Study shows HPV-16 vaccine demonstrated more than 8 years of protection against disease


    Other study shows GARDASIL(R) significantly reduced abnormal Pap tests
    and follow-up procedures

    KIRKLAND, QC, May 8 /CNW Telbec/ - The monovalent human papillomavirus
(HPV) type 16 L1 virus-like particle (VLP) vaccine demonstrated efficacy
against HPV-16 infection for an average of 8.5 years in a Phase II extension
follow-up study, according to data presented at the 25th Annual International
Papillomavirus Conference in Malmö, Sweden. The monovalent vaccine is a
component of GARDASIL(R) (Quadrivalent Human Papillomavirus (Types 6, 11, 16,
18) Recombinant Vaccine).
    "Canadian physicians are frequently asked about the long-term efficacy of
the HPV vaccine. I am therefore encouraged by these results for the HPV-16
vaccine showing more than eight years of protection against the major cervical
cancer causing HPV type," said Marc Steben, Canadian physician and HPV vaccine
    In another study in women who were naive to 14 common HPV types,
GARDASIL(R) reduced the number of abnormal Pap test results by 17 to 45 per
cent, depending on the abnormality, and reduced colposcopies by 20 per cent,
cervical biopsies by 22 per cent as well as surgery and other invasive
treatments by 42 per cent.
    "Every year in Canada, there are approximately 400,000 abnormal Pap
tests, which lead to thousands of other resource-intensive procedures such as
colposcopies and cervical biopsies," said James A. Mansi, Regional Director,
Medical Affairs, Vaccines, Merck Frosst Canada. "Abnormal Pap tests and
treatment of precancerous cervical lesions have been calculated to cost
Canadians close to $300 million a year."
    "When I tell patients that their Pap tests are abnormal, not only do they
have to deal with this immediate stressful reality but also with further tests
and treatments that can be equally or more stressful," said Marc Steben.
"Abnormal Pap tests and the necessary follow-up procedures have a real human
cost that should not be underestimated."
    GARDASIL(R) is currently indicated for use in girls and young women 9
through 26 years of age for the prevention of cervical cancer, vulvar cancer,
vaginal cancer, their precancerous lesions and genital warts caused by HPV
types 6, 11, 16 and 18.

    Efficacy of the Prophylactic Human Papillomavirus (HPV) type 16 L1
    Virus-like Particle (VLP) Vaccine

    The HPV 16 VLP vaccine, a component of GARDASIL(R), remained effective
against HPV-16 infection and associated precancerous lesions an average of 8.5
and up to 9.5 years after administration, as demonstrated in a follow-up study
of 290 women from a randomized, placebo-controlled clinical trial.
    These women had participated in a Phase IIb randomized-controlled trial
of the prophylactic HPV-16 L1 VLP vaccine between November 1998 and January
2004. They were enrolled in an extended follow-up study between March 2006 and
May 2008 to evaluate the vaccine's long-term efficacy.
    During the extended follow-up period, no one in the vaccine group
developed HPV-16 infection (vaccine efficacy = 100 percent; 95 percent
confidence interval (CI): 25 to 100 percent) or HPV-16 associated cervical
intraepithelial neoplasia (CIN) (vaccine efficacy = 100 percent; 95 percent
confidence interval (CI): (less than)0 to 100 percent). In the placebo group,
six women developed HPV-16 infection and three women developed HPV-16
associated CIN during the follow-up period.
    During the combined trial and extended follow-up period, vaccine efficacy
against HPV-16 infection was 96 percent (95 percent CI: 73 to 100 percent) and
100 percent against CIN in the vaccine group (95 percent CI: 47 to 100
percent). In the placebo group, 21 women developed HPV-16 infection and eight
women developed HPV-16 associated CIN.

    Impact of GARDASIL(R) on Abnormal Pap Tests and Procedures

    In two randomized, placebo-controlled, efficacy trials, a total of 17,622
women received either three doses of GARDASIL(R) or placebo over six months.
Pap testing occurred at the start of the study and then at intervals of six to
12 months. An analysis of the reduction of healthcare utilization endpoints
(Pap tests and procedures) was conducted in a population of women who were
naive to 14 common HPV types and had a normal Pap test on day 1. The analysis
evaluated squamous intraepithelial lesions (SIL) which are similar to cervical
intraepithelial neoplasia (CIN) except that CIN is evaluated through a
microscope and SIL is evaluated through further microbiological study of the
    After an average follow-up of 3.6 years, when compared to women receiving
placebo (n=4679), women who received GARDASIL(R) (n=4616) had significant
reductions in the following abnormal Pap test results: atypical squamous cells
of undetermined significance associated with a high risk type of HPV (17 to 22
per cent reduction), low-grade squamous intraepithelial lesion (17 per cent
reduction), atypical squamous cells/cannot exclude high-grade squamous
intraepithelial lesion (36 per cent reduction), and high-grade squamous
intraepithelial lesion (45 per cent reduction).

    The Significant Burden of HPV

    Three in four (75 per cent) sexually active Canadians will have at least
one HPV infection in their lifetime.(1) While most infections will clear on
their own, the burden of genital HPV-related diseases is significant. In
addition to 400,000 abnormal Pap tests, HPV infections in Canada annually lead
to approximately 85,000 consultations due to genital warts and 41,450(2) new
cases of genital warts, as well as 1,400 cervical cancer diagnoses and 400
cervical cancer deaths.(3)
    To consult the April 10 position paper on human papillomavirus by the
World Health Organization, go to:

    About Merck Frosst

    At Merck Frosst, patients come first. Merck Frosst Canada Ltd. is a
research-driven pharmaceutical company discovering, developing and marketing a
broad range of innovative medicines and vaccines to improve human health.
Merck Frosst is one of the top 25 R&D investors in Canada, with an investment
of close to $110 million in 2007. 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

    (R) Trademark of Merck & Co., Inc. Used under license.

    (1) Health Canada, It's Your Health HPV Web site.  (Accessed at
    (2) Twenty Year Trends (1985-2004) in the Incidence and Prevalence of
        Anogenital Warts in Manitoba. 2008 Report to Cancer Care Manitoba.
        p. 37.
    (3) Health Canada Web site. (Accessed at:

For further information:

For further information: Sheila Murphy, Manager, Public Affairs, Merck
Frosst Canada Ltd., (514) 428-2748; Roch Landriault, NATIONAL Public
Relations, (514) 843-2345; Claude Arsenault, NATIONAL Public Relations, (514)

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