Gardasil(R) may offer additional protection against 10 extra cancer-causing HPV types


    - First study to meet WHO efficacy standards for cross-protection

    MONTREAL, Oct. 5 /CNW Telbec/ - Gardasil(R) (Quadrivalent Human
Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine) has been shown to be
up to 100 per cent effective at preventing cervical cancer caused by HPV types
16 and 18, which account for more than 70 per cent of all cases. It is also
the only HPV vaccine effective at preventing most cases of genitals warts. In
a recent study, Gardasil(R) has shown to provide 38 per cent cross-protection
efficacy against 10 additional cancer-causing HPV types that contribute to
approximately 20 per cent of cervical cancer cases around the world. These new
findings are being presented today at the European Research Organization on
Genital Infection and Neoplasia (EUROGIN) Conference in Monte Carlo.
    Cross-protection is a term used to describe the potential impact that a
vaccine designed to protect against certain types of HPV can have on other HPV
not included in the vaccine. The new data presented at EUROGIN measured the
efficacy of the four vaccine HPV types (6, 11, 16 and 18) to provide
cross-protection against 10 additional HPV types (31, 33, 35, 39, 45, 51, 52,
56, 58 and 59). These 10 additional types were chosen because, when pooled
together, they are the largest contributors to cervical cancer in the world,
after HPV types 16 and 18(1).
    "This study examining the impact of an HPV vaccine on cervical disease
caused by HPV types not found in the vaccine shows true cross-protection,"
said Dr. Michel Roy, a gynaecologic oncologist at the Hôtel-Dieu de Québec
Hospital and Professor of Gynaecology at the University of Laval. "This
promising new data shows that the vaccine provides cross-protection against 10
cancer-causing types not found in the vaccine, indicating a potential extra
benefit to HPV vaccination."

    Cross-protection results based on studies of 17,599 women in 16 countries

    For this cross-protection study, researchers analyzed combined results
from two studies, FUTURE I and FUTURE II, which were phase III, prospective,
double-blind, placebo controlled, randomized studies conducted among 17,599
women ages 16 to 23 in 16 countries. Among generally HPV-naive women,
vaccination with Gardasil resulted in:

    - Reduced incidence of HPV 31- and HPV 45-related CIN(*) 2/3 or AIS(xx)
      by 62 per cent;
    - Reduced incidence of HPV 31-, 33-, 45-, 52-, and 58-related CIN 2/3 or
      AIS by 44 per cent;
    - Reduced incidence of HPV 31-, 33-, 35-, 39-, 45-, 51-, 52-, 56-, 58-,
      59-related CIN 2/3 or AIS by 38 per cent.

    (*)  Abnormal changes in the cells of the cervix that will lead to cancer
         if not treated.
    (xx) Adenocarcinoma in situ, an abnormal proliferation of glands that
         will lead to cancer if not treated.

    HPV vaccine and cervical cancer

    While this new data on the broader protection for cervical cancer are
compelling, it has been demonstrated that Gardasil(R) provides wider-ranging
and earlier benefits than the prevention of cervical cancer alone.
    "Wider benefit because it also helps prevent cervical lesions, vulvar
lesions and genital warts; earlier benefit because cervical lesions and
genital warts occur much faster than cervical cancer, often within only a few
months after exposure to the virus," said Dr. Michel Roy.
    Clinical studies have shown Gardasil to be 96 to 100 per cent effective at
preventing diseases caused by the four HPV types (6, 11, 16 and 18) that
account for more than 90 per cent of genital warts, approximately 70 per cent
of cervical and anogenital cancers and high-grade pre-cancers as well as 35 to
50 per cent of low-grade cervical, vaginal and vulvar lesions. All four types
also cause abnormal Pap test results(2).
    Three in four (75 per cent) sexually active Canadians will have at least
one HPV infection episode in their lifetime(3). HPV infections annually lead
to approximately 400,000 abnormal Pap smear results(4), 85,000 consultations
due to genital warts and 36,000 new cases of genital warts(5), as well as
1,400 cervical cancer diagnoses and 400 cervical cancer deaths(6). HPV is also
linked to other cancers in both men and women, such as cancer of the penis,
anus, vagina and vulva, as well as loss of female fertility(7).

    About Merck Frosst

    At Merck Frosst, patients come first. Merck Frosst Canada Ltd. is a
research-driven pharmaceutical company. Merck Frosst discovers, develops and
markets a broad range of innovative medicines to improve human health. Merck
Frosst is one of the top 20 R&D investors in Canada, with an investment of
$114 million in 2006. The Company is committed to fostering partnerships to
deliver the most valuable health outcomes for Canadian patients. More
information about Merck Frosst is available at

    Forward-Looking Statement

    This press release contains "forward-looking statements" as that term is
defined in the Private Securities Litigation Reform Act of 1995. These
statements are based on management's current expectations and involve risks
and uncertainties, which may cause results to differ materially from those set
forth in the statements. The forward-looking statements may include statements
regarding product development, product potential or financial performance. No
forward-looking statement can be guaranteed, and actual results may differ
materially from those projected. Merck undertakes no obligation to publicly
update any forward-looking statement, whether as a result of new information,
future events, or otherwise. Forward-looking statements in this press release
should be evaluated together with the many uncertainties that affect Merck's
business, particularly those mentioned in the cautionary statements in Item 1
of Merck's Form 10-K for the year ended Dec. 31, 2006, and in its periodic
reports on Form 10-Q and Form 8-K, which the Company incorporates by


SOURCES: ------------------------ (1) Brown, D, HPV Type 6/11/16/18 Vaccine: First Analysis of Cross- Protection against Persistent Infection, Cervical Intraepithelial Neoplasia (CIN), and Adenocarcinoma In Situ (AIS) Caused by Oncogenic HPV Types in Addition to 16/18. Presented at the 47th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Chicago. (2) Efficacy of a Prophylactic Quadrivalent Human Papillomavirus (HPV) (Types 6, 11, 16, 18) L1 Virus-Like Particle (VLP) Vaccine for Prevention of Cervical Dysplasia and External Genital Lesions (EGL). Presented by C. Sattler at the 45th Annual Interscience Conference on Antimicrobial Agents and Chemotherapy (ICAAC) in Washington, DC. (3) Health Canada, It's Your Health HPV Web site. (Accessed at (4) Statement by the Society of Obstetricians and Gynaecologists of Canada (SOGC) on CMAJ Commentary, "Human papillomavirus, vaccines and women's health: questions and cautions". (Accessed on August 14, 2007 at: (5) Brisson, M et al. The health and economic burden of HPV infection, genital warts, cervical dysplasia and cervical cancer in Canada. Presented at the 7th Canadian Immunization Conference (CIC) on December 3, 2006 in Winnipeg. (6) Public Health Agency of Canada, Cervical Cancer Screening in Canada: 1998 Surveillance Report, Executive Summary. (Accessed at: (7) Statement by the Society of Obstetricians and Gynaecologists of Canada (SOGC) on CMAJ Commentary, "Human papillomavirus, vaccines and women's health: questions and cautions". (Accessed on August 14, 2007 at:

For further information:

For further information: Medical expert available for interviews: Elise
Giasson, Public Affairs, Merck Frosst Canada Ltd., (514) 428-3711; Sylvie
Robitaille, NATIONAL - MONTREAL, (514) 843-2354; Sara Sauvé, NATIONAL -
VANCOUVER, (604) 638-7451; Karissa Boley, NATIONAL - CALGARY, (403) 531-0331
ext. 239; Barbara Biggar, WINNIPEG, (204) 883-2699

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