MONTREAL, May 17 /CNW Telbec/ - Results published today in The Lancet on
more than 18,000 women reveal that the HPV vaccine Gardasil(TM) (Quadrivalent
Human Papillomavirus (Types 6, 11, 16, 18) Recombinant Vaccine) provided 100
per cent protection against vulvar and vaginal disease caused by the four
vaccine HPV types among women who were not already infected with any of these
four strains. Results were sustained throughout the trial and represent three
years of follow-up, an additional year on the data presented to Health Canada
for the approval of Gardasil(TM).
"Treatment of vulvar cancer often entails mutilating surgery of the
genitals with negative impacts on personal image and sexual life. We have a
hard time talking about this cancer because the consequences are so dire,"
said Dr. Marc Steben, a Canadian clinical study investigator, family practice
physician and an author of this new publication. "We know the four HPV types
in the vaccine do not cause all cases of vulvar and vaginal cancer,
nonetheless, our study shows that the HPV vaccine has the potential to reduce
the burden of these cancers, and unlike cervical cancer, no screening programs
currently exist."
On average, 436 Canadian women are newly diagnosed with vulvar or vaginal
cancer each year(1), and approximately 128 women die from their disease(2).
HPV is responsible for roughly 80 percent of these cases(3). Vulvar and
vaginal cancers, specifically those related to HPV infection, are becoming
more common in young women. Although tumours in the vulva occur two to three
times more frequently as those in the vagina, they are still a rare finding.
Nevertheless, Canada has among the highest reported rates of vulvar cancer
worldwide(4). In the USA the incidence of vulvar cancers increased more than
400 percent between 1973 and 2000, and invasive vulvar cancer increased
20 percent during the same time period(5).
Gardasil(TM) was approved by Health Canada in July 2006. The vaccine is
indicated for females between nine and 26 years of age for the prevention of
cervical cancer, vulvar cancer, vaginal cancer, precancerous lesions at these
sites and genital warts caused by HPV 6, 11, 16 and 18. These four HPV types
cause the most disease, including most cases of cervical cancer and genital
warts. HPV types 16 and 18 account for 70 per cent of cervical cancer cases
and types 6 and 11 cause about 90 per cent of cases of genital warts, and all
four types cause a large number of "abnormal" Pap test results and low-grade
cervical lesions.
In January 2007, the National Advisory Committee on Immunization (NACI)
recommended that all Canadian girls and women aged 9 to 26 should be routinely
vaccinated. Because of the importance of preventing HPV diseases, the federal
government recently made available $300 million to the provinces and
territories to support the launch of HPV vaccination programs.
Conclusive results for women not already infected with vaccine HPV types
In the combined analysis Gardasil(TM) provided 100 percent protection
from HPV 16- and 18-related high-grade vulval intraepithelial neoplasia (VIN
2/3) and vaginal intraepithelial neoplasia (VaIN 2/3) in women who were not
exposed to the relevant HPV types throughout the duration of the study; no
cases were observed in the vaccine group (n=7,811) compared to 15 cases in the
placebo group (n=7,785).
The studies used for this analysis combine findings from one phase 2
study and two phase 3 studies (Protocol 007, (FUTURE I) Protocol 013, (FUTURE
II) Protocol 015). All three studies-conducted at 157 sites in 24
countries-were double-blind, placebo-controlled and randomized. More than
18,000 women participated in the three trials and were between the ages of 16
to 26 at the time of enrolment. They received three doses of either
Gardasil(TM) or placebo at day one, month two and month six. The combined
analysis evaluated the impact of Gardasil(TM) on the incidence of high-grade
vulvar and vaginal pre-cancers (VIN 2/3 and VaIN 2/3), common precursors to
vulvar and vaginal cancers, caused by HPV types 16 and 18.
Impact of Gardasil(TM) in women already infected with HPV types targeted
by the vaccine
This study also assessed the efficacy of Gardasil(TM) in a broader
population, including those who had HPV 6-, 11-, 16- or 18-related infection
or disease at study initiation. In this group, Gardasill(TM) reduced the
incidence of HPV 16- or 18- related VIN 2-3 or VaIN 2-3 by 71 percent; 9 cases
were observed in the vaccine group (n=9,087); 31 cases were observed in the
placebo group (n=9,087). In eight of the nine vaccine cases and two of the
placebo cases, individuals were infected with HPV 16 or 18 prior to receiving
the first dose(6). There were also five cases of VIN 2/3 or VaIN 2/3 in the
placebo group that were associated with HPV type 6 and not associated with
type 16 or 18. None were associated with HPV type 11(7).
In all three studies used in the analysis, the adverse events observed
were similar to what has been previously reported.
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 20 R&D investors in Canada, with an investment
of $114 million in 2006. More information about Merck Frosst is available at
http://www.merckfrosst.com.
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, 2005, and in its periodic
reports on Form 10-Q and Form 8-K, which the Company incorporates by
reference.
GARDASIL(TM) is a Trademark of Merck & Co., Inc. Used under license.
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(1) Statistics Canada Incidence of cancer of the vagina and vulva,
Canada (C51.0-C51.9, C52.9). Health Statistics Division, Canadian
Cancer Registry.
(2) Statistics Canada/ CANSIM table 102-0522. Deaths, by cause,
Chapter II: Neoplasms (C00 to D48), age group and sex, Canada,
2000-2003
(3) http://www.healthfinder.gov/news/newsstory.asp?docID=533105
(4) Woman's Health Surveillance Report. Published September 30, 2003.
(Accessed at
http://www.cihi.ca/cihiweb/dispPage.jsp?cw_page=PG_29_E&cw_topic=29&cw_rel=AR_
342_E)
(5) Lancet, p. 1693
(6) Lancet, p. 1698
(7) Lancet, p. 1697
For further information: Sheila Murphy, (514) 428-2748; Elise Giasson,
(514) 428-3711; Merck Frosst Canada Ltd.
