Studies Demonstrate Gardasil® Has Long Duration of Protection From HPV Disease

Lyon, France (ots/PRNewswire) -

Data represents the largest follow-up available for an HPV vaccine

Data from two large, long term follow-up studies continue to show
that vaccination with Gardasil offers a long duration of protection
from human papillomavirus (HPV) diseases related to HPV types 6, 11,
16 and 18. HPV-related diseases include cervical cancer and genital
warts.

The interim data, presented at the 28th International
Papillomavirus Conference (IPV) in Puerto Rico, showed that young
women[1] and adolescent girls and boys[2] vaccinated with Gardasil
were protected from HPV-related diseases for up to eight years
following vaccination. Furthermore, data on immunogenicity[3] (the
degree to which an immune response is induced) showed that immune
levels remained high for nine years following vaccination.

"These latest data show an encouraging trend of continued
protection with Gardasil against HPV-related cervical, vaginal and
vulvar disease in women through eight years," said Professor Susanne
Krueger Kjaer, Danish Cancer Society. "These studies provide further
evidence for the ongoing efficacy, immunogenicity, and safety of
Gardasil."

The European studies were conducted in Sweden, Denmark, Norway and
Iceland. One study followed young women aged between 16-23 years and
the second study followed adolescent boys and girls between 9-15
years. The studies will continue tracking the study participants for
at least 14 years.

Benoit Soubeyrand, Executive Director, Medical Affairs for Sanofi
Pasteur MSD, stated: "These data tell us that Gardasil can in effect
help protect people from HPV diseases during the entire period when
they are most at risk - from adolescence into early adulthood. That's
nearly a decade of protection that could save many lives over time."

More than 100 million doses of Gardasil(R) have been distributed
worldwide since 2006.

Notes to Editors

About the studies

The Scandinavian study[1] among young women is an extension of the
pivotal Phase III FUTURE II clinical trial of Gardasil. The study is
being conducted through the national health registry systems in four
Nordic countries: Denmark, Iceland, Norway and Sweden. Because of the
extensive nationwide registers in these countries, it is possible to
conduct follow-up studies that can track the health of the study
participants well into the future, beyond the original study's
timeframe. The Long Term Follow-Up (LTFU) study evaluated
effectiveness against the early stages of cervical cancer, vulvar
cancer and vaginal cancer related to HPV types 6/11/16/18. Data from
this Scandinavian study showed a trend of continued protection, with
no breakthrough cases of disease, through eight years. Analysis and
observation of the study participants will be followed for 10 years,
for a total of 14 years post vaccination.

The study among adolescent girls and boys[2] aged 10-15 years
followed a randomized, double-blind trial of 1,781 participants.
Safety, immunogenicity and effectiveness of Gardasil were assessed
following vaccination in this population as they got older and as
some became sexually active. Results also showed persistence of high
immune response to HPV types 6, 11, 16 or 18 over 8 years in study
participants. In this follow up period there were no cases of disease
related to vaccine HPV types 6, 11, 16 or 18 through 8 years. This
study will continue to follow participants through at least 10 years
of post-vaccination follow-up.

References:

1) Krueger Kjaer S et al. Long-term effectiveness of Gardasil(TM) in the
Nordic countries. Poster and abstract presented at the 28th International
Papillomavirus Conference, Puerto Rico, Nov 30- Dec 6 2012.
2) Saah A et al. Long-term extension study of Gardasil in adolescents; results
through month 96. Poster and abstract presented at the 28th International
Papillomavirus Conference, Puerto Rico, Nov 30- Dec 6 2012.
3) Nygard M et al. A long term follow-up study of the immunogenicity of the
quadrivalent HPV (qHPV) vaccine in Scandinavia and Iceland. Poster and abstract
presented at the 28th International Papillomavirus Conference, Puerto Rico, Nov 30-
Dec 6 2012.

About Sanofi Pasteur MSD

Sanofi Pasteur MSD is a joint venture between Sanofi Pasteur, the
vaccine division of Sanofi, and Merck, known as MSD outside the USA
and Canada. Combining innovation and expertise, Sanofi Pasteur MSD is
the only company in Europe dedicated exclusively to vaccines. Sanofi
Pasteur MSD is able to draw on the research expertise of Sanofi
Pasteur and Merck to focus on the development of new vaccines for
Europe to improve the acceptability, efficacy and tolerability of
vaccination.

For further information please contact:

Caroline ASHE
Senior Director External Communications Europe
Sanofi Pasteur MSD
Tel : +33-4-37-28-4040
Mob : +33-6-33-46-1365
CAshe@spmsd.com

ots Originaltext: Sanofi Pasteur MSD GmbH
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