuation rates (3.8%) similar to the group receiving
    OBT alone (3.8%).

    "Maraviroc is an important additional treatment option for R5
    tropic treatment-experienced patients in Europe," noted Gerd
    Faetkenheuer, MD, Department of Internal Medicine, University of
    Cologne, Germany. "Although other treatments are currently available,
    maraviroc targets the fight against the HIV virus in a new way."

    Further details and product information will be available in the
    European Public Assessment Report on the web site of the European
    Medicines Agency at www.emea.europa.eu.

    Pfizer's Ongoing Commitment to HIV/AIDS

    Pfizer scientists discovered maraviroc in 1997. Maraviroc's
    clinical program initiated the first combined phase 2b/3 trial design
    in HIV to efficiently characterize its clinical profile and submit
    data to regulatory authorities as quickly as possible. Maraviroc,
    known as Selzentry(TM) in the United States, was approved by the U.S.
    Food and Drug Administration (FDA) on August 6, 2007 and is currently
    available in the U.S.

    In December 2006, Pfizer announced plans to establish a
    multi-national Expanded Access Program, a clinical study that provides
    maraviroc to patients who have limited or no approved treatment
    options due to resistance or intolerance to existing drug classes. The
    program is open for enrollment with a target to enroll patients from
    over 30 countries.

    Pfizer is committed to bringing meaningful improvement to the
    lives of people living with HIV/AIDS and those at risk around the
    world. This commitment is embodied in significant philanthropic
    activities that provide access to life-saving medicines, resources and
    skills to help improve patient care for people throughout the world
    living with HIV/AIDS.

    Current initiatives include the building of the Infectious Disease
    Institute in Kampala, Uganda, the Pfizer Global Health Fellows
    Program, the Diflucan Partnership Program and ConnectHIV, an HIV
    prevention program in the U.S.