Health Canada grants priority review status to Pfizer's maraviroc, a new treatment approach for HIV



    If approved, maraviroc will be the first new oral treatment for the
    management of HIV in more than a decade
    - - -
    Announcement comes as new clinical results demonstrate that maraviroc
    significantly reduces viral load in treatment-experienced patients
    - - -
    Expanded Access Program will provide Canadian patients access to
    experimental medicine which tackles HIV in an entirely new way

    KIRKLAND, QC, March 1 /CNW/ - Earlier this week, Health Canada granted
priority review for maraviroc, an oral medicine that blocks viral entry to
human cells. Rather than fighting HIV inside white blood cells, maraviroc
prevents the virus from entering uninfected cells by blocking its primary
route of entry, the CCR5 co-receptor. If approved, maraviroc would be the
first new class of oral HIV medicines in more than a decade, helping meet the
urgent need of patients living with HIV/AIDS.
    Priority reviews are granted to potential medicines that, if approved,
would represent an improved overall risk/benefit profile for a disease or
condition not adequately managed by a medicine marketed in Canada. "We are
extremely satisfied with Health Canada's decision to grant priority review to
maraviroc" said Dr. Bernard Prigent, Vice-President & Medical Director at
Pfizer Canada. "We expect that CCR5 antagonists will quickly become a
critically important treatment option for Canadian patients resistant to, or
intolerant of their current therapies" added Prigent.
    The Health Canada priority review decision comes as a pivotal maraviroc
trial was presented this week at the 14th Conference on Retroviruses and
Opportunistic Infections (CROI), one of the world's largest HIV/AIDS research
meetings. It showed that approximately twice as many patients receiving
maraviroc in addition to standard treatment achieved undetectable virus in the
blood than if only the optimized regimen were given. "Data from the studies
are remarkably consistent and demonstrate significant decreases in viral load
and increases in CD4 cells when maraviroc is added to the standard treatment,"
said Dr. Benoit Trottier, MD, medical research director of Clinique médicale
l'Actuel and maraviroc clinical trial investigator.
    In December 2006, Pfizer Inc announced plans to establish a multinational
Expanded Access Program (EAP), a clinical study protocol that provides
maraviroc to patients who have limited or no approved treatment options
because of resistance to, or intolerance of existing therapies. Health Canada
has recently approved the EAP, which will begin enrolling Canadian patients in
the next few weeks. In total, 21 centres from 11 cities will take part in this
innovative protocol. The EAP will be available until marketing approval and
reimbursement have been obtained.

    About Pfizer

    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. 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.




For further information:

For further information: Teresa Pavlin, Fleishman-Hillard Canada Inc.,
(416) 214-0701; Sylvie Tessier, Pfizer Canada Inc., 1-866-973-4937


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