Health Canada Approves Novel Treatment for HIV



    CELSENTRI(TM) (maraviroc) Tablets Available, First in a New Class of
    Oral HIV Medicines in More than a Decade

    KIRKLAND, QC, Oct. 15 /CNW/ - CELSENTRI (maraviroc) tablets, the first in
a new class of oral HIV medicines in more than 10 years, is now approved and
available in Canada. CELSENTRI blocks entry of HIV into T cells (CD4+ white
blood cells), significantly reducing the level of HIV in treatment-experienced
patients.
    "There is an important need for new medicines to help the many Canadians
living with HIV/AIDS who are running out of effective medications to control
the virus," said Dr. Sharon Walmsley, MSc, FRCPC, Department of Medicine,
University of Toronto. "The approval of maraviroc is a significant
breakthrough in that it provides a new class that blocks an early step in the
viral life cycle that can be used for people with HIV who have developed
resistance to our currently available drugs."
    CELSENTRI is the first in a class of drugs known as CCR5 antagonists,
which block the CCR5 co-receptor, the virus' main entry route into the body's
immune cells or CD4+ cells. CELSENTRI stops the CCR5-tropic HIV-1, which is
also known as "R5 virus" on the surface of the cell before it enters, rather
than fighting the virus inside the cell as do all other classes of oral HIV
medicines. A tropism test confirms that a patient is infected with R5 virus.
    Earlier this year, Health Canada granted CELSENTRI priority review
status. Priority reviews are granted to medicines that would represent an
improved overall risk/benefit profile for a disease or condition not
adequately managed by a medicine currently available in Canada.
    "The approval of CELSENTRI is a Pfizer research and development success
story," said Dr. Bernard Prigent, Vice President & Medical Director, Pfizer
Canada. "Our hope is that CELSENTRI will offer a much needed new option to
many people living with HIV in Canada."

    CELSENTRI - A Unique Development Story

    The development of CELSENTRI goes back to 1996 when a group of people
infected with HIV were found to have a gene mutation that left them immune to
the disease. The virus was not able to enter their immune cells. "We developed
CELSENTRI after observing research around a small group of people who did not
develop symptoms from their HIV. They carried a gene mutation that provided
them with a natural protection against HIV," said Dr. Manos Perros, Executive
Director, Head of Antiviral Research, Pfizer Global Research and Development.
"CELSENTRI was developed by Pfizer scientists to mimic this gene defect in
order to provide similar protection against the virus."

    Clinical Data Support

    Health Canada approval of CELSENTRI is based on six-month data from the
ongoing double-blind, placebo controlled clinical trials, MOTIVATE 1 & 2. In
the MOTIVATE trials, approximately twice as many patients receiving CELSENTRI
combined with an optimized background therapy (OBT) achieved undetectable
viral load at 24 weeks compared with those receiving OBT alone. In the trials,
patients receiving CELSENTRI with OBT also experienced significantly greater
viral load reductions and increases in CD4+ cell counts compared with those
receiving OBT alone.

    Dosing and Administration

    While the recommended dose of CELSENTRI is 300 mg twice a day (BID), this
dose is easily adjusted to account for concomitant medications. CELSENTRI can
be taken with or without food. CELSENTRI must be given in combination with
other antiretroviral medications. For full dosing information, please visit
www.pfizer.ca.

    Pfizer's Ongoing Commitment to HIV/AIDS

    Pfizer established a multi-national expanded access program (EAP), which
was announced earlier this year in Canada. This program provides CELSENTRI in
countries where it is not yet commercially available to patients who have
limited treatment options due to resistance or intolerance to existing
therapies. For the first time in Canada, this program offering access to the
drug on a compassionate basis will continue for a limited time allowing
patients early access to CELSENTRI until provincial reimbursement programs are
determined.
    Canadian patients will also continue to have access to CELSENTRI through
Pfizer Canada's FIRST RE

SOURCE(R) program which is designed to assist patients who have private insurance maximize their benefit coverage for medications. 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 Pfizer's products, partnerships, pipeline and philanthropy. Current initiatives include: construction and funding of the Infectious Disease Institute in Kampala, Uganda; the Pfizer Global Health Fellows Program; the Diflucan(R) Partnership Program; and the U.S. Southern States HIV/AIDS Prevention Initiative. About Pfizer Pfizer Canada Inc. is the Canadian operation of Pfizer Inc, the world's leading pharmaceutical company. Pfizer discovers, develops, manufactures and markets prescription medicines for humans and animals. Pfizer Inc invests more than US$7 Billion annually in R&D to discover and develop life-saving and life-enhancing medicines. Canadian headquarters of Pfizer Global Pharmaceuticals are in Kirkland, Quebec. For more information, visit www.pfizer.ca. The following B-Roll is available at the listed times and co ordinates: DATE OF FEED: Monday, October 15, 2007 TIME OF FEED: 10:00 - 10:30 am ET 2:00 - 2:30 pm ET CO ORDINATES: Anik F2 C Transponder 7B Audio subcarrier 6.2 and 6.8 Downlink frequency 3980 vertical TOC CFA TX 1 On-Demand Coordinates / URL available from 10:00 a.m. ET onwards, Monday, October 15th 2007 http://cnw.pondeserver.com/story_details.asp?fn=143

For further information:

For further information: Teresa Pavlin, Fleishman-Hillard Canada Inc.,
(416) 214-0701; Julie-Catherine Racine, Pfizer Canada, (514) 693-4602


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